−Removed: ITEM 8 – FINANCIAL STATEMENTS AND
−Removed: SUPPLEMENTARY DATA
+Added: ITEM 8 – FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: Report of Independent Registered Public Accounting
+Added: Report of Independent Registered Public Accounting Firm
Consolidated balance sheets as of December 31, 2023 and 2022
−Removed: Consolidated statements of operations
−Removed: for the years ended December 31, 2022 and 2021
−Removed: Consolidated statements of comprehensive
−Removed: loss for the years ended December 31, 2022 and 2021
−Removed: Consolidated statements of stockholders’
−Removed: equity for the years ended December 31, 2022 and 2021
−Removed: Consolidated statements of cash
−Removed: flows for the years ended December 31, 2022 and 2021
+Added: Consolidated statements of operations for the years ended December 31, 2023 and 2022
+Added: Consolidated statements of comprehensive loss for the years ended December 31, 2023 and 2022
+Added: Consolidated statements of stockholders’ equity for the years ended December 31, 2023 and 2022
+Added: Consolidated statements of cash flows for the years ended December 31, 2023 and 2022
Notes to consolidated financial statements
−Removed: REPORT OF INDEPENDENT
−Removed: REGISTERED PUBLIC ACCOUNTING FIRM
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC
+Added: ACCOUNTING FIRM
To the Board of Directors and Stockholders of
2 unchanged sentences
We have audited the accompanying consolidated balance
−Removed: sheets of Tonix Pharmaceuticals Holding Corp and Subsidiaries (the “Company”) as of December 31, 2022 and 2021, and the related
−Removed: consolidated statements of operations, comprehensive loss, stockholders’ equity, and cash flows for each of the years then ended,
−Removed: and the related notes (collectively referred to as the “financial statements”).
+Added: sheets of Tonix Pharmaceuticals Holding Corp.
+Added: and Subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the
+Added: related consolidated statements of operations, comprehensive loss, stockholders’ equity, and cash flows for each of the years then
+Added: ended, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements
−Removed: present fairly, in all material respects, the consolidated financial position of the Company as of the Company as of December 31, 2022
−Removed: and 2021, and the consolidated results of their operations and their cash flows for each of the years then ended, in conformity with
−Removed: accounting principles generally accepted in the United States of America.
+Added: present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023 and 2022, and the
+Added: consolidated results of their operations and their cash flows for each of the years then ended, in conformity with accounting principles
+Added: generally accepted in the United States of America.
Going Concern
31 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: The critical audit matter communicated below is a
−Removed: matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit
−Removed: committee and that:
+Added: Critical Audit Matters
+Added: The critical audit matters communicated below are
+Added: matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the
+Added: audit committee and that:
(1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments.
−Removed: The communication of the critical audit matter does not alter in any way our opinion on
+Added: The communication of the critical audit matters does not alter in any way our opinion on
the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
−Removed: on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: on the critical audit matters or on the accounts or disclosures to which they relate.
Accrual and prepaid balance for clinical trial expenses
34 unchanged sentences
to prior-period expenses to identify unusual fluctuations, if any.
+Added: Valuation of intangible assets acquired in a business combination
+Added: As described in Note 12 to the consolidated financial
+Added: statements, the Company acquired certain assets from Upsher-Smith Laboratories LLC, which was accounted for as a business combination
+Added: using the acquisition method of accounting.
+Added: The acquired intangible assets consisted of developed technology related to Zembrace and Tosymra,
+Added: including the value associated with the acquired patents, customer relationships, and trademarks and tradenames associated with the technology.
+Added: The developed technology intangible assets were valued as composite assets under the premise that each asset is reliant on one another
+Added: to generate cash flow, and is not considered separable from the technology.
+Added: The intangible assets had an estimated acquisition date fair
+Added: value of $10.1 million.
+Added: The accounting for business combinations, including valuation of intangible assets, was also identified as a critical
+Added: accounting estimate by management.
+Added: We identified valuation of intangible assets acquired
+Added: in a business combination as a critical audit matter due to the significant judgment and estimation required by management in the use
+Added: of fair valuation methodologies, including sensitive significant assumptions such as revenue growth rates and risk premium.
+Added: led to a high degree of auditor subjectivity, and significant audit effort was required in performing our procedures and evaluating audit
+Added: evidence relating to estimates made by management.
+Added: Addressing the matter involved performing procedures
+Added: and evaluating audit evidence, in connection with forming our overall opinion on the consolidated financial statements.
+Added: We obtained an
+Added: understanding of Management’s process and evaluated the design of controls over developing its estimate of the purchase price allocation.
+Added: Our procedures also included, among others, assessing the appropriateness of the valuation methodology utilized, testing of significant
+Added: assumptions, and ensuring completeness and accuracy of the underlying data used by the Company.
+Added: We involved our valuation specialist to
+Added: assist in evaluating the valuation methodologies and risk premium used in the purchase price allocation valuation.
We have served as the Company’s auditor since
1 unchanged sentence
Iselin, New Jersey
−Removed: March 13, 2023
+Added: April 1, 2024
TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: CONSOLIDATED BALANCE
+Added: CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 2023 AND 2022
−Removed: (In Thousands, Except Par Value and Share Amounts)
+Added: (In Thousands, Except Par Value and Share
Current assets:
Cash and cash equivalents
−Removed: Prepaid expenses and other
+Added: Inventory, net
+Added: Prepaid expenses and other current assets
Total current assets
Property and equipment, net
+Added: Intangible assets, net
Operating lease right-to-use assets
4 unchanged sentences
Accrued expenses and other current liabilities
+Added: Term loan payable, short term
Lease liability, short term
Total current liabilities
+Added: Term loan payable, long term
+Added: Series C Warrant liabilities
+Added: Series D Warrant liabilities
Lease liability, long term
2 unchanged sentences
Stockholders’ equity:
−Removed: Preferred stock, $ 0.001
+Added: Preferred stock, $ 0.001 par value;
5,000,000 shares authorized
−Removed: Series B Convertible Preferred stock, 0
−Removed: shares designated as of both December 31, 2022 and 2021;
+Added: Series B Convertible Preferred stock, 0 shares designated as of both December 31, 2023 and 2022;
issued and outstanding - None
−Removed: Series A Convertible Preferred stock, 0
−Removed: shares designated as of both December 31, 2022 and 2021;
+Added: Series A Convertible Preferred stock, 0 shares designated as of both December 31, 2023 and December 31, 2022;
issued and outstanding - none
−Removed: Common stock, $ 0.001
−Removed: 1,000,000,000
−Removed: and 25,000,000 shares
−Removed: authorized as of December 31, 2022 and 2021, respectively;
−Removed: and 15,638,274
−Removed: shares issued and outstanding as of December 31, 2022 and 2021, respectively and 93,741
−Removed: shares to be issued as of December 31, 2022 and December 31, 2021, respectively
+Added: Common stock, $ 0.001 par value;
+Added: 160,000,000 shares authorized;
+Added: 58,614,593 and 12,368,620 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively and 66,329 and 14,999 shares to be issued as of December 31, 2023 and December 31, 2022, respectively
Additional paid in capital
2 unchanged sentences
Total stockholders’ equity
−Removed: Total liabilities and stockholders’
+Added: Total liabilities and stockholders’ equity
See the accompanying notes to the consolidated
1 unchanged sentence
TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF OPERATIONS
−Removed: (In Thousands, Except Share and Per Share Amounts)
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: (In Thousands, Except Share and Per Share
Year ended December 31,
+Added: Product revenue, net
COSTS AND EXPENSES:
+Added: Cost of sales
Research and development
General and administrative
+Added: Total Operating Expenses
Operating loss
−Removed: Interest income
−Removed: Preferred stock
−Removed: deemed dividend
+Added: Other income, net
+Added: Preferred stock deemed dividend
Net loss available to common stockholders
−Removed: Net loss per common share, basic and
−Removed: Weighted average common shares outstanding,
−Removed: basic and diluted
+Added: Net loss to common stockholders per common share, basic and diluted
+Added: Weighted average common shares outstanding, basic and diluted
See the accompanying notes to the consolidated
1 unchanged sentence
TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF COMPREHENSIVE LOSS
+Added: CONSOLIDATED STATEMENTS OF COMPREHENSIVE
(In Thousands)
6 unchanged sentences
TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF STOCKHOLDERS’ EQUITY
−Removed: (In Thousands, Except Share and Per Share Amounts)
+Added: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
+Added: (In Thousands, Except Share and Per Share
Comprehensive
−Removed: Income (loss)
Balance, December 31, 2022
−Removed: Issuance of common stock under At-the-market offering, net
−Removed: of transactional expenses of $ 3,078
−Removed: Issuance of common stock under 2022 Purchase Agreement
+Added: Repurchase of common stock under Share Repurchase Program, including transactional expenses of $ 334
Issuance of common stock under 2022 Purchase agreement
−Removed: Issuance of commitment shares under 2022 Purchase agreement
−Removed: Preferred stock deemed dividend
+Added: Issuance of common stock under At-the-market offering, net of transactional expenses of $ 137
+Added: Issuance of common stock and warrants under AGP Financing, net of transactional expenses of $ 2,663
+Added: Issuance of common stock upon exercise of prefunded common warrants
Employee stock purchase plan
Stock-based compensation
−Removed: Foreign currency transaction loss
+Added: Foreign currency transaction gain
Balance, December 31, 2023
3 unchanged sentences
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
−Removed: (In Thousands, Except Share and Per Share Amounts)
+Added: (In Thousands, Except Share and Per Share
Comprehensive
−Removed: Income (loss)
Balance, December 31, 2021
−Removed: Issuance of common stock in January 2021 ($ 25.60
−Removed: per share), net of transactional expenses of $ 3,096
−Removed: Issuance of common stock in exchange for exercise of warrants
−Removed: in March 2021 ($ 18.24
−Removed: Issuance of common stock in February 2021 ($ 38.40
−Removed: per share), net of transactional expenses of $ 5,002
−Removed: Issuance of common stock under At-the-market offering, net
−Removed: of transactional expenses of $ 2,332
−Removed: Issuance of common stock under 2021 Purchase Agreement, net
−Removed: of transactional expenses of $ 75
+Added: Issuance of common stock under At-the-market offering, net of transactional expenses of $ 3,078
Issuance of commitment shares under 2022 Purchase agreement
−Removed: Issuance of common stock in the acquisition of the OyaGen license
−Removed: Issuance of commitment shares under Lincoln park Purchase agreement
+Added: Issuance of common stock under 2022 Purchase agreement
+Added: Issuance of common stock under 2021 Purchase agreement
+Added: Preferred stock deemed dividend
Employee stock purchase plan
Stock-based compensation
−Removed: Foreign currency transaction loss
+Added: Foreign currency transaction gain
Balance, December 31, 2022
−Removed: See the accompanying notes to the consolidated
−Removed: financial statements
+Added: See the accompanying notes to the
+Added: consolidated financial statements
TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF CASH FLOWS
+Added: CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
1 unchanged sentence
CASH FLOWS FROM OPERATING ACTIVITIES:
−Removed: Adjustments to reconcile net loss to net cash used in operating
+Added: $ ( 116,658 )
+Added: $ ( 110,218 )
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
−Removed: Common stock issued to acquire in-process research and development
Stock-based compensation
+Added: Change in fair value of warrant liabilities
+Added: Offering costs allocated to warrant liabilities
+Added: Gain on sale of property and equipment
Changes in operating assets and liabilities:
−Removed: Prepaid expenses
+Added: Prepaid expenses and other
Accounts payable
−Removed: Lease liabilities and ROU asset, net
+Added: Operating lease liabilities and ROU asset, net
Accrued expenses and other current liabilities
2 unchanged sentences
Purchase of property and equipment
+Added: Disposal of property and equipment
+Added: Purchase of a business
Net cash used in investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Proceeds from exercise of warrants
Proceeds from ESPP
−Removed: Proceeds, net of $ 6,659
−Removed: expenses, from sale of convertible redeemable preferred stock
−Removed: Redemption of convertible redeemable preferred stock
−Removed: Proceeds, net of $ 3,078
−Removed: expenses, from sale of common stock and warrants
+Added: Proceeds, net of $ 6,659 expenses, from sale of convertible redeemable preferred stock
+Added: Redemption of convertible preferred stock
+Added: Proceeds from debt financing
+Added: Proceeds, net of $ 2,800 and $ 3,078 expenses, from sale of common stock and warrants
+Added: Proceeds from allocated warrant liabilities
+Added: Repurchase of common stock
Net cash provided by financing activities
Effect of currency rate change on cash
−Removed: Net (decrease) increase in cash, cash equivalents and restricted
−Removed: Cash, cash equivalents and restricted
−Removed: cash beginning of the period
−Removed: Cash, cash equivalents and restricted
−Removed: cash end of period
+Added: Net decrease in cash, cash equivalents and restricted cash
+Added: Cash, cash equivalents and restricted cash beginning of the period
+Added: Cash, cash equivalents and restricted cash end of period
Supplemental disclosures of cash flow information:
−Removed: Purchases of property and equipment
−Removed: included in accounts payable and accrued liabilities
+Added: Purchases of property and equipment included in accounts payable and accrued liabilities
+Added: Debt financing costs included in accrued liabilities and other current liabilities
+Added: Issuance costs included in accrued liabilities and other current liabilities
Preferred stock deemed dividend
−Removed: See the accompanying notes to consolidated financial
−Removed: TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
+Added: New operating leases and lease amendments
+Added: See the accompanying notes to consolidated
financial statements
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTE 1 – BUSINESS
Tonix Pharmaceuticals Holding
Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc.
−Removed: (“Tonix Sub”), is a clinical-stage biopharmaceutical
−Removed: company focused on discovering, licensing, acquiring and developing therapeutics and vaccines to treat and prevent human disease and alleviate
−Removed: The therapeutics include both small molecules and biologics.
−Removed: All drug product and vaccine candidates are still in development
−Removed: and none are approved or marketed.
−Removed: The consolidated financial
−Removed: statements include the accounts of Tonix Pharmaceuticals Holding Corp.
−Removed: and its wholly owned subsidiaries, Tonix Sub, Krele LLC, Tonix
−Removed: Pharmaceuticals (Canada), Inc., Tonix Medicines, Inc., Jenner LLC, Tonix R&D Center LLC, Tonix Pharma Holdings Limited and Tonix Pharma
+Added: (“Tonix Sub”), is a fully-integrated biopharmaceutical
+Added: company focused on developing and commercializing therapeutics to treat and prevent human disease and alleviate suffering.
+Added: The therapeutics
+Added: under development include both small molecules and biologics.
+Added: Tonix, through its recent acquisition, markets Zembrace® SymTouch®
+Added: (sumatriptan injection) 3 mg (“Zembrace”) and Tosymra® (sumatriptan nasal spray) 10 mg (“Tosymra”).
+Added: and Tosymra, which were acquired as of June 30, 2023 (See Note 12), are each indicated for the treatment of acute migraine with or without
+Added: aura in adults.
+Added: All other drug product and vaccine candidates are still in development and are not approved or marketed.
+Added: The consolidated financial statements
+Added: include the accounts of Tonix Pharmaceuticals Holding Corp.
+Added: and its wholly owned subsidiaries, Tonix Sub, Krele LLC, Tonix Pharmaceuticals
+Added: (Canada), Inc., Tonix Medicines, Inc., Jenner Institute LLC, Tonix R&D Center LLC, Tonix Pharma Holdings Limited and Tonix Pharma
Limited (collectively hereafter referred to as the “Company” or “Tonix”).
1 unchanged sentence
have been eliminated in consolidation.
+Added: Going Concern
The accompanying financial
−Removed: statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization
−Removed: of assets and satisfaction of liabilities and commitments in the normal course of business.
−Removed: The Company has suffered recurring losses
−Removed: from operations and negative cash flows from operating activities.
−Removed: At December 31, 2022, the Company had working capital of approximately
−Removed: $ 112.6 million.
−Removed: 31, 2022, the Company had an accumulated deficit of approximately $ 470.0
−Removed: The Company held cash and cash equivalents of approximately $ 120.2
−Removed: million as of December 31, 2022.
−Removed: The Company believes that
−Removed: its cash resources at December 31, 2022 and the proceeds that it raised from equity offerings in the first quarter of 2023, net of amounts
−Removed: paid to repurchase shares in the first quarter of 2023 (See Note 22), will meet its operating and capital expenditure requirements into
−Removed: the fourth quarter of 2023, but not beyond.
+Added: statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates
+Added: the realization of assets and satisfaction of liabilities and commitments in the normal course of business.
+Added: The Company has suffered
+Added: recurring losses from operations and negative cash flows from operating activities.
+Added: At December 31, 2023, the Company had working
+Added: capital of approximately $ 28.9 million.
+Added: At December 31, 2023, the Company had an accumulated deficit of approximately $600.7 million.
+Added: The Company held cash and cash equivalents of approximately $24.9 million as of December 31, 2023.
+Added: The Company believes
+Added: that its cash resources at December 31, 2023 and the proceeds that it raised from equity offerings in the first quarter of 2024
+Added: (See Note 23), will not meet its operating and capital expenditure requirements through the second quarter of 2024.
These factors raise
substantial doubt about the Company’s ability to continue as a going concern.
−Removed: The Company faces significant challenges and uncertainties
−Removed: and, as a result, its available capital resources may be consumed more rapidly than currently expected due to changes it may make in its
−Removed: research and development spending plans.
−Removed: The Company believes that it has the ability to obtain additional funding through public and
−Removed: private financing and collaborative arrangements with strategic partners to increase the funds available to fund operations.
−Removed: the Company may not be able to raise capital on terms acceptable to the Company.
−Removed: Without additional funds, it may be forced to delay,
−Removed: scale back or eliminate some of its research and development activities, or other operations and potentially delay product development
−Removed: in an effort to provide sufficient funds to continue operations.
−Removed: If any of these events occurs, the Company’s ability to achieve
−Removed: its development and commercialization goals would be adversely affected.
−Removed: The financial statements do not include any adjustments that
−Removed: might result from the outcome of this uncertainty.
−Removed: 2 – SIGNIFICANT ACCOUNTING POLICIES
−Removed: On May 16, 2022, the Company
−Removed: filed a Certificate of Change with the Nevada Secretary of State, effective May 17, 2022.
−Removed: Pursuant to the Certificate of Change, the Company
−Removed: effected a 1-for-32
−Removed: reverse stock split of its issued and outstanding shares of common stock.
−Removed: The Company accounted for the reverse stock split on a retrospective
−Removed: basis pursuant to ASC 260, Earnings Per Share.
−Removed: All authorized, issued and outstanding common stock, common stock warrants, stock option
−Removed: awards, exercise prices and per share data have been adjusted in these consolidated financial statements, on a retroactive basis, to reflect
−Removed: the reverse stock split for all periods presented.
+Added: The Company continues to face significant challenges
+Added: and uncertainties and must obtain additional funding through public and private financing and collaborative arrangements with strategic
+Added: partners to increase the funds available to fund operations.
+Added: However, the Company may not be able to raise capital on terms acceptable
+Added: to the Company, or at all.
+Added: Without additional funds, it may be forced to delay, scale back or eliminate some of its research and
+Added: development activities, or other operations and potentially delay product development in an effort to provide sufficient funds
+Added: to continue operations.
+Added: If any of these events occurs, its ability to achieve our development and commercialization goals would
+Added: be adversely affected and the Company may be forced to cease operations.
+Added: The financial statements do not include any adjustments
+Added: that might result from the outcome of this uncertainty.
+Added: NOTE 2 – SIGNIFICANT ACCOUNTING
+Added: Reverse Stock Split
+Added: On May 9, 2023, the
+Added: Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023.
+Added: Pursuant to the Certificate of
+Added: Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock.
+Added: accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share.
+Added: All authorized, issued
+Added: and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted
+Added: in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented.
Authorized preferred stock was not adjusted because of the reverse stock split.
−Removed: and uncertainties
−Removed: The Company’s primary
−Removed: efforts are devoted to conducting research and development of innovative pharmaceutical and biological products to address public health
−Removed: The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions
−Removed: to continue for the foreseeable future.
−Removed: Further, the Company does not have any commercial products available for sale and has not generated
−Removed: revenues, and there is no assurance that if its products are approved for sale, that the Company will be able to generate cash flow to
−Removed: fund operations.
+Added: Risks and uncertainties
+Added: The Company’s
+Added: primary efforts are devoted to conducting research and development of innovative pharmaceutical and biological products to address
+Added: public health challenges.
+Added: The Company has experienced net losses and negative cash flows from operations since inception and expects
+Added: these conditions to continue for the foreseeable future.
+Added: Further, the Company now has commercial products available for sale, and
+Added: generates revenue from the sale of its Zembrace® SymTouch® and Tosymra® products, with no assurance that the Company
+Added: will be able to generate sufficient cash flow to fund operations from its commercial products or products in development if and
+Added: 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.
−Removed: Moreover, the extent to which COVID-19 impacts the Company’s operations
−Removed: will depend on future developments, which are highly uncertain and cannot be predicted with confidence at this time.
−Removed: The preparation of financial
−Removed: statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates and
−Removed: assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date
−Removed: of the financial statements, and the reported amounts of expenses during the reporting period.
−Removed: Actual results could differ from those
−Removed: Significant estimates include the assumptions used in the fair value of stock-based compensation and other equity instruments,
−Removed: and the percent of completion of research and development contracts.
−Removed: Equivalents and Restricted Cash
−Removed: The Company considers cash
−Removed: equivalents to be those investments which are highly liquid, readily convertible to cash and have an original maturity of three months
−Removed: or less when purchased.
−Removed: At December 31, 2022 and December 31, 2021, cash equivalents, which consisted of money market funds, amounted
−Removed: to $ 116.3 million
−Removed: and $ 120.4 million, respectively.
−Removed: cash, which is included in Other non-current assets on the consolidated balance sheet at December 31, 2022 and December 31, 2021 of approximately
−Removed: $ 241,000 and $ 240,000 ,
−Removed: respectively, collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and New York
−Removed: City (see Note 19).
−Removed: following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets
−Removed: that sum to the total of the same amounts shown in the consolidated statement of cash flows:
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Use of estimates
+Added: The preparation of
+Added: financial statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management to make
+Added: estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities
+Added: at the date of the financial statements, and the reported amounts of expenses during the reporting period.
+Added: Actual results could
+Added: differ from those estimates.
+Added: Significant estimates include, but are not limited to, provisions for product returns, coupons, rebates,
+Added: chargebacks, discounts, allowances, inventory realization, the assumptions used in the fair value of stock-based compensation and
+Added: other equity instruments, the percent of completion of research and development contracts, fair value estimates for assets acquired
+Added: in business combinations, and assessment of useful lives of acquired intangible assets.
+Added: Business Combinations
+Added: The Company accounts
+Added: for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No.
+Added: 2017-01, Business Combinations
+Added: Clarifying the Definition of a Business.
+Added: Business combinations are accounted for using the acquisition method, whereby
+Added: the consideration transferred is allocated to the net assets acquired based on their respective fair values measured on the acquisition
+Added: The difference between the fair value of these assets and the purchase price is recorded as goodwill.
+Added: Transaction costs other
+Added: than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
+Added: part of the business acquisition transaction and are expensed as incurred.
+Added: Segment Information and Concentrations
+Added: segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the
+Added: chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.
+Added: The Company views its operations and manages its business in one segment.
+Added: Company has two products that each accounted for more than 10 % of total revenues during the year ended December 31, 2023.
+Added: products collectively accounted for 100 % of revenues during the year ended December 31, 2023.
+Added: of December 31, 2023, accounts receivable from five customers accounted for 26 % , 21 % , 16 % , 14 % and 13 % of total accounts receivable.
+Added: For the year ended December 31, 2023, revenues from five customers accounted for 23 % , 21 % , 19 % , 17 % and 10 % of net product revenues,
+Added: respectively.
+Added: As of December 31, 2022, and for the year ended December 31, 2022, the Company had no commercialized products and
+Added: therefore had no accounts receivable or revenues.
+Added: Cash, Cash Equivalents and Restricted Cash
+Added: Company considers cash equivalents to be those investments which are highly liquid, readily convertible to cash and have an original
+Added: maturity of three months or less when purchased.
+Added: At December 31, 2023, and December 31, 2022, cash equivalents, which consisted
+Added: of money market funds, amounted to approximately $ 23,000 and $ 116.3 million, respectively.
+Added: Restricted cash, which is included
+Added: in Other non-current assets on the consolidated balance sheet, at December 31, 2023, of approximately $ 0.9 million, collateralizes
+Added: a letter of credit issued in connection with the lease of office space in Chatham, New Jersey (see Note 20) and restricted cash
+Added: held by vendors in escrow accounts for patient support services.
+Added: Restricted cash at December 31, 2022, of approximately $ 241,000 ,
+Added: collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and New York, New
+Added: The following table
+Added: provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum
+Added: to the total of the same amounts shown in the consolidated statement of cash flows:
(in thousands)
1 unchanged sentence
Restricted cash
−Removed: and equipment
−Removed: Property and equipment are
−Removed: stated at cost, less accumulated depreciation.
−Removed: Depreciation is calculated using the straight-line method over the asset’s estimated
−Removed: useful life, which ranges from 20
−Removed: years for buildings, 15
−Removed: years for land improvements, and laboratory equipment, three
−Removed: years for computer assets, five
−Removed: years for furniture and all other equipment and term of lease for leasehold improvements.
−Removed: Depreciation on assets begin when the
−Removed: asset is available for its intended use.
−Removed: Depreciation and amortization expense for the years ended December 31, 2022, and 2021 was $ 1,253,000 and
−Removed: respectively.
−Removed: The Company’s property and equipment is located in the United States.
−Removed: assets with indefinite lives
−Removed: During the year ended December
−Removed: 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life.
−Removed: Identifiable intangibles
−Removed: with indefinite lives, which are included in Other non-current assets on the consolidated balance sheet, are not amortized but are tested
−Removed: for impairment annually or whenever events or changes in circumstances indicate that their carrying amount may be less than fair value.
−Removed: As of December 31, 2022, and 2021, the Company believed that no impairment existed.
−Removed: The Company determines if
−Removed: an arrangement is, or contains, a lease at inception.
+Added: Accounts Receivable, net
+Added: Accounts receivable
+Added: consists of amounts due from our wholesale and other third-party distributors and pharmacies and have standard payment terms that
+Added: generally require payment within 30 to 90 days.
+Added: For certain customers, the accounts receivable for the customer is net of prompt
+Added: payment or specialty pharmacy discounts.
+Added: We do not adjust our receivables for the effects of a significant financing component
+Added: at contract inception if we expect to collect the receivables in one year or less from the time of sale.
+Added: We provide reserves against
+Added: accounts receivable for estimated losses that may result from a customer’s inability to pay.
+Added: Amounts determined to be uncollectible
+Added: are charged or written-off against the reserve.
+Added: However, during the period covered by the Transition Services Agreement, the Seller
+Added: has agreed to collect the accounts receivable on behalf of the Company and net settle within 45 days from each month-end.
+Added: 12 for further details.
+Added: The Company had no accounts receivable as of December 31, 2022.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: As of December
+Added: 31, 2023 , the Company did not have an allowance for doubtful accounts.
+Added: An allowance for doubtful accounts is determined
+Added: based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends
+Added: expected to affect future collections experience.
+Added: Any allowance would reduce the net receivables to the amount that is expected
+Added: to be collected.
+Added: The payment history of the Company’s customers will be considered in future assessments of collectability
+Added: as these patterns are established over a longer period .
+Added: Concentration of Credit Risk
+Added: Financial instruments
+Added: that potentially subject us to concentrations of credit risk include cash and cash equivalents, and accounts receivable.
+Added: to minimize the risks related to cash and cash equivalents by investing in a broad and diverse range of financial instruments,
+Added: and we have established guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain
+Added: Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due
+Added: to the wide variety of customers using our products, as well as their dispersion across different geographic areas.
+Added: We monitor the financial
+Added: performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile.
+Added: We continue to monitor these conditions and assess their possible impact on our business.
+Added: Inventories are recorded
+Added: at the lower of cost or net realizable value, with cost determined by the weighted average cost method.
+Added: The Company periodically
+Added: reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking
+Added: into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand.
+Added: If non-saleable
+Added: items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value
+Added: in the period that the decline in value is first recognized.
+Added: Although the Company makes every effort to ensure the accuracy of
+Added: forecasts of future product demand, any significant unanticipated decreases in demand could have a material impact on the carrying
+Added: value of inventories and reported operating results.
+Added: The Company’s reserves were approximately $ 21,000 as of December 31,
+Added: The Company did not have inventory on hand prior to the acquisition of Zembrace and Tosymra on June 30, 2023.
+Added: Property and equipment
+Added: Property and equipment
+Added: are stated at cost, less accumulated depreciation.
+Added: Depreciation is calculated using the straight-line method over the asset’s
+Added: estimated useful life, which ranges from 20 to 30 years for buildings, 15 years for land improvements and laboratory equipment,
+Added: three years for computer assets, five years for furniture and all other equipment and the shorter of the useful life or term of
+Added: lease for leasehold improvements.
+Added: Depreciation on assets begins when the asset is placed in service.
+Added: Depreciation and amortization
+Added: expense for the years ended December 31, 2023, and 2022, were $ 3.8 million and $ 1.3 million, respectively.
+Added: All property and equipment
+Added: are located in the United States.
+Added: Intangible assets, net
+Added: Intangible assets deemed
+Added: to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any.
+Added: intangible assets consist of developed technology intangible assets acquired in connection with the acquisition of certain products
+Added: from Upsher Smith Laboratories, LLS (“Upsher Smith”) consummated on June 30, 2023 (See Note 5).
+Added: The acquired intangible
+Added: assets are amortized using the straight-line method over the estimated useful lives of the respective assets.
+Added: Amortization expense
+Added: for the year ended December 31, 2023, was $ 477,000 .
+Added: The annual impairment assessment date will be June 30.
+Added: No triggering events
+Added: were identified during the period of July 1, 2023 through December 31, 2023.
+Added: During the year ended
+Added: December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life.
+Added: intangibles with indefinite lives, which are included in Intangible assets, net on the consolidated balance sheet, are not amortized
+Added: but are tested for impairment annually or whenever events or changes in circumstances indicate that their carrying amount may be
+Added: less than fair value.
+Added: As of December 31, 2023, the Company believed that no impairment existed.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Goodwill represents
+Added: the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business
+Added: Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate
+Added: that the carrying amount of goodwill may be impaired.
+Added: As of December 31, 2023, the Company has recognized goodwill in connection
+Added: with the USL Acquisition consummated on June 30, 2023 (See Note 5).
+Added: The annual impairment assessment date will be June 30.
+Added: No triggering
+Added: events were identified during the period of July 1, 2023 through December 31, 2023.
+Added: The Company determines
+Added: if an arrangement is, or contains, a lease at inception.
Operating leases are included in operating lease right-of-use (“ROU”)
−Removed: assets, lease liability, short term and lease liability, long term in the Company’s consolidated balance sheets.
−Removed: ROU assets represent
−Removed: the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease
−Removed: payments arising from the lease.
−Removed: Operating lease ROU assets and liabilities are recognized at commencement date based on the present
−Removed: value of lease payments over the lease term.
−Removed: As the Company’s leases do not provide an implicit rate, the Company uses an incremental
−Removed: borrowing rate based on the information available at the transition date and subsequent lease commencement dates in determining the present
−Removed: value of lease payments.
−Removed: This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to
+Added: assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s consolidated balance
+Added: ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent
+Added: its obligation to make lease payments arising from the lease.
+Added: Operating lease ROU assets and liabilities are recognized at commencement
+Added: date based on the present value of lease payments over the lease term.
+Added: As the Company’s leases do not provide an implicit
+Added: rate, the Company uses an incremental borrowing rate based on the information available at the transition date and subsequent lease
+Added: commencement dates in determining the present value of lease payments.
+Added: This is the rate the Company would have to pay if borrowing
+Added: on a collateralized basis over a similar term to each lease.
The operating lease ROU asset excludes lease incentives.
−Removed: The Company’s lease terms may include options to extend or
−Removed: terminate the lease when it is reasonably certain that the Company will exercise that option.
−Removed: Lease expense for lease payments made under
−Removed: operating leases is recognized on a straight-line basis over the lease term.
−Removed: Preferred Stock
−Removed: Preferred shares subject to
−Removed: mandatory redemption are classified as liability instruments and are measured at fair value.
−Removed: The Company classifies conditionally redeemable
−Removed: preferred shares, which includes preferred shares that feature redemption rights that are either within the control of the holder or subject
−Removed: to redemption upon the occurrence of uncertain events not solely within the Company’s control, as temporary equity (“mezzanine”)
−Removed: until such time as the conditions are removed or lapse.
−Removed: and Development Costs
−Removed: The Company outsources certain
−Removed: of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products for testing,
−Removed: as well as licensing fees and costs associated with planning and conducting clinical trials.
−Removed: The value ascribed to patents and other intellectual
−Removed: property acquired has been expensed as research and development costs, as such property is related to particular research and development
−Removed: projects and had no alternative future uses.
−Removed: The Company estimates its
−Removed: expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical
−Removed: site agreements in connection with conducting clinical trials.
−Removed: The financial terms of these contracts are subject to negotiations, which
−Removed: vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided
+Added: The Company’s
+Added: lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that
+Added: Lease expense for lease payments made under operating leases is recognized on a straight-line basis over the lease term.
+Added: Deferred financing costs
+Added: Deferred financing
+Added: costs represent the cost of obtaining financing arrangements and are amortized over the term of the related debt agreement using
+Added: the effective interest method.
+Added: Deferred financing costs related to term debt arrangements are reflected as a direct reduction of
+Added: the related debt liability on the consolidated balance sheet.
+Added: Amortization of deferred financing costs are included in interest
+Added: expense on the consolidated statements of operations.
+Added: Original issue discount
+Added: Certain term debt issued
+Added: by the Company provides the debt holder with an original issue discount.
+Added: Original issue discounts are reflected as a direct reduction
+Added: of the related debt liability on the consolidated balance sheets and are amortized over the term of the related debt agreement
+Added: using the effective interest method.
+Added: Amortization of original issue discounts are included in interest expense on the consolidated
+Added: statements of operations.
+Added: Convertible Preferred Stock
+Added: Preferred shares subject
+Added: to mandatory redemption are classified as liability instruments and are measured at fair value.
+Added: The Company classifies conditionally
+Added: redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control
+Added: of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control, as
+Added: temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.
+Added: Revenue Recognition
+Added: The Company records
+Added: and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects
+Added: the consideration to which the Company expects to be entitled in exchange for those goods or services.
+Added: The Company’s revenues
+Added: primarily result from contracts with customers, which are generally short-term and have a single performance obligation - the delivery
+Added: The Company’s performance obligation to deliver products is satisfied at the point in time that the goods are
+Added: received by the customer, which is when the customer obtains title to and has the risks and rewards of ownership of the products,
+Added: which is generally upon shipment or delivery to the customer as stipulated by the terms of the sale agreements.
+Added: The transaction
+Added: price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods to
+Added: The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both.
+Added: contractual payment terms are typically 30 to 90 days .
+Added: Revenues from product sales, net of gross-to-net
+Added: deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable
+Added: of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved.
+Added: Taxes assessed by governmental
+Added: authorities and collected from customers are excluded from product sales.
+Added: Shipping and handling activities are considered to be
+Added: fulfillment activities and not a separate performance obligation.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Many of the Company’s
+Added: products sold are subject to a variety of deductions.
+Added: Revenues are recognized net of estimated rebates and chargebacks, cash discounts,
+Added: distributor fees, sales return provisions and other related deductions.
+Added: Deductions to product sales are referred to as gross-to-net
+Added: deductions and are estimated and recorded in the period in which the related product sales occur.
+Added: Accruals for these provisions
+Added: are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset
+Added: within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash).
+Added: Amounts recorded for revenue
+Added: deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates
+Added: and assumptions.
+Added: The following section briefly describes the nature of the Company’s provisions for variable consideration
+Added: and how such provisions are estimated:
+Added: Chargebacks -
+Added: The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with
+Added: these indirect customers to establish pricing for the Company’s products, and in-turn, the indirect customers and entities
+Added: independently purchase these products.
+Added: Because the price paid by the indirect customers and/or entities is lower than the price
+Added: paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual
+Added: price with the indirect customers and the wholesale customer’s purchase price.
+Added: The Company’s provision for chargebacks
+Added: is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler
+Added: inventory levels as well as historical chargeback rates.
+Added: The Company continually monitors its reserve for chargebacks and adjusts
+Added: the reserve accordingly when expected chargebacks differ from actual experience.
+Added: Rebates - The
+Added: Company participates in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified
+Added: recipients, and primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts,
+Added: specialty pharmacy program fees and other governmental rebates or applicable allowances.
+Added: Managed Care Rebates are processed in the quarter following the quarter in which they are earned.
+Added: 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.
+Added: All rebates earned but not paid are estimated by the Company according to historical payments trended for market growth assumptions.
+Added: Medicaid and State Agency rebates are based upon historical experience of claims submitted by various states.
+Added: The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for Medicaid rebates.
+Added: The accrual of State Agency reserves is based on historical payment rates.
+Added: There is an approximate three-month lag from the time of product sale until the rebate is paid.
+Added: Tri-Care represents a regionally managed health care program for active duty and retired members, dependents and survivors of the US military.
+Added: The Tri-Care program supplements health care resources of the US military with civilian health care professionals for greater access and quality healthcare coverage.
+Added: Through the Tri-Care program, the Company provides pharmaceuticals on a direct customer basis.
+Added: 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.
+Added: 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.
+Added: Applicable pharmaceutical products sold during this coverage gap timeframe are discounted by the Company.
+Added: Since the nature of the program is that coverage limits are reset at the beginning of the calendar year;
+Added: the payments escalate each quarter as the participants reach the coverage limit before reaching the catastrophic coverage threshold.
+Added: The Company has determined that the cost of this reserve will be viewed as an annual cost.
+Added: 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.
+Added: Prompt-Pay and other
+Added: Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue
+Added: and as a reduction in the accounts receivable at the time of sale based on the customer’s contracted discount rate.
+Added: sales discounts represent programs the Company has in place to reduce costs to the patient.
+Added: This includes copay buy down and eVoucher
+Added: Product Returns
+Added: - Consistent with industry practice, the Company offers customers a right to return any unused product.
+Added: The customer’s right
+Added: of return commences typically six months prior to product expiration date and ends one year after product expiration date.
+Added: returned for expiration are reimbursed at current wholesale acquisition cost or indirect contract price.
+Added: The Company estimates
+Added: the amount of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction
+Added: of revenue in the period the related product revenue is recognized.
+Added: The Company estimates products returns as a percentage of sales
+Added: to its customers.
+Added: The rate is estimated by using historical sales information, including its visibility and estimates into the
+Added: inventory remaining in the distribution channel.
+Added: Adjustments are made to the current provision for returns when data suggests product
+Added: returns may differ from original estimates.
+Added: Research and Development Costs
+Added: The Company outsources
+Added: certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products
+Added: for testing, as well as licensing fees and costs associated with planning and conducting clinical trials.
+Added: The value ascribed to
+Added: patents and other intellectual property acquired has been expensed as research and development costs, as such property is related
+Added: to particular research and development projects and had no alternative future uses.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: The Company estimates its expenses resulting from its
+Added: obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in
+Added: connection with conducting clinical trials.
+Added: The financial terms of these contracts are subject to negotiations, which vary from
+Added: 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.
−Removed: The Company determines
−Removed: accrual estimates taking into account discussion with applicable personnel and outside service providers as to the progress or state of
−Removed: consummation of trials, or the services completed.
−Removed: During the course of a clinical
−Removed: trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates.
−Removed: The Company makes estimates of
−Removed: its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time.
−Removed: The Company’s
−Removed: clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party
−Removed: From time to time, the Company may enter into
−Removed: arrangements with governmental entities for the purpose of obtaining funding for research and development activities.
−Removed: The Company is reimbursed
−Removed: for costs incurred that are associated with specified research and development activities included in the grant application approved by
−Removed: the government authority.
−Removed: The Company classifies government grants received under these arrangements as a reduction to the related
−Removed: research and development expense in the same period as the relevant expenses are incurred.
−Removed: In August 2022, the Company announced that
−Removed: it received a Cooperative Agreement grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes
−Removed: of Health, to support the development of its TNX-1300 product candidate for the treatment of cocaine intoxication.
−Removed: No funding was received
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: All stock-based payments to
−Removed: employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock options,
−Removed: are measured at fair value on the grant date and recognized in the consolidated statements of operations as compensation or other expense
−Removed: over the requisite service period.
−Removed: The Company accounts for share-based awards in accordance with the provisions of the Accounting Standards
−Removed: Codification (“ASC”) 718, Compensation – Stock Compensation.
−Removed: Currency Translation
+Added: determines accrual estimates taking into account discussion with applicable personnel and outside service providers as to the progress
+Added: or state of consummation of trials, or the services completed.
+Added: During the course of
+Added: a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates.
+Added: makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that
+Added: The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations
+Added: and other third-party vendors.
+Added: Government Grants
+Added: From time to time,
+Added: the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development
+Added: The Company is reimbursed for costs incurred that are associated with specified research and development activities
+Added: included in the grant application approved by the government authority.
+Added: The Company classifies government grants received under
+Added: these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are
+Added: In August 2022, the Company announced that it received a Cooperative Agreement grant from the National Institute on Drug
+Added: Abuse (“NIDA”), part of the National Institutes of Health, to support the development of its TNX-1300 product candidate
+Added: for the treatment of cocaine intoxication.
+Added: During the year ended December 31, 2023, we received $ 2.7 million in funding as a reduction
+Added: of related research and development expense .
+Added: Included in Prepaid expenses and other is an additional $ 0.2 million which was not received until January 2024.
+Added: No funding was received during 2022.
+Added: Stock-based Compensation.
+Added: All stock-based payments
+Added: to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock
+Added: options, are measured at fair value on the grant date and recognized in the consolidated statements of operations as compensation
+Added: expense over the requisite service period.
+Added: The Company accounts for share-based awards in accordance with the provisions of the
+Added: Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation.
+Added: Foreign Currency Translation
Operations of the Company’s
1 unchanged sentence
dollar is the functional currency of the other foreign subsidiaries.
−Removed: Balance sheet accounts of the Canadian subsidiary were translated
−Removed: from foreign currency into U.S.
−Removed: dollars at the exchange rate in effect at the balance sheet date and income statement accounts were translated
−Removed: at the average rate of exchange prevailing during the period.
−Removed: Translation adjustments resulting from this process were included in accumulated
−Removed: other comprehensive loss on the consolidated balance sheets.
−Removed: Comprehensive
−Removed: Income (Loss)
+Added: Balance sheet accounts of the Canadian subsidiary
+Added: were translated from foreign currency into U.S.
+Added: dollars at the exchange rate in effect at the balance sheet date and income statement
+Added: accounts were translated at the average rate of exchange prevailing during the period.
+Added: Translation adjustments resulting from this
+Added: process were included in accumulated other comprehensive loss on the consolidated balance sheets.
Comprehensive Income (Loss)
−Removed: is defined as the change in equity of a business during a period from transactions and other events and circumstances from non-owners
−Removed: It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners.
+Added: Comprehensive income
+Added: (loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances from
+Added: non-owners sources.
+Added: It includes all changes in equity during a period except those resulting from investments by owners and distributions
Other comprehensive income (loss) represents foreign currency translation adjustments.
−Removed: Deferred income tax assets
−Removed: and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards and temporary
−Removed: differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured at the current enacted
−Removed: The Company records a valuation allowance on its deferred income tax assets if it is not more likely than not that these deferred
−Removed: income tax assets will be realized.
−Removed: The Company recognizes a
−Removed: tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination
+Added: Deferred income tax
+Added: assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards
+Added: and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured
+Added: at the current enacted tax rates.
+Added: The Company records a valuation allowance on its deferred income tax assets if it is not more
+Added: likely than not that these deferred income tax assets will be realized.
+Added: The Company recognizes
+Added: 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.
−Removed: The tax benefits recognized in the consolidated financial statements
−Removed: from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate
+Added: The tax benefits recognized in the consolidated financial
+Added: statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized
+Added: upon ultimate settlement.
As of December 31, 2023, the Company has not recorded any unrecognized tax benefits.
−Removed: The Company’s policy is to recognize
−Removed: interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
−Removed: The computation of basic and
−Removed: diluted loss per share for the years ended December 31, 2022 and 2021 excludes potentially dilutive securities when their inclusion would
−Removed: be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.
−Removed: All warrants issued participate
−Removed: 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
−Removed: common stock.
−Removed: For purposes of computing EPS, these warrants are considered to participate with common stock in earnings of the Company.
−Removed: Therefore, the Company calculates basic and diluted EPS using the two-class method.
−Removed: Under the two-class method, net income for the period
−Removed: is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed
−Removed: No income was allocated to the warrants for the years ended December 31, 2022 and 2021, as results of operations were a loss
−Removed: for the period.
−Removed: dilutive securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2022 and 2021, are as follows:
+Added: The Company’s
+Added: policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Derivative Instruments and Warrant Liabilities
+Added: The Company evaluates
+Added: all of its financial instruments, including issued warrants to purchase common stock under ASC 815 – Derivatives and Hedging,
+Added: to determine if such instruments are derivatives or contain features that qualify as embedded derivatives (See Note 17).
+Added: For derivative
+Added: financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value
+Added: and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations.
+Added: The Company uses the Black-Scholes option pricing model to value the derivative instruments at inception and subsequent valuation
+Added: dates, which is adjusted for instrument-specific terms as applicable.
+Added: From time to time,
+Added: certain equity-linked instruments may be classified as derivative liabilities due to the Company having insufficient authorized
+Added: shares to fully settle the equity-linked financial instruments in shares.
+Added: In such case, the Company has adopted a sequencing approach
+Added: under ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity to determine the classification of its contracts
+Added: at issuance and at each subsequent reporting date.
+Added: In the event that reclassification of contracts between equity and assets or
+Added: liabilities is necessary, the Company first allocates remaining authorized shares to equity on the basis of the earliest issuance
+Added: date of potentially dilutive instruments, with the earliest issuance date receiving the first allocation of shares.
+Added: of identical issuance dates, shares are then allocated to equity beginning with instruments with the latest maturity date first.
+Added: Per Share Data
+Added: The computation of
+Added: basic and diluted loss per share for the year ended December 31, 2023, and 2022 excludes potentially dilutive securities when their
+Added: inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during
+Added: All warrants and preferred
+Added: stock issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the
+Added: Board of Directors, on the Company’s common stock.
+Added: For the purposes of computing EPS, these warrants and preferred stock
+Added: are considered to participate with common stock in earnings of the Company.
+Added: Therefore, the Company calculates basic and diluted
+Added: EPS using the two-class method.
+Added: Under the two-class method, net income for the period is allocated between common stockholders
+Added: and participating securities according to dividends declared and participation rights in undistributed earnings.
+Added: The weighted average
+Added: number of outstanding shares of common stock used in the denominator for the calculation of basic loss per share for the year ended
+Added: December 31, 2023, include pre-funded warrants that are accounted for as equity instruments, beginning with their respective issuance
+Added: dates, as their stated exercise price of $ 0.0001 is non-substantive and there are no further vesting conditions or limitations
+Added: No income was allocated to the warrants and preferred stock for the year ended December 31, 2023, and 2022, as results
+Added: of operations were a loss for the periods.
+Added: Potentially dilutive
+Added: securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2023, and 2022, are as follows:
Warrants to purchase common stock
Options to purchase common stock
−Removed: Issued Accounting Pronouncements
−Removed: In August 2020, the FASB issued
−Removed: 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
−Removed: in Entity’s Own Equity (Subtopic 815-40):
−Removed: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ,
−Removed: which simplifies accounting for convertible instruments by removing major separation models required under current GAAP.
−Removed: removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and
−Removed: it also simplifies the diluted earnings per share calculation in certain areas.
−Removed: The Company will adopt ASU 2020-06 on January 1, 2023,
−Removed: under the modified retrospective method of transition.
−Removed: The Company does not anticipate the adoption of ASU 2020-06 to impact the Company’s
−Removed: financial position, results of operations or cash flows.
+Added: Recently Adopted Accounting Pronouncements
+Added: In August 2020, the
+Added: Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
+Added: 2020-06, Debt—Debt
+Added: with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic
+Added: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , which simplifies accounting
+Added: for convertible instruments by removing major separation models required under current GAAP.
+Added: The ASU also removes certain settlement
+Added: conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it also simplifies
+Added: the diluted earnings per share calculation in certain areas.
+Added: The Company adopted ASU 2020-06 on January 1, 2023, under the modified
+Added: retrospective method of transition.
+Added: The adoption of ASU 2020-06 did not impact the Company’s financial position, results
+Added: of operations or cash flows.
+Added: In June 2016, the FASB
+Added: issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments .
+Added: The main objective of ASU 2016-13 is to provide
+Added: financial statement users with more decision-useful information about an entity’s expected credit losses on financial instruments
+Added: and other commitments to extend credit at each reporting date.
+Added: To achieve this objective, the amendments in this update replace
+Added: the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires
+Added: consideration of a broader range of reasonable and supportable information to develop credit loss estimates.
+Added: ASU 2016-13 will be
+Added: effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years,
+Added: using a modified retrospective approach.
+Added: Early adoption is permitted.
+Added: The Company adopted ASU 2016-13 and related updates as of
+Added: January 1, 2023.
+Added: The adoption of ASU 2016-13 did not impact the Company’s financial position, results of operations or cash
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 3 – PROPERTY AND EQUIPMENT, NET
−Removed: and equipment, net consisted of the following (in thousands):
+Added: Recent Accounting Pronouncements Not
+Added: In November 2023, the
+Added: Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment
+Added: Reporting--Improvements to Reportable Segment Disclosures , which requires incremental disclosures about a public entity’s
+Added: reportable segments but does not change the definition of a segment or the guidance for determining reportable segments.
+Added: guidance requires disclosure of significant segment expenses that are (1) regularly provided to (or easily computed from information
+Added: regularly provided to) the chief operating decision maker and (2) included in the reported measure of segment profit or loss.
+Added: new standard also allows companies to disclose multiple measures of segment profit or loss if those measures are used to assess
+Added: performance and allocate resources.
+Added: The guidance will first be effective in our annual disclosures for the year ending December
+Added: 31, 2024, and will be adopted retrospectively unless impracticable.
+Added: Early adoption is permitted.
+Added: The Company is in the process
+Added: of assessing the impact of ASU 2023-07 on our disclosures.
+Added: In December 2023, the
+Added: FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires disaggregated information about our effective
+Added: tax rate reconciliation as well as information on income taxes paid.
+Added: The guidance will first be effective in our annual disclosures
+Added: for the year ending December 31, 2025, and should be applied on a prospective basis with the option to apply retrospectively.
+Added: adoption is permitted.
+Added: The Company is in the process of assessing the impact of ASU 2023-09 on our disclosures.
+Added: In March 2024, the
+Added: SEC adopted new rules relating to the disclosure of a range of climate-change-related physical and transition risks, data, and
+Added: opportunities.
+Added: The adopted rule contains several new disclosure obligations, including, (i) disclosure on how the board of directors
+Added: and management oversee climate-related risks and certain climate-related governance items, (ii) disclosure of information related
+Added: to a registrant’s climate-related targets, goals, and/or transition plans, and (iii) disclosure on whether and how climate-related
+Added: events and transition activities impact line items above a threshold amount on a registrant’s consolidate financial statements,
+Added: including the impact of the financial estimates and the assumptions used.
+Added: This new rule will first be effective in the Company’s
+Added: disclosures for the year ending December 31, 2027.
+Added: The Company is in the process of assessing the impact on our consolidated financial
+Added: statements and disclosures.
+Added: NOTE 3 – INVENTORY
+Added: The components of inventory
+Added: consisted of the following as of December 31, 2023:
(in thousands)
+Added: Raw Materials
+Added: Work-in-process
+Added: Finished Goods
+Added: Inventory gross
+Added: Inventory reserves
+Added: Total Inventory
+Added: NOTE 4 – PROPERTY AND EQUIPMENT,
+Added: Property and equipment,
+Added: net consisted of the following (in thousands):
+Added: (in thousands)
Property and equipment, net:
4 unchanged sentences
Construction in progress
−Removed: Accumulated depreciation and
−Removed: On October 1, 2021, the Company
−Removed: completed the acquisition of its approximately 45,000
−Removed: square foot research and development facility in Frederick, Maryland totaling $ 17.5
−Removed: million, to process development activities.
−Removed: Of the total purchase price, $ 2.1
−Removed: million was allocated to the value of land acquired, and $ 13.9
−Removed: million was allocated to buildings, and approximately $ 1.5
−Removed: million was allocated to Office furniture and equipment and Laboratory equipment.
−Removed: During the year ended December 31, 2022, the
−Removed: assets became ready for the intended use and were placed in service.
−Removed: On September 28, 2020, the
−Removed: Company completed the purchase of its approximately 45,000
−Removed: square foot facility in Dartmouth, Massachusetts for $ 4 .0
−Removed: million, to house its new Advanced Development Center for the development and manufacturing of vaccines.
−Removed: Of the total purchase price,
−Removed: million was allocated to the value of land acquired, and $ 2.8
−Removed: million was allocated to buildings.
−Removed: Additionally, the Company incurred approximately $ 38.8
−Removed: million of costs during the year ended December 31, 2022, bringing total costs incurred-to-date to $ 61.6
−Removed: million, of which the majority relates to the build-out of the facility.
−Removed: During the year ended December 31, 2022, the assets became
−Removed: ready for the intended use and were placed in service.
−Removed: On December 23, 2020, the
−Removed: Company completed the purchase of its approximately 44 -acre
−Removed: site in Hamilton, Montana for $ 4.5
−Removed: million, for the construction of a vaccine development and commercial scale manufacturing facility.
−Removed: As of December 31, 2022, the
−Removed: asset was not ready for its intended use.
−Removed: 4 – OTHER BALANCE SHEET INFORMATION
−Removed: of selected captions in the consolidated balance sheets consist of:
+Added: Property and equipment gross
+Added: Accumulated depreciation and amortization
+Added: Property and equipment, net
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: October 1, 2021, the Company completed the acquisition of its approximately 45,000 square foot research and development facility
+Added: in Frederick, Maryland totaling $ 17.5 million, to process development activities.
+Added: Of the total purchase price, $ 2.1 million was
+Added: allocated to the value of land acquired, and $ 13.9 million was allocated to buildings, and approximately $ 1.5 million was allocated
+Added: to office furniture and equipment and laboratory equipment.
+Added: As of August 1, 2022, the assets became ready for the intended use
+Added: and were placed in service.
+Added: September 28, 2020, the Company completed the purchase of its approximately 45,000 square foot facility in Dartmouth, Massachusetts
+Added: for $ 4 .0 million, to house its new Advanced Development Center for the development and manufacturing of vaccines.
+Added: purchase price, $ 1.2 million was allocated to the value of land acquired, and $ 2.8 million was allocated to buildings.
+Added: Additionally,
+Added: the Company incurred approximately $ 38.8 million of costs during the year ended December 31, 2022, bringing total costs incurred-to-date
+Added: to $ 61.6 million, of which the majority related to the build-out of the facility.
+Added: As of October 1, 2022, the assets became ready
+Added: for the intended use and were placed in service.
+Added: December 23, 2020, the Company completed the purchase of its approximately 44 -acre site in Hamilton, Montana for $ 4.5 million,
+Added: for the construction of a vaccine development and commercial scale manufacturing facility.
+Added: As of December 31, 2023, the asset
+Added: was not ready for its intended use.
+Added: the year ended December 31, 2023, property and equipment with a net book value of approximately $ 0.9 million were sold for net
+Added: proceeds of approximately $ 1 .0 million.
+Added: NOTE 5 – GOODWILL AND INTANGIBLE ASSETS
+Added: The following table
+Added: provides the gross carrying value of goodwill as follows:
(in thousands)
+Added: Balance at December 31, 2022
+Added: Acquired during the period (see Note 12)
+Added: Balance at December 31, 2023
+Added: The following table
+Added: provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
+Added: (in thousands)
+Added: Intangible assets subject to amortization
+Added: Developed technology
+Added: Accumulated amortization
+Added: Intangible assets not subject to amortization
+Added: Internet domain rights
+Added: Total intangible assets, net
+Added: During the year ended December 31, 2023,
+Added: the Company recorded amortization of $ 477,000 .
+Added: At December 31, 2023,
+Added: the related amortization for each of the next five years ended December 31 is as follows (in thousands):
+Added: Year Ending December 31,
+Added: 2028 and beyond
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTE 6 – FAIR VALUE MEASUREMENTS
+Added: Fair value measurements
+Added: affect the Company’s accounting for certain of its financial assets.
+Added: Fair value is defined as the price that would be received
+Added: to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date
+Added: and is measured according to a hierarchy that includes:
+Added: Observable inputs, such as quoted prices in active markets.
+Added: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly.
+Added: Level 2 assets and liabilities include debt securities with quoted market prices that are traded less frequently than exchange-traded instruments.
+Added: This category includes U.S.
+Added: government agency-backed debt securities and corporate-debt securities.
+Added: Unobservable inputs in which there is little or no market data.
+Added: As of December 31,
+Added: 2023, and December 31, 2022, the Company used Level 1 quoted prices in active markets to value cash equivalents of $ 0.1 million
+Added: and $ 116.3 million, respectively.
+Added: The Company did not have any Level 2 or Level 3 assets or liabilities as of December 31, 2022.
+Added: As of December 31, 2023, Level 3 liabilities include a portion of the Series D Warrants and all Series C Warrants issued on December
+Added: 22, 2023, which did not meet the criteria for equity classification due to insufficient authorized shares to settle the instruments
+Added: and are therefore accounted for as liabilities at fair value.
+Added: The Company estimates
+Added: the fair value of the Series D Warrants and the Series C Warrants using significant unobservable inputs, which represent Level
+Added: 3 measurements within the fair value hierarchy.
+Added: The Company estimated the fair value of these instruments using the Black-Scholes
+Added: option pricing model, which was then adjusted by applying a discount for lack of marketability (“DLOM”) based on the
+Added: expected timing of receipt of stockholder approval to increase the number of authorized shares and to allow the Warrants to become
+Added: exercisable in accordance with Nasdaq Listing Rule 5635.
+Added: The significant unobservable
+Added: inputs used in the valuation models at issuance and as of December 31, 2023, to measure the fair value of the Series D Warrants
+Added: and the Series C Warrants are as follows:
+Added: Series C Warrants
+Added: Series D Warrants
+Added: Valuation Date:
+Added: December 22, 2023
+Added: December 31, 2023
+Added: December 22, 2023
+Added: December 31, 2023
+Added: Common stock price
+Added: Risk-free rate
+Added: Expected term (in years)
+Added: Expected volatility
+Added: Dividend yield
+Added: Discount for lack of marketability
+Added: The liability-classified
+Added: Series D Warrants and the Series C Warrants were recognized at their aggregate issuance date fair values totaling $ 22.5 million.
+Added: From the date of issuance to December 31, 2023, the Company recognized a change in fair value resulting in a loss of $0.3 million
+Added: related to the liability-classified warrants.
+Added: Changes in the fair value of the liability-classified warrants are recognized as
+Added: a component of other income, net in the consolidated statement of operations.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTE 7 – OTHER BALANCE SHEET INFORMATION
+Added: Components of selected
+Added: captions in the consolidated balance sheets consist of:
+Added: (in thousands)
Prepaid expenses and other:
Contract-related
+Added: Debt interest and fees
Accrued expenses and other current liabilities:
Contract-related
+Added: Upsher Smith obligation
Compensation and compensation-related
+Added: Product returns
Construction in progress
Professional fees and other
−Removed: 5 – FAIR VALUE MEASUREMENTS
−Removed: Fair value measurements affect
−Removed: the Company’s accounting for certain of its financial assets.
−Removed: Fair value is defined as the price that would be received to sell
−Removed: an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and is measured
−Removed: according to a hierarchy that includes:
−Removed: Observable inputs, such as quoted prices in active markets.
−Removed: Inputs, other than quoted prices in active markets, that are observable
−Removed: either directly or indirectly.
−Removed: Level 2 assets and liabilities include debt securities with quoted market prices that are traded less
−Removed: frequently than exchange-traded instruments.
−Removed: This category includes U.S.
−Removed: government agency-backed debt securities and corporate-debt securities.
−Removed: Unobservable inputs in which there is little or no market data.
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: As of December 31, 2022, and
−Removed: December 31, 2021, the Company used Level 1 quoted prices in active markets to value cash equivalents of $ 116.3
−Removed: million and $ 120.4
−Removed: million, respectively.
−Removed: The Company did not have any Level 2 or Level 3 assets or liabilities as of both December 31, 2022 and 2021.
−Removed: 6 – STOCKHOLDERS’ EQUITY
−Removed: On May 16, 2022, the Company
−Removed: filed a Certificate of Change with the Nevada Secretary of State, effective May 17, 2022.
−Removed: Pursuant to the Certificate of Change, the
−Removed: Company effected a 1-for-32
−Removed: reverse stock split of its issued and outstanding shares of common stock, whereby 599,679,596
−Removed: outstanding shares of the Company’s common stock were exchanged for 18,740,141
−Removed: shares of the Company’s common stock.
−Removed: In connection with the reverse stock split, the Company issued an additional 130,462
−Removed: shares of the Company’s common stock due to fractional shares.
−Removed: Furthermore, pursuant to the Certificate of Change, the number
−Removed: of authorized shares of common stock was reduced from 800
−Removed: million to 50 million.
−Removed: share amounts and number of shares in the consolidated financial statements and related notes have been retroactively restated to reflect
−Removed: the reverse stock split.
−Removed: On August 5, 2022, the Company
−Removed: filed an amendment to its articles of incorporation, as amended, to increase the number of shares of common stock authorized from 50,000,000
−Removed: to 150,000,000 .
−Removed: On December 13, 2022, the
−Removed: Company filed an amendment to its articles of incorporation, as amended, to increase the number of shares of common stock authorized from
−Removed: 150,000,000 to 1,000,000,000 .
−Removed: 7 – TEMPORARY EQUITY
−Removed: On October 26, 2022, the Company
−Removed: closed on an offering (“the October offering”) with certain institutional investors (the “Investors”), pursuant
−Removed: to which the Company issued and sold, in a private placement, 1,400,000
−Removed: shares of the Company’s Series A Convertible Redeemable Preferred Stock, par value $ 0.001
−Removed: per share (the “Series A Preferred Stock”), and 100,000
−Removed: shares of the Company’s Series B Convertible Redeemable Preferred Stock, par value $ 0.001
−Removed: per share (the “Series B Preferred Stock,” and together with the Series A Preferred Stock, the “Preferred Stock”),
−Removed: at an offering price of $ 9.50
−Removed: per share, representing a 5 %
−Removed: original issue discount (“OID) to the stated value of $ 10.00
−Removed: per share, for gross proceeds of $ 14.3
−Removed: million in the aggregate for the October offering, before the deduction of fees and offering expenses.
−Removed: The shares of Preferred Stock
−Removed: were convertible, at a conversion price of $ 1.00
−Removed: per share (subject in certain circumstances to adjustments), into shares of the Company’s common stock, at the option of the holders
−Removed: and, in certain circumstances, by the Company.
−Removed: On December 13, 2022, an amendment
−Removed: (the “December Amendment”) to the Company’s Articles of Incorporation, as amended, to increase the Company’s authorized
−Removed: shares of common stock from 150,000,000
−Removed: to 1,000,000,000 , was approved at
−Removed: a special meeting of shareholders.
−Removed: The Series A Preferred Stock had the right to vote on such December Amendment on an as-converted to
−Removed: common stock basis.
−Removed: The shares of the Series B Preferred Stock were automatically voted in a manner that “mirrored” the proportions
−Removed: on which the shares of Common Stock (excluding any shares of Common Stock that were not voted) and Series A Preferred Stock were voted
−Removed: to increase the Authorized Shares.
−Removed: The December Amendment required the approval of the majority of the votes associated with the Company’s
−Removed: outstanding stock entitled to vote on the proposal.
−Removed: Because the Series B Preferred Stock were automatically and without further action
−Removed: of the purchaser voted in a manner that “mirrored” the proportions on which the shares of Common Stock (excluding any shares
−Removed: of Common Stock that were not voted) and Series A Preferred Stock were voted on the December Amendment, abstentions by common stockholders
−Removed: did not have any effect on the votes cast by the holders of the Series B Preferred Stock.
−Removed: The Certificates of Designation for the Preferred
−Removed: Stock provides that the Preferred
−Removed: Stock have no voting rights other than the right to vote on the December Amendment and as a class on certain other specified matters ,
−Removed: and, with respect to the Series B Certificate of Designation, the
−Removed: right to cast 2,500 votes per share of Series B Preferred Stock on the December Amendment .
−Removed: The holders of Preferred Stock
−Removed: were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of Common Stock.
−Removed: The Preferred
−Removed: Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of Common Stock at a conversion
−Removed: price of $ 1.00
−Removed: The holders of the Preferred Stock had the right to require the Company to redeem their shares of preferred stock for cash
−Removed: of the stated value of such shares through January 23, 2023.
−Removed: The Company had the option to redeem the Preferred Stock for cash at 105 %
−Removed: of the stated value, subject to the holders’ rights to convert the shares prior to such redemption.
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: million in gross proceeds of the October offering was held in an escrow account, along with an additional $ 1.5
−Removed: million deposited by the Company to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 %
−Removed: redemption price until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment
−Removed: to redeeming holders.
−Removed: Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to the
−Removed: the Preferred Stock had a redemption feature at the option of the holder, it was classified as temporary equity.
−Removed: Series A Preferred Stock and Series B Preferred Stock was recorded at redemption value of approximately $ 14.7
−Removed: million and $ 1.1
−Removed: million, respectively, as calculated in the following table (in thousands):
−Removed: A Preferred Stock
−Removed: B Preferred Stock
+Added: NOTE 8 – DEBT FINANCING
+Added: Long-term debt consists of the following:
+Added: (in thousands)
+Added: current portion
+Added: Total long-term debt
+Added: unamortized debt discount and deferred financing costs
+Added: Total long-term debt, net
+Added: December 8, 2023, the Company entered into a Loan and Guaranty Agreement (the “Loan Agreement”) by and among the Company,
+Added: Krele LLC, Tonix Pharmaceuticals, Inc., Jenner and Tonix R&D Center (“Loan Parties”), with JGB Capital, LP, JGB
+Added: Partners, LP, JGB (Cayman) Port Ellen Ltd., and any other lender from time to time party hereto (collectively, the “Lenders”),
+Added: and JGB Collateral LLC, as administrative agent and collateral agent for the Lenders (in such capacity, “JGB Agent”)
+Added: for a 36 -month term loan (the “Term Loan”) in the aggregate principal amount of $ 11 .0 million, with a maturity date
+Added: of December 8, 2026 (the “Maturity Date”).
+Added: The Term Loan was funded with an original issue discount of 9 % of the principal
+Added: 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
+Added: interest rate on the outstanding borrowings.
+Added: Borrowings under the
+Added: Term Loan bear interest at a fluctuating rate equal to the greater of (i) the prime rate as defined in the Loan Agreement plus
+Added: 3.5 % and (ii) 12 % .
+Added: Interest is payable monthly in arrears commencing in December 2023.
+Added: In connection with the Term Loan, the Company
+Added: deposited into a reserve account $ 1.8 million to be used exclusively to fund interest payments related to the Term Loan.
+Added: is reflected in Prepaid expenses and other current assets on the consolidated balance sheet.
+Added: Commencing on March
+Added: 8, 2024 and continuing monthly through the Maturity Date, the outstanding principal will be due and payable in monthly installments
+Added: of $ 0.2 million, with the final remaining balance of unpaid principal and interest due and payable on the Maturity Date.
+Added: the Company must pay a monthly collateral monitoring charge equal to 0.23 % of the outstanding principal amount of the term loan
+Added: as of the date of payment.
+Added: The Company incurred $ 1.1 million in issuance costs, which is being amortized over the term of
+Added: the debt as an adjustment to the effective interest rate on the outstanding borrowings.
+Added: The Loan Agreement
+Added: provides for voluntary prepayments of the Term Loan, in whole or in part, subject to a prepayment premium.
+Added: The Loan Agreement contains
+Added: customary affirmative and negative covenants by the Company, which among other things, will require the Borrowers to provide certain
+Added: financial reports to the lenders, to maintain a deposit account to fund interest payments, and limit the ability of the Company
+Added: to incur or guarantee additional indebtedness, pay dividends or make other equity distributions, sell assets, engage in certain
+Added: transactions, and effect a consolidation or merger.
+Added: The obligations of the Company under the Loan Agreement may be accelerated
+Added: upon customary events of default, including non-payment of principal, interest, fees and other amounts, covenant default, insolvency,
+Added: material judgements, inaccuracy of representations and warranties, invalidity of guarantees.
+Added: The Term Loan is secured by first
+Added: priority security interests in the Company’s R&D Center in Frederick, Maryland, the Advanced Development Center in North
+Added: Dartmouth, Massachusetts, and substantially all of the relevant deposit accounts.
+Added: As of December 31,
+Added: 2023, the carrying amount of the Term Loan approximated its fair value as the contractual interest rate for the Term Loan was representative
+Added: of the then market interest rate.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Annual future principal
+Added: payments due on the Term Loan as of December 31, 2023 are as follows (in thousands):
+Added: Fiscal years ending
+Added: NOTE 9 – STOCKHOLDERS’ EQUITY
+Added: May 9, 2023, the Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023.
+Added: the Certificate of Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common
+Added: stock, whereby 64,627,246 outstanding shares of the Company’s common stock were exchanged for 10,340,506 shares of the Company’s
+Added: common stock.
+Added: In connection with the reverse stock split, the Company issued an additional 131,902 shares of the Company’s
+Added: common stock due to fractional shares.
+Added: Furthermore, pursuant to the Certificate of Change, the number of authorized shares of
+Added: common stock was reduced from 1,000,000,000 to 160,000,000 .
+Added: All per share amounts and number of shares in the consolidated financial
+Added: statements and related notes have been retroactively restated to reflect the reverse stock split.
+Added: October 17, 2023, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”)
+Added: indicating that, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days,
+Added: the Company no longer meets the requirement to maintain a minimum bid price of $ 1 per share, as set forth in Nasdaq Listing Rule
+Added: 55450(a)(1) (the “Minimum Bid Price Requirement”).
+Added: Company was initially provided with a 180 calendar day period, or until April 15, 2024, in which to regain compliance.
+Added: event that the Company does not regain compliance within this 180 -day period, the Company may be eligible to seek an additional
+Added: 180 day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other
+Added: initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provides
+Added: written notice to Nasdaq of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock
+Added: split, if necessary.
+Added: On January 25, 2024,
+Added: the Company filed a Certificate of Amendment to its Articles of Incorporation, as amended, with the Secretary of State of the State
+Added: 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
+Added: (the “Charter Amendment”).
+Added: The Charter Amendment was approved by the Company’s shareholders at a special meeting
+Added: of shareholders held on January 25, 2024.
+Added: NOTE 10 – TEMPORARY EQUITY
+Added: On October 26, 2022,
+Added: the Company closed on an offering (“the October offering”) with certain institutional investors (the “Investors”),
+Added: pursuant to which the Company issued and sold, in a private placement, 1,400,000 shares of the Company’s Series A Convertible
+Added: Redeemable Preferred Stock, par value $ 0.001 per share (the “Series A Preferred Stock”), and 100,000 shares of the
+Added: Company’s Series B Convertible Redeemable Preferred Stock, par value $ 0.001 per share (the “Series B Preferred Stock,”
+Added: and together with the Series A Preferred Stock, the “Preferred Stock”), at an offering price of $ 9.50 per share, representing
+Added: a 5 % original issue discount (“OID) to the stated value of $ 10.00 per share, for gross proceeds of $ 14.3 million in the aggregate
+Added: for the October offering, before the deduction of fees and offering expenses.
+Added: The shares of Preferred Stock were convertible, at
+Added: a conversion price of $ 6.25 per share (subject in certain circumstances to adjustments), into shares of the Company’s common
+Added: stock, at the option of the holders and, in certain circumstances, by the Company.
+Added: December 13, 2022, an amendment (the “December Amendment”) to the Company’s Articles of Incorporation, as amended,
+Added: to increase the Company’s authorized shares of common stock from 24,000,000 to 160,000,000 , as adjusted for the reverse
+Added: split, was approved at a special meeting of shareholders.
+Added: The Series A Preferred Stock had the right to vote on such December
+Added: Amendment on an as-converted to common stock basis.
+Added: The shares of the Series B Preferred Stock were automatically voted in a manner
+Added: that “mirrored” the proportions on which the shares of common stock (excluding any shares of common stock that were
+Added: not voted) and Series A Preferred Stock were voted to increase the Authorized Shares.
+Added: The December Amendment required the approval
+Added: of the majority of the votes associated with the Company’s outstanding stock entitled to vote on the proposal.
+Added: Series B Preferred Stock were automatically and without further action of the purchaser voted in a manner that “mirrored”
+Added: the proportions on which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred
+Added: Stock were voted on the December Amendment, abstentions by common stockholders did not have any effect on the votes cast by the
+Added: holders of the Series B Preferred Stock.
+Added: The Certificates of Designation for the Preferred Stock provides that the Preferred Stock
+Added: have no voting rights other than the right to vote on the December Amendment and as a class on certain other specified matters ,
+Added: and, with respect to the Series B Certificate of Designation, the right to cast 2,500 votes per share of Series B Preferred Stock
+Added: on the December Amendment .
+Added: holders of Preferred Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any,
+Added: on shares of common stock.
+Added: The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by
+Added: the Company, into shares of common stock at a conversion price of $ 6.25 per share.
+Added: The holders of the Preferred Stock had the
+Added: right to require the Company to redeem their shares of preferred stock for cash at 105 % of the stated value of such shares through
+Added: January 23, 2023.
+Added: The Company had the option to redeem the Preferred Stock for cash at 105 % of the stated value, subject to the
+Added: holders’ rights to convert the shares prior to such redemption.
+Added: $ 14.3 million in gross proceeds of the October offering was held in an escrow account, along with an additional $ 1.5 million deposited
+Added: by the Company to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 % redemption
+Added: price until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to
+Added: redeeming holders.
+Added: Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Since the Preferred
+Added: Stock had a redemption feature at the option of the holder, it was classified as temporary equity.
+Added: The Series A Preferred Stock
+Added: and Series B Preferred Stock was recorded at redemption value of approximately $ 14.7 million and $1.1 million, respectively, as
+Added: calculated in the following table (in thousands):
Gross Proceeds
2 unchanged sentences
Preferred stock subject to possible redemption
−Removed: During December 2022, the
−Removed: Company received redemption notices for all outstanding shares of Preferred Stock.
−Removed: The Preferred Stock was redeemed during December 2022
−Removed: of the $ 10.00
−Removed: stated value of the Preferred Stock, or $ 15.8
−Removed: million in the aggregate.
−Removed: On June 24, 2022, the Company
−Removed: closed on an offering (“the Offering”) with certain institutional investors (the “Investors”), pursuant to which
−Removed: the Company issued and sold, in a private placement, 2,500,000
−Removed: shares of the Company’s Series A Convertible Redeemable Preferred Stock, par value $ 0.001
−Removed: per share (the “Series A Preferred Stock”), and 500,000
−Removed: shares of the Company’s Series B Convertible Redeemable Preferred Stock, par value $ 0.001
−Removed: per share (the “Series B Preferred Stock,” and together with the Series A Preferred Stock, the “Preferred Stock”),
−Removed: at an offering price of $ 9.50
−Removed: per share, representing a 5 %
−Removed: original issue discount (“OID) to the stated value of $ 10.00
−Removed: per share, for gross proceeds of $ 28.5
−Removed: million in the aggregate for the Offering, before the deduction of fees and offering expenses.
−Removed: The shares of Preferred Stock were convertible,
−Removed: at a conversion price of $ 4.00
−Removed: per share (subject in certain circumstances to adjustments), into shares of the Company’s common stock, at the option of the holders
−Removed: and, in certain circumstances, by the Company.
−Removed: On August 5, 2022, an amendment
−Removed: (the “Amendment”) to the Company’s Articles of Incorporation, as amended, to increase the Company’s authorized
−Removed: shares of common stock from 50,000,000
−Removed: to 150,000,000 ,
−Removed: was approved at a special meeting of shareholders.
−Removed: The Series A Preferred Stock had the right to vote on such Amendment on an as-converted
−Removed: to common stock basis.
−Removed: The shares of the Series B Preferred Stock were automatically voted in a manner that “mirrored” the
−Removed: proportions on which the shares of Common Stock (excluding any shares of Common Stock that were not voted) and Series A Preferred Stock
−Removed: were voted to increase the Authorized Shares.
−Removed: The Amendment required the approval of the majority of the votes associated with the Company’s
−Removed: outstanding stock entitled to vote on the proposal.
−Removed: Because the Series B Preferred Stock were automatically and without further action
−Removed: of the purchaser voted in a manner that “mirrored” the proportions on which the shares of Common Stock (excluding any shares
−Removed: of Common Stock that were not voted) and Series A Preferred Stock were voted on the Amendment, abstentions by common stockholders did
−Removed: not have any effect on the votes cast by the holders of the Series B Preferred Stock.
−Removed: The Certificates of Designation for the Preferred
−Removed: Stock provides that the Preferred
−Removed: Stock have no voting rights other than the right to vote on the Amendment and as a class on certain other specified matters , and,
−Removed: with respect to the Series B Certificate of Designation, the
−Removed: right to cast 2,500 votes per share of Series B Preferred Stock on the Amendment .
−Removed: The holders of Preferred Stock
−Removed: were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of Common Stock.
−Removed: The Preferred
−Removed: Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of Common Stock at a conversion
−Removed: price of $ 4.00
−Removed: The holders of the Preferred Stock had the right to require the Company to redeem their shares of preferred stock for cash
−Removed: of the stated value of such shares through September 22, 2022.
−Removed: The Company had the option to redeem the Preferred Stock for cash at 105 %
−Removed: of the stated value, subject to the holders’ rights to convert the shares prior to such redemption.
−Removed: million in gross proceeds of the Offering was held in an escrow account, along with an additional $ 3 .0
−Removed: million deposited by the Company to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 %
−Removed: redemption price until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment
−Removed: to redeeming holders.
−Removed: Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to the
−Removed: the Preferred Stock had a redemption feature at the option of the holder, it was classified as temporary equity.
−Removed: The Series A Preferred
−Removed: Stock and Series B Preferred Stock was recorded at redemption value of approximately $ 26.3
−Removed: million and $ 5.2
−Removed: million, respectively, as calculated in the following table (in thousands):
−Removed: A Preferred Stock
−Removed: B Preferred Stock
+Added: During December 2022,
+Added: the Company received redemption notices for all outstanding shares of Preferred Stock.
+Added: The Preferred Stock was redeemed during
+Added: December 2022 at 105 % of the $ 10.00 stated value of the Preferred Stock, or $ 15.8 million in the aggregate.
+Added: On June 24, 2022, the
+Added: Company closed on an offering (“the Offering”) with certain institutional investors (the “Investors”),
+Added: pursuant to which the Company issued and sold, in a private placement, 2,500,000 shares of the Company’s Series A Convertible
+Added: Redeemable Preferred Stock, par value $ 0.001 per share (the “Series A Preferred Stock”), and 500,000 shares of the
+Added: Company’s Series B Convertible Redeemable Preferred Stock, par value $ 0.001 per share (the “Series B Preferred Stock,”
+Added: and together with the Series A Preferred Stock, the “Preferred Stock”), at an offering price of $ 9.50 per share, representing
+Added: a 5 % OID to the stated value of $ 10.00 per share, for gross proceeds of $ 28.5 million in the aggregate for the Offering, before
+Added: the deduction of fees and offering expenses.
+Added: The shares of Preferred Stock were convertible, at a conversion price of $ 25.00 per
+Added: share (subject in certain circumstances to adjustments), into shares of the Company’s common stock, at the option of the
+Added: holders and, in certain circumstances, by the Company.
+Added: August 5, 2022, an amendment (the “Amendment”) to the Company’s Articles of Incorporation, as amended, to increase
+Added: the Company’s authorized shares of common stock from 8,000,000 to 24,000,000 , as adjusted for the reverse split, was approved
+Added: at a special meeting of shareholders.
+Added: The Series A Preferred Stock had the right to vote on such Amendment on an as-converted to
+Added: common stock basis.
+Added: The shares of the Series B Preferred Stock were automatically voted in a manner that “mirrored”
+Added: the proportions on which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred
+Added: Stock were voted to increase the Authorized Shares.
+Added: The Amendment required the approval of the majority of the votes associated
+Added: with the Company’s outstanding stock entitled to vote on the proposal.
+Added: Because the Series B Preferred Stock were automatically
+Added: and without further action of the purchaser voted in a manner that “mirrored” the proportions on which the shares of
+Added: common stock (excluding any shares of common stock that were not voted) and Series A Preferred Stock were voted on the Amendment,
+Added: abstentions by common stockholders did not have any effect on the votes cast by the holders of the Series B Preferred Stock.
+Added: Certificates of Designation for the Preferred Stock provides that the Preferred Stock have no voting rights other than the right
+Added: to vote on the Amendment and as a class on certain other specified matters , and, with respect to the Series B Certificate of Designation,
+Added: the right to cast 2,500 votes per share of Series B Preferred Stock on the Amendment .
+Added: The holders of Preferred
+Added: Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of common stock.
+Added: The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of
+Added: common stock at a conversion price of $ 25.00 per share.
+Added: The holders of the Preferred Stock had the right to require the Company
+Added: to redeem their shares of preferred stock for cash at 105 % of the stated value of such shares through September 22, 2022.
+Added: had the option to redeem the Preferred Stock for cash at 105 % of the stated value, subject to the holders’ rights to convert
+Added: the shares prior to such redemption.
+Added: $ 28.5 million in gross proceeds of the Offering was held in an escrow account, along with an additional $ 3 .0 million deposited
+Added: by the Company to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 % redemption
+Added: price until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to
+Added: redeeming holders.
+Added: Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to
+Added: Since the Preferred
+Added: Stock had a redemption feature at the option of the holder, it was classified as temporary equity.
+Added: The Series A Preferred Stock
+Added: and Series B Preferred Stock was recorded at redemption value of approximately $26.3 million and $5.2 million, respectively, as
+Added: calculated in the following table (in thousands):
Gross Proceeds
2 unchanged sentences
Preferred stock subject to possible redemption
−Removed: During August 2022, the Company
−Removed: received redemption notices for all outstanding shares of Preferred Stock.
−Removed: The Preferred Stock was redeemed during August 2022 at 105 %
−Removed: of the $ 10.00
−Removed: stated value of the Preferred Stock, or $ 31.5
−Removed: million in the aggregate.
+Added: During August 2022,
+Added: the Company received redemption notices for all outstanding shares of Preferred Stock.
+Added: The Preferred Stock was redeemed during
+Added: August 2022 at 105 % of the $ 10.00 stated value of the Preferred Stock, or $ 31.5 million in the aggregate.
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 8 – ASSET PURCHASE AGREEMENT WITH KATANA
−Removed: On December 22, 2020, the
−Removed: Company entered into an asset purchase agreement (the “Katana Asset Purchase Agreement”) with Katana Pharmaceuticals, Inc.
−Removed: (“Katana”) pursuant to which Tonix acquired Katana assets related to insulin resistance and related syndromes, including obesity
−Removed: (the “Katana Assets”).
−Removed: In connection with the acquisition of the Katana Assets, Tonix assumed Katana’s rights and obligations
−Removed: under that certain Exclusive License Agreement by and between Katana and The University of Geneva (“Geneva”) (the “Geneva
−Removed: License “Agreement”) pursuant to an Assignment and Assumption Agreement with Geneva (“Geneva Assignment and Assumption
−Removed: Agreement”), dated December 22, 2020.
−Removed: As consideration for entering into the Katana Asset Purchase Agreement, Tonix paid $ 0.7
−Removed: million to Katana.
−Removed: The costs associated with the cash payments were recorded to research and development expenses in the statement
−Removed: of operations for the year ended December 31, 2020.
−Removed: Because the Katana intellectual property was acquired prior to U.S.
−Removed: Food and Drug
−Removed: Administration (FDA) approval, the cash consideration totaling $ 0.7
−Removed: million, was expensed as research and development costs since there is no alternative future use and the acquired intellectual
−Removed: property does not constitute a business.
−Removed: Pursuant to the terms of the
−Removed: Geneva Assignment and Assumption Agreement, Geneva has granted to Tonix an exclusive license, with the right to sublicense, certain patents
−Removed: related to the Katana Assets.
−Removed: Tonix is obligated to use commercially reasonable efforts to diligently develop, manufacture, and sell products
−Removed: claimed or covered by the patent and will use commercially reasonable efforts to diligently develop markets for such products.
−Removed: License Agreement specifies developmental milestones and the period of time during which such milestones must be completed and provides
−Removed: for an annual maintenance fee payable to Geneva.
−Removed: As of December 31, 2022, no milestone payments have been accrued or paid in relation
−Removed: to this agreement.
−Removed: 9 – ASSET PURCHASE AGREEMENT WITH TRIGEMINA
−Removed: On June 11, 2020, the Company
−Removed: entered into an asset purchase agreement (the “Trigemina Asset Purchase Agreement”) with Trigemina, Inc.
−Removed: (“Trigemina”)
−Removed: and certain shareholders named therein (the “Executive Shareholders”) pursuant to which Tonix acquired Trigemina assets related
−Removed: to migraine and pain treatment technologies (the “Trigemina Assets”).
−Removed: In connection with the acquisition of the Trigemina
−Removed: Assets, Tonix assumed Trigemina’s rights and obligations under that certain Amended and Restated Exclusive License Agreement, dated
−Removed: November 30, 2007, as amended, by and between Trigemina and The Board of Trustees of the Leland Stanford Junior University (“Stanford”)
−Removed: (the “Stanford License “Agreement”) pursuant to an Assignment and Assumption Agreement with Stanford (“Assignment
−Removed: and Assumption Agreement”), dated June 11, 2020.
−Removed: As consideration for entering into the Asset Purchase Agreement, Tonix paid $ 824,759
−Removed: to Trigemina and issued to Trigemina 62,500
−Removed: shares of the Company’s common stock, valued at $ 21.76
−Removed: per share, based on the closing stock price on June 11, 2020, and paid Stanford $ 250,241
−Removed: pursuant to the terms of the Assignment and Assumption Agreement.
−Removed: The common stock is unregistered and subject to a 12-month lock-up and
−Removed: a Shareholder Voting Agreement, dated June 11, 2020, pursuant to which Trigemina and the Executive Shareholders have agreed to vote the
−Removed: common stock on any matter put to a vote of the shareholders of the Company in accordance with management’s recommendations.
−Removed: the costs associated with the cash payments and share issuance, totaling $ 2.4
−Removed: million, were recorded to research and development expenses in the statement of operations for the year ended December 31, 2020.
−Removed: Because the Trigemina intellectual property was acquired prior to FDA approval, the cash and stock consideration, was expensed as research
−Removed: and development costs since there is no alternative future use and the acquired intellectual property does not constitute a business.
−Removed: Pursuant to the terms of the
−Removed: Assignment and Assumption Agreement, Stanford has granted to Tonix an exclusive license, with the right to sublicense, certain patents
−Removed: related to the Trigemina Assets.
−Removed: Stanford has reserved for itself the right to practice under the patents for academic research and educational
−Removed: Tonix is obligated to use commercially reasonable efforts to diligently develop, manufacture, and sell products claimed or covered
−Removed: by the patent and will use commercially reasonable efforts to diligently develop markets for such products.
−Removed: The Trigemina License Agreement
−Removed: specifies developmental milestones and the period of time during which such milestones must be completed and provides for an annual maintenance
−Removed: fee payable to Stanford.
−Removed: As of December 31, 2022, other than the annual maintenance fee, no milestone payments have been accrued or paid
−Removed: in relation to this agreement.
−Removed: 10 – ASSET PURCHASE AGREEMENT WITH TRIMARAN
−Removed: On August 19, 2019, the Company
−Removed: entered into an asset purchase agreement (the “Asset Purchase Agreement”) with TRImaran Pharma, Inc.
−Removed: and the selling shareholders named therein (the “Selling Shareholders”) pursuant to which Tonix acquired TRImaran’s
−Removed: assets related to certain pyran-based compounds (the “Assets”).
−Removed: In connection with the acquisition of the Assets, Tonix entered
−Removed: into a First Amended and Restated Exclusive License Agreement (the “WSU License Agreement”) with Wayne State University (“WSU”)
−Removed: on August 19, 2019, as subsequently amended.
−Removed: As consideration for entering into the Asset Purchase Agreement, Tonix paid $ 100,000
−Removed: to TRImaran and has assumed certain liabilities of TRImaran totaling $ 68,500 .
−Removed: The $ 168,500
−Removed: was previously recorded to research and development expenses in the statement of operations.
−Removed: Upon the achievement of specified development,
−Removed: regulatory and sales milestones, Tonix also agreed to pay TRImaran and the Selling Shareholders, in restricted stock or cash, at Our option,
−Removed: a total of approximately $ 3.4
−Removed: Pursuant to the terms of the Asset Purchase Agreement, TRImaran and the Selling Shareholders are prohibited from disclosing
−Removed: confidential information related to the Assets and are restricted from engaging, for a period of three years, in the development or commercialization
−Removed: of any therapeutic containing any pyran-based drug compound for the treatment of post-traumatic stress disorder, attention deficit hyperactivity
−Removed: disorder or major depressive disorder.
−Removed: Also for a period of three years, if TRImaran or any Selling Shareholder engage in the research
−Removed: or development of any potential therapeutic compound for the treatment of any central nervous system disorder, TRImaran or such Selling
−Removed: Shareholder is obliged to provide notice and opportunity to Tonix to make an offer to acquire or license rights with respect to such product
−Removed: Pursuant to the terms of the
−Removed: WSU License Agreement, WSU has granted to Tonix an exclusive license, with the right to sublicense, certain patents, technical information
−Removed: and material (collectively, the “Technology”) related to the Assets.
−Removed: WSU has reserved for itself the right to practice the
−Removed: Technology for academic research and educational purposes.
−Removed: Tonix is obligated to use commercially reasonable efforts to obtain regulatory
−Removed: approval for one or more products utilizing the Technology (“WSU Products”) and to use commercially reasonable marketing efforts
−Removed: throughout the term of the WSU License Agreement.
−Removed: The WSU License Agreement specifies developmental milestones and the period of time
−Removed: during which such milestones must be completed and provides for an annual maintenance fee payable to WSU.
−Removed: Tonix is obligated to substantially
−Removed: manufacture WSU Products in the United States if WSU Products will be sold in the United States.
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: Pursuant to the WSU License
−Removed: Agreement, Tonix paid $ 75,000
−Removed: to WSU as reimbursement of certain patent expenses, and, upon the achievement of specified development, regulatory and sales milestones,
−Removed: the Company also agreed to pay WSU, milestone payments totaling approximately $ 3.4
−Removed: Tonix has also agreed to pay WSU single-digit royalties on net sales of WSU Products sold by Tonix or a sublicensee on
−Removed: a tiered basis based on net sales, and additional sublicense fees on certain consideration received from sublicensees.
−Removed: Royalties on each
−Removed: particular WSU Product are payable on a country-by-country and Product-by-Product basis until the date of expiration of the last valid
−Removed: claim in the last to expire of the issued patents covered by the WSU License Agreement.
−Removed: Royalties payable on net sales of WSU Products
−Removed: may be reduced by 50 %
−Removed: of the royalties payable by Tonix to any third party for intellectual property rights which are necessary for the practice of the rights
−Removed: licensed to Tonix under the WSU License Agreement, provided that the royalty payable on a WSU Product may not be reduced by more than
−Removed: Each party also has the right to terminate the agreement for customary reasons such as material breach and bankruptcy.
−Removed: The WSU License
−Removed: Agreement contains provisions relating to termination, indemnification, confidentiality and other customary matters for an agreement of
−Removed: As of December 31, 2022, no milestone payments have been accrued or paid in relation to this agreement.
−Removed: 11 – LICENSE AGREEMENT WITH CURIA
+Added: NOTE 11 – REVENUES
+Added: Disaggregation of Net Revenues
+Added: The Company’s net product revenues
+Added: are summarized below:
+Added: Zembrace Symtouch
+Added: Total product revenues
+Added: All sales are generated
+Added: in the United States.
+Added: Gross-to-Net Sales Accruals
+Added: We record gross-to-net
+Added: sales accruals for chargebacks, rebates, sales and other discounts, and product returns, which are all customary to the pharmaceutical
+Added: Our provision for gross-to-net allowances
+Added: was $ 2.9 million at December 31, 2023, $ 0.6 million of which was recorded as a reduction to accounts receivable and $ 2.3 million
+Added: recorded as a component of accrued expenses.
+Added: NOTE 12 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH
+Added: On June 30, 2023, the Company completed
+Added: the acquisition of certain assets from Upsher Smith related to Zembrace SymTouch (sumatriptan injection) 3 mg (“Zembrace”)
+Added: and Tosymra (sumatriptan nasal spray) 10 mg (“Tosymra”) products (such businesses collectively, the “Business”)
+Added: and certain inventory related to the Business for an aggregate purchase price of approximately $ 26.5 million, including certain deferred
+Added: payments and subject to customary adjustments (such transaction, the “USL Acquisition”).
+Added: On June 30, 2023, in connection with the USL Acquisition, the Company and
+Added: Upsher Smith entered into a Transition Services Agreement (the “Transition Services Agreement”), pursuant to which Upsher Smith will provide
+Added: 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
+Added: for the seventh through ninth months, plus additional monthly fees for each service category totaling up to $ 150,000 per month.
+Added: has amended the transitional services agreement with Upsher Smith so that Upsher Smith can continue to provide administrative services.
+Added: Company has assumed certain obligations of Seller, including the payment of quarterly earn-out payments on annual net sales from
+Added: the Business in the U.S.
+Added: for Tosymra, 4 % for net sales of $ 0 to $ 30 million, 7 % of net sales of $ 30 to $ 75 million;
+Added: 9 % for net sales of $ 75 to $ 100 million;
+Added: 12 % for net sales of $ 100 to $ 150 million;
+Added: and 15 % for net sales greater than $ 150 million.
+Added: Earn-out payments with respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed
+Added: patent(s) with respect to the United States or, outside the United States, the expiration of the last valid claim covering the
+Added: product in the relevant country of the territory.
+Added: For Zembrace, earn-out payments on annual net sales in the U.S.
+Added: are 3 % for net
+Added: sales of $ 0 to $ 30 million, 6 % of net sales of $ 30 to $ 75 million;
+Added: 12 % for net sales of $ 75 to $ 100 million;
+Added: 16 % for net sales
+Added: of greater than $ 100 million.
+Added: Such earn-out payments are payable until July 19, 2025.
+Added: Upon the entry of a generic version of the
+Added: relevant product, the applicable earn-out rates shall be reduced by 90 % percent with respect to Zembrace, and by 66.7 % percent
+Added: Prior to Purchaser or a licensee filing an application for marketing authorization for either of the products in
+Added: a permitted country outside the U.S., the parties will negotiate in good faith the earn-out payment rates annual net sales tiers
+Added: that will apply for such country, based on the market opportunity for the product in such country.
+Added: If the parties fail to agree,
+Added: then the earn-out payment rates and annual net sales tiers described above will apply.
+Added: addition, the Company has assumed the obligation to pay an additional 3 % royalty on net sales of Tosymra, plus an additional 3 %
+Added: if a patent containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra
+Added: 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
+Added: of a licensed patent, and up to $ 15 million per Tosymra product on the achievement of sales milestones.
+Added: As consideration for
+Added: acquisition of the Business and certain product-related inventories, the Company paid approximately $ 23.5 million in cash upfront.
+Added: On the earlier of March 2024 and the completion of the transition services to be provided by Upsher Smith, as described above, the Company
+Added: agreed to pay an additional deferred payment of $ 3 .0 million in cash, which is included in Accrued expenses and other current liabilities
+Added: on the accompanying balance sheet.
+Added: The following table summarizes the components of the purchase consideration (in thousands):
+Added: Purchase consideration
+Added: Closing cash consideration
+Added: Inventory adjustment payment liability
+Added: Deferred payment liability
+Added: Purchase price to be allocated
+Added: The USL Acquisition
+Added: was accounted for as a business combination using the acquisition method, in accordance with the provisions of ASC 805, Business
+Added: Combinations and ASU No.
+Added: 2017-01, Business Combinations (Topic 805):
+Added: Clarifying the Definition of a Business.
+Added: and intangible assets acquired were recorded at their estimated fair values on the acquisition date, and the difference between
+Added: the fair value of these assets and the purchase price has been recorded as goodwill.
+Added: The purchase price allocation is based upon
+Added: preliminary valuations and estimates and assumptions which are subject to change.
+Added: As the Company receives additional information
+Added: about facts and circumstances that existed at the acquisition date, the fair values of the acquired inventory and intangible assets
+Added: may be adjusted, with the offset recorded to goodwill.
+Added: The following table
+Added: represents the allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized in the
+Added: Company’s consolidated balance sheets (in thousands):
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Preliminary purchase price allocation
+Added: Prepaid expenses and other
+Added: Intangible assets, net
+Added: Fair value of assets acquired
+Added: The acquired inventory
+Added: consists of Upsher Smith’s raw materials, semi-finished goods, and finished goods inventory as of the Closing date.
+Added: The fair value
+Added: was determined based on the estimated selling price of the inventory, less the estimated total costs to complete, disposal effort
+Added: and holding costs.
+Added: $ 1.0 million of goodwill arising from the USL Acquisition represents expected synergies from combining operations, intangible
+Added: assets that do not qualify for separate recognition, and other factors, of which all is expected to be deductible for tax purposes,
+Added: subject to any limitations.
+Added: Intangible assets eligible
+Added: for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
+Added: criterion in the accounting guidance.
+Added: The identifiable intangible assets acquired and their estimated useful lives for amortization
+Added: are as follows (in thousands):
+Added: Developed technology - Tosymra
+Added: Developed technology - Zembrace
+Added: The developed technology
+Added: intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer relationships,
+Added: and trademarks and trade names associated with the technology.
+Added: The developed technology intangible assets were valued as composite
+Added: assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from the
+Added: technology, and are assumed to have similar useful lives.
+Added: The composite intangible assets were valued using a multi-period excess
+Added: earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization.
+Added: assumptions used in estimating the fair values of intangible assets include forecasted financial information, the weighted average
+Added: cost of capital, customer retention rates, and certain other assumptions.
+Added: The fair values assigned
+Added: to the assets acquired are based on reasonable assumptions and estimates that market participants would use.
+Added: Actual results may
+Added: differ from these estimates and assumptions.
+Added: Supplemental Pro Forma Information
+Added: following unaudited pro forma consolidated financial information reflects the results of operations of the Company for the year
+Added: ended December 31, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives effect to
+Added: transactions that are directly attributable to the acquisition.
+Added: These amounts are based on financial information of the acquired
+Added: business and are not necessarily indicative of what the Company’s operating results would have been had the acquisition taken
+Added: place on the date presented, nor is it indicative of the Company’s future operating results.
+Added: The net loss of USL acquisition
+Added: is included in the Company’s consolidated results since the date of acquisition.
+Added: The revenue and net loss of the USL
+Added: Acquisition business reflected in the consolidated statements the year ended December 31, 2023 would have been $ 7.6
+Added: million and $ 2.4
+Added: million, respectively.
+Added: Net Product Sales
+Added: $ ( 119,905 )
+Added: $ ( 130,342 )
+Added: The pro forma information
+Added: for all periods presented include additional amortization expense related to the fair value of the acquired intangible assets as
+Added: if such assets were acquired on January 1, 2022.
+Added: The pro forma financial information for the year ended December 31, 2022 also
+Added: reflects an increase in Cost of Sales related to the preliminary acquisition-date fair value adjustment to inventory.
+Added: As described above,
+Added: in connection with the USL Acquisition, the Company and Upsher Smith entered into a Transition Services Agreement with the Seller related
+Added: to providing ongoing services associated with the assets acquired, such as procuring and selling migraine therapy products, providing
+Added: accounting and billing services and collecting accounts receivable and paying trade payables.
+Added: The Seller collected and will continue
+Added: to collect cash on behalf of Tonix for revenue generated by sales of the assets acquired from June 30, 2023 through the transition
+Added: period and the Seller is obligated to transfer cash generated by such sales to the Buyer.
+Added: The amount due to Upsher Smith
+Added: for reimbursement of services performed under the transition services agreement was $ 0.5 million as of December 31, 2023.
+Added: The transition
+Added: service fees were netted against the receivables collected of $ 5.1 million and liabilities paid of $ 4.4 million, including gross-to-net
+Added: on behalf of the Company with the net amount due to the Company of $ 0.2 million recorded within prepaid expenses and other on the consolidated
+Added: balance sheet as of December 31, 2023.
+Added: NOTE 13 – ASSET PURCHASE AGREEMENT WITH HEALION
+Added: On February 2, 2023,
+Added: the Company entered into an asset purchase agreement (the “Healion Asset Purchase Agreement”) with Healion Bio Inc.,
+Added: (“Healion”) pursuant to which the Company acquired all the pre-clinical infectious disease assets of Healion, including
+Added: its portfolio of next-generation antiviral technology assets.
+Added: Healion’s drug portfolio includes a class of broad-spectrum
+Added: small molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900, formerly known
+Added: As consideration for entering into the Healion Asset Purchase Agreement, the Company paid $ 1.2 million to Healion.
+Added: the Healion intellectual property was acquired prior to U.S.
+Added: Food and Drug Administration (FDA) approval, the cash consideration
+Added: totaling $ 1.2 million, was expensed as research and development costs since there is no alternative future use and the acquired
+Added: intellectual property does not constitute a business.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTE 14 – LICENSE AGREEMENT WITH CURIA
On December 12, 2022,
−Removed: the Company entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs for the
−Removed: treatment or prophylaxis of SARS-CoV-2 infection.
−Removed: We believe that the licensing of these mAbs strengthens our pipeline of
−Removed: next-generation therapeutics to treat COVID-19, which is caused by SARS-CoV-2.
−Removed: As consideration for entering into the License
−Removed: Agreement, we paid a license fee of approximately $ 0.4
−Removed: million to Curia.
−Removed: The License Agreement also provides for single-digit royalties and contingent milestone payments.
−Removed: December 31, 2022, other than the upfront fee, no payments have been accrued or paid in relation to this agreement.
−Removed: 12 – LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA
+Added: the Company entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs for the treatment
+Added: or prophylaxis of SARS-CoV-2 infection.
+Added: We believe that the licensing of these mAbs strengthens our pipeline of next-generation
+Added: therapeutics to treat COVID-19, which is caused by SARS-CoV-2.
+Added: As consideration for entering into the License Agreement, we paid
+Added: a license fee of approximately $ 0.4 million to Curia.
+Added: The License Agreement also provides for single-digit royalties and contingent
+Added: milestone payments.
+Added: As of December 31, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this
+Added: NOTE 15 – LICENSE AGREEMENT WITH
+Added: UNIVERSITY OF ALBERTA
On May 18, 2022, the
7 unchanged sentences
accrued or paid in relation to this agreement.
−Removed: 13 – LICENSE AGREEMENT WITH OYAGEN
−Removed: On April 14, 2021, the Company
−Removed: and OyaGen, Inc.
−Removed: (“OyaGen”) entered into an exclusive License Agreement (the “OyaGen License Agreement”) pursuant
−Removed: to which OyaGen granted to Tonix an exclusive license to certain patents and technical information related to an antiviral inhibitor of
−Removed: SARS-CoV-2, sangivamycin, and to develop and commercialize products thereunder, and to acquire rights to any technology based thereon
−Removed: for the prevention or treatment of COVID-19 developed by OyaGen during the term of the License Agreement.
−Removed: As consideration for entering
−Removed: into the License Agreement, Tonix paid a low-seven digit license fee to OyaGen, and issued to OyaGen and an affiliated entity an aggregate
−Removed: shares of the Company’s common stock.
−Removed: The shares were valued at $ 3 .0
−Removed: million, which was recorded as research and development expense.
−Removed: The OyaGen License also provided for single-digit royalties and contingent
−Removed: milestone payments.
−Removed: In July 2022, the Company notified OyaGen of its intent to terminate the OyaGen License Agreement, and the agreement
−Removed: was terminated effective September 20, 2022.
−Removed: 14 – LICENSE AGREEMENT WITH INSERM
+Added: NOTE 16 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY
On February 13, 2023,
−Removed: the Company entered into a license agreement (the “Inserm License Agreement”) pursuant to which it licensed technology
−Removed: using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic failure to thrive disease from Inserm
−Removed: (the French National Institute of Health and Medical Research), Aix-Marseille Université and Centre Hospitalier Universitaire
−Removed: The Inserm License Agreement provides for the payment of annual fees and milestone payments upon the occurrence of
−Removed: specified sales milestones totaling approximately $ 0.4
−Removed: million, as well royalties on net sales of products based on the licensed technology, and assignment/transfer and sublicense
−Removed: As of December 31, 2022, no milestone payments have been accrued or paid in relation to this agreement.
−Removed: 15 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY
−Removed: On September 16, 2019, the
−Removed: Company entered into an exclusive License Agreement (the “Columbia License Agreement”) with the Trustees of Columbia University
−Removed: in the City of New York (“Columbia”), as subsequently amended, pursuant to which Columbia granted to Tonix an exclusive license,
−Removed: with the right to sublicense, certain patents and technical information (collectively, the “TFF2 Technology”) related to a
−Removed: recombinant Trefoil Family Factor 2 (TFF2), and to develop and commercialize products thereunder (each, a “TFF2 Product”).
−Removed: Pursuant to the terms of the Columbia License Agreement, Columbia reserved for itself the right to practice the TFF2 Technology for academic
−Removed: research and educational purposes.
−Removed: The Company paid a five-digit
−Removed: license fee to Columbia as consideration for entering into the Columbia License Agreement, which was recorded to research and development
−Removed: expenses in the statement of operations for the year ended December 31, 2019.
−Removed: The Company is obligated to use Commercially Reasonable
−Removed: Efforts, as defined in the Columbia License Agreement, to develop and commercialize the TFF2 Product, and to achieve specified developmental
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: The Company is obligated to
−Removed: pay Columbia single-digit royalties on net sales of (i) TFF2 Products sold by Tonix or a sublicensee and (ii) any other products that
−Removed: involve material or technical information related to the TFF2 Product and transferred to Tonix pursuant to the Columbia License Agreement
−Removed: (“Other Products”) sold by Tonix or a sublicensee.
−Removed: Royalties on each particular TFF2 Product are payable on a country-by-country
−Removed: and Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the issued
−Removed: patents covered by the Columbia License Agreement, and (ii) a specified period of time after the first commercial sale of a TFF2 Product
−Removed: in the country in question.
−Removed: Royalties on each particular Other Product are payable on a country-by-country and product-by-product basis
−Removed: until a specified period of time after the first commercial sale of such particular Other Product in such country.
−Removed: Royalties payable on
−Removed: net sales of the TFF2 Product and Other Products may be reduced by 50 %
−Removed: of the royalties payable by Tonix to any third party for intellectual property rights which are necessary for the practice of the rights
−Removed: licensed to Tonix under the Columbia License Agreement, provided that the royalty payable on a Product or Other Product may not be reduced
−Removed: by more than 50 %.
−Removed: The Company is also
−Removed: obligated to make contingent milestone payments to Columbia totaling $ 4.1
−Removed: million on a Product-by-Product basis upon the achievement of certain development, approval and sales milestones related to a
−Removed: TFF2 Product.
−Removed: In addition, the Company shall pay Columbia 5 %
−Removed: of consideration, other than royalty payments and certain other categories of consideration, payable to the Company by a
−Removed: As of December 31, 2022, no milestone payments have been accrued or paid in relation to this agreement.
−Removed: On May 20, 2019, the Company
−Removed: entered into an exclusive License Agreement (the “License Agreement”) with Columbia pursuant to which Columbia, for itself
−Removed: and on behalf of the University of Kentucky and the University of Michigan (collectively, the “Institutions”) granted to the
−Removed: Company an exclusive license, with the right to sublicense, certain patents, technical information and material (collectively, the “Technology”)
−Removed: related to a double-mutant cocaine esterase, and to develop and commercialize products thereunder (each, a “Product”).
−Removed: to the terms of the License Agreement, Columbia has reserved for itself and the Institutions the right to practice the Technology for
−Removed: academic research and educational purposes.
−Removed: The Company paid a six-digit
−Removed: license fee to Columbia as consideration for entering into the License Agreement.
−Removed: The Company is obligated to use Commercially Reasonable
−Removed: Efforts, as defined in the License Agreement, to develop and commercialize the Product, and to achieve specified developmental milestones.
−Removed: The Company agreed to pay
−Removed: Columbia single-digit royalties on net sales of (i) Products sold by the Company or a sublicensee and (ii) any other products that involve
−Removed: material or technical information related to the Product and transferred to the Company pursuant to the License Agreement (“Other
−Removed: Products”) sold by the Company or a sublicensee.
−Removed: Royalties on each particular Product are payable on a country-by-country and Product-by-Product
−Removed: basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the issued patents covered by the
−Removed: License Agreement, (ii) a specified period of time after the first commercial sale of a Product in the country in question, or (iii) expiration
−Removed: of any market exclusivity period granted by a regulatory agency.
−Removed: Royalties on each particular Other Product are payable on a country-by-country
−Removed: and product-by-product basis until the later of (i) a specified period of time after the first commercial sale of such particular Other
−Removed: Product in such country or (ii) expiration of any market exclusivity period granted by a regulatory agency.
−Removed: Royalties payable on net sales
−Removed: of the Product and Other Products may be reduced by 50 %
−Removed: of the royalties payable by the Company to any third party for intellectual property rights which are necessary for the practice of the
−Removed: rights licensed to the Company under the License Agreement, provided that the royalty payable on a Product or Other Product may not be
−Removed: reduced by more than 50 %.
−Removed: The Company is also
−Removed: obligated to make contingent milestone payments to Columbia totaling $ 3 million
−Removed: on a Product-by-Product basis upon the achievement of certain development, approval and sales milestones related to a Product.
−Removed: addition, the Company shall pay Columbia 5 %
−Removed: of consideration, other than royalty payments and certain other categories of consideration, payable to the Company by a
−Removed: As of December 31, 2022, no milestone payments have been accrued or paid in relation to this agreement.
−Removed: 16 – SALE OF COMMON STOCK
+Added: Tonix exercised an option to obtain an exclusive license from Columbia University (“Columbia) for the development of a portfolio
+Added: of both fully human and murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100
+Added: product candidates, respectively.
+Added: The licensed mAbs were developed as part of a research collaboration and option agreement between
+Added: Tonix and Columbia.
+Added: As of December 31, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this
+Added: NOTE 17 – SALE OF COMMON STOCK
+Added: December 2023 Financing
+Added: December 20, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain
+Added: institutional investors, pursuant to which the Company sold and issued (i) 25,343,242 shares of the Company’s common stock,
+Added: (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 28,710,812 shares of common stock and (iii)
+Added: Series C warrants to purchase up to 81,081,081 shares of common stock (the “Series C Warrants”), and (iv) Series D
+Added: warrants to purchase up to 81,081,081 shares of common stock (the “Series D Warrants” and, together with the Series
+Added: C Warrants, the “Common Warrants”).
+Added: The securities sold in the offering were sold in fixed combinations as units.
+Added: The offering price per share of common stock and accompanying Common Warrants was $ 0.555 , and the offering price per Pre-Funded
+Added: Warrant and accompanying Common Warrants was $ 0.5549 .
+Added: The offering closed on December 22, 2023, generating gross proceeds of approximately
+Added: $ 30 .0 million, before deducting offering expenses of $ 2.3 million payable by the Company.
+Added: At the closing of the offering, 6,509,010
+Added: Pre-Funded Warrants were immediately exercised into shares of common stock for nominal proceeds.
+Added: Pre-Funded Warrants have an exercise price of $ 0.0001
+Added: per share, are immediately exercisable subject to certain ownership limitations, and can be exercised at any time until exercised in
+Added: The Series C Warrants have an exercise price of $ 0.555
+Added: per share, and are exercisable on the later of approval by the Company’s stockholders of (i) a proposal to approve the filing
+Added: of an amendment to the Company’s Articles of Incorporation, increasing the number of authorized shares of common stock from 160,000,000
+Added: to 1,000,000,000
+Added: and (ii) a proposal to allow the Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 (the later of such
+Added: events, the “Approval Date”) and will expire on the later of (a) 10
+Added: trading days following the Approval Date and (b) the earlier of (x) the two
+Added: year anniversary of the Approval Date and (y) 10
+Added: trading days following the public announcement of the U.S.
+Added: Food and Drug Administration’s (“FDA”) acknowledgement and
+Added: acceptance of the New Drug Application (“NDA”) relating to the Company’s TNX-102 SL product candidate in patients with fibromyalgia.
+Added: Warrants have an exercise price of $ 0.85
+Added: per share and are exercisable beginning on the Approval Date through the five-year
+Added: anniversary of the Approval Date.
+Added: the closing of the offering, the Company determined that certain of the Common Warrants did not meet the criteria for equity classification
+Added: due to the lack of sufficient authorized and unissued shares to settle the instruments.
+Added: The Company has adopted a sequencing approach
+Added: under ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity to determine the classification of its contracts
+Added: at issuance and at each subsequent reporting date, whereby shares are allocated based on the earliest issuance date of potentially
+Added: dilutive instruments, with the earliest issuance date receiving the first allocation of shares.
+Added: In the event of identical issuance
+Added: dates, shares are then allocated beginning with instruments with the latest maturity date first.
+Added: Pursuant to this sequencing approach,
+Added: the Company’s authorized and unissued shares were applied to the Pre-Funded Warrants and the Common Warrants in the following
+Added: (i) the Pre-Funded Warrants, (ii) the Series D Warrants, and (iii) the Series C Warrants.
+Added: Based on this analysis, the Company
+Added: determined that the authorized shares are sufficient to settle the remaining Pre-Funded Warrants and 50,933,271 Series D Warrants
+Added: and were therefore classified in equity.
+Added: The remaining 30,147,810 Series D Warrants and the Series C Warrants associated with
+Added: the deficit shares were classified as liabilities and are accounted for at fair value.
+Added: $ 30 .0 million in gross proceeds received by the Company were first allocated to the Series C Warrants and the liability-classified
+Added: Series D Warrants at their respective fair values of approximately $ 14.4 million and $ 8.1 million, respectively.
+Added: proceeds of approximately $ 7.5 million were allocated to the shares of common stock, the Pre-Funded Warrants, and the equity-classified
+Added: Series D Warrants on a relative fair value basis.
+Added: The issuance costs totaling $ 2.3 million were allocated between the equity and
+Added: liability-classified instruments on a relative fair value basis.
+Added: Issuance costs of $ 1.4 million allocated to the shares, the Pre-Funded
+Added: Warrants, and the equity-classified Series D Warrants were recognized as a discount to the proceeds allocated to the equity-classified
+Added: Issuance costs of $ 0.9 million were allocated to the liability-classified Series D Warrants and the Series C Warrants
+Added: and expensed within Selling, general and administrative expense on the consolidated statements of operations.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: The liability-classified
+Added: Series D Warrants and all of the Series C Warrants are presented within non-current liabilities on the consolidated balance sheets
+Added: as of December 31, 2023, and will be adjusted to fair value at each subsequent balance sheet date until the warrants are reclassified
+Added: to equity or settled.
+Added: Changes in the fair value of the liability-classified warrants are recognized as a component of other income,
+Added: net in the consolidated statement of operations.
+Added: On January 25, 2024,
+Added: the Company’s stockholders approved the proposal to file an amendment to the Company’s Articles of Incorporation to
+Added: increase the number of authorized shares of common stock from 160,000,000 to 1,000,000,000 .
+Added: September 2023 Financing
+Added: September 28, 2023, the Company sold 4,050,000 shares of common stock;
+Added: pre-funded warrants to purchase up to 4,950,000 shares
+Added: of common stock, and accompanying Series A warrants to purchase up to 9,000,000 shares of common stock with an exercise price
+Added: of $ 0.50 per share and expiring five years from date of issuance, and Series B warrants to purchase up to 9,000,000 shares of
+Added: common stock with an exercise price of $ 0.50 per share and expiring one year from date of issuance in a public offering, which
+Added: closed on October 3, 2023.
+Added: The offering price per share of common stock and accompanying warrants was $ 0.50 , and the offering
+Added: price per share of pre-funded warrant and accompanying warrants was $ 0.4999 .
+Added: Company incurred offering expenses of approximately $ 0.5 million, including placement agent fees of approximately $ 0.3 million.
+Added: The Company received net proceeds of approximately $ 4 .0 million, after deducting the underwriting discount and other offering
+Added: July 2023 Financing
+Added: July 27, 2023, the Company sold 2,530,000 shares of common stock;
+Added: pre-funded warrants to purchase up to 4,470,000 shares of common
+Added: stock and accompanying common warrants to purchase up to 7,000,000 shares of common stock with an exercise price of $ 1.00 per
+Added: share in a public offering that closed on August 1, 2023.
+Added: The offering price per share of common stock and accompanying common
+Added: warrant was $ 1.00 , and the offering price per share of pre-funded warrant and accompanying common warrant was $ 0.9999 .
+Added: Company incurred offering expenses of approximately $ 0.7 million, including placement agent fees of approximately $ 0.5 million.
+Added: The Company received net proceeds of approximately $ 6.3 million, after deducting the underwriting discount and other offering
2022 Lincoln Park Transaction
−Removed: On August 16, 2022, the Company
−Removed: entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights agreement (the “2022 Registration
−Removed: Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
−Removed: Pursuant to the terms of the 2022 Purchase
−Removed: Agreement, Lincoln Park has agreed to purchase from the Company up to $ 50,000,000
−Removed: of the Company’s common stock (subject to certain limitations) from time to time during the term of the 2022 Purchase Agreement.
−Removed: Pursuant to the terms of the 2022 Registration Rights Agreement, the Company filed with the SEC a registration statement to register for
−Removed: resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the 2022 Purchase Agreement.
−Removed: Pursuant to the terms of the
−Removed: 2022 Purchase Agreement, at the time the Company signed the 2022 Purchase Agreement and the 2022 Registration Rights Agreement, the Company
−Removed: issued 625,000
−Removed: shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of the Company’s common stock under
−Removed: the 2022 Purchase Agreement.
−Removed: The commitment shares were valued at $ 1,000,000
−Removed: 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
−Removed: be raised under the 2022 Purchase Agreement.
−Removed: During the year ended December
−Removed: 31, 2022, the Company sold 1 .0
−Removed: million shares of common stock under the 2022 Purchase Agreement, for net proceeds of approximately $ 0.5 million.
−Removed: Subsequent to December
−Removed: 31, 2022, the Company sold 0.6
−Removed: million shares of common stock under the 2022 Purchase Agreement with Lincoln Park for net proceeds of approximately $ 0.4
−Removed: PHARMACEUTICALS HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: Agreement with Lincoln Park
−Removed: On December 3, 2021, the Company
−Removed: entered into a purchase agreement (the “Purchase Agreement with Lincoln Park”) and a registration rights agreement (the “Lincoln
−Removed: Park Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
−Removed: Pursuant to the terms of
−Removed: the Purchase Agreement with Lincoln Park, Lincoln Park agreed to purchase from the Company up to $ 80,000,000
−Removed: of the Company’s common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement with
+Added: August 16, 2022, the Company entered into an equity line of credit with Lincoln Park Capital Fund, LLC (“Lincoln Park”),
+Added: pursuant to which Lincoln Park agreed to purchase up to $ 50,000,000 of the Company’s common stock (subject to certain limitations)
+Added: from time to time.
+Added: The Company filed with the SEC a registration statement to register for resale under the Securities Act the
+Added: shares that have been or may be issued to Lincoln Park under the 2022 Purchase Agreement.
+Added: The Company issued 100,000 shares of
+Added: common stock to Lincoln Park as consideration for its commitment to purchase shares of the Company’s common stock.
+Added: The commitment
+Added: 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
+Added: to equity as a cost of capital to be raised under the equity line of credit.
+Added: During the year ended
+Added: December 31, 2023, the Company sold 0.1 million shares of common stock under the equity line of credit with Lincoln Park, for net
+Added: proceeds of approximately $ 0.4 million.
+Added: During the year ended December 31, 2022, the Company sold 0.2 million shares of common
+Added: stock under the equity line of credit with Lincoln Park, for net proceeds of approximately $ 0.5 million.
+Added: Purchase Agreement with Lincoln Park
+Added: December 3, 2021, the Company entered into a purchase agreement (the “Purchase Agreement with Lincoln Park”) and a
+Added: registration rights agreement (the “Lincoln Park Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC
(“Lincoln Park”).
−Removed: Pursuant to the terms of the Lincoln Park Registration Rights Agreement, the Company filed with the SEC a registration statement
−Removed: to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the Purchase Agreement
−Removed: with Lincoln Park.
−Removed: Pursuant to the terms of the
−Removed: Purchase Agreement with Lincoln Park, at the time the Company signed the Purchase Agreement with Lincoln Park and the Lincoln Park Registration
−Removed: Rights Agreement, the Company issued 90,910
−Removed: shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the Purchase Agreement
−Removed: with Lincoln Park.
−Removed: The commitment shares were valued at $ 1.6
−Removed: million and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost
−Removed: of capital to be raised under the Purchase Agreement with Lincoln Park.
−Removed: During the year ended December
−Removed: 31, 2022, the Company sold 2.9
−Removed: million shares of common stock under the Purchase Agreement with Lincoln Park, for net proceeds of approximately $ 8.7
−Removed: Under applicable rules of
−Removed: the NASDAQ Global Market, the Company could not issue or sell more than 19.99 %
−Removed: of the shares of its common stock outstanding immediately prior to the execution of the Purchase Agreement with Lincoln Park (approximately
−Removed: million shares) to Lincoln Park under the Purchase Agreement with Lincoln Park without stockholder approval, unless the average
−Removed: price of all applicable sales of its common stock to Lincoln Park under the Purchase Agreement with Lincoln Park equals or exceeds a threshold
−Removed: As the Company has issued approximately 2.9
−Removed: million shares to Lincoln Park, by December 31, 2022, under the Purchase Agreement with Lincoln Park at less than the threshold
−Removed: amount, the Company will not sell any additional shares under the Purchase Agreement with Lincoln Park without shareholder approval.
−Removed: Lincoln Park Transaction
−Removed: On May 14, 2021, the Company
−Removed: entered into a purchase agreement (the “2021 Purchase Agreement”) and a registration rights agreement (the “2021 Registration
−Removed: Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
−Removed: Pursuant to the terms of the 2021 Purchase
−Removed: Agreement, Lincoln Park agreed to purchase from the Company up to $ 80,000,000
−Removed: of the Company’s common stock (subject to certain limitations) from time to time during the term of the 2021 Purchase Agreement.
−Removed: Pursuant to the terms of the 2021 Registration Rights Agreement, the Company filed with the SEC a registration statement to register for
−Removed: resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the 2021 Purchase Agreement.
−Removed: Pursuant to the terms of the
−Removed: 2021 Purchase Agreement, at the time the Company signed the 2021 Purchase Agreement and the 2021 Registration Rights Agreement, the Company
−Removed: issued 40,000
−Removed: shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2021 Purchase
−Removed: The commitment shares were valued at $ 1.6
−Removed: million and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost
−Removed: of capital to be raised under the 2021 Purchase Agreement.
−Removed: the year ended December 31, 2021, the Company sold an aggregate of approximately 2 .0
−Removed: million shares of common stock under the 2021 Purchase Agreement, for gross proceeds of approximately $ 41.3
−Removed: During the year ended December 31, 2022, no shares of common stock were sold under the 2021 Purchase Agreement.
−Removed: Under applicable rules of
−Removed: the NASDAQ Global Market, the Company could not issue or sell more than 19.99 %
−Removed: of the shares of its common stock outstanding immediately prior to the execution of the 2021 Purchase Agreement (approximately 2 .0
−Removed: million shares) to Lincoln Park under the 2021 Purchase Agreement without stockholder approval, unless the average price of all applicable
−Removed: sales of its common stock to Lincoln Park under the 20121 Purchase Agreement equals or exceeds a threshold amount.
−Removed: As the Company has
−Removed: issued approximately 2 .0
−Removed: million shares to Lincoln Park under the 2021 Purchase Agreement, at less than the threshold amount, the Company will not sell any additional
−Removed: shares under the 2021 Purchase Agreement without shareholder approval.
−Removed: 2021 Financing
−Removed: On February 8, 2021, the Company
−Removed: entered into a securities purchase agreement with certain institutional investors relating to the issuance and sale of 1.8
−Removed: million shares of its common stock, in a registered direct public offering (the “February 2021 Financing”), with A.G.P/Alliance
−Removed: Global Partners (“AGP”), acting as placement agent.
−Removed: The public offering price for each share of common stock was $ 38.40 .
−Removed: The February 2021 Financing closed on February 9, 2021.
−Removed: AGP received a cash fee of 7 %
−Removed: of the gross proceeds, for an aggregate amount of $ 4.9
−Removed: The Company incurred other offering expenses of approximately $ 0.1
−Removed: The Company received net proceeds of approximately $ 65 .0
−Removed: million, after deducting the fees and other offering expenses.
−Removed: 2021 Financing
−Removed: On January 11, 2021, the Company
−Removed: entered into a securities purchase agreement with certain institutional investors relating to the issuance and sale of 1.6
−Removed: million shares of its common stock in a registered direct public offering (the “January 2021 Financing”), with AGP as placement
−Removed: The public offering price for each share of common stock was $ 25.60 .
−Removed: The January 2021 Financing closed on January 13, 2021.
−Removed: AGP received a cash fee of 7 %
−Removed: of the gross proceeds, for an aggregate of $ 2.8
−Removed: The Company incurred other offering expenses of approximately $ 0.3
−Removed: The Company received net proceeds of approximately $ 36.9
−Removed: million, after deducting the fees and other offering expenses.
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
+Added: Pursuant to the terms of the Purchase Agreement with Lincoln Park, Lincoln Park agreed to purchase
+Added: from the Company up to $ 80,000,000 of the Company’s common stock (subject to certain limitations) from time to time during
+Added: the term of the Purchase Agreement with Lincoln Park.
+Added: Pursuant to the terms of the Lincoln Park Registration Rights Agreement,
+Added: the Company filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been
+Added: or may be issued to Lincoln Park under the Purchase Agreement with Lincoln Park.
+Added: to the terms of the Purchase Agreement with Lincoln Park, at the time the Company signed the Purchase Agreement with Lincoln Park
+Added: and the Lincoln Park Registration Rights Agreement, the Company issued 14,546 shares of common stock to Lincoln Park as consideration
+Added: for its commitment to purchase shares of our common stock under the Purchase Agreement with Lincoln Park.
+Added: The commitment shares
+Added: were valued at $ 1.6 million and recorded as an addition to equity for the issuance of the common stock and treated as a reduction
+Added: to equity as a cost of capital to be raised under the Purchase Agreement with Lincoln Park.
+Added: the year ended December 31, 2022, the Company sold 0.5 million shares of common stock under the Purchase Agreement with Lincoln
+Added: Park, for net proceeds of approximately $ 8.7 million.
+Added: No sales occurred in 2023.
+Added: Under applicable rules
+Added: of the NASDAQ Global Market, the Company could not issue or sell more than 19.99 % of the shares of its common stock outstanding
+Added: immediately prior to the execution of the Purchase Agreement with Lincoln Park (approximately 0.5 million shares) to Lincoln Park
+Added: under the Purchase Agreement with Lincoln Park without stockholder approval, unless the average price of all applicable sales of
+Added: its common stock to Lincoln Park under the Purchase Agreement with Lincoln Park equals or exceeds a threshold amount.
+Added: As the Company
+Added: has issued approximately 0.5 million shares to Lincoln Park, by December 31, 2022, under the Purchase Agreement with Lincoln Park
+Added: at less than the threshold amount, the Company will not sell any additional shares under the Purchase Agreement with Lincoln Park
+Added: without shareholder approval.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
At-the-Market Offerings
−Removed: On April 8, 2020, the
−Removed: Company entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which the Company may issue and sell,
−Removed: from time to time, shares of the Company’s common stock having an aggregate offering price of up to $ 320 .0
−Removed: million in at-the-market offerings (“ATM”) sales.
−Removed: AGP will act as sales agent and will be paid a 3 %
−Removed: commission on each sale under the Sales Agreement.
−Removed: The Company’s common stock will be sold at prevailing market prices at the time
−Removed: of the sale, and, as a result, prices will vary.
−Removed: During the year ended December 31, 2022, the Company sold approximately 56.4
−Removed: million shares of common stock under the Sales Agreement, for net proceeds of approximately $ 85.3
−Removed: During the year ended December 31, 2021, the Company sold approximately 3.5
−Removed: million shares of common stock under the Sales Agreement, for net proceeds of approximately $ 69.3
−Removed: Subsequent to December 31, 2022, the Company has sold 2.1
−Removed: million shares of common stock under the Sales Agreement, for net proceeds of approximately $ 1.4
−Removed: 17 – STOCK-BASED COMPENSATION
−Removed: Incentive Plans
−Removed: On May 3, 2019, the Company’s
−Removed: stockholders approved the Tonix Pharmaceuticals Holding Corp.
−Removed: 2019 Stock Incentive Plan (the “2019 Plan”).
−Removed: The 2019 Plan provided
−Removed: for the issuance of up to 4,375
−Removed: shares of common stock.
−Removed: With the adoption of the 2020 Plan (as defined below), no further grants may be made under the 2019 Plan.
−Removed: 16, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp.
−Removed: 2020 Stock Incentive Plan (the “2020
−Removed: The 2020 Plan provided for the issuance of up to 18,750
−Removed: shares of common stock.
−Removed: With the adoption of the Amended and Restated 2020 Plan (as defined below), no further grants may be made under
−Removed: the 2020 Plan.
−Removed: On May 1, 2020, the Company’s
−Removed: stockholders approved the Tonix Pharmaceuticals Holding Corp.
−Removed: Amended and Restated 2020 Stock Incentive Plan (“Amended and Restated
−Removed: 2020 Plan”), and together with the 2020 Plan and the 2019 Plan, the “Plans”).
−Removed: Under the terms of the Amended
−Removed: and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3) stock appreciation
−Removed: rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards.
−Removed: The Amended and Restated 2020 Plan initially
−Removed: provided for the issuance of up to 312,500
−Removed: shares of common stock, which amount will be increased to the extent that awards granted under the Plans are forfeited, expire
−Removed: or are settled for cash (except as otherwise provided in the Amended and Restated 2020 Plan).
−Removed: In addition, the Amended and Restated 2020
−Removed: Plan contains an “evergreen provision” providing for an annual increase in the number of shares of our common stock available
−Removed: 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
−Removed: and ending on (and including) January 1, 2030, in an amount equal to the difference between (x) twenty percent ( 20 %)
−Removed: of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, and (y) the total number of
−Removed: shares of common stock reserved under the Amended and Restated 2020 Plan on December 31 st of such preceding calendar year
−Removed: (including shares subject to outstanding awards, issued pursuant to awards or available for future awards).
−Removed: The Board of Directors determines
−Removed: the exercise price, vesting and expiration period of the grants under the Amended and Restated 2020 Plan.
−Removed: However, the exercise price
−Removed: of an incentive stock option may not be less than 110 %
−Removed: of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100 %
−Removed: of fair value for a grantee who is not a 10% shareholder.
−Removed: The fair value of the common stock is determined based on quoted market price
−Removed: or in absence of such quoted market price, by the Board of Directors in good faith.
+Added: April 8, 2020, the Company entered into a sales agreement with AGP pursuant to which the Company may issue and sell shares of
+Added: its common stock having an aggregate offering price of up to $ 320 .0 million in at-the-market offerings (“ATM”) sales
+Added: at prevailing market prices at the time of the sale, and, as a result, prices will vary.
+Added: AGP receives a 3 % commission on each
+Added: ATM sale under the Sales Agreement.
+Added: the year ended December 31, 2023, the Company sold approximately 1 .0 million shares of common stock under the Sales Agreement,
+Added: for net proceeds of approximately $ 3 .0 million.
+Added: During the year ended December 31, 2022, the Company sold approximately 9.1 million
+Added: shares of common stock under the Sales Agreement, for net proceeds of approximately $ 85.3 million.
+Added: Stock Repurchases
+Added: the first quarter of 2023, the Company has repurchased 2,512,044 of its shares of common stock outstanding under the 2022 share
+Added: repurchase program for up to $ 12.5 million at prices ranging from $ 2.75 to $ 8.61 per share for a gross aggregate cost of approximately
+Added: $ 12.5 million.
+Added: In addition, the Company incurred expenses of $ 0.3 million.
+Added: January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant to which the Company may repurchase up
+Added: to an additional $ 12.5 million in value of its outstanding common stock from time to time on the open market and in privately
+Added: negotiated transactions subject to market conditions, share price and other factors.
+Added: During the first quarter of 2023, the
+Added: Company has repurchased 160,000 of our shares of common stock outstanding under the new 2023 share repurchase program at $ 7.12
+Added: per share for a gross aggregate cost of $ 1.1 million.
+Added: No additional repurchases have occurred since the first quarter of 2023.
+Added: The timing and amount
+Added: of any shares repurchased will be determined based on the Company’s evaluation of market conditions and other factors
+Added: and the New Share Repurchase Program may be discontinued or suspended at any time.
+Added: Repurchases will be made
+Added: in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements
+Added: to which the Company may be subject.
+Added: Repurchases may be made, in part, under a Rule 10b5-1 plan, which allows stock repurchases when
+Added: the Company might otherwise be precluded from doing so.
+Added: NOTE 18 – STOCK-BASED COMPENSATION
+Added: On May 1, 2020, the
+Added: Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp.
+Added: Amended and Restated 2020 Stock Incentive Plan (“Amended
+Added: and Restated 2020 Plan”).
+Added: Under the terms of
+Added: the Amended and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock,
+Added: (3) stock appreciation rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards.
+Added: and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will be increased
+Added: to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in
+Added: the Amended and Restated 2020 Plan).
+Added: In addition, the Amended and Restated 2020 Plan contains an “evergreen provision”
+Added: providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated
+Added: 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
+Added: 1, 2030, in an amount equal to the difference between (x) twenty percent ( 20 %) of the total number of shares of common stock outstanding
+Added: on December 31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the Amended
+Added: and Restated 2020 Plan on December 31 st of such preceding calendar year (including shares subject to outstanding awards,
+Added: issued pursuant to awards or available for future awards).
+Added: The Board of Directors determines the exercise price, vesting and expiration
+Added: period of the grants under the Amended and Restated 2020 Plan.
+Added: However, the exercise price of an incentive stock option may not
+Added: 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
+Added: for a grantee who is not a 10% shareholder.
+Added: The fair value of the common stock is determined based on quoted market price or in
+Added: absence of such quoted market price, by the Board of Directors in good faith.
Additionally, the expiration period of grants under
−Removed: the Amended and Restated 2020 Plan may not be more than ten
−Removed: As of December 31, 2022, 627,744
−Removed: options were available for future grants under the Amended and Restated 2020 Plan.
−Removed: summary of the stock option activity and related information for the Plans for the years ended December 31, 2022, and 2021 is as
−Removed: Weighted- Average
+Added: the Amended and Restated 2020 Plan may not be more than ten years .
+Added: As of December 31, 2023, 1,071,599 options were available for
+Added: future grants under the Amended and Restated 2020 Plan.
+Added: A summary of the stock
+Added: option activity and related information for the Plans for the year ended December 31, 2023 is as follows:
Exercise Price
−Removed: Weighted-Average
−Removed: Remaining Contractual Term
−Removed: Aggregate Intrinsic
+Added: Weighted-Average Remaining Contractual Term
+Added: Aggregate Intrinsic Value
Outstanding at December 31, 2021
4 unchanged sentences
Exercisable at December 31, 2023
−Removed: The aggregate intrinsic value
−Removed: in the preceding table represents the total pretax intrinsic value, based on options with an exercise price less than the Company’s
−Removed: closing stock price at the respective dates.
−Removed: The weighted average grant
−Removed: date fair value of options granted during the years ended December 31, 2022 and 2021, was $ 5.25
−Removed: per share, respectively.
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: The Company measures the
−Removed: fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: weighted average fair value of options granted during the year ended December 31, 2023, and December 31, 2022 was $ 3.99 per share
+Added: and $ 32.81 , respectively.
+Added: The Company measures
+Added: 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.
1 unchanged sentence
award is measured on the grant date.
−Removed: most stock options granted pursuant to the Plans vest 12 months from the date of grant and 1/36 th each
−Removed: month thereafter for 24 months and expire ten
−Removed: years from the date of grant.
−Removed: In addition, the Company issues options to directors which vest over a one-year period.
−Removed: The Company also issues premium options to executive officers which have an exercise price greater than the grant
−Removed: date fair value and has issued performance-based options which vest when target parameters are met or probable of being met, subject
−Removed: in each case to a one
−Removed: year minimum service period prior to vesting.
−Removed: Stock-based compensation expense related to awards is amortized over the
−Removed: applicable service period using the straight-line method.
−Removed: assumptions used in the valuation of stock options granted during the year ended December 31, 2022 and 2021 were as follows:
+Added: One-third of most stock options granted pursuant to the Plans vest 12 months from the date
+Added: of grant and 1/36th each month thereafter for 24 months and expire ten years from the date of grant.
+Added: In addition, the Company issues
+Added: options to directors which vest over a one-year period.
+Added: The Company also issues premium options to executive officers which have
+Added: an exercise price greater than the grant date fair value and has issued performance-based options which vest when target parameters
+Added: are met or probable of being met, subject in each case to a one-year minimum service period prior to vesting.
+Added: Stock-based compensation
+Added: expense related to awards is amortized over the applicable service period using the straight-line method.
+Added: The assumptions used
+Added: in the valuation of stock options granted during the year ended December 31, 2023 and 2022 were as follows:
+Added: December 31, 2023
+Added: December 31, 2022
Risk-free interest rate
+Added: 3.42 % to 4.35
+Added: 1.67 % to 3.05
Expected term of option
+Added: 5.0 to 10 years
+Added: 5.5 to 10 years
Expected stock price volatility
+Added: 122.19 % - 142.72
+Added: 120.32 % - 133.22
Expected dividend yield
−Removed: The risk-free interest rate
−Removed: is based on the yield of Daily U.S.
−Removed: Treasury Yield Curve Rates with terms equal to the expected term of the options as of the grant date.
−Removed: expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting Bulletin, and the expected
−Removed: stock price volatility is based on the Company’ historical stock price volatility.
+Added: The risk-free interest
+Added: rate is based on the yield of Daily U.S.
+Added: Treasury Yield Curve Rates with terms equal to the expected term of the options as of
+Added: the grant date.
+Added: The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
+Added: Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
+Added: Stock-based compensation
+Added: expense relating to options granted of $ 9.3 million, of which $ 6.4 million and $ 2.9 million, related to General and Administration
+Added: and Research and Development, respectively was recognized for the year ended December 31, 2023.
Stock-based compensation expense
−Removed: relating to options granted of $ 10.9
−Removed: million, of which $ 7.9
−Removed: million and $ 3 .0
−Removed: million, related to General and Administration and Research and Development, respectively was recognized for the year ended December 31,
−Removed: Stock-based compensation expense relating to options granted of $ 7.9
−Removed: million, of which $ 5.5
−Removed: million and $ 2.4
−Removed: million, related to General and Administration and Research and Development, respectively was recognized for the year ended December
−Removed: As of December 31, 2022, the
−Removed: Company had approximately $ 11.6
−Removed: million of unrecognized compensation cost related to non-vested awards granted under the Plans, which the Company expects to recognize
−Removed: over a weighted average period of 1.73
−Removed: Stock Purchase Plans
−Removed: On May 3, 2019, the Company’s
−Removed: stockholders approved the Tonix Pharmaceuticals Holdings Corp.
−Removed: 2019 Employee Stock Purchase Plan (the “2019 ESPP”).
−Removed: of adoption of the 2020 ESPP, as defined below, by the stockholders, no further grants may be made under the 2019 ESPP Plan.
−Removed: 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp.
−Removed: 2020 Employee Stock Purchase Plan (the “2020
−Removed: No further grants may be made under the 2020 ESPP Plan.
−Removed: On May 6, 2022, the Company’s stockholders approved the Tonix
−Removed: Pharmaceuticals Holdings Corp.
−Removed: 2022 Employee Stock Purchase Plan (the “2022 ESPP”, and together with the 2019 ESPP and the
−Removed: 2020 ESPP, the “ESPP Plans”)).
−Removed: The 2022 ESPP allows eligible
−Removed: employees to purchase up to an aggregate of 93,750 shares
−Removed: of the Company’s common stock.
−Removed: Under the 2022 ESPP, on the first day of each offering period, each eligible employee for that offering
−Removed: period has the option to enroll for that offering period, which allows the eligible employees to purchase shares of the Company’s
−Removed: common stock at the end of the offering period.
−Removed: Each offering period under the 2022 ESPP is for six months, which can be modified from
−Removed: time-to-time.
−Removed: Subject to limitations, each participant will be permitted to purchase a number of shares determined by dividing the employee’s
−Removed: accumulated payroll deductions for the offering period by the applicable purchase price, which is equal to 85
−Removed: percent of the fair market value of our common stock at the beginning or end of each offering period, whichever is less.
−Removed: A participant
−Removed: must designate in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period for
−Removed: the purchase of stock under the 2022 ESPP, subject to the statutory limit under the Code.
+Added: relating to options granted of $ 10.9 million, of which $ 7.9 million and $ 3 .0 million, related to General and Administration and
+Added: Research and Development, respectively was recognized for the year ended December 31, 2022.
As of December 31,
−Removed: shares were available for future sales under the 2022 ESPP.
−Removed: The 2022 and 2020 ESPP
−Removed: are considered compensatory plans with the related compensation cost expensed over the six-month offering period.
−Removed: For the year ended December
−Removed: 31, 2022 and 2021, $ 46,000
−Removed: and $ 89,000 ,
−Removed: respectively were expensed.
−Removed: In January 2021, 1,703
−Removed: shares that were purchased as of December 31, 2020, under the 2020 ESPP, were issued.
−Removed: Accordingly, during the first quarter of 2021, approximately
−Removed: of employee payroll deductions accumulated at December 31, 2020, related to acquiring such shares, was transferred from accrued expenses
−Removed: to additional paid in capital.
−Removed: The remaining $ 4,000
−Removed: was returned to the employees.
−Removed: In January 2022, 4,033
−Removed: shares that were purchased as of December 31, 2021, under the 2020 ESPP, were issued.
+Added: 2023, the Company had approximately $ 6.1 million of total unrecognized compensation cost related to non-vested awards granted under
+Added: the Plans, which the Company expects to recognize over a weighted average period of 1.70 years.
+Added: Employee Stock Purchase Plans
+Added: On May 6, 2022, the
+Added: Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp.
+Added: 2022 Employee Stock Purchase Plan.
+Added: ESPP"), which was replaced by the Tonix Pharmaceuticals Holdings Corp.
+Added: 2023 Employee Stock Purchase Plan (the “2023
+Added: ESPP”, and together with the 2022 ESPP, the “ESPP Plans”), which was approved by the Company’s stockholders on
+Added: The 2023 ESPP allows
+Added: eligible employees to purchase up to an aggregate of 800,000 shares of the Company’s common stock.
+Added: Under the 2023
+Added: ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for that
+Added: offering period, which allows the eligible employees to purchase shares of the Company’s common stock at the end of the offering
+Added: Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time.
+Added: Subject to limitations,
+Added: each participant will be permitted to purchase a number of shares determined by dividing the employee’s accumulated
+Added: payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair
+Added: market value of our common stock at the beginning or end of each offering period, whichever is less.
+Added: A participant must designate
+Added: in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period for the purchase
+Added: of stock under the 2023 ESPP, subject to the statutory limit under the Code.
+Added: As of December 31, 2023, 800,000 shares were available
+Added: for future sales under the 2023 ESPP.
+Added: ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period.
+Added: the year ended December 31, 2023 and 2022, $ 34,000 and $ 46,000 , respectively, was expensed.
+Added: In January 2022, 646 shares that were
+Added: purchased as of December 31, 2021, under the 2020 ESPP, were issued.
Accordingly, during the first quarter of 2022, approximately
−Removed: of employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from accrued expenses
−Removed: to additional paid in capital.
−Removed: The remaining $ 30,000
−Removed: was returned to the employees.
−Removed: As of December 31, 2022, approximately $ 43,000
−Removed: of employee payroll deductions have accumulated and have been recorded in accrued expenses.
−Removed: In January 2023, 93,741
+Added: $ 40,000 of employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from
+Added: accrued expenses to additional paid in capital.
+Added: The remaining $ 30,000 was returned to the employees.
+Added: In January 2023, 14,999 shares
+Added: that were purchased as of December 31, 2022, under the 2022 ESPP, were issued.
+Added: Accordingly, during the first quarter of 2023,
+Added: approximately $ 29,000 of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred
+Added: from accrued expenses to additional paid in capital.
+Added: The remaining $ 14,000 was returned to the employees.
+Added: As of December 31, 2023,
+Added: approximately $ 44,000 of employee payroll deductions have accumulated and have been recorded in accrued expenses.
2024, 66,359 shares that were purchased as of December 31, 2023, under the 2022 ESPP, were issued.
−Removed: Accordingly, during the first quarter of 2023, approximately
−Removed: of employee payroll deductions accumulated at December 31, 2023, related to acquiring such shares, was transferred from accrued expenses
−Removed: to additional paid in capital.
−Removed: The remaining $ 14,000
−Removed: was returned to the employees.
−Removed: 18 – WARRANTS TO PURCHASE COMMON STOCK
−Removed: following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2022:
−Removed: TONIX PHARMACEUTICALS
−Removed: HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
+Added: Accordingly, during the first
+Added: quarter of 2024, approximately $ 24,000 of employee payroll deductions accumulated at December 31, 2023, related to acquiring such
+Added: shares, was transferred from accrued expenses to additional paid in capital.
+Added: The remaining $ 20,000 was returned to the employees.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTE 19 – STOCK WARRANTS
+Added: The following table
+Added: summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2023:
+Added: December 2025
+Added: December 2028
+Added: November 2024
+Added: February 2025
+Added: In connection with
+Added: the July 2023 Financing, the Company issued 4,470,000 prefunded common warrants with an exercise price of $ 0.0001 .
+Added: All prefunded
+Added: common warrants were exercised during the year ended December 31, 2023.
+Added: Additionally, the Company issued common warrants to purchase up
+Added: to an aggregate of 7,000,000 shares of the Company’s common stock.
+Added: The common warrants are exercisable at $ 1.00 per share, expire
+Added: five years from the date of issuance.
+Added: In connection with the September
+Added: 2023 Financing, the Company issued 4,950,000
+Added: prefunded common warrants with an exercise price of $ 0.0001 .
+Added: All prefunded common warrants were exercised during the year ended December 31, 2023.
+Added: Additionally, the Company issued common warrants
+Added: to purchase up to an aggregate of 18,000,000
+Added: shares of the Company’s common stock.
+Added: The common warrants are exercisable at $ 0.50
+Added: per share, expire five
+Added: years from the date of issuance.
+Added: In connection with the
+Added: December 2023 Financing, the Company issued 28,710,812
+Added: prefunded common warrants with an exercise price of $ 0.0001 .
+Added: Only 6,509,010
+Added: prefunded common warrants were exercised during the year ended December 31, 2023.
+Added: Subsequent to December 31, 2023, 15,043,244
+Added: prefunded common warrants were exercised.
+Added: Additionally, the Company issued Series C common warrants to purchase up to an
+Added: aggregate of 81,081,081
+Added: shares of the Company’s common stock.
+Added: The common warrants are exercisable at $ 0.555
+Added: per share, expire two
+Added: years from the date of issuance.
+Added: Additionally, the Company issued Series D common warrants to purchase up to an
+Added: aggregate of 81,081,081
+Added: shares of the Company’s common stock.
+Added: The common warrants are exercisable at $ 0.85
+Added: per share, expire five
+Added: years from the date of issuance.
No warrants were exercised
during the year ended December 31, 2022.
−Removed: During the year ended December
−Removed: 31, 2021, 107
−Removed: warrants from the February 2020 Financing, with an exercise price of $ 18.24 ,
−Removed: were exercised for proceeds of approximately $ 2,000 .
−Removed: During the year ended December
−Removed: 31, 2021, 5,441
−Removed: warrants with a per share exercise price of $ 630.00
−Removed: and $ 687.50 ,
−Removed: respectively, expired.
−Removed: The Company has various operating
−Removed: lease agreements, which are primarily for office space.
−Removed: These agreements frequently include one or more renewal options and require the
−Removed: Company to pay for utilities, taxes, insurance and maintenance expense.
−Removed: No lease agreement imposes a restriction on the Company’s
−Removed: ability to engage in financing transactions or enter into further lease agreements.
−Removed: At December 31, 2022, the Company has right-of-use
−Removed: assets of $ 0.7
−Removed: million and a total lease liability for operating leases of $ 0.7
−Removed: million of which $ 0.3
−Removed: million is included in long-term lease liabilities and $ 0.4
−Removed: million is included in current lease liabilities.
−Removed: December 31, 2022, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows
−Removed: (in thousands):
+Added: For the year ended
+Added: December 31, 2023, 2,453 warrants with an exercise price of $ 7,000.00 expired.
+Added: 1, 2024, the Company issued 3,900,000 pre-funded common warrants with an exercise price of $ 0.0001 .
+Added: Additionally, the Company issued Series
+Added: E warrants to purchase up to 14,666,666 shares of common stock with an exercise price of $ 0.33 per share and expiring five and a half
+Added: years from date of issuance.
+Added: Additionally, the Company entered
+Added: into warrant amendments with certain holders of its Common Warrants.
+Added: The exercise price of each Existing Warrant will be amended to $ 0.33
+Added: upon approval by the Company’s stockholders of a proposal to allow the Existing Warrants to become exercisable in accordance with
+Added: Nasdaq Listing Rule 5635, or as otherwise provided in the Amendment if stockholder approval is not obtained by October 1, 2024.
+Added: Upon stockholder
+Added: approval, the termination date for Common Warrants to purchase up to an aggregate of 6,950,000 shares will be amended to April 1, 2029 ;
+Added: the termination date for Series A Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029 ;
+Added: termination date for Series B Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029 ;
+Added: the termination
+Added: date for Series C Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be the earlier of (i) April 1, 2026
+Added: and (ii) 10 trading days following notice by the Company to the Series C Warrant holder of the Company’s public announcement of
+Added: the FDA’s acknowledgement and acceptance of the Company’s NDA relating to TNX-102 SL in patients with Fibromyalgia;
+Added: the termination
+Added: date for Series D Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be April 1, 2029 .
+Added: The other terms of
+Added: the Existing Warrants will remain unchanged.
+Added: If stockholder approval is not obtained on or by October 1, 2024, then the Company
+Added: has agreed to automatically amend the exercise price of the Existing Warrants to the Minimum Price (as defined in Nasdaq Listing Rule
+Added: 5635(d)) of the Common Stock on October 1, 2024 if and only if the Minimum Price is below the then current exercise price.
+Added: NOTE 20 – LEASES
+Added: Company has various operating lease agreements, which are primarily for office space.
+Added: These agreements frequently include one
+Added: or more renewal options and require the Company to pay for utilities, taxes, insurance and maintenance expense.
+Added: No lease agreement
+Added: imposes a restriction on the Company’s ability to engage in financing transactions or enter into further lease agreements.
+Added: At December 31, 2023, the Company has right-of-use assets of $ 0.8 million and a total lease liability for operating leases of
+Added: $ 0.9 million of which $ 0.6 million is included in long-term lease liabilities and $ 0.3 million is included in current lease liabilities.
+Added: During the year ended December 31, 2023, the Company exited a lease which had a right-of-use assets, net of $ 0.2 million and a
+Added: total lease liability for operating leases of $ 0.2 million.
+Added: At December 31, 2023,
+Added: 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,
+Added: 2028 and beyond
Included interest
−Removed: During the year ended December
−Removed: 31, 2022, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an additional operating
−Removed: lease liability of approximately $ 386,000
−Removed: based on the present value of the minimum rental payments.
−Removed: The Company also recognized a corresponding increase to ROU assets of approximately
−Removed: which represents a non-cash investing and financing activity.
−Removed: During the year ended December
−Removed: 31, 2021, the Company entered into lease amendments, resulting in the Company recognizing an operating lease liability of approximately
−Removed: based on the present value of the future minimum rental payments.
−Removed: The Company also recognized corresponding ROU assets of approximately
−Removed: Operating lease expense was
−Removed: million for both years ended December 31, 2022 and 2021.
−Removed: information related to leases was as follows:
−Removed: Cash paid for amounts included in the
−Removed: measurement of lease liabilities:
+Added: During the year ended
+Added: December 31, 2023, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an
+Added: additional operating lease liability of approximately $ 898,000 based on the present value of the minimum rental payments.
+Added: also recognized a corresponding increase to ROU assets of approximately $ 898,000 , which represents a non-cash operating activity.
+Added: During the year ended
+Added: December 31, 2022, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an
+Added: additional operating lease liability of approximately $ 386,000 based on the present value of the minimum rental payments.
+Added: also recognized a corresponding increase to ROU assets of approximately $ 386,000 , which represents a non-cash operating activity.
+Added: Other information related to leases is as follows:
+Added: Operating lease expense
+Added: was $ 0.6 million for both the years ended December 31, 2023 and 2022.
+Added: TONIX PHARMACEUTICALS HOLDING CORP.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Other information related to leases is as follows:
+Added: Cash paid for amounts included in the measurement of lease liabilities:
December 31, 2023
December 31, 2022
−Removed: Operating cash flow from operating leases (in
+Added: Operating cash flow from operating leases (in thousands)
Weighted Average Remaining Lease Term
2 unchanged sentences
Operating leases
−Removed: 20 – COMMITMENTS
−Removed: The Company has entered into
−Removed: contracts with various contract research organizations with outstanding commitments aggregating approximately $ 58.6
−Removed: million at December 31, 2022 for future work to be performed.
−Removed: The Company entered into a
−Removed: construction contract with outstanding commitments aggregating approximately $ 2 .0
−Removed: million at December 31, 2022 for future work to be performed.
−Removed: contribution plan
−Removed: The Company has a qualified
−Removed: defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby all eligible employees may participate.
−Removed: Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) Plan, subject to defined limitations.
−Removed: Company is required to make contributions to the 401(k) Plan equal to 100
−Removed: percent of each participant’s pretax contributions of up to six
−Removed: percent of his or her eligible compensation, and the Company is also required to make a contribution equal to three
−Removed: percent of each participant’s salary, on an annual basis, subject to limitations under the Code.
−Removed: The Company charged operations
−Removed: million and $ 0.4
−Removed: million for the year ended December 31, 2022, and 2021, respectively, for contributions under the 401(k) Plan.
−Removed: TONIX PHARMACEUTICALS HOLDING CORP.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 21 – INCOME TAXES –
−Removed: of the net loss consist of the following (in thousands):
+Added: NOTE 21 – COMMITMENTS
+Added: Contractual agreements
+Added: The Company has entered
+Added: into contracts with various contract research organizations with outstanding commitments aggregating approximately $ 23.2 million
+Added: at December 31, 2023 for future work to be performed.
+Added: Defined contribution plan
+Added: Company has a qualified defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby
+Added: all eligible employees may participate.
+Added: Participants may elect to defer a percentage of their annual pretax compensation
+Added: to the 401(k) Plan, subject to defined limitations.
+Added: The Company is required to make contributions to the 401(k) Plan equal to
+Added: 100 percent of each participant’s pretax contributions of up to six percent of his or her eligible compensation, and the
+Added: Company is also required to make a contribution equal to three percent of each participant’s salary, on an annual basis,
+Added: subject to limitations under the Code.
+Added: The Company charged operations $ 1.3 million and $ 0.9 million for the year ended December
+Added: 31, 2023 and 2022, respectively, for contributions under the 401(k) Plan.
+Added: NOTE 22 – INCOME TAXES
+Added: Components of the net loss consist of the
+Added: following (in thousands):
Year ended December 31,
−Removed: In 2022, the foreign losses
−Removed: are primarily comprised of $ 86.7
−Removed: million related to the Irish operations and $ 1.5
−Removed: million related to the Bermudan operations of Tonix International Holding.
−Removed: In 2021, the foreign losses were primarily comprised
−Removed: million related to the Bermudan operations of Tonix International Holding.
−Removed: reconciliation of the effect of applying the federal statutory rate to the net loss and the effective income tax rate used to calculate
−Removed: the Company’s income tax provision is as follows:
+Added: 2023, the foreign losses are primarily comprised of $ 98.4 million related to the Irish operations netted against
+Added: $ 0.2 million related to Canada operations of Tonix International Holding.
+Added: In 2022, the foreign losses are primarily comprised
+Added: of the $ 86.7 million related to the Irish operations and $ 1.5 million related to the Bermudan operations of Tonix International
+Added: A reconciliation of
+Added: the effect of applying the federal statutory rate to the net loss and the effective income tax rate used to calculate the Company’s
+Added: income tax provision is as follows:
Year Ended December 31,
4 unchanged sentences
Income Tax Provision
−Removed: tax assets (liabilities) and related valuation allowance as of December 31, 2022 and 2021 were as follows (in thousands):
+Added: Deferred tax assets
+Added: (liabilities) and related valuation allowance as of December 31, 2023 and 2022 were as follows (in thousands):
Deferred tax assets/(liabilities):
4 unchanged sentences
Net deferred tax assets
−Removed: The Company has incurred research
−Removed: and development (“R&D”) expenses, a portion of which qualifies for tax credits.
−Removed: The Company conducted an R&D credit
−Removed: study to quantify the amount of credits and has claimed an R&D credit on its 2014-2017 tax returns.
−Removed: A portion of these R&D credit
−Removed: carryforwards are subject to annual limitations in their use in accordance with Internal Revenue Service Code (“IRC”) section
−Removed: The R&D credit carryforwards at December 31, 2022 have been reduced to $ 0 .0
−Removed: million to reflect IRC section 383 ownership changes through December 31, 2022 and the resulting inability to utilize a portion of the
−Removed: R&D credit prior to its expiration.
−Removed: At December 31, 2022, the
−Removed: Company has $ 165.5
−Removed: million of Ireland net operating loss (“NOL”) carryforwards that do not expire.
−Removed: As of December 31, 2022, the Company's
−Removed: Federal NOL carryforwards of $ 3.6
−Removed: million, which do
−Removed: not expire, but their utilization is limited to 80 % of taxable income.
−Removed: Additionally, the Company has New Jersey NOL carryforwards
−Removed: million and Massachusetts NOL carryforwards of $ 0.3
−Removed: million, which both expire
−Removed: in 20 years .
−Removed: The NOL carryforwards at December 31, 2022 have been reduced to reflect IRC section 382 ownership changes through December
−Removed: 31, 2022 and the resultant inability due to annual limitations, to utilize a portion of the NOL prior to its expiration.
−Removed: Management assesses the available
−Removed: positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing deferred tax assets.
−Removed: A significant piece of objective negative evidence evaluated was the cumulative loss incurred over the three-year period ended December
−Removed: Such objective evidence limits the ability to consider other subjective evidence such as our projections for future growth.
−Removed: As such, the Company has determined that it is not more likely than not that the deferred tax assets will be realized and accordingly,
−Removed: has provided a full valuation allowance against its gross deferred tax assets.
−Removed: The increase in the valuation allowance for the years ended
−Removed: December 31, 2022 and 2021 were $ 9.5
−Removed: million, and $ 15.3
−Removed: million respectively.
−Removed: The Company recognizes interest
−Removed: accrued related to unrecognized tax benefits and penalties as income tax expense.
−Removed: However, as of December 31, 2022 there are no unrecognized
−Removed: tax benefits recorded.
−Removed: The Company is subject to taxation in the United States and various states and foreign jurisdictions.
−Removed: As of December
−Removed: 31, 2022, the Company’s tax returns remain open and subject to examination by the tax authorities for the tax years 2019 and after.
+Added: The Company has incurred
+Added: research and development (“R&D”) expenses, a portion of which qualifies for tax credits.
+Added: The Company conducted
+Added: an R&D credit study to quantify the amount of credits and has claimed an R&D credit on its 2014-2017 tax returns.
+Added: of these R&D credit carryforwards are subject to annual limitations in their use in accordance with Internal Revenue Service
+Added: Code (“IRC”) section 383.
+Added: The R&D credit carryforwards at December 31, 2023 have been reduced to $ 0 .0 million to
+Added: reflect IRC section 383 ownership changes through December 31, 2023 and the resulting inability to utilize a portion of the R&D
+Added: credit prior to its expiration.
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 22 – SUBSEQUENT EVENTS
−Removed: January 1, 2023, the Company has repurchased 15,700,269
−Removed: of its shares of common stock outstanding under its $ 12.5 million
−Removed: s hare repurchase program at prices ranging from $ 0.44 to
−Removed: per share for a gross aggregate cost of approximately $ 12.5
−Removed: January 2023, the Board of Directors approved a new share repurchase
−Removed: program pursuant to which the Company may repurchase up to $ 12.5
−Removed: million in value of its outstanding common stock from time to time on the open market and in privately negotiated transactions
−Removed: subject to market conditions, share price and other factors.
−Removed: Since January 1, 2023, the
−Removed: Company has repurchased 1,000,000 of
−Removed: its shares of common stock outstanding under the new share repurchase program at $ 1.14
−Removed: per share for a gross aggregate cost of $ 1.1
−Removed: timing and amount of any shares repurchased will be determined based on the Company’s
−Removed: evaluation of market conditions and other factors and the New Share Repurchase Program may
−Removed: be discontinued or suspended at any time.
−Removed: Repurchases will be made in accordance
−Removed: with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements to which the
−Removed: Company may be subject.
−Removed: Repurchases may be made, in part, under a Rule 10b5-1 plan,
−Removed: which allows stock repurchases when the Company might otherwise be precluded from
−Removed: to December 31, 2022, the Company regained compliance with the minimum bid price requirement for
−Removed: continued listing on The Nasdaq Capital Market because the Company’s shares had a closing bid price at or above $ 1.00
−Removed: per share for a minimum of 10
−Removed: consecutive business days, as set forth in Nasdaq Listing Rule 5550(a)(2).
−Removed: February 2, 2023, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Healion
−Removed: Bio Inc., pursuant to which the Company acquired all the pre-clinical infectious disease assets
−Removed: of Healion, including its portfolio of next-generation antiviral technology assets.
−Removed: Healion’s drug portfolio includes a class of
−Removed: broad-spectrum small molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900, formerly
−Removed: known as HB-121.
−Removed: As consideration for entering into the Asset Purchase Agreement, the Company paid $ 1.2
−Removed: million to Healion.
−Removed: Because the Healion intellectual property was acquired prior to FDA approval, the cash consideration totaling
−Removed: million, is expected to be expensed as research and development costs since there is no alternative future use and the acquired
−Removed: intellectual property does not constitute a business.
−Removed: On February 13, 2023, the
−Removed: Company announced that it exercised an option to obtain an exclusive license from Columbia for the development of a portfolio of both
−Removed: fully human and murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including the Company’s TNX-3600 and TNX-4100
−Removed: product candidates, respectively.
−Removed: The licensed mAbs were developed as part of a research collaboration and option agreement between the
−Removed: Company and Columbia.
−Removed: On February 23, 2023, the
−Removed: Company granted options to purchase an aggregate of 4,394,303
−Removed: shares of the Company’s common stock to employees with an exercise price of $ 0.73 ,
−Removed: with a term of ten
−Removed: years , vesting 1/3
−Removed: on the first anniversary and 1/36 th
−Removed: each month thereafter for 24 months.
−Removed: Additionally, the Company granted options to purchase 1,327,500
−Removed: shares of the Company’s common stock to certain employees with an exercise price of $ 0.91 ,
−Removed: with a term of ten
−Removed: years , vesting 1/3
−Removed: on the first anniversary and 1/36 th
−Removed: each month thereafter for 24 months.
−Removed: Subsequent to December 31,
−Removed: 2022, the Company sold 2.1
−Removed: million shares of common stock under the Sales Agreement with AGP for net proceeds of approximately $ 1.4
−Removed: Subsequent to December 31,
−Removed: 2022, the Company sold 0.6
−Removed: million shares of common stock under the 2022 Purchase Agreement with Lincoln Park for net proceeds of approximately $ 0.4
−Removed: ITEM 9 - CHANGES IN AND DISAGREEMENTS
−Removed: WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES
+Added: December 31, 2023, the Company has $ 263.4 million of Ireland NOL carryforwards that do not expire.
+Added: As of December 31, 2023, the
+Added: Company’s Federal NOL carryforwards of $ 0.2 million, which do not expire.
+Added: The Company has New Jersey NOL carryforwards of $ 0.2
+Added: million, Massachusetts NOL carryforwards of $ 0.01 million, and Montana NOL carryforwards of $ 0.05 million, all of which expire
+Added: in 20 years , are subject to annual limitations in their use in accordance with IRC section 382.
+Added: The NOL carryforwards at December
+Added: 31, 2023 have been reduced to reflect IRC section 382 ownership changes through December 31, 2023 and the resultant inability
+Added: due to annual limitations, to utilize a portion of the NOL prior to its expiration.
+Added: assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use
+Added: the existing deferred tax assets.
+Added: A significant piece of objective negative evidence evaluated was the cumulative loss incurred
+Added: over the three-year period ended December 31, 2023.
+Added: Such objective evidence limits the ability to consider other subjective evidence
+Added: such as our projections for future growth.
+Added: As such, the Company has determined that it is not more likely than not that the deferred
+Added: tax assets will be realized and accordingly, has provided a full valuation allowance against its gross deferred tax assets.
+Added: increase/(decrease) in the valuation allowance for the years ended December 31, 2023 and 2022 were $ 14.5 million, and $ 9.5 million
+Added: respectively.
+Added: The Company recognizes
+Added: interest accrued related to unrecognized tax benefits and penalties as income tax expense.
+Added: However, as of December 31, 2023 there
+Added: are no unrecognized tax benefits recorded.
+Added: The Company is subject to taxation in the United States and various states and foreign
+Added: jurisdictions.
+Added: As of December 31, 2023, the Company’s tax returns remain open and subject to examination by the tax authorities
+Added: for the tax years 2020 and after.
+Added: NOTE 23 – SUBSEQUENT EVENTS
+Added: On January 25, 2024, the
+Added: Company filed a Certificate of Amendment to its Articles of Incorporation, as amended, with the Secretary of State of the State of Nevada
+Added: to increase the number of authorized shares of the Company’s common stock from 160,000,000 to 1,000,000,000 shares.
+Added: The Amendment
+Added: was approved by the Company’s shareholders at a special meeting of shareholders held on January 25, 2024.
+Added: On February 27, 2024,
+Added: the Company granted options to purchase an aggregate of 4,261,104 shares of the Company’s common stock to employees with
+Added: an exercise price of $ 0.37 , with a term of ten years , vesting 1/3 on the first anniversary and 1/36 th each month thereafter
+Added: for 24 months.
+Added: Additionally, the Company granted options to purchase 2,860,680 shares of the Company’s common stock to certain
+Added: employees with an exercise price of $ 0.46 , with a term of ten years , vesting 1/3 on the first anniversary and 1/36 th each
+Added: month thereafter for 24 months.
+Added: Finally, the Company granted options to purchase 1,309,911 shares of the Company’s common
+Added: stock to an employee with an exercise price of $ 0.37 , with a term of ten years , vesting in 6 months.
+Added: 28, 2024, the Company sold 10,766,666 shares of common stock, pre-funded warrants to purchase up to 3,900,000 shares of common stock,
+Added: and accompanying Series E warrants to purchase up to 14,666,666 shares of common stock with an exercise price of $ 0.33 per share and expiring
+Added: five and a half years from date of issuance in a public offering, which closed on April 1, 2024.
+Added: The offering price per share of common
+Added: stock was $ 0.30 , accompanying warrants was $ 0.33 , and the offering price per share of pre-funded warrants was $ 0.2999 .
+Added: incurred offering expenses of approximately $ 0.5 million, including placement agent fees of approximately $ 0.3 million.
+Added: The Company received
+Added: net proceeds of approximately $ 3.9 million, after deducting the underwriting discount and other offering expenses.
+Added: Additionally, the Company entered
+Added: into warrant amendments with certain holders of its Common Warrants.
+Added: The exercise price of each Existing Warrant will be amended to $ 0.33
+Added: upon approval by the Company’s stockholders of a proposal to allow the Existing Warrants to become exercisable in accordance with
+Added: Nasdaq Listing Rule 5635, or as otherwise provided in the Amendment if stockholder approval is not obtained by October 1, 2024.
+Added: Upon stockholder
+Added: approval, the termination date for Common Warrants to purchase up to an aggregate of 6,950,000 shares will be amended to April 1, 2029 ;
+Added: the termination date for Series A Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029 ;
+Added: termination date for Series B Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029 ;
+Added: the termination
+Added: date for Series C Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be the earlier of (i) April 1, 2026
+Added: and (ii) 10 trading days following notice by the Company to the Series C Warrant holder of the Company’s public announcement of
+Added: the FDA’s acknowledgement and acceptance of the Company’s NDA relating to TNX-102 SL in patients with Fibromyalgia;
+Added: the termination
+Added: date for Series D Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be April 1, 2029 .
+Added: The other terms of
+Added: the Existing Warrants will remain unchanged.
+Added: If stockholder approval is not obtained on or by October 1, 2024, then the Company
+Added: has agreed to automatically amend the exercise price of the Existing Warrants to the Minimum Price (as defined in Nasdaq Listing Rule
+Added: 5635(d)) of the Common Stock on October 1, 2024 if and only if the Minimum Price is below the then current exercise price.
+Added: ITEM 9 - CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
+Added: ACCOUNTING AND FINANCIAL DISCLOSURES
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.