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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended June 30, 2024

 

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Transition Period from _________ to _________

 

Commission file number: 001-36019

 

TONIX PHARMACEUTICALS HOLDING CORP.

(Exact name of registrant as specified in its charter)

 

Nevada   26-1434750
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)

 

26 Main Street, Suite 101    
Chatham, New Jersey   07928
(Address of Principal Executive Offices)   (Zip Code)

 

(862) 799-9155

(Registrant’s telephone number, including area code)

 

 Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock   TNXP   The NASDAQ Global Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒   No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company.  See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer     Accelerated filer  
Non-accelerated filer     Smaller reporting company  
        Emerging growth company  
             

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No   ☒.

 

As of August 16, 2024, there were 22,004,159 shares of registrant’s common stock outstanding. 

 

 

 

 

 

 

TONIX PHARMACEUTICALS HOLDING CORP.

 

INDEX

 

PART I. FINANCIAL INFORMATION    
         
  ITEM 1. Financial Statements    
         
    Condensed consolidated balance sheets as of June 30, 2024 (unaudited) and December 31, 2023   3
         
    Condensed consolidated statements of operations for the three and six months ended June 30, 2024 and 2023 (unaudited)   4
         
    Condensed consolidated statements of comprehensive loss for the three and six months ended June 30, 2024 and 2023 (unaudited)   5
         
    Condensed consolidated statements of stockholders’ equity for three and the six months ended June 30, 2024 and 2023 (unaudited)   6-7
         
    Condensed consolidated statements of cash flows for the six months ended June 30, 2024 and 2023 (unaudited)   8
         
    Notes to condensed consolidated financial statements (unaudited)   9-34
         
  ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   35
         
  ITEM 3. Quantitative and Qualitative Disclosures about Market Risk   50
         
  ITEM 4. Controls and Procedures   50
         
PART II. OTHER INFORMATION    
         
  ITEM 1. Legal Proceedings   51
  ITEM 1A. Risk Factors   51
  ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds   51
  ITEM 3. Defaults Upon Senior Securities   51
  ITEM 4. Mine Safety Disclosures   51
  ITEM 5. Other Information   51
  ITEM 6. Exhibits   52
         
  SIGNATURES   53

   

2

 

  

PART I – FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

TONIX PHARMACEUTICALS HOLDING CORP. 
CONDENSED CONSOLIDATED BALANCE SHEETS 
(In Thousands, Except Par Value and Share Amounts)
(unaudited)

 

   June 30,   December 31, 
   2024   2023 
ASSETS          
Current assets:          
Cash and cash equivalents  $4,156   $24,948 
Accounts receivable, net   3,339     
Inventory   9,457    13,639 
Prepaid expenses and other current assets   8,335    9,181 
Total current assets   25,287    47,768 
           
Property and equipment, net   43,247    94,028 
           
Intangible assets, net   120    9,743 
Goodwill       965 
Operating lease right-to-use assets   692    824 
Other non-current assets   961    1,129 
           
Total assets  $70,307   $154,457 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $10,406   $3,782 
Accrued expenses and other current liabilities   8,540    12,482 
Term loan payable, short term   2,820    2,350 
Lease liability, short term   277    270 
Total current liabilities   22,043    18,884 
           
Term loan payable, long term   5,668    6,561 
Series C warrant liabilities       14,595 
Series D warrant liabilities       8,260 
Lease liability, long term   493    632 
           
Total liabilities   28,204    48,932 
           
Commitments (See Note 17)          
           
Stockholders’ equity:          
Preferred stock, $0.001 par value; 5,000,000 shares authorized, 0 shares designated as of both June 30, 2024, and December 31, 2023; 0 shares issued and outstanding - as of both June 30, 2024 and December 31, 2023        
           
Common stock, $0.001 par value; 1,000,000,000 shares authorized; 9,832,587 and 2,077,088 shares issued and outstanding as of June 30, 2024, and December 31, 2023, respectively and 2,074 shares to be issued as of December 31, 2023   10    3 
Additional paid in capital   736,709    706,412 
Accumulated deficit   (694,373)   (600,658)
Accumulated other comprehensive loss   (243)   (232)
           
Total stockholders’ equity   42,103    105,525 
           
Total liabilities and stockholders’ equity  $70,307   $154,457 

 

See the accompanying notes to the condensed consolidated financial statements 

 

3

 

 

 TONIX PHARMACEUTICALS HOLDING CORP. 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)

(unaudited)

 

                     
   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2024   2023   2024   2023 
REVENUE:                
Product revenue, net  $2,208   $   $4,690   $ 
COSTS AND EXPENSES:                    
Cost of revenue  $3,367   $   $5,027   $ 
Research and development   9,698    21,976    22,561    48,487 
Selling, general and administrative   7,502    7,026    16,812    14,417 
Asset impairment charges   58,957        58,957     
    79,524    29,002    103,357    62,904 
                     
Operating loss   (77,316)   (29,002)   (98,667)   (62,904)
                     
(Loss) gain on change in fair value of warrant liabilities   (855       6,150     
Other (expense) income, net   (605)   646    (1,198)   1,543 
                     
Net loss available to common stockholders  $(78,776)  $(28,356)  $(93,715)  $(61,361)
                     
Net loss per common share, basic and diluted  $(19.28)  $(49.23)  $(27.33)  $(107.45)
                     
Weighted average common shares outstanding, basic and diluted   4,085,132    576,047    3,428,906    571,089 

 

See the accompanying notes to the condensed consolidated financial statements 

 

4

 

 

TONIX PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In Thousands)

(unaudited)

 

                     
   Three Months Ended June 30,   Six Months Ended June 30, 
   2024   2023   2024   2023 
Net loss  $(78,776)  $(28,356)  $(93,715)  $(61,361)
                     
Other comprehensive loss:                    
Foreign currency translation loss   (3)   (1)   (11)   (45)
                     
Comprehensive loss  $(78,779)  $(28,357)  $(93,726)  $(61,406)

 

See the accompanying notes to the condensed consolidated financial statements

 

5

 

 

TONIX PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

(In Thousands, Except Share and Per Share Amounts)

(unaudited)

 

               Accumulated         
           Additional   Other         
   Common stock   Paid in   Comprehensive   Accumulated     
   Shares   Amount   Capital   Gain (loss)   Deficit   Total 
Balance, December 31, 2023   2,077,088   $2   $706,413   $(232)  $(600,658)  $105,525 
Issuance of common stock upon exercise of prefunded common warrants   470,102    1    (1)            
Fair value of warrants reclassified from liabilities to equity           15,850            15,850 
Employee stock purchase plan   2,074        23            23 
Stock-based compensation           1,692            1,692 
Foreign currency transaction loss               (8)       (8)
Net loss                   (14,939)   (14,939)
Balance, March 31, 2024   2,549,264    3    723,977    (240)   (615,597)   108,143 
Issuance of common stock, net of transactional expenses of $1,704   4,369,807    4    10,726            10,730 
 Issuance of common stock upon exercise of prefunded common warrants   2,913,516    3    (3            
Fair value of warrants reclassified from equity to liabilities           

(9,977

)           (9,977)
Fair value of warrants reclassified from liabilities to equity           10,832            10,832 
Stock-based compensation           1,154            1,154 
Foreign currency transaction loss               (3)       (3)
Net loss                   (78,776)   (78,776)
Balance, June 30, 2024   9,832,587   $10   $736,709   $(243)  $(694,373)  $42,103 

 

See the accompanying notes to the condensed consolidated financial statements 

 

6

 

  

TONIX PHARMACEUTICALS HOLDING CORP. 

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY 

(In Thousands, Except Share and Per Share Amounts) 

(unaudited)

 

               Accumulated         
           Additional   Other         
   Common stock   Paid in   Comprehensive   Accumulated     
   Shares   Amount   Capital   Gain (loss)   Deficit   Total 
Balance, December 31, 2022   631,704   $1   $677,386   $(167)  $(470,038)  $207,182 
Repurchase of common stock under share repurchase program, including transactional expenses of $334   (83,502)       (3)       (13,962)   (13,965)
Issuance of common stock under 2022 Purchase agreement with Lincoln Park   3,000        441            441 
Issuance of common stock net of transactional expenses of $101   16,089        1,995            1,995 
Employee stock purchase plan   469        29            29 
Stock-based compensation           2,794            2,794 
Foreign currency transaction loss               (44)       (44)
Net loss                   (33,005)   (33,005)
Balance, March 31, 2023   567,760    1    682,642    (211)   (517,005)   165,427 
Issuance of common stock net of transactional expenses of $36   13,766        1,029            1,029 
Stock-based compensation           2,364            2,364 
Foreign currency transaction loss               (1)       (1)
Net loss                   (28,356)   (28,356)
Balance, June 30, 2023   581,526   $1   $686,035   $(212)  $(545,361)  $140,463 

 

See the accompanying notes to the condensed consolidated financial statements

 

7

 

 

TONIX PHARMACEUTICALS HOLDING CORP

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 

(In Thousands) 

(unaudited)

 

           
   Six Months Ended June 30, 
   2024   2023 
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss  $(93,715)  $(61,361)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   2,415    1,814 
Asset impairment charges   58,957     
Change in fair value of warrant liabilities   (6,150)    

Inventory write-off

   1,738     
Amortization of debt discount   431     
Stock-based compensation   2,846    5,158 
Changes in operating assets and liabilities:          
Accounts receivable   (3,339)    
Inventory   2,444     
Prepaid expenses and other   1,011    268 
Accounts payable   6,703    (571)
Lease liabilities and ROU asset, net   (2)   7 
Accrued expenses and other current liabilities   (833)   (1,593)
Net cash used in operating activities   (27,494)   (56,278)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchase of a business       (22,174)
Purchase of property and equipment   (108)   (5,644)
Net cash used in investing activities   (108)   (27,818)
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Deferred payment related to purchase a business   (3,000)    
Repurchase of common stock       (13,965)
Proceeds from ESPP   23    29 
Payment of term loan   (940)    
Proceeds, net of $1,704 and $137 expenses, from sale of common stock and warrants   10,730    3,465 
Net cash provided by (used in) financing activities   6,813    (10,471)
           
Effect of currency rate change on cash   (3)   (43)
           
Net decrease in cash, cash equivalents and restricted cash   (20,792)   (94,610)
Cash, cash equivalents and restricted cash beginning of the period   25,850    120,470 
           
Cash, cash equivalents and restricted cash end of period  $5,058   $25,860 
           
Supplemental disclosures of cash flow information:          
Interest expense paid  $653    
Non-cash financing and investing activities:          
Purchases of property and equipment included in accounts payable and accrued liabilities  $106   $1,164 

 

See the accompanying notes to the condensed consolidated financial statements

 

8

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

NOTE 1 – BUSINESS 

 

Tonix Pharmaceuticals Holding Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), is a fully-integrated biopharmaceutical company focused on developing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix aims to transform therapies for pain management and modernize solutions for public health challenges.  

 

Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s priority is to submit a New Drug Application (“NDA”) to the FDA in the second half of 2024 for TNX-102 SL for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for fibromyalgia. TNX-102 SL is also expected to be tested by the University of North Carolina under a physician IND for Acute Stress Reaction in a trial funded by the U.S. Department of Defense (DoD), Congressionally Directed Medical Research Program, or CDMRP for approximately $3 million. Tonix’s CNS portfolio also includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, in Phase 2 development that is funded by the U.S. National Institute of Drug Abuse or NIDA. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix is developing a broad-spectrum antiviral termed TNX-4200 under a contract for up to $34 million from the DoD Defense Threat Reduction Agency. Tonix’s development candidates are investigational drugs or biologics and are not approved for any indication. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. 

 

The consolidated financial statements include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Sub, Krele LLC, Tonix Pharmaceuticals (Canada), Inc., Tonix Medicines, Inc., Jenner Institute LLC, Tonix R&D Center LLC, Tonix Pharma Holdings Limited and Tonix Pharma Limited (collectively, the “Company” or “Tonix”). All intercompany balances and transactions have been eliminated in consolidation.

 

Going Concern

 

The accompanying financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered recurring losses from operations and negative cash flows from operating activities. At June 30, 2024, the Company had working capital of approximately $3.2 million. At June 30, 2024, the Company had an accumulated deficit of approximately $694.4 million. The Company held cash and cash equivalents of approximately $4.2 million as of June 30, 2024. During the fourth quarter of 2023, the Company engaged CBRE, an international real estate brokerage firm, to potentially find a strategic partner for, or buyer of, its Advanced Development Center in North Dartmouth, Massachusetts (“ADC”), to align with the Company’s current business objectives and priorities. As of June 30, 2024, the Company does not have a commitment in place to sell the ADC.

 

The Company believes that its cash resources at June 30, 2024 and the gross proceeds of $4.4 million that it raised from an equity offering in the third quarter of 2024 (See Note 18), will not meet its operating and capital expenditure requirements through the third quarter of 2024.

 

These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company continues to face significant challenges and uncertainties and must obtain additional funding through public and private financing and collaborative arrangements with strategic partners to increase the funds available to fund operations. However, the Company may not be able to raise capital on terms acceptable to the Company, or at all. Without additional funds, it may be forced to delay, scale back or eliminate some or all of its research and development activities or other operations, and potentially delay product development in an effort to maintain sufficient funds to continue operations. If any of these events occurs, the Company’s ability to achieve development and commercialization goals will be adversely affected and the Company may be forced to cease operations. Moreover, the Company may default under the terms of its existing indebtedness. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.  

 

NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES

 

Interim financial statements

 

The unaudited condensed consolidated interim financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included.

 

9

 

  

 TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

The condensed consolidated balance sheet as of December 31, 2023, contained herein has been derived from audited financial statements.

 

Operating results for the three and six months ended June 30, 2024 are not necessarily indicative of results that may be expected for the year ending December 31, 2024. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2024.

 

Reverse Stock Split

 

On June 10, 2024, the Company effected a 1-for-32 reverse stock split of its issued and outstanding shares of common stock, The Company accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All issued and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted in these condensed consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented. Authorized common and preferred stock were not adjusted because of the reverse stock split.

 

Risks and uncertainties

 

The Company’s primary efforts are devoted to conducting research and development of innovative pharmaceutical and biological products to address public health challenges. The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future. Further, the Company now has commercial products available for sale, and generates revenue from the sale of its Zembrace SymTouch and Tosymra products, with no assurance that the Company will be able to generate sufficient cash flow to fund operations from its commercial products or products in development if and when approved. In addition, there can be no assurance that the Company’s research and development will be successfully completed or that any product will be approved or commercially viable.

 

Use of estimates

 

The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include, but are not limited to, impairments, provisions for product returns, coupons, rebates, chargebacks, discounts, allowances, inventory realization, the assumptions used in the fair value of stock-based compensation and other equity instruments, the percent of completion of research and development contracts, fair value estimates for assets acquired in business combinations, and assessment of useful lives of acquired intangible assets. 

 

10

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

Business Combinations

 

The Company accounts for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. Business combinations are accounted for using the acquisition method, whereby the consideration transferred is allocated to the net assets acquired based on their respective fair values measured on the acquisition date. The difference between the fair value of these assets and the purchase price is recorded as goodwill. Transaction costs other than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered part of the business acquisition transaction and are expensed as incurred.

 

Segment Information and Concentrations

 

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The Company considers its chief executive officer to be the Company’s CODM. The CODM manages its operations and allocates resources based on the Company’s consolidated results and therefore operates as one segment.

 

The Company has two products that each accounted for more than 10% of total revenues during the three and six months ended June 30, 2024. These products collectively accounted for 100% of revenues during the three and six months ended June 30, 2024.

 

As of June 30, 2024, accounts receivable from five customers accounted for 31%, 26%, 23%, 11% and 9% of total accounts receivable. For the three months ended June 30, 2024, revenues from five customers accounted for 27%, 26%, 23%, 18% and 5% of net product revenues, respectively. For the six months ended June 30, 2024, revenues from five customers accounted for 24%, 24%, 22%, 16% and 13% of net product revenues, respectively. The Company had no commercialized products for the three and six months ended June 30, 2023, and therefore had no accounts receivable or revenues in the comparative period.

 

Cash, Cash Equivalents and Restricted Cash

 

The Company considers cash equivalents to be those investments which are highly liquid, readily convertible to cash and have an original maturity of three months or less when purchased. At June 30, 2024 and June 30, 2023, cash equivalents, which consisted of money market funds, amounted to $24,000 and $19.2 million, respectively. Restricted cash, which is included in Other non-current assets on the condensed consolidated balance sheet, at June 30, 2024, of approximately $0.9 million collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey (see Note 16) and restricted cash held by vendors in escrow accounts for patient support services. Restricted cash at June 30, 2023, of approximately $243,000, collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and New York, New York.

 

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:

 

    June 30,
2024
    June 30,
2023
 
    (in thousands)  
Cash and cash equivalents   $ 4,156     $ 25,617  
Restricted cash     902       243  
Total   $ 5,058     $ 25,860  

 

 

11

 

 

TONIX PHARMACEUTICALS HOLDING CORP.  

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

Accounts Receivable, net

 

Accounts receivable consists of amounts due from our wholesale and other third-party distributors and pharmacies and have standard payment terms that generally require payment within 30 to 90 days. For certain customers, the accounts receivable for the customer is net of cash discounts, chargebacks and customer rebates. We do not adjust our receivables for the effects of a significant financing component at contract inception if we expect to collect the receivables in one year or less from the time of sale. We provide reserves against accounts receivable for estimated losses that may result from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve.

 

As of June 30, 2024, the Company did not have an allowance for credit losses, as the Company’s exposure to credit losses is de minimis. An allowance for credit losses is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period.  

 

Concentration of Credit Risk

 

Financial instruments that potentially subject us to concentrations of credit risk include cash and cash equivalents, and accounts receivable. We attempt to minimize the risks related to cash and cash equivalents by investing in a broad and diverse range of financial instruments, and we have established guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain liquidity. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the variety of customers using our products, as well as their dispersion across different geographic areas.

 

We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. We continue to monitor these conditions and assess their possible impact on our business.

 

Inventories

 

Inventories are recorded at the lower of cost or net realizable value, with cost determined by the weighted average cost method. Acquired inventory was valued at estimated selling price less a reasonable margin. The Company periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value in the period that the decline in value is first recognized. During the three months ended June 30, 2024, the Company recorded write-downs related to Tosymra and Zembrace finished goods inventory of approximately $1.7 million based on an assessment of inventory on hand and projected sales prior to the respective expiration dates. Although the Company makes every effort to ensure the accuracy of forecasts of future product demand, any significant unanticipated decreases in demand could have a material impact on the carrying value of inventories and reported operating results.

 

12

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

The Company did not have inventory on hand prior to the acquisition of Zembrace and Tosymra on June 30, 2023.

 

Property and equipment  

 

Property and equipment are stated at cost, less accumulated depreciation. Depreciation and amortization is calculated using the straight-line method over the asset’s estimated useful life, which ranges from 20 to 40 years for buildings, 15 years for land improvements and laboratory equipment, three years for computer assets, five years for furniture and all other equipment and the shorter of the useful life or term of lease for leasehold improvements. Depreciation and amortization on assets begin when the asset is placed in service. Depreciation and amortization expense for the three months ended June 30, 2024, and 2023 was $0.9 million, for both reporting periods. Depreciation and amortization expense for the six months ended June 30, 2024, and 2023 was $1.9 million and $1.8 million, respectively. The Company’s property and equipment is located in the United States.

 

Intangible assets, net

 

Intangible assets deemed to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any. Finite-lived intangible assets consist of developed technology intangible assets acquired in connection with the acquisition of certain products from Upsher Smith Laboratories, LLC (“Upsher Smith”) consummated on June 30, 2023 (See Note 5). The acquired intangible assets are amortized using the straight-line method over the estimated useful lives of the respective assets. Amortization expense for the three and six months ended June 30, 2024, was $0.2 million and $0.5 million, respectively. The Company recorded a full impairment of its developed technology assets during the three months ended June 30, 2024, discussed further below.

 

During the year ended December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life. Identifiable intangibles with indefinite lives, which are included in Intangible assets, net on the consolidated balance sheet, are not amortized but are tested for impairment annually or whenever events or changes in circumstances indicate that their carrying amount may be less than fair value. The Company completed the required annual impairment test for the indefinite-lived intangible as of June 30, 2024, its annual impairment assessment date, by performing a qualitative assessment to evaluate whether it is more likely than not that the fair value of its indefinite-lived intangible is less than its carrying amount, resulting in no impairment.

 

13

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

Impairment testing of long-lived assets

 

The Company evaluates long-lived assets for impairment, including property and equipment, finite-lived intangibles assets and operating lease right-to-use assets whenever events or changes in circumstances indicate that their net book value may not be recoverable. When such factors and circumstances exist, the Company compares the projected undiscounted future cash flows associated with the related asset or group of assets over their estimated useful lives against their respective carrying amount. Impairment, if any, is based on the excess of the carrying amount over the fair value, based on market value when available, or discounted expected cash flows, of those assets and is recorded in the period in which the determination is made.

 

During the three months ended June 30, 2024, the Company identified certain triggering events related to the ADC and the decommissioning of the ADC. The Company determined that the carrying value of the ADC was not recoverable and that the carrying value exceeded its fair value. As such, the Company recorded a non-cash impairment charge of $48.8 million, which is reflected in asset impairment charges in the consolidated statements of operations for the three and six months ended June 30, 2024.

 

Additionally, due to a sustained decline in revenues and continued delays in building out the sales team for its commercialized products, the Company also tested its commercialized products asset group for recoverability as of June 30, 2024. The Company determined that the carrying value was not recoverable and therefore estimated the fair value of the asset group using a discounted cash flow analysis. The Company recorded a non-cash impairment charge for the amount of $9.2 million, representing the excess carrying value over the fair value, consisting of $6.2 million and $3.0 million for the Zembrace and Tosymra developed technology intangible assets, respectively, which is reflected in asset impairment charges in the consolidated statements of operations for the three and six months ended June 30, 2024. 

 

Goodwill

 

Goodwill represents the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business combination. Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate that the carrying amount of goodwill may be impaired. The Company previously recognized goodwill in connection with the USL Acquisition consummated on June 30, 2023 (See Note 5). The Company completed the required annual impairment test for goodwill as of June 30, 2024, which resulted in full non-cash impairment of the Company’s $965,000 of goodwill, which is reflected in asset impairment charges in the consolidated statements of operations for the three and six months ended June 30, 2024. 

 

Leases

 

The Company determines if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the transition date and subsequent lease commencement dates in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments made under operating leases is recognized on a straight-line basis over the lease term.

 

Deferred financing costs

 

Deferred financing costs represent the cost of obtaining financing arrangements and are amortized over the term of the related debt agreement using the effective interest method. Deferred financing costs related to term debt arrangements are reflected as a direct reduction of the related debt liability on the consolidated balance sheet. Amortization of deferred financing costs are included in interest expense on the consolidated statements of operations.

 

Original issue discount

 

Certain term debt issued by the Company provides the debt holder with an original issue discount. Original issue discounts are reflected as a direct reduction of the related debt liability on the consolidated balance sheets and are amortized over the term of the related debt agreement using the effective interest method. Amortization of original issue discounts are included in interest expense on the consolidated statements of operations.

 

Revenue Recognition

 

The Company records and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company’s revenues primarily result from contracts with customers, which are generally short-term and have a single performance obligation - the delivery of product. The Company’s performance obligation to deliver products is satisfied at the point in time that the goods are received by the customer, which is when the customer obtains title to and has the risks and rewards of ownership of the products, which is generally upon shipment or delivery to the customer as stipulated by the terms of the sale agreements. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Our contractual payment terms are typically 30 to 90 days.

 

14

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

Revenues from product sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved. Taxes assessed by governmental authorities and collected from customers are excluded from product sales. Shipping and handling activities are considered to be fulfillment activities and not a separate performance obligation.

 

Many of the Company’s products sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts, distributor fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates and assumptions. The following section briefly describes the nature of the Company’s provisions for variable consideration and how such provisions are estimated:

 

Chargebacks - The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with these indirect customers to establish pricing for the Company’s products, and in-turn, the indirect customers and entities independently purchase these products. Because the price paid by the indirect customers and/or entities is lower than the price paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and the wholesale customer’s purchase price. The Company’s provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts the reserve accordingly when expected chargebacks differ from actual experience.

 

Rebates - The Company participates in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified recipients, and primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts, specialty pharmacy program fees and other governmental rebates or applicable allowances.

 

  Managed Care Rebates are processed in the quarter following the quarter in which they are earned. The managed care reporting entity submits utilization data after the end of the quarter and the Company processes the payment in accordance with contract terms. All rebates earned but not paid are estimated by the Company according to historical payments trended for market growth assumptions.

 

  Medicaid and State Agency rebates are based upon historical experience of claims submitted by various states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month lag from the time of product sale until the rebate is paid.

 

  Tri-Care represents a regionally managed health care program for active duty and retired members, dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a reserve amount is established to represent the proportionate rebate amount associated with product sales.

 

  Coverage Gap refers to the Medicare prescription drug program and represents specifically the period between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review of the liability based on payment trends and any revision to the projected annual cost.

 

15

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

Prompt-Pay and other Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue and as a reduction in the accounts receivable at the time of sale based on the customer’s contracted discount rate. Consumer sales discounts represent programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher programs.

 

Product Returns - Consistent with industry practice, the Company offers customers a right to return any unused product. The customer’s right of return commences typically six months prior to product expiration date and ends one year after product expiration date. Products returned for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates the amount of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales to its customers. The rate is estimated by using historical sales information, including its visibility and estimates into the inventory remaining in the distribution channel. Adjustments are made to the current provision for returns when data suggests product returns may differ from original estimates.

 

Research and Development Costs

 

The Company outsources certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to patents and other intellectual property acquired has been expensed as research and development costs, as such property is related to particular research and development projects and had no alternative future uses.

 

 The Company estimates its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company accounts for trial expenses according to the timing of various aspects of the trial. The Company determines accrual estimates taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed.

 

During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.

 

Government Grants

 

From time to time, the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities included in the grant application approved by the government authority. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are incurred. In August 2022, the Company received a Cooperative Agreement grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, to support the development of its TNX-1300 product candidate for the treatment of cocaine intoxication. During the six months ended June 30, 2024, we received $0.5 million in funding as a reduction of related research and development expense. Included in prepaid expenses and other current assets is an additional $0.3 million which was received in July 2024 and resulted in a further reduction of research and development expense during the six months ended June 30, 2024. During the six months ended June 30, 2023, we received $1.9 million in funding as a reduction of related research and development expense.

 

16

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

Stock-based Compensation.

 

All stock-based payments to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock options, are measured at fair value on the grant date and recognized in the consolidated statements of operations as compensation expense over the requisite service period. The Company accounts for share-based awards in accordance with the provisions of the Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation.

 

Foreign Currency Translation

 

Operations of the Company’s Canadian subsidiary, Tonix Pharmaceuticals (Canada), Inc., are conducted in local currency, which represents its functional currency. The U.S. dollar is the functional currency of the other foreign subsidiaries. Balance sheet accounts of the Canadian subsidiary were translated from foreign currency into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement accounts were translated at the average rate of exchange prevailing during the period. Translation adjustments resulting from this process were included in accumulated other comprehensive loss on the consolidated balance sheets.

 

Comprehensive Income (Loss)

 

Comprehensive income (loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances from non-owners sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.

 

Income Taxes

 

Deferred income tax assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured at the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more likely than not that these deferred income tax assets will be realized.

 

The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. As of June 30, 2024, the Company has not recorded any unrecognized tax benefits. The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.

 

Derivative Instruments and Warrant Liabilities

 

The Company evaluates all of its financial instruments, including issued warrants to purchase common stock under ASC 815 – Derivatives and Hedging, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives (See Note 13). For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations. The Company uses the Black-Scholes option pricing model to value the derivative instruments at inception and subsequent valuation dates, which is adjusted for instrument-specific terms as applicable.

 

From time to time, certain equity-linked instruments may be classified as derivative liabilities due to the variable exercise price of the shares to fully settle the equity-linked financial instruments in shares. In such case, the Company has adopted a sequencing approach under ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity to determine the classification of its contracts at issuance and at each subsequent reporting date.

 

In the event that reclassification of contracts between equity and assets or liabilities is necessary, the Company first allocates remaining authorized shares to equity on the basis of the earliest issuance date of potentially dilutive instruments, with the earliest issuance date receiving the first allocation of shares. In the event of identical issuance dates, shares are then allocated to equity beginning with instruments with the latest maturity date first.

 

The classification of derivative instruments is reassessed at each reporting date. If the classification changes as a result of events during a reporting period, the instrument is reclassified as of the date of the event that caused the reclassification. There is no limit on the number of times a contract may be reclassified.

 

17

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

Per Share Data

 

The computation of basic and diluted loss per share for the quarters ended June 30, 2024 and 2023 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period. Prefunded warrants are assumed exercised on date of issuance and are included in the basic EPS calculation.

 

All warrants issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the Board of Directors, on the Company’s common stock. For purposes of computing EPS, these warrants are considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated to the warrants for the three and six months ended June 30, 2024, and 2023, as results of operations were a loss for the periods.

 

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of June 30, 2024 and 2023, are as follows:

 

    2024     2023  
Warrants to purchase common stock     10,535,363       101  
Options to purchase common stock     310,797       43,441  
Totals     10,846,160       43,542  

 

Recent Accounting Pronouncements Not Yet Adopted

 

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting--Improvements to Reportable Segment Disclosures, which requires incremental disclosures about a public entity’s reportable segments but does not change the definition of a segment or the guidance for determining reportable segments. The new guidance requires disclosure of significant segment expenses that are (1) regularly provided to (or easily computed from information regularly provided to) the chief operating decision maker and (2) included in the reported measure of segment profit or loss. The new standard also allows companies to disclose multiple measures of segment profit or loss if those measures are used to assess performance and allocate resources. The guidance will first be effective in our annual disclosures for the year ending December 31, 2024, and will be adopted retrospectively unless impracticable. Early adoption is permitted. The Company is in the process of assessing the impact of ASU 2023-07 on our disclosures.

 

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires disaggregated information about our effective tax rate reconciliation as well as information on income taxes paid. The guidance will first be effective in our annual disclosures for the year ending December 31, 2025, and should be applied on a prospective basis with the option to apply retrospectively. Early adoption is permitted. The Company is in the process of assessing the impact of ASU 2023-09 on our disclosures.

 

18

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

In March 2024, the SEC adopted new rules relating to the disclosure of a range of climate-change-related physical and transition risks, data, and opportunities. The adopted rule contains several new disclosure obligations, including, (i) disclosure on how the board of directors and management oversee climate-related risks and certain climate-related governance items, (ii) disclosure of information related to a registrant’s climate-related targets, goals, and/or transition plans, and (iii) disclosure on whether and how climate-related events and transition activities impact line items above a threshold amount on a registrant’s consolidated financial statements, including the impact of the financial estimates and the assumptions used. This new rule will first be effective in the Company’s disclosures for the year ending December 31, 2027. The Company is in the process of assessing the impact on our consolidated financial statements and disclosures.

 

NOTE 3 – INVENTORY

 

The components of inventory consisted of the following (in thousands):

 

    June 30,
2024
    December 31,
2023
 
    (in thousands)  
Raw Materials   $ 3,351     $ 3,611  
Work-in-process     1,953       2,539  
Finished Goods     4,153       7,489  
Total Inventory   9,457     13,639  

 

During the three months ended June 30, 2024, the Company recorded write-downs related to Tosymra and Zembrace finished goods inventory of approximately $1.7 million based on an assessment of inventory on hand and projected sales prior to the respective expiration dates. 

 

 

 

NOTE 4 – PROPERTY AND EQUIPMENT, NET

 

Property and equipment, net consisted of the following (in thousands):

 

    June 30,
2024
    December 31,
2023
 
    (in thousands)  
Property and equipment, net:                
Land   $ 8,011     $ 8,011  
Land improvements                     305                        326  
Buildings               24,504                 66,749  
Office furniture and equipment     1,367       2,366  
Laboratory equipment     12,116       21,904  
Leasehold improvements     34       34  
Property and equipment gross     46,337       99,390  
Less: Accumulated depreciation and amortization     (3,090 )     (5,362 )
Property and equipment, net   $ 43,247     $ 94,028  

 

19

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

 During the three months ended June 30, 2024, primarily as a result of the Company’s decision to decommission its ADC facility in Dartmouth, Massachusetts, the Company recognized a non-cash impairment charge of $48.8 million, which is reflected in asset impairment charges in the consolidated statements of operations for the three and six months ended June 30, 2024. The 45,000 square foot facility was purchased on September 28, 2020, for $4.0 million and incurred approximately $61.6 million to the build-out of the facility.

 

On October 1, 2021, the Company completed the acquisition of its approximately 45,000 square foot research and development facility in Frederick, Maryland totaling $17.5 million, to process development activities. Of the total purchase price, $2.1 million was allocated to the value of land acquired, and $13.9 million was allocated to buildings, and approximately $1.5 million was allocated to office furniture and equipment and laboratory equipment. As of August 1, 2022, the assets became ready for the intended use and were placed in service.  

 

On December 23, 2020, the Company completed the purchase of its approximately 44-acre site in Hamilton, Montana for $4.5 million, for the construction of a vaccine development and commercial scale manufacturing facility. As of June 30, 2024, the asset was not ready for its intended use. 

 

NOTE 5 – GOODWILL AND INTANGIBLE ASSETS

 

The following table provides the gross carrying value of goodwill as follows:

 

    Amounts  
    (in thousands)
Balance at December 31, 2023   $ 965  
Impairment of goodwill     (965)  
Balance at June 30, 2024   $ -  

 

The Company completed its annual impairment test for goodwill as of June 30, 2024, which resulted in full impairment of the Company’s $965,000 of goodwill, which is reflected in asset impairment charges in the consolidated statements of operations for the three and six months ended June 30, 2024.

 

The following table provides the gross carrying amount and accumulated amortization for each major class of intangible asset:

 

    June 30,
2024
    December 31,
2023
 
    (in thousands)  
Intangible assets subject to amortization                
Developed technology   $ 10,100     $ 10,100  
Less: Impairment charge     9,147        
Less: Accumulated amortization     953       477  
Total   $     $ 9,623  
Intangible assets not subject to amortization                
Internet domain rights   $ 120     $ 120  
Total intangible assets, net   $ 120     $ 9,743  

 

During the three and six months ended June 30, 2024, the Company recorded amortization of $238,000 and $476,000, respectively. No amortization was recorded during the same periods in 2023.

 

As a result of certain triggering events identified impacting the Company’s commercialized products asset group during the three months ended June 30, 2024, the Company tested the asset group for impairment as of June 30, 2024, resulting in a full impairment of its Zembrace and Tosymra developed technology intangible assets, of $6.2 million and $3.0 million, respectively, which is reflected in asset impairment charges in the consolidated statements of operations for the three and six months ended June 30, 2024. 

 

 

20

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

   

NOTE 6 – FAIR VALUE MEASUREMENTS 

 

Fair value measurements affect the Company’s accounting for certain of its financial assets. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and is measured according to a hierarchy that includes:

 

  Level 1: Observable inputs, such as quoted prices in active markets.

 

  Level 2: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly. Level 2 assets and liabilities include debt securities with quoted market prices that are traded less frequently than exchange-traded instruments. This category includes U.S. government agency-backed debt securities and corporate-debt securities.

 

  Level 3: Unobservable inputs in which there is little or no market data.

 

As of June 30, 2024, and December 31, 2023, the Company used Level 1 quoted prices in active markets to value cash equivalents which were de minimis for both periods presented. The Company did not have any Level 2 or Level 3 assets or liabilities as of June 30, 2024. As of December 31, 2023, Level 3 liabilities included a portion of the Company’s outstanding Series D Warrants and all of the Company’s outstanding Series C Warrants issued in December 2023, which did not meet the criteria for equity classification due to insufficient authorized shares to settle the instruments and were therefore accounted for as liabilities at fair value. After the Company received stockholder approval to increase the number of authorized shares on January 25, 2024, the liability classified Series D Warrants and the Series C Warrants met all requirements for equity classification and, as a result, the Company reclassified them to equity as of January 25, 2024.

 

The Company used the Black-Scholes option pricing model to estimate the fair value of the Series D Warrants and the Series C Warrants using significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. For periods prior to the receipt of stockholder approval, the fair value was then adjusted by applying a discount for lack of marketability (“DLOM”) based on the expected timing of receipt of stockholder approval to increase the number of authorized shares and to allow the Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635. Additionally, between April 1, 2024 and May 22, 2024, Level 3 liabilities included a portion of the Company’s outstanding August 2023 Warrants, Series A Warrants, Series B Warrants, Series C Warrants, and Series D Warrants (collectively, the “Existing Warrants”), as a result of certain Warrant Amendments entered into upon the closing of an equity financing on April 1, 2024, which provided for adjustments to the exercise prices of the Existing Warrants, contingent on approval by the Company’s stockholders of a proposal to allow the Existing Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635. The Company determined that the exercise price adjustment provision that is contingent on stockholder approval precluded the Existing Warrants from being indexed to the Company’s own stock, and therefore were reclassified to liabilities at post-modification fair value on April 1, 2024. After the Company received stockholder approval on May 22, 2024, thereby reducing the exercise prices of each of the Existing Warrants to $10.56 per share, the Existing Warrants met all requirements for equity classification and the Company reclassified them to equity as of May 22, 2024. To estimate the fair value of the Existing Warrants on the reclassification dates, the Company used a Black-Scholes option pricing model, probability weighted for different scenarios as applicable.

 

The following table summarizes the range of significant assumptions used in determining the fair value of liability-classified warrants as of December 31, 2023 and on the respective reclassification dates for the three and six months ended June 30, 2024: 

 

    Three months ended   Six months ended   As of
    June 30, 2024   June 30, 2024   December 31, 2023
Common stock price   $ 6.080   $ 6.080 - 9.888   $ 12.896
Risk-free rate     4.39%-5.37%     4.01% - 5.37%     3.84% - 4.23%
Expected term (in years)     0.86 - 5.00     0.86 - 5.00     1.78 - 5.15
Expected volatility     105.00% - 120.00%     105.00% - 120.00%     108.00%
Discount for lack of marketability     N/A     N/A     5.00%

 

21

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

A reconciliation of the beginning and ending balances for the liability-classified warrants measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows for the three and six months ended June 30, 2024:

 

   Warrant liabilities
Balance at December 31, 2023  $22,855 
Fair value - mark to market adjustment   (7,005)
Warrants reclassified from liabilities to equity   (15,850)
Balance at March 31, 2024  $  
Warrants reclassified from equity to liabilities   9,977 
Fair value - mark to market adjustment   855 
Warrants reclassified from liabilities to equity   (10,832)
Balance at June 30, 2024  $  

 

There were no liability-classified warrants measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three or six months ended June 30, 2023. Changes in the fair value of the liability-classified warrants are recognized as a separate component in the consolidated statement of operations. 

 

NOTE 7 – DEBT FINANCING

 

Long-term debt consists of the following:

 

   June 30, 2024  December 31, 2023
Term Loan  $10,060   $11,000 
Less: current portion   (2,820)   (2,350)
Total long-term debt   7,240    8,650 
Less: unamortized debt discount and deferred financing costs   (1,572)   (2,089)
Total long-term debt, net  $5,668   $6,561 

 

On December 8, 2023, the Company entered into a Loan and Guaranty Agreement (the “Loan Agreement”) by and among the Company, Krele LLC, Tonix Pharmaceuticals, Inc., Jenner and Tonix R&D Center (collectively, the “Loan Parties”), with JGB Capital, LP, JGB Partners, LP, JGB (Cayman) Port Ellen Ltd., and any other lender from time to time party hereto (collectively, the “Lenders”), and JGB Collateral LLC, as administrative agent and collateral agent for the Lenders (in such capacity, “JGB Agent”) for a 36-month term loan (the “Term Loan”) in the aggregate principal amount of $11.0 million, with a maturity date of December 8, 2026 (the “Maturity Date”). The Term Loan was funded with an original issue discount of 9% of the principal amount of the Term Loan, or $1.0 million, which is being amortized over the term of the debt as an adjustment to the effective interest rate on the outstanding borrowings.

 

Borrowings under the Term Loan bear interest at a fluctuating rate equal to the greater of (i) the prime rate as defined in the Loan Agreement plus 3.5% and (ii) 12%. Interest is payable monthly in arrears commencing in December 2023. In connection with the Term Loan, the Company deposited into a reserve account $1.8 million to be used exclusively to fund interest payments related to the Term Loan. The remaining deposit as of June 30, 2024 totals $0.9 million, which is reflected in Prepaid expenses and other current assets on the consolidated balance sheet.

 

Commencing on March 8, 2024 and continuing monthly through the Maturity Date, the outstanding principal is due and payable in monthly installments of $0.2 million, with the final remaining balance of unpaid principal and interest due and payable on the Maturity Date. In addition, the Company must pay a monthly collateral monitoring charge equal to 0.23% of the outstanding principal amount of the term loan as of the date of payment. The Company incurred $1.1 million in issuance costs, which is being amortized over the term of the debt as an adjustment to the effective interest rate on the outstanding borrowings.

 

22

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

The Loan Agreement provides for voluntary prepayments of the Term Loan, in whole or in part, subject to a prepayment premium. The Loan Agreement contains customary affirmative and negative covenants by the Company, which among other things, will require the Borrowers to provide certain financial reports to the lenders, to maintain a deposit account to fund interest payments, and limit the ability of the Company to incur or guarantee additional indebtedness, pay dividends or make other equity distributions, sell assets, engage in certain transactions, and effect a consolidation or merger. The obligations of the Company under the Loan Agreement may be accelerated upon customary events of default, including non-payment of principal, interest, fees and other amounts, covenant default, insolvency, material judgements, inaccuracy of representations and warranties, invalidity of guarantees. The Term Loan is secured by first priority security interests in the Company’s R&D Center in Frederick, Maryland, the Advanced Development Center in North Dartmouth, Massachusetts, and substantially all of the relevant deposit accounts.

 

As of June 30, 2024 and December 31, 2023, the carrying amount of the Term Loan approximated its fair value as the contractual interest rate for the Term Loan was representative of the then market interest rate.

 

Annual future principal payments due on the Term Loan as of March 31, 2024 are as follows (in thousands):

 

Fiscal years ending      
Remainder of 2024   $ 1,410
2025     2,820
2026     5,830
    $ 10,060

 

 

23

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

NOTE 8 – STOCKHOLDERS’ EQUITY

 

On June 10, 2024, the Company effected a 1-for-32 reverse stock split of its issued and outstanding shares of common stock, whereby 95,543,805 outstanding shares of the Company’s common stock were exchanged for 2,985,924 shares of the Company’s common stock. In connection with the reverse stock split, the Company issued an additional 245,205 shares of the Company’s common stock due to fractional shares. All per share amounts and number of shares in the condensed consolidated financial statements and related notes have been retroactively restated to reflect the reverse stock split. As a result of the reverse-stock-split, on June 26, 2024, the Company’s stock regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on the NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5550(a)(2).

 

On January 25, 2024, the Company filed a Certificate of Amendment to its Articles of Incorporation, as amended, with the Secretary of State of the State of Nevada to increase the number of authorized shares of the Company’s common stock from 160,000,000 to 1,000,000,000 shares (the “Charter Amendment”). The Charter Amendment was approved by the Company’s shareholders at a special meeting of shareholders held on January 25, 2024.

 

 NOTE 9 – REVENUES

 

Disaggregation of Net Revenues

 

The Company’s net product revenues are summarized below: 

                 
   

Three months ended 

June 30, 

 
    2024   2023  
Zembrace Symtouch   $ 1,727   $  
Tosymra     481      
Total product revenues   $ 2,208   $  

                 
   

Six months ended 

June 30, 

 
    2024   2023  
Zembrace Symtouch   $ 3,574   $  
Tosymra     1,116      
Total product revenues   $ 4,690   $  

 

Gross-to-Net Sales Accruals

 

We record gross-to-net sales accruals for chargebacks, rebates, sales and other discounts, and product returns, which are all customary to the pharmaceutical industry.

 

Our provision for gross-to-net allowances was $4.3 million at June 30, 2024, $0.6 million of which was recorded as a reduction to accounts receivable and $3.7 million recorded as a component of accrued expenses.

 

NOTE 10 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH

 

On June 30, 2023, the Company completed the acquisition of certain assets from Upsher Smith related to Zembrace SymTouch (sumatriptan injection) 3 mg (“Zembrace”) and Tosymra (sumatriptan nasal spray) 10 mg (“Tosymra”) products (such businesses collectively, the “Business”) and certain inventory related to the Business for an aggregate purchase price of approximately $26.5 million, including certain deferred payments and subject to customary adjustments (such transaction, the “USL Acquisition”).

 

On June 30, 2023, in connection with the USL Acquisition, the Company and Upsher Smith entered into a Transition Services Agreement (the “Transition Services Agreement”), pursuant to which Upsher Smith provided certain transition services to the Company for base fees equal to $100,000 per month for the first six months, and $150,000 per months for the seventh through ninth months, plus additional monthly fees for each service category totaling up to $150,000 per month. The Company has amended the transitional services agreement with Upsher Smith so that Upsher Smith can continue to provide for the management of certain government rebates. Upsher Smith will be reimbursed by the Company at cost for any rebates they pay on the Company’s behalf.

 

The Company has assumed certain obligations of Upsher Smith, including the payment of quarterly royalty payments on annual net sales from the Business in the U.S. as follows: for Tosymra, 4% for net sales of $0 to $30 million, 7% of net sales of $30 to $75 million; 9% for net sales of $75 to $100 million; 12% for net sales of $100 to $150 million; and 15% for net sales greater than $150 million. Royalty payments with respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with respect to the United States or, outside the United States, the expiration of the last valid claim covering the product in the relevant country of the territory.

 

For Zembrace, royalty payments on annual net sales in the U.S. are 3% for net sales of $0 to $30 million, 6% of net sales of $30 to $75 million; 12% for net sales of $75 to $100 million; 16% for net sales of greater than $100 million. Such royalty payments are payable until July 19, 2025. Upon the entry of a generic version of the relevant product, the applicable royalty rates shall be reduced by 90% percent with respect to Zembrace, and by 66.7% percent for Tosymra. Prior to Purchaser or a licensee filing an application for marketing authorization for either of the products in a permitted country outside the U.S., the parties will negotiate in good faith the royalty payment rates annual net sales tiers that will apply for such country, based on the market opportunity for the product in such country. If the parties fail to agree, then the royalty payment rates and annual net sales tiers described above will apply. 

 

24

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

In addition, the Company has assumed the obligation to pay an additional 3% royalty on net sales of Tosymra, plus an additional 3% if a patent containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the applicable country or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a licensed patent, and up to $15 million per Tosymra product on the achievement of sales milestones.

 

As consideration for acquisition of the Business and certain product-related inventories, the Company paid approximately $23.5 million in cash upfront. In April 2024, the Company paid the additional deferred payment of $3.0 million in cash.

 

The following table summarizes the components of the purchase consideration (in thousands):

 

Purchase consideration   Amount  
Closing cash consideration   $ 22,174  
Inventory adjustment payment liability     1,348  
Deferred payment liability     3,000  
Purchase price to be allocated   $ 26,522  

 

The USL Acquisition was accounted for as a business combination using the acquisition method, in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. The tangible and intangible assets acquired were recorded at their estimated fair values on the acquisition date, and the difference between the fair value of these assets and the purchase price has been recorded as goodwill. The purchase price allocation is based upon preliminary valuations and estimates and assumptions which are subject to change. As the Company receives additional information about facts and circumstances that existed at the acquisition date, the fair values of the acquired inventory and intangible assets may be adjusted, with the offset recorded to goodwill.

 

The following table represents the allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized in the Company’s consolidated balance sheets (in thousands):

 

Purchase price allocation   Amount  
Inventory   $ 13,700  
Prepaid expenses and other     1,757  
Intangible assets, net     10,100  
Goodwill     965  
Fair value of assets acquired   $ 26,522  

    

The acquired inventory consists of Upsher Smith’s raw materials, semi-finished goods, and finished goods inventory as of the Closing date. The fair value was determined based on the estimated selling price of the inventory, less the estimated total costs to complete, disposal effort and holding costs.

 

Intangible assets eligible for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization are as follows (in thousands):

 

    Fair Value     Useful Life
(years)
 
Developed technology - Tosymra   $ 3,400       8  
Developed technology - Zembrace     6,700       13  
Total   $ 10,100          

 

The developed technology intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer relationships, and trademarks and trade names associated with the technology. The developed technology intangible assets were valued as composite assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from the technology, and are assumed to have similar useful lives. The composite intangible assets were valued using a multi-period excess earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization. The key assumptions used in estimating the fair values of intangible assets include forecasted financial information, the weighted average cost of capital, customer retention rates, and certain other assumptions.

 

25

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

The fair values assigned to the assets acquired are based on reasonable assumptions and estimates that market participants would use. Actual results may differ from these estimates and assumptions. 

 

As the Closing occurred on the last day of the second quarter of 2023, the operations of the Business had no impact on the Company’s operating results for the three or six months ended June 30, 2023.

 

Supplemental Pro Forma Information

 

The following unaudited pro forma consolidated financial information reflects the results of operations of the Company for the three and six months ended June 30, 2023 as if the USL Acquisition had occurred as of January 1, 2023, and gives effect to transactions that are directly attributable to the acquisition, including additional amortization expense related to the fair value of intangible assets acquired and an increase in Cost of Sales related to the acquisition-date fair value adjustment to inventory. On an unaudited pro forma basis, consolidated Net Product Sales and Net Loss for the three and six months ended June 30, 2023, would have been $3.5 million and $29.7 million, and $7.6 million and $64.2 million, respectively. These amounts are based on financial information of the acquired business and are not necessarily indicative of what the Company’s operating results would have been had the acquisition taken place on the date presented, nor is it indicative of the Company’s future operating results. The net loss of USL Acquisition business is included in the Company’s consolidated results since the date of acquisition. The revenue and net loss of the USL Acquisition business reflected in the condensed consolidated statements for the three and six months ended June 30, 2024, is $2.2 million and $13.3 million, and $4.7 million and $14.8 million, respectively.

 

As described above, in connection with the USL Acquisition, the Company and Upsher Smith entered into a Transition Services Agreement with Upsher Smith related to providing ongoing services associated with the assets acquired, such as procuring and selling migraine therapy products, providing accounting, and billing services and collecting accounts receivable and paying trade payables. Upsher Smith collected and will continue to collect cash on behalf of Tonix for revenue generated by sales of the assets acquired from June 30, 2023, through the transition period and the Seller is obligated to transfer cash generated by such sales to the Company. On April 1, 2024, the Company amended the transitional services agreement with Upsher Smith so that Upsher Smith will only provide for the management of certain government rebates. Upsher Smith will be reimbursed by the Company at cost for any rebates they pay on the Company’s behalf.

 

NOTE 11 – ASSET PURCHASE AGREEMENT WITH HEALION

 

On February 2, 2023, the Company entered into an asset purchase agreement (the “Healion Asset Purchase Agreement”) with Healion Bio Inc., (“Healion”) pursuant to which the Company acquired all the pre-clinical infectious disease assets of Healion, including its portfolio of next-generation antiviral technology assets. Healion’s drug portfolio includes a class of broad-spectrum small molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900, formerly known as HB-121. As consideration for entering into the Healion Asset Purchase Agreement, the Company paid $1.2 million to Healion. Because the Healion intellectual property was acquired prior to U.S. Food and Drug Administration (FDA) approval, the cash consideration totaling $1.2 million, was expensed as research and development costs since there is no alternative future use and the acquired intellectual property does not constitute a business. 

 

NOTE 12 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY

 

On February 13, 2023, Tonix exercised an option to obtain an exclusive license from Columbia University (“Columbia) for the development of a portfolio of both fully human and murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100 product candidates, respectively. The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia. As of June 30, 2024, other than the upfront fee, no payments have been accrued or paid in relation to this agreement.

 

26

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

NOTE 13 – SALE AND PURCHASE OF COMMON STOCK

 

June 2024 Financings

 

On June 12, 2024, the Company entered into a securities purchase agreement with certain investors, pursuant to which the Company sold 1,199,448 shares of common stock and pre-funded warrants to purchase up to 2,568,110 shares of common stock. The offering price per share of common stock was $1.065, and the offering price per share of pre-funded warrant was $1.064.

 

The offering closed on June 13, 2024. The Company incurred offering expenses of approximately $0.5 million, including placement agent fees of approximately $0.3 million. The Company received net proceeds of approximately $3.5 million, after deducting the underwriting discount and other offering expenses.

 

On June 27, 2024, the Company entered into a securities purchase agreement with certain institutional and retail investors, pursuant to which the Company sold 2,833,900 shares of common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock. The offering price per share of common stock was $0.57, and the offering price per share of pre-funded warrant was $0.5699.

 

The offering closed on June 28, 2024. The Company incurred offering expenses of approximately $0.5 million, including placement agent fees of approximately $0.3 million. The Company received net proceeds of approximately $3.5 million, after deducting the underwriting discount and other offering expenses.

 

March 2024 Financing

 

On March 28, 2024, the Company entered into an agreement to sell 336,459 shares of common stock, pre-funded warrants to purchase up to 121,875 shares of common stock, and accompanying Series E warrants to purchase up to 458,334 shares of common stock with an exercise price of $10.56 per share and expiring five and a half years from date of issuance in a public offering, which closed on April 1, 2024. The offering price per share of common stock was $9.60, and the offering price per share of pre-funded warrants was $9.5968.

 

The Company incurred offering expenses of approximately $0.5 million, including placement agent fees of approximately $0.3 million. The Company received net proceeds of approximately $3.9 million, after deducting the underwriting discount and other offering expenses.

 

Additionally, with the closing of the financing on April 1, 2024, the Company entered into warrant amendments (collectively, the “Warrant Amendments”) with certain holders of its common warrants (referred to herein as the “Existing Warrants”). The Company agreed to amend the exercise price of each Existing Warrant to $10.56 upon approval by the Company’s stockholders of a proposal to allow the Existing Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 or, if stockholder approval is not obtained by October 1, 2024, the Company agreed to automatically amend the exercise price of the Existing Warrants to the Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) of the Company’s common stock on October 1, 2024, if and only if the Minimum Price is below the then current exercise price. Upon stockholder approval, the termination date for the warrants issued August 2023 (the “August Warrants”) to purchase up to an aggregate of 217,188 shares was amended to April 1, 2029; the termination date for Series A Warrants to purchase up to an aggregate of approximately 278,125 shares is April 1, 2029; the termination date for Series B Warrants to purchase up to an aggregate of approximately 278,125 shares is April 1, 2025; the termination date for Series C Warrants to purchase up to an aggregate of approximately 1,088,248 shares is the earlier of (i) April 1, 2026 and (ii) 10 trading days following notice by the Company to the Series C Warrant holders of the Company’s public announcement of the FDA’s acknowledgement and acceptance of the Company’s NDA relating to TNX-102 SL in patients with Fibromyalgia; the termination date for Series D Warrants to purchase up to an aggregate of approximately 1,088,248 shares is April 1, 2029. The other terms of the Existing Warrants remained unchanged.

 

The Company evaluated the Warrant Amendments as of April 1, 2024, and determined that the potential adjustment to the exercise price that is contingent on stockholder approval precluded the Existing Warrants from being indexed to the Company’s own stock, and as a result, did not meet the criteria for equity classification under ASC 815-40. The Company accounted for the Warrant Amendments as a direct and incremental cost of the March 2024 financing and recognized the incremental fair value resulting from the modified terms of approximately $3.0 million as an offset to the proceeds received. As all of the Existing Warrants were equity-classified prior to the Warrant Amendments, the net impact to the condensed consolidated statement of stockholders’ equity was zero. The Company then reclassified the Existing Warrants from equity to liabilities at post-modification fair value on April 1, 2024.

 

27

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

On May 22, 2024, at the annual meeting of the Company’s stockholders, the Company’s stockholders approved the proposal to amend the exercise prices of the Existing Warrants to $10.56 per share and extend the expiration dates. The Company determined the Existing Warrants met all of the criteria for equity classification as of the approval date. The Existing Warrants were adjusted to fair value through May 22, 2024, when the warrants were reclassified to equity. Changes in the fair value of the liability-classified warrants were recognized as a separate component in the consolidated statement of operations.

 

December 2023 Financing

 

On December 20, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to which the Company sold and issued (i) 791,977 shares of the Company’s common stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 897,213 shares of common stock and (iii) Series C warrants to purchase up to 2,533,784 shares of common stock (the “Series C Warrants”), and (iv) Series D warrants to purchase up to 2,533,784 shares of common stock (the “Series D Warrants” and, together with the Series C Warrants, the “Common Warrants”). The securities sold in the offering were sold in fixed combinations as units. The offering price per share of common stock and accompanying Common Warrants was $17.76, and the offering price per Pre-Funded Warrant and accompanying Common Warrants was $17.7568. The offering closed on December 22, 2023, generating gross proceeds of approximately $30.0 million, before deducting offering expenses of $2.3 million payable by the Company. At the closing of the offering, 203,407 Pre-Funded Warrants were immediately exercised into shares of common stock for nominal proceeds.

 

The Pre-Funded Warrants have an exercise price of $0.0001 per share, are immediately exercisable subject to certain ownership limitations, and can be exercised at any time until exercised in full. The Series C Warrants have an exercise price of $17.76 per share, and are exercisable on the later of approval by the Company’s stockholders of (i) a proposal to approve the filing of an amendment to the Company’s Articles of Incorporation, increasing the number of authorized shares of common stock from 160,000,000 to 1,000,000,000 and (ii) a proposal to allow the Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 (the later of such events, the “Approval Date”) and will expire on the later of (a) 10 trading days following the Approval Date and (b) the earlier of (x) the two year anniversary of the Approval Date and (y) 10 trading days following the public announcement of the U.S. Food and Drug Administration’s (“FDA”) acknowledgement and acceptance of the New Drug Application (“NDA”) relating to the Company’s TNX-102 SL product candidate in patients with fibromyalgia. The Series D Warrants have an exercise price of $27.20 per share and are exercisable beginning on the Approval Date through the five-year anniversary of the Approval Date.

 

Upon the closing of the offering, the Company determined that certain of the Common Warrants did not meet the criteria for equity classification due to the lack of sufficient authorized and unissued shares to settle the instruments. The Company has adopted a sequencing approach under ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity to determine the classification of its contracts at issuance and at each subsequent reporting date, whereby shares are allocated based on the earliest issuance date of potentially dilutive instruments, with the earliest issuance date receiving the first allocation of shares. In the event of identical issuance dates, shares are then allocated beginning with instruments with the latest maturity date first. Pursuant to this sequencing approach, the Company’s authorized and unissued shares were applied to the Pre-Funded Warrants and the Common Warrants in the following order: (i) the Pre-Funded Warrants, (ii) the Series D Warrants, and (iii) the Series C Warrants. Based on this analysis, the Company determined that the authorized shares are sufficient to settle the remaining Pre-Funded Warrants and 1,591,665 Series D Warrants and were therefore classified in equity. The remaining 942,120 Series D Warrants and the Series C Warrants associated with the deficit shares were classified as liabilities and are accounted for at fair value.

 

The $30.0 million in gross proceeds received by the Company were first allocated to the Series C Warrants and the liability-classified Series D Warrants at their respective fair values of approximately $14.4 million and $8.1 million, respectively. The residual proceeds of approximately $7.5 million were allocated to the shares of common stock, the Pre-Funded Warrants, and the equity-classified Series D Warrants on a relative fair value basis. The issuance costs totaling $2.3 million were allocated between the equity and liability-classified instruments on a relative fair value basis. Issuance costs of $1.4 million allocated to the shares, the Pre-Funded Warrants, and the equity-classified Series D Warrants were recognized as a discount to the proceeds allocated to the equity-classified instruments. Issuance costs of $0.9 million were allocated to the liability-classified Series D Warrants and the Series C Warrants and expensed within Selling, general and administrative expense on the consolidated statements of operations.

 

28

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

On January 25, 2024, the Company’s stockholders approved the proposal to file an amendment to the Company’s Articles of Incorporation to increase the number of authorized shares of common stock from 160,000,000 to 1,000,000,000.

 

The liability-classified Series D Warrants and all of the Series C Warrants were presented within non-current liabilities on the consolidated balance sheets as of December 31, 2023, and were adjusted to fair value through January 25, 2024, when the warrants were reclassified to equity. Changes in the fair value of the liability-classified warrants were recognized as a separate component in the consolidated statement of operations.

 

September 2023 Financing

 

On September 28, 2023, the Company sold 126,563 shares of common stock; pre-funded warrants to purchase up to 154,687 shares of common stock, and accompanying Series A warrants to purchase up to 281,250 shares of common stock with an exercise price of $16.00 per share and expiring five years from date of issuance, and Series B warrants to purchase up to 281,250 shares of common stock with an exercise price of $16.00 per share and expiring one year from date of issuance in a public offering, which closed on October 3, 2023. The offering price per share of common stock and accompanying warrants was $16.00, and the offering price per share of pre-funded warrant and accompanying warrants was $15.99.

 

The Company incurred offering expenses of approximately $0.5 million, including placement agent fees of approximately $0.3 million. The Company received net proceeds of approximately $4.0 million, after deducting the underwriting discount and other offering expenses.

 

July 2023 Financing

 

On July 27, 2023, the Company sold 79,062 shares of common stock; pre-funded warrants to purchase up to 139,688 shares of common stock and accompanying common warrants to purchase up to 218,750 shares of common stock with an exercise price of $32.00 per share in a public offering that closed on August 1, 2023. The offering price per share of common stock and accompanying common warrant was $32.00, and the offering price per share of pre-funded warrant and accompanying common warrant was $31.99.

 

The Company incurred offering expenses of approximately $0.7 million, including placement agent fees of approximately $0.5 million. The Company received net proceeds of approximately $6.3 million, after deducting the underwriting discount and other offering expenses.

 

2022 Lincoln Park Transaction

 

On August 16, 2022, the Company entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights agreement (the “2022 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the terms of the 2022 Purchase Agreement, Lincoln Park has agreed to purchase from the Company up to $50,000,000 of the Company’s common stock (subject to certain limitations) from time to time during the term of the 2022 Purchase Agreement. Pursuant to the terms of the 2022 Registration Rights Agreement, the Company filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the 2022 Purchase Agreement.

 

Pursuant to the terms of the 2022 Purchase Agreement, at the time the Company signed the 2022 Purchase Agreement and the 2022 Registration Rights Agreement, the Company issued 3,125 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of the Company’s common stock under the 2022 Purchase Agreement. The commitment shares were valued at $1,000,000 and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under the 2022 Purchase Agreement.

 

29

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

During the three and six months ended June 30, 2023, the Company sold 0 and 3,000 shares, respectively, of common stock under the 2022 Purchase Agreement, for net proceeds of approximately $0 and $0.4 million, respectively. No shares were sold during 2024 under the 2022 Purchase Agreement.  

 

At-the-Market Offerings

 

On April 8, 2020, the Company entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which the Company may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $320.0 million in at-the-market offerings (“ATM”) sales. AGP will act as sales agent and will be paid a 3% commission on each sale under the Sales Agreement. The Company’s common stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. There were no sales under the Sales Agreement during the three and six months ended June 30, 2024. During the three and six months ended June 30, 2023, the Company sold approximately 13,766 and 29,855 shares, respectively, of common stock under the Sales Agreement, for net proceeds of approximately $1.0 million and $3.0 million, respectively. There will be no more sales under the 2020 ATM.

 

Stock repurchases.

 

During the quarter ended March 31, 2023, the Company repurchased 78,502 of its shares of common stock outstanding under its 2022 share repurchase program for $12.5 million at prices ranging from $88.00 to $275.52 per share for a gross aggregate cost of approximately $12.5 million.

 

In January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant to which the Company may repurchase up to $12.5 million in value of its outstanding common stock from time to time on the open market and in privately negotiated transactions subject to market conditions, share price and other factors. During the quarter ended March 31, 2023, the Company repurchased 5,000 of its shares of common stock outstanding under the new 2023 share repurchase program at $227.84 per share for a gross aggregate cost of $1.1 million.

 

The timing and amount of any shares repurchased will be determined based on the Company’s evaluation of market conditions and other factors and the New Share Repurchase Program may be discontinued or suspended at any time. Repurchases will be made in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements to which the Company may be subject. Repurchases may be made, in part, under a Rule 10b5-1 plan, which allows stock repurchases when the Company might otherwise be precluded from doing so.  

 

NOTE 14 – STOCK-BASED COMPENSATION

 

On May 1, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan (“Amended and Restated 2020 Plan”).

 

Under the terms of the Amended and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3) stock appreciation rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards. The Amended and Restated 2020 Plan initially provided for the issuance of up to 1,563 shares of common stock, which amount will be increased to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen provision” providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated 2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January 1, 2030, in an amount equal to the difference between (x) twenty percent (20%) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the Amended and Restated 2020 Plan on December 31st of such preceding calendar year (including shares subject to outstanding awards, issued pursuant to awards or available for future awards). The Board of Directors determines the exercise price, vesting and expiration period of the grants under the Amended and Restated 2020 Plan. However, the exercise price of an incentive stock option may not be less than 110% of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100% of fair value for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of grants under the Amended and Restated 2020 Plan may not be more than ten years. As of June 30, 2024, 55,544 options were available for future grants under the Amended and Restated 2020 Plan.

 

30

 

 

TONIX PHARMACEUTICALS HOLDING CORP. 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2024 AND 2023 (UNAUDITED)

 

General

 

A summary of the stock option activity and related information for the Plans for the six months ended June 30, 2024, is as follows:

 

    Shares     Weighted-Average
Exercise Price
    Weighted-Average
Remaining
Contractual Term
    Aggregate
Intrinsic
Value
 
Outstanding at December 31, 2023     43,245     $ 50,542.10       8.75     $  
Grants     288,934       12.19                  
Exercised                            
Forfeitures or expirations     (21,382 )     42,044.88