Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Par Value and Share Amounts)
(unaudited)
March 31,
December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$ 7,049
$ 24,948
Inventory, net
12,351
13,639
Prepaid expenses and other current assets
10,698
9,181
Total current assets
30,098
47,768
Property and equipment, net
93,058
94,028
Intangible assets, net
9,505
9,743
Goodwill
965
965
Operating lease right-to-use assets
757
824
Other non-current assets
960
1,129
Total assets
$ 135,343
$ 154,457
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 6,649
$ 3,782
Accrued expenses and other current liabilities
10,733
12,482
Term loan payable, short term
2,820
2,350
Lease liability, short term
277
270
Total current liabilities
20,479
18,884
Term loan payable, long term
6,158
6,561
Series C warrant liabilities
—
14,595
Series D warrant liabilities
—
8,260
Lease liability, long term
563
632
Total liabilities
27,200
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 March 31, 2024, and December 31, 2023; 0 shares issued and outstanding - as of both March 31, 2024 and December 31, 2023
—
—
Common stock, $ 0.001 par value; 1,000,000,000 shares authorized; 73,724,196 and 58,614,593 shares issued and outstanding as of March 31, 2024, and December 31, 2023, respectively and 66,359 shares to be issued as of December 31, 2023
74
59
Additional paid in capital
723,906
706,356
Accumulated deficit
( 615,597 )
( 600,658 )
Accumulated other comprehensive loss
( 240 )
( 232 )
Total stockholders’ equity
108,143
105,525
Total liabilities and stockholders’ equity
$ 135,343
$ 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 March 31,
2024
2023
REVENUES:
Product revenue, net
$ 2,482
$ —
COSTS AND EXPENSES:
Cost of sales
1,660
—
Research and development
12,863
26,511
General and administrative
9,310
7,391
Total operating expenses
23,833
33,902
Operating loss
( 21,351 )
( 33,902 )
Gain on change in fair value of warrant liabilities
7,005
—
Other (expense) income, net
( 593 )
897
Net loss available to common stockholders
$ ( 14,939 )
$ ( 33,005 )
Net loss to common stockholders per common share, basic and diluted
$ ( 0.18 )
$ ( 3.21 )
Weighted average common shares outstanding, basic and diluted
80,879,108
10,268,500
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 March 31,
2024
2023
Net loss
$ ( 14,939 )
$ ( 33,005 )
Other comprehensive loss:
Foreign currency translation loss
( 8 )
( 44 )
Total other comprehensive loss
( 8 )
( 44 )
Comprehensive loss
$ ( 14,947 )
$ ( 33,049 )
See
the accompanying notes to the condensed consolidated financial statements
5
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’
EQUITY
THREE MONTHS ENDED MARCH 31, 2024
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
Additional
Other
Common stock
Paid in
Comprehensive
Accumulated
Shares
Amount
Capital
Gain (loss)
Deficit
Total
Balance, December 31, 2023
58,614,593
$ 59
$ 706,356
$ ( 232 )
$ ( 600,658 )
$ 105,525
Issuance of common stock upon exercise of prefunded common warrants
15,043,244
15
( 15 )
—
—
—
Fair value of warrants reclassified from liabilities to equity
—
—
15,850
—
—
15,850
Employee stock purchase plan
66,359
—
23
—
—
23
Stock-based compensation
—
—
1,692
—
—
1,692
Foreign currency translation loss
—
—
—
( 8 )
—
( 8 )
Net loss
—
—
—
—
( 14,939 )
( 14,939 )
Balance, March 31, 2024
73,724,196
$ 74
$ 723,906
$ ( 240 )
$ ( 615,597 )
$ 108,143
See
the accompanying notes to the condensed consolidated financial statements
6
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’
EQUITY
THREE MONTHS ENDED MARCH 31, 2023
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
Additional
Other
Common stock
Paid in
Comprehensive
Accumulated
Shares
Amount
Capital
Gain (loss)
Deficit
Total
Balance, December 31, 2022
12,368,620
$ 12
$ 677,375
$ ( 167 )
$ ( 470,038 )
$ 207,182
Repurchase of common stock under share repurchase program, including transactional expenses of $ 334
( 2,672,044 )
( 3 )
—
—
( 13,962 )
( 13,965 )
Issuance of common stock under 2022 Purchase agreement with Lincoln Park
96,000
—
441
—
—
441
Issuance of common stock net of transactional expenses of $ 101
514,493
1
1,994
—
—
1,995
Employee stock purchase plan
14,999
—
29
—
—
29
Stock-based compensation
—
—
2,794
—
—
2,794
Foreign currency translation loss
—
—
—
( 44 )
—
( 44 )
Net loss
—
—
—
—
( 33,005 )
( 33,005 )
Balance, March 31, 2023
10,322,068
$ 10
$ 682,633
$ ( 211 )
$ ( 517,005 )
$ 165,427
See
the accompanying notes to the condensed consolidated financial statements
7
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(unaudited)
Three Months Ended March 31,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 14,939 )
$ ( 33,005 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
1,210
893
Amortization of debt discount
302
—
Change in fair value of warrant liabilities
( 7,005 )
—
Stock-based compensation
1,692
2,794
Changes in operating assets and liabilities:
Prepaid expenses and other
( 1,355 )
( 1,206 )
Inventory
1,288
—
Accounts payable
2,976
575
Operating lease liabilities and ROU asset, net
2
( 5 )
Accrued expenses and other current liabilities
( 1,746 )
( 2,957 )
Net cash used in operating activities
( 17,575 )
( 32,911 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 108 )
( 3,799 )
Net cash used in investing activities
( 108 )
( 3,799 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of term loan
( 235 )
—
Repurchase of common stock
—
( 13,965 )
Proceeds from ESPP
23
29
Proceeds, net of expenses of $ 0 and $ 101 , from sale of common stock and warrants
—
2,436
Net cash used in financing activities
( 212 )
( 11,500 )
Effect of currency rate change on cash
( 4 )
( 43 )
Net decrease in cash, cash equivalents and restricted cash
( 17,899 )
( 48,253 )
Cash, cash equivalents and restricted cash beginning of the period
25,850
120,470
Cash, cash equivalents and restricted cash end of period
$ 7,951
$ 72,217
Supplemental disclosures of cash flow information:
Non-cash financing activities:
Purchases of property and equipment included in accounts payable and accrued liabilities
$ —
$ 363
See
the accompanying notes to the condensed consolidated financial statements
8
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 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. The therapeutics under development include both small molecules and biologics. Tonix
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg (“Zembrace”) and Tosymra® (sumatriptan nasal spray)
10 mg (“Tosymra”). Zembrace and Tosymra, which were acquired as of June 30, 2023 (See Note 10), are each indicated
for the treatment of acute migraine with or without aura in adults. All other drug product and vaccine candidates are still in
development and are not approved or marketed.
The 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 hereafter referred to as the “Company” or “Tonix”). All
intercompany balances and transactions have been eliminated in consolidation.
Going Concern
The accompanying
financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which
contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company
has suffered recurring losses from operations and negative cash flows from operating activities. At March 31, 2024, the Company had
working capital of approximately $ 9.6
million. At March 31, 2024, the Company had an accumulated deficit of approximately $ 615.6
million. The Company held cash and cash equivalents of approximately $ 7.0
million as of March 31, 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 March 31, 2024, the Company does not have a commitment in place to sell the building.
The Company believes
that its cash resources at March 31, 2024 and the gross proceeds of $ 4.4 million, that it raised from an equity offering in the second quarter of 2024
(See Note 18), will not meet its operating and capital expenditure requirements through the second quarter of 2024.
These factors raise substantial
doubt about the Company’s ability to continue as a going concern. 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 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, its ability to achieve development and commercialization goals would be adversely affected and the Company may
be forced to cease operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES
Interim financial statements
The unaudited condensed
consolidated interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article
8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a
fair presentation have been included.
The condensed consolidated
balance sheet as of December 31, 2023, contained herein has been derived from audited financial statements.
Operating results for
the three months ended March 31, 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.
9
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
Reverse Stock Split
On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock. The Company
accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All authorized, issued
and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted
in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented.
Authorized preferred stock was not adjusted because of the reverse stock split.
Risks and uncertainties
The Company’s
primary efforts are devoted to conducting research and development of innovative pharmaceutical and biological products to address
public health challenges. The Company has experienced net losses and negative cash flows from operations since inception and expects
these conditions to continue for the foreseeable future. Further, the Company 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, 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.
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, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views
its operations and manages its business in one segment.
The Company has two
products that each accounted for more than 10 % of total revenues during the quarter ended March 31, 2024. These products collectively
accounted for 100 % of revenues during the quarter ended March 31, 2024.
As of March 31, 2024,
accounts receivable from five customers accounted for 23 % , 22 % , 21 % , 19 % and 13 % of total accounts receivable. For the quarter
ended March 31, 2024, revenues from five customers accounted for 22 % , 21 % , 21 % , 20 % and 14 % of net product revenues, respectively.
The Company had no commercialized products for the quarter ended March 31, 2023, and therefore had no accounts receivable or revenues
in the comparative period.
10
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
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 March 31, 2024, and March 31, 2023, cash equivalents, which consisted of money market funds,
amounted to approximately $ 24,000 and $ 71.2 million, respectively. Restricted cash, which is included in Other non-current assets
on the consolidated balance sheet at March 31, 2024, of approximately $ 0.9 million collateralizes a letter of credit issued in
connection with the lease of office space in Chatham, New Jersey (see Note 16) and restricted cash held by vendors in escrow accounts
for patient support services. Restricted cash at March 31, 2023, of approximately $ 242,000 , 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:
March 31,
2024
March 31,
2023
(in thousands)
Cash and cash equivalents
$
7,049
$
71,975
Restricted cash
902
242
Total
$
7,951
$
72,217
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 prompt
payment or specialty pharmacy discounts. 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. However, during the period covered by the Transition Services Agreement, the Seller
has agreed to collect the accounts receivable on behalf of the Company and net settle within 45 days from each month-end. See Note
10 for further details. The Company had no accounts receivable as of March 31, 2023.
As
of March 31, 2024 , the Company did not have an allowance for credit losses, as the Company’s
exposure to credit losses is deminimis. 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 wide 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 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. 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.
11
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
The Company’s
reserves were approximately $ 21,000 for both March 31, 2024, and December 31, 2023. 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 30
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 quarters ended March 31, 2024, and 2023 was $ 1.0
million and $ 0.9
million, respectively. The Company’s property and equipment is located in the United States.
Impairment
testing of long-lived assets
The
Company evaluates long-lived assets for impairment 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.
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 quarter ended March 31, 2024, was $ 0.2
million. The annual impairment assessment date for indefinite lived intangible assets is June 30. No triggering events were
identified during the period of July 1, 2023, through March 31, 2024.
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. As of March 31, 2024, the Company believed that no impairment existed.
Goodwill
Goodwill represents
the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business
combination. Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate
that the carrying amount of goodwill may be impaired. As of March 31, 2024, the Company has recognized goodwill in connection with
the USL Acquisition consummated on June 30, 2023 (See Note 5). The annual impairment assessment date is June 30. No triggering
events were identified during the period of July 1, 2023 through March 31, 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.
12
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
Original issue discount
Certain term debt issued
by the Company provides the debt holder with an original issue discount. Original issue discounts are reflected as a direct reduction
of the related debt liability on the consolidated balance sheets and are amortized over the term of the related debt agreement
using the effective interest method. Amortization of original issue discounts are included in interest expense on the consolidated
statements of operations.
Revenue Recognition
The Company records
and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects
the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company’s revenues
primarily result from contracts with customers, which are generally short-term and have a single performance obligation - the delivery
of product. The Company’s performance obligation to deliver products is satisfied at the point in time that the goods are
received by the customer, which is when the customer obtains title to and has the risks and rewards of ownership of the products,
which is generally upon shipment or delivery to the customer as stipulated by the terms of the sale agreements. The transaction
price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods to
a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Our
contractual payment terms are typically 30 to 90 days .
Revenues from product
sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue
recognized is not probable of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved.
Taxes assessed by governmental authorities and collected from customers are excluded from product sales. Shipping and handling
activities are considered to be fulfillment activities and not a separate performance obligation.
Many of the Company’s
products sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts,
distributor fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net
deductions and are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions
are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset
within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue
deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates
and assumptions. The following section briefly describes the nature of the Company’s provisions for variable consideration
and how such provisions are estimated:
Chargebacks -
The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with
these indirect customers to establish pricing for the Company’s products, and in-turn, the indirect customers and entities
independently purchase these products. Because the price paid by the indirect customers and/or entities is lower than the price
paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual
price with the indirect customers and the wholesale customer’s purchase price. The Company’s provision for chargebacks
is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler
inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts
the reserve accordingly when expected chargebacks differ from actual experience.
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.
13
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
●
Medicaid and State Agency rebates are based upon historical experience of claims submitted by various states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month lag from the time of product sale until the rebate is paid.
●
Tri-Care represents a regionally managed health care program for active duty and retired members, dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a reserve amount is established to represent the proportionate rebate amount associated with product sales.
●
Coverage Gap refers to the Medicare prescription drug program and represents specifically the period between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review of the liability based on payment trends and any revision to the projected annual cost.
Prompt-Pay and other
Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue
and as a reduction in the accounts receivable at the time of sale based on the customer’s contracted discount rate. Consumer
sales discounts represent programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher
programs.
Product Returns
- Consistent with industry practice, the Company offers customers a right to return any unused product. The customer’s right
of return commences typically six months prior to product expiration date and ends one year after product expiration date. Products
returned for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates
the amount of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction
of revenue in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales
to its customers. The rate is estimated by using historical sales information, including its visibility and estimates into the
inventory remaining in the distribution channel. Adjustments are made to the current provision for returns when data suggests product
returns may differ from original estimates.
Research and Development Costs
The Company outsources
certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products
for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to
patents and other intellectual property acquired has been expensed as research and development costs, as such property is related
to particular research and development projects and had no alternative future uses.
The Company estimates
its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under
clinical site agreements in connection with conducting clinical trials. 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.
14
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
Government Grants
From time to time, the
Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development
activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities
included in the grant application approved by the government authority. The Company classifies government grants received under
these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are
incurred. In August 2022, the Company announced that it received a Cooperative Agreement grant from the National Institute on Drug
Abuse (“NIDA”), part of the National Institutes of Health, to support the development of its TNX-1300 product candidate
for the treatment of cocaine intoxication. Included in Prepaid expenses and other current assets is $ 0.3
million which was received in April 2024, and resulted in a reduction of research and development expense during the quarter ended
March 31, 2024. No funding was received during the quarter ended March 31, 2023.
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 March 31, 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 Company having insufficient authorized
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.
15
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
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.
Per Share Data
The computation of
basic and diluted loss per share for the quarter ended March 31, 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.
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 the purposes of computing earnings per share (“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. The weighted average
number of outstanding shares of common stock used in the denominator for the calculation of basic loss per share for the quarter
ended March 31, 2024 include pre-funded warrants that are accounted for as equity instruments, beginning with their respective
issuance dates, as their stated exercise price of $ 0.0001 is non-substantive and there are no further vesting conditions or limitations
on exercise. No income was allocated to the warrants for the quarter ended March 31, 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 March 31, 2024, and 2023, are as follows:
2024
2023
Warrants to purchase common stock
194,321,463
3,196
Options to purchase common stock
9,749,782
1,318,633
Totals
204,071,245
1,321,829
16
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
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.
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):
March 31,
2024
December 31,
2023
(in thousands)
Raw Materials
$
3,373
$
3,611
Work-in-process
1,981
2,539
Finished Goods
7,018
7,510
12,372
$
13,660
Less: Inventory reserves
( 21
)
( 21 )
Total Inventory
$
12,351
$
13,639
NOTE 4 – PROPERTY AND EQUIPMENT,
NET
Property and equipment,
net consisted of the following (in thousands):
March 31,
2024
December 31,
2023
(in thousands)
Property and equipment, net:
Land
$
8,011
$
8,011
Land improvements
326
326
Buildings
66,749
66,749
Office furniture and equipment
2,368
2,366
Laboratory equipment
21,904
21,904
Leasehold improvements
34
34
99,392
99,390
Less: Accumulated depreciation and amortization
( 6,334
)
( 5,362
)
$
93,058
$
94,028
17
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
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 September 28, 2020,
the Company completed the purchase of its approximately 45,000 square foot facility in Dartmouth, Massachusetts for $ 4 .0 million,
to house its new Advanced Development Center for the development and manufacturing of vaccines. Of the total purchase price, $ 1.2
million was allocated to the value of land acquired, and $ 2.8 million was allocated to buildings. Additionally, the Company incurred
approximately $ 38.8 million of costs during the year ended December 31, 2022, bringing total costs incurred-to-date to $ 61.6 million,
of which the majority related to the build-out of the facility. As of October 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 March 31, 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
Acquired during the period
—
Balance at March 31, 2024
$
965
The following table
provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
March 31,
2024
December 31,
2023
(in thousands)
Intangible assets subject to amortization
Developed technology
$
10,100
$
10,100
Less: Accumulated amortization
715
477
Total
$
9,385
$
9,623
Intangible assets not subject to amortization
Internet domain rights
$
120
$
120
Total intangible assets, net
$
9,505
$
9,743
During the quarter ended March 31, 2024, the
Company recorded amortization of $ 238,000 . No amortization was recorded during the quarter ended March 31, 2023.
At March 31, 2024,
the related amortization for each of the next five years is as follows (in thousands):
Year Ending December 31,
Remainder of 2024
$
715
2025
953
2026
953
2027
953
2028 and beyond
5,811
$
9,385
18
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
MARCH 31, 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 March 31, 2024,
and December 31, 2023, the Company used Level 1 quoted prices in active markets to value cash equivalents which were deminimis for
both periods presented. The Company did not have any Level 2 or Level 3 assets or liabilities as of March 31, 2024. As of December
31, 2023, Level 3 liabilities included a portion of the Series D Warrants and all 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.
The significant unobservable
inputs used in the valuation models as of January 25, 2024, the reclassification date, and as of December 31, 2023, to measure
the fair value of the Series D Warrants and the Series C Warrants are as follows:
Series C Warrants
Series D Warrants
Valuation Date:
January 25,
2024
December 31,
2023
January 25,
2024
December 31,
2023
Common stock price
$
0.309
$
0.403
$
0.309
$
0.403
Risk-free rate
4.52
%
4.23
%
4.01
%
3.84
%
Expected term (in years)
1.71
1.78
5.00
5.15
Expected volatility
106.00
%
108.0
%
106.00
%
108.0
%
Dividend yield
0.0
%
0.0
%
0.0
%
0.0
%
Discount for lack of marketability
N/A
5.0
%
N/A
5.0
%
From December 31, 2023
to the reclassification date, the Company recognized a change in fair value resulting in a gain of $ 7 .0 million related to the
liability-classified warrants prior to meeting the criteria for equity classification. 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:
March 31, 2024
December 31, 2023
Term Loan
$
10,765
$
11,000
Less: current portion
( 2,820 )
( 2,350 )
Total long-term debt
7,945
8,650
Less: unamortized debt discount and deferred financing costs
( 1,787 )
( 2,089 )
Total long-term debt, net
$
6,158
$
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 (“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.
19
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
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 March 31, 2024 totals
$ 1.3 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.
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 March 31, 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
$
2,115
2025
2,820
2026
5,830
$
10,765
NOTE 8 – STOCKHOLDERS’ EQUITY
On October 17, 2023,
the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating
that, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days, the Company
no longer meets the requirement to maintain a minimum bid price of $ 1 per share, as set forth in Nasdaq Listing Rule 55450(a)(1)
(the “Minimum Bid Price Requirement”).
20
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
The Company was
initially provided with a 180 -calendar day period, or until April 15, 2024, in which to regain compliance. In the event that the
Company did not regain compliance within this 180 -day period, the Company was eligible to seek an additional 180 day compliance
period if it met the continued listing requirement for market value of publicly held shares and all other initial listing standards
for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provided written notice to Nasdaq of
its intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. On April
16, 2024, the Company received a letter from Nasdaq, stating that the Company was successful in receiving an additional 180-day compliance
period.
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
March 31,
2024
2023
Zembrace Symtouch
$
1,847
$
—
Tosymra
635
—
Total product revenues
$
2,482
$
—
All sales are generated
in the United States.
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 $ 3.0 million at March 31, 2024, $ 0.6 million of which was recorded as a reduction to accounts receivable and $ 2.4
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 will provide certain transition services to the Company for base fees
equal to $ 100,000 per month for the first six months, and $ 150,000 per months for the seventh through ninth months, plus additional
monthly fees for each service category totaling up to $ 150,000 per month. 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.
21
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
For
Zembrace, royalty payments on annual net sales in the U.S. are 3 % for net sales of $ 0 to $ 30 million, 6 % of net sales of $ 30 to
$ 75 million; 12 % for net sales of $ 75 to $ 100 million; 16 % for net sales of greater than $ 100 million. Such royalty payments are
payable until July 19, 2025. Upon the entry of a generic version of the relevant product, the applicable royalty rates shall be
reduced by 90 % percent with respect to Zembrace, and by 66.7 % percent for Tosymra. Prior to Purchaser or a licensee filing an application
for marketing authorization for either of the products in a permitted country outside the U.S., the parties will negotiate in good
faith the royalty payment rates annual net sales tiers that will apply for such country, based on the market opportunity for the
product in such country. If the parties fail to agree, then the royalty payment rates and annual net sales tiers described above
will apply.
In
addition, the Company has assumed the obligation to pay an additional 3 % royalty on net sales of Tosymra, plus an additional 3 %
if a patent containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra
in the applicable country or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim
of a licensed patent, and up to $ 15 million per Tosymra product on the achievement of sales milestones.
As consideration for
acquisition of the Business and certain product-related inventories, the Company paid approximately $ 23.5 million in cash upfront.
On the earlier of March 2024 and the completion of the transition services to be provided by Upsher Smith, as described above,
the Company agreed to pay an additional deferred payment of $ 3.0 million in cash, which is included in Accrued expenses and other
current liabilities on the accompanying balance sheet as of March 31, 2024. The Company paid the deferred payment to the Seller
in full at the beginning of April 2024.
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.
The $ 1 .0 million of
goodwill arising from the USL Acquisition represents expected synergies from combining operations, intangible assets that do not
qualify for separate recognition, and other factors, of which all is expected to be deductible for tax purposes, subject to any
limitations.
22
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
Intangible assets eligible
for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization
are as follows (in thousands):
Fair Value
Useful Life
(years)
Developed technology - Tosymra
$
3,400
9
Developed technology - Zembrace
6,700
14
Total
$
10,100
The developed technology
intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer relationships,
and trademarks and trade names associated with the technology. The developed technology intangible assets were valued as composite
assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from the
technology, and are assumed to have similar useful lives. The composite intangible assets were valued using a multi-period excess
earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization. The key
assumptions used in estimating the fair values of intangible assets include forecasted financial information, the weighted average
cost of capital, customer retention rates, and certain other assumptions.
The fair values assigned
to the assets acquired are based on reasonable assumptions and estimates that market participants would use. Actual results may
differ from these estimates and assumptions.
Supplemental Pro Forma Information
The following unaudited
pro forma consolidated financial information reflects the results of operations of the Company for the three months ended March
31, 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 months ended March 31, 2023, would have been $ 4 .0
million and $ 35.4 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 months ended March 31, 2024, is $ 2.5 million and $ 1.5 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.
The amount due to Upsher
Smith for reimbursement of services performed under the transition services agreement was $ 0.4 million
as of March 31, 2024. The transition service fees were netted against the receivables collected of $ 3.3
million and liabilities paid of $ 0.4
million, including gross-to-net on behalf of the Company with the net amount due to the Company of $ 2.5
million recorded within prepaid expenses and other on the consolidated balance sheet as of March 31, 2024. The amount due to USL for reimbursement of services performed under the transition services
agreement was $ 0.5 million as of December 31, 2023. The transition service fees were netted against the receivables collected of $ 5.1
million and liabilities paid of $ 4.4 million, including gross-to-net on behalf of the Company with the net amount due to the Company of
$ 0.2 million recorded within prepaid expenses and other on the consolidated balance sheet as of December 31, 2023.
23
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2024 AND 2023 (UNAUDITED)
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 March 31, 2024, other than the upfront fee, no payments have been accrued
or paid in relation to this agreement.
NOTE
13 – SALE AND PURCHASE OF COMMON STOCK
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) 25,343,242 shares of the Company’s common stock,
(ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 28,710,812 shares of common stock and (iii)
Series C warrants to purchase up to 81,081,081 shares of common stock (the “Series C Warrants”), and (iv) Series D
warrants to purchase up to 81,081,081 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 $ 0.555 , and the offering price per Pre-Funded
Warrant and accompanying Common Warrants was $ 0.5549 . 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, 6,509,010
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 $ 0.555 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 $ 0.85 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 50,933,271 Series D Warrants
and were therefore classified in equity. The remaining 30,147,810 Series D Warrants and the Series C Warrants associated with
the deficit shares were classified as liabilities and are accounted for at fair value.
24
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2024 AND 2023 (UNAUDITED)
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.
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
4,050,000 shares of common stock; pre-funded warrants to purchase up to 4,950,000 shares of common stock, and accompanying Series A warrants
to purchase up to 9,000,000 shares of common stock with an exercise price of $ 0.50 per share and expiring five years from date of issuance,
and Series B warrants to purchase up to 9,000,000 shares of common stock with an exercise price of $ 0.50 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 $ 0.50 , and the offering price per share of pre-funded warrant and accompanying warrants was $ 0.4999 .
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 2,530,000
shares of common stock; pre-funded warrants to purchase up to 4,470,000 shares of common stock and accompanying common warrants to purchase
up to 7,000,000 shares of common stock with an exercise price of $ 1.00 per share in a public offering that closed on August 1, 2023. The
offering price per share of common stock and accompanying common warrant was $ 1.00 , and the offering price per share of pre-funded warrant
and accompanying common warrant was $ 0.9999 .
The 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 100,000 shares of common stock to Lincoln Park as consideration for its commitment to purchase
shares of the Company’s common stock under the 2022 Purchase Agreement. The commitment shares were valued at $ 1,000,000
and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital
to be raised under the 2022 Purchase Agreement.
During
the quarter ended March 31, 2023, the Company sold 0.1 million shares of common stock under the 2022 Purchase Agreement, for net
proceeds of approximately $ 0.4 million.
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 quarter ended March
31, 2024. During the quarter ended March 31, 2023, the Company sold approximately 0.5 million shares of common stock under the
Sales Agreement, for net proceeds of approximately $ 2 .0 million.
Stock
repurchases.
During the quarter ended March 31 , 2023, the Company had repurchased 2,512,044
of its shares of common stock outstanding under its 2022 share repurchase program for up to $ 12.5 million at prices ranging from
$ 2.75 to $ 8.61 per share for a gross aggregate cost of approximately $ 12.5 million.
In
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 had repurchased 160,000 of its shares of common stock
outstanding under the new 2023 share repurchase program at $ 7.12 per share for a gross aggregate cost of $ 1.1 million.
25
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2024 AND 2023 (UNAUDITED)
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 50,000 shares of common stock, which amount will
be increased to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise
provided in the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen
provision” providing for an annual increase in the number of shares of our common stock available for issuance under the
Amended and Restated 2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on
(and including) January 1, 2030, in an amount equal to the difference between (x) twenty percent ( 20 %) of the total number of
shares of common stock outstanding on December 31st of the preceding calendar year, and (y) the total number of shares of common
stock reserved under the Amended and Restated 2020 Plan on December 31 st of such preceding calendar year (including
shares subject to outstanding awards, issued pursuant to awards or available for future awards). The Board of Directors determines
the exercise price, vesting and expiration period of the grants under the Amended and Restated 2020 Plan. However, the exercise
price of an incentive stock option may not be less than 110 % of fair value of the common stock at the date of the grant for a
10% or more shareholder and 100 % of fair value for a grantee who is not a 10% shareholder. The fair value of the common stock
is determined based on quoted market price or in absence of such quoted market price, by the Board of Directors in good faith.
Additionally, the expiration period of grants under the Amended and Restated 2020 Plan may not be more than ten years . As of March
31, 2024, 1,973,136 options were available for future grants under the Amended and Restated 2020 Plan.
General
A
summary of the stock option activity and related information for the Plans for the three months ended March 31, 2024, is as follows:
Shares
Weighted-Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic
Value
Outstanding
at December 31, 2023
1,375,539
$
89.62
8.75
$
—
Grants
8,477,582
0.40
Exercised
—
—
Forfeitures
or expirations
( 103,339
)
65.60
Outstanding
at March 31, 2024
9,749,782
$
12.30
9.72
$
—
Exercisable
at March 31, 2024
573,301
$
169.31
8.06
$
The
aggregate intrinsic value in the preceding table represents the total pretax intrinsic value, based on options with an exercise
price less than the Company’s closing stock price at the respective dates.
The
weighted average fair value of options granted for the three-month periods ended March 31, 2024 and 2023 was $ 0.33 and $ 4.13 per
share, respectively.
26
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2024 AND 2023 (UNAUDITED)
The
Company measures the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain
assumptions discussed below, and the closing market price of the Company’s common stock on the date of the grant. The fair
value of the award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months
from the date of grant and 1/36 th each month thereafter for 24 months and expire ten years from the date of grant. In addition,
the Company issues options to directors which vest over a one-year period. The Company also issues premium options to executive
officers which have an exercise price greater than the grant date fair value and has issued performance-based options which vest
when target parameters are met or probable of being met, subject in each case to a one year minimum service period prior to vesting.
Stock-based compensation expense related to awards is amortized over the applicable service period using the straight-line method.
The
assumptions used in the valuation of stock options granted during the three months ended March 31, 2024, and 2023 were as follows:
Three
Months Ended
March 31, 2024
Three
Months Ended
March 31, 2023
Risk-free
interest rate
4.23 %
to 5.33
%
3.59 %
to 4.02
%
Expected
term of option
5.25
to 6.00 years
5.00
to 6.00 years
Expected
stock price volatility
111.89 %
to 137.79
%
133.07 %
to 142.72
%
Expected
dividend yield
0.0
0.0
The
risk-free interest rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of
the options as of the grant date. The expected term of options is determined using the simplified method, as provided in an SEC
Staff Accounting Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
Stock-based
compensation expense relating to options granted of $ 1.7 million, of which $ 1.2 million and $ 0.5 million, related to General and
Administration and Research and Development, respectively was recognized for the quarter ended March 31, 2024.
Stock-based
compensation expense relating to options granted of $ 2.8 million, of which $ 2.0 million and $ 0.8 million, related to General and
Administration and Research and Development, respectively was recognized for the quarter ended March 31, 2023.
As
of March 31, 2024, the Company had approximately $ 6.9 million of total unrecognized compensation cost related to non-vested awards
granted under the Plans, which the Company expects to recognize over a weighted average period of 2.05 years.
Employee
Stock Purchase Plans
On
May 6, 2022, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase
Plan. (the “2022 ESPP”), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase
Plan (the “2023 ESPP”, and together with the 2022 ESPP, the “ESPP Plans”), which was approved by the Company’s
stockholders on May 5, 2023.
The
2023 ESPP allows eligible employees to purchase up to an aggregate of 800,000 shares of the Company’s common stock.
Under the 2023 ESPP, on the first day of each offering period, each eligible employee for that offering period has the option
to enroll for that offering period, which allows the eligible employees to purchase shares of the Company’s common stock
at the end of the offering period. Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time.
Subject to limitations, each participant will be permitted to purchase a number of shares determined by dividing the employee’s
accumulated payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of
the fair market value of our common stock at the beginning or end of each offering period, whichever is less. A participant must
designate in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period
for the purchase of stock under the 2023 ESPP, subject to the statutory limit under the Code. As of March 31, 2024, 733,641 shares
were available for future sales under the 2023 ESPP.
The
ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For
the quarter ended March 31, 2024 and 2023, $ 27,000 and $ 0 , respectively, was expensed. In January 2023, 14,999 shares that were
purchased as of December 31, 2022, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023, approximately
$ 29,000 of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred from
accrued expenses to additional paid in capital. The remaining $ 14,000 was returned to the employees. As of December 31, 2023,
approximately $ 44,000 of employee payroll deductions had accumulated and had been recorded in accrued expenses. In January
2024, 66,359 shares that were purchased as of December 31, 2023, under the 2022 ESPP, were issued. Accordingly, during the first
quarter of 2024, approximately $ 24,000 of employee payroll deductions accumulated at December 31, 2023, related to acquiring such
shares, was transferred from accrued expenses to additional paid in capital. The remaining $ 20,000 was returned to the employees.
27
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2024 AND 2023 (UNAUDITED)
NOTE
15 – WARRANTS TO PURCHASE COMMON STOCK
The
following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at March 31,
2024:
Exercise
Number
Expiration
Price
Outstanding
Date
$
0.0001
7,158,558
N/A
$
0.555
81,081,081
December
2025
$
0.85
81,081,081
December
2028
$
0.50
18,000,000
October
2028
$
1.00
7,000,000
August
2028
$
100.00
125
November
2024
$
114.00
618
February
2025
194,321,463
During
the quarter ended March 31, 2024, 15,043,244 prefunded common warrants were exercised. Subsequent to the quarter ended March 31,2024,
7,158,558 prefunded warrants were exercised.
No
warrants were exercised during the quarter ended March 31, 2023.
NOTE
16 – LEASES
The
Company has various operating lease agreements, which are primarily for office space. These agreements frequently include one
or more renewal options and require the Company to pay for utilities, taxes, insurance and maintenance expense. No lease agreement
imposes a restriction on the Company’s ability to engage in financing transactions or enter into further lease agreements.
At March 31, 2024, the Company has right-of-use assets of $ 0.8 million and a total lease liability for operating leases of $ 0.8
million of which $ 0.5 million is included in long-term lease liabilities and $ 0.3 million is included in current lease liabilities.
28
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
At March 31, 2024,
future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):
Year Ending December 31,
Remainder of 2024
$
232
2025
299
2026
142
2027
139
2028 and beyond
108
920
Included interest
( 80
)
$
840
No new leases or amendments
were entered into during the quarter ended March 31, 2024. During the quarter ended March 31, 2023, the Company entered into lease
amendments, resulting in the Company recognizing an additional operating lease liability of approximately $ 528,000 based on the
present value of the minimum rental payments. The Company also recognized a corresponding increase to ROU assets of approximately
$ 528,000 .
Operating lease expenses
were $ 0.1 for both the quarters ended March 31, 2024, and 2023.
Other information related to leases is as follows:
As of and for the
Cash paid for amounts included in the measurement of lease liabilities:
Three Months Ended
March 31, 2024
Three Months Ended
March 31, 2023
Operating cash flow from operating leases (in thousands)
$
74
$
138
Weighted Average Remaining Lease Term
Operating leases
3.60 years
2.81 years
Weighted Average Discount Rate
Operating leases
4.62
%
3.60
%
NOTE 17 – COMMITMENTS
Contractual agreements
The Company has entered
into contracts with various contract research organizations with outstanding commitments aggregating approximately $ 20.8 million
at March 31, 2024 for future work to be performed.
Defined contribution plan
The Company established
a qualified defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby all eligible
employees may participate. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) Plan,
subject to defined limitations. The Company is required to make contributions to the 401(k) Plan equal to 100 percent of each participant’s
pretax contributions of up to six percent of his or her eligible compensation, and the Company is also required to make a contribution
equal to three percent of each participant’s salary, on an annual basis, subject to limitations under the Code. For the three
months ended March 31, 2024 and 2023, the Company charged operations $ 300,000 for both periods for contributions under the 401(k)
Plan.
29
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2024 AND 2023 (UNAUDITED)
NOTE 18 – SUBSEQUENT EVENTS
On March 28, 2024,
the Company entered into an agreement to sell 10,766,666 shares of common stock, pre-funded warrants to purchase up to 3,900,000 shares of common stock, and
accompanying Series E warrants to purchase up to 14,666,666 shares of common stock with an exercise price of $ 0.33 per share and
expiring 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 $ 0.30 , accompanying warrants was $ 0.33 , and the offering price per share of pre-funded warrants was $ 0.2999 .
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 with certain holders of its Common Warrants. The exercise price of each Existing Warrant
will be amended to $ 0.33
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 as otherwise provided in the Amendment if stockholder approval is not obtained by October 1, 2024.
Stockholders will vote on this proposal on May 22, 2024. Upon stockholder approval, the termination date for Common Warrants to
purchase up to an aggregate of 6,950,000
shares will be amended to April
1, 2029 ; the termination date for Series A Warrants to purchase up to an aggregate of approximately 8,900,000
shares will be April
1, 2029 ; the termination date for Series B Warrants to purchase up to an aggregate of approximately 8,900,000
shares will be April
1, 2029 ; the termination date for Series C Warrants to purchase up to an aggregate of approximately 34,823,928
shares will be the earlier of (i) April
1, 2026 and (ii) 10
trading days following notice by the Company to the Series C Warrant holder 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 34,823,928
shares will be April
1, 2029 . The other terms of the Existing Warrants will remain unchanged. If stockholder approval is not obtained on or by
October 1, 2024, then the Company has 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 Common Stock on October 1, 2024 if and only if the Minimum Price is below the
then current exercise price.
30
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.