Quarterly Report (10-q)

Date : 08/14/2019 @ 10:11AM
Source : Edgar (US Regulatory)
Stock : SiNtx Technologies Inc (SINT)
Quote : 1.52  -0.08 (-5.00%) @ 1:00AM
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Last Trade
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Quarterly Report (10-q)

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

 

For the quarterly period ended June 30, 2019

 

OR

 

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

 

Commission File Number 001-33624

 

 

SINTX Technologies, Inc.

(previously known as “Amedica Corporation”)

(Exact name of registrant as specified in its charter)

 

 

DELAWARE   84-1375299
(State or other jurisdiction   (IRS Employer
of incorporation or organization)   Identification No.)

 

1885 West 2100 South, Salt Lake City, UT   84119
(Address of principal executive offices)   (Zip Code)

 

(801) 839-3500

(Registrant’s telephone number, including area code)

 

 

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

 

Title of each class   Trading Symbols   Name of each exchange on which registered
Common Stock   SINT   The NASDAQ Capital Market

 

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

 

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

 

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

 

Large accelerated filer [  ] Accelerated filer [  ]
       
Non-accelerated filer [  ] Smaller reporting company [X]
       
    Emerging growth company [  ]

 

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

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes [  ] No  [X]

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

 

1,957,930 shares of common stock, $0.01 par value, were outstanding at August 12, 2019.

 

 

 

     
     

 

SINTX Technologies, Inc.

(previously known as Amedica Corporation)

Table of Contents

 

Part I. Financial Information  
Item 1. Financial Statements  
Condensed Consolidated Balance Sheets (unaudited) 3
Condensed Consolidated Statements of Operations (unaudited) 4
Condensed Consolidated Statements of Stockholders’ Equity (unaudited) 5
Condensed Consolidated Statements of Cash Flows (unaudited) 6
Notes to Condensed Consolidated Financial Statements (unaudited) 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
Item 3. Quantitative and Qualitative Disclosures About Market Risk 26
Item 4. Controls and Procedures 26
Part II. Other Information  
Item 1. Legal Proceedings 27
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 27
Item 3. Defaults Upon Senior Securities 27
Item 4. Mine Safety Disclosures 27
Item 5. Other Information 27
Item 6. Exhibits 28
Signatures 29

 

  2  
     

 

SINTX Technologies, Inc.

(previously known as Amedica Corporation)

Condensed Consolidated Balance Sheets - Unaudited

(in thousands, except share and per share data)

 

    June 30, 2019     December 31, 2018  
                 
Assets                
Current assets:                
Cash and cash equivalents   $ 3,192     $ 5,447  
Trade accounts receivable, net of allowance of $6 and $56, respectively     173       263  
Prepaid expenses and other current assets     234       171  
Inventories     85       52  
Notes receivable, current portion     1,399       1,084  
Total current assets     5,083       7,017  
                 
Inventories, net     596       624  
Property and equipment, net     87       124  
Intangible assets, net     44       46  
Long-term note receivable, net of current portion     2,897       3,669  
Operating lease right-of-use-asset     2,535       -  
Other long-term assets     35       35  
Total assets   $ 11,277     $ 11,515  
                 
Liabilities and stockholders’ equity                
Current liabilities:                
Accounts payable   $ 295     $ 301  
Accrued liabilities     813       838  
Derivative liabilities, current portion     454       1,062  
Current portion of operating lease liability     587       169  
Other current liabilities     23       10  
Total current liabilities     2,172       2,380  
                 
Operating lease liability, net of current portion     2,050       -  
Derivative liabilities, net of current portion     502       504  
Other long-term liabilities     113       232  
Total liabilities     4,837       3,116  
                 
Commitments and contingencies     -       -  
                 
Stockholders’ equity:                
Convertible preferred stock, $0.01 par value, 130,000,000 shares authorized; 737 shares and 4,074 shares issued and outstanding at June 30, 2019 and December 31, 2018.     -       -  
Common stock, $0.01 par value, 250,000,000 shares authorized; 1,854,898 shares, and 726,455 shares issued and outstanding at June 30, 2019 and December 31, 2018.     19       7  
Additional paid-in capital     238,062       237,673  
Accumulated deficit     (231,641 )     (229,281 )
Total stockholders’ equity     6,440       8,399  
Total liabilities and stockholders’ equity   $ 11,277     $ 11,515  

 

The condensed consolidated balance sheet as of December 31, 2018, has been prepared using information from the audited consolidated balance sheet as of that date.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

  3  
     

 

SINTX Technologies, Inc.

(previously known as Amedica Corporation)

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except share and per share data)

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2019     2018     2019     2018  
Product revenue   $ 167     $ -     $ 264     $ -  
Costs of revenue     133       -       212       -  
Gross profit     34       -       52       -  
Operating expenses:                                
Research and development     836       956       1,554       1,833  
General and administrative     615       935       1,586       2,242  
Sales and marketing     105       11       164       58  
Total operating expenses     1,556       1,902       3,304       4,133  
Loss from operations     (1,522 )     (1,902 )     (3,252 )     (4,133 )
Other income (expenses):                                
Interest expense     (2 )     (809 )     (2 )     (1,284 )
Interest income     115       -       237       -  
Change in fair value of derivative liabilities     631       1,209       610       2,020  
Loss on extinguishment of debt     -       -       -       (340 )
Offering costs     -       (682 )     -       (682 )
Loss on extinguishment of derivative liabilities     -       -       -       (1,252 )
Other income, net     48       3       48       5  
Total other income (expense), net     792       (279 )     893       (1,533 )
Net loss from continuing operations before income taxes     (730 )     (2,181 )     (2,359 )     (5,666 )
Provision for income taxes     -       -       -       -  
Loss from continuing operations     (730 )     (2,181 )     (2,359 )     (5,666 )
Loss from discontinued operations     -       (131 )     -       (44 )
Net loss   $ (730 )   $ (2,312 )   $ (2,359 )   $ (5,710 )
Deemed dividend related to the beneficial conversion feature and accretion of a discount on series B preferred stock     (2,358 )     (7,334 )     (2,358 )     (7,334 )
Net loss attributable to common stockholders   $ (3,088 )   $ (9,646 )   $ (4,717 )   $ (13,044 )
Net loss per share – basic and diluted                                
Basic – continuing operations   $ (0.78 )   $ (11.19 )   $ (2.84 )   $ (36.66 )
Basic – discontinued operations     -       (0.67 )     -       (0.28 )
Basic - deemed dividend and accretion of a discount on conversion of series B preferred stock     (2.53 )     (37.62 )     (2.84 )     (47.46 )
Basic – attributable to common stockholders   $ (3.31 )   $ (49.48 )   $ (5.68 )   $ (84.40 )
                                 
Diluted – continuing operations   $ (1.46 )   $ (12.06 )   $ (3.58 )   $ (39.01 )
Diluted – discontinued operations     -       (0.42 )     -       (0.28 )
Diluted - deemed dividend and accretion of a discount on conversion of series B preferred stock     (2.53 )     (23.33 )     (2.84 )     (47.46 )
Diluted – attributable to common stockholders   $ (3.99 )   $ (35.81 )   $ (6.42 )   $ (86.75 )
Weighted average common shares outstanding:                                
Basic     931,859       194,933       829,724       154,545  
Diluted     931,859       314,354       829,724       154,545  

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

  4  
     

 

SINTX Technologies, Inc.

(previously known as Amedica Corporation)

Condensed Consolidated Statements of Stockholders’ Equity - Unaudited

(in thousands, except share and per share data)

 

    Preferred Stock     Common Stock     Paid-In     Accumulated     Total  
    Shares     Amount     Shares     Amount     Capital     Deficit     Equity  
Balance at December 31, 2017     -     $ -       100,935     $ 1     $ 226,070     $ (220,629 )   $ 5,442  
Common stock issued from exercise of warrants     -       -       27,139       -       1,633       -       1,633  
Issuance of common stock in exchange for reduction in debt     -       -       19,348       -       1,453       -       1,453  
Issuance of preferred stock from offering, net of issuance costs     15       -       -       -       6,754       -       6,754  
Warrants issued in association with debt     -       -       -       -       98       -       98  
Loss on extinguishment of derivative liabilities     -       -       -       -      

1,040

      -      

1,040

 
Deemed dividend related to adjustment of the exercise price of warrants issued with debt     -       -       -       -       (9 )     -       (9 )
Accretion of change in warrant exercise price     -       -       -       -       9       -       9  
Common stock issued due to conversion of preferred stock     (4 )     -       102,886       1       (1 )     -       -  
Accretion of convertible preferred stock discount     -       -       -       -       7,334       -       7,334  
Deemed dividend related to the issuance of preferred stock     -       -       -       -       (7,334 )     -       (7,334 )
Extinguishment of derivative liabilities     -       -       -       -       565       -       565  
Stock-based compensation     -       -       -       -       34       -       34  
Net loss     -       -       -       -       -       (5,710 )     (5,710 )
Balance at June 30, 2018     11     $ -       250,308     $

2

    $ 237,646     $ (226,339 )   $ 11,309  

 

    Preferred Stock     Common Stock     Paid-In     Accumulated     Total  
    Shares     Amount     Shares     Amount     Capital     Deficit     Equity  
Balance at December 31, 2018     4,074     $ -       726,455     $ 7     $ 237,673     $ (229,281 )   $ 8,399  

Common stock issued from exercise of warrants

    -       -      

500

      -       1       -       1  

Common stock issued due to conversion of preferred stock

   

(3,337

)     -       983,528       10       (10 )     -       -  
Stock based compensation     -       -       -       -       1       -       1  
Common stock issued for cash     -     -       144,415       1       396            

397

 
Removal of derivative liability upon exercise of warrant     -       -       -       -       1       -       1  
Net loss     -       -       -       -       -       (2,359 )     (2,359 )
Balance at June 30, 2019     737     $ -       1,854,898     $ 18     $ 238,062     $ (231,640 )   $ 6,440  

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

  5  
     

 

SINTX Technologies, Inc.

(previously known as Amedica Corporation)

Condensed Consolidated Statements of Cash Flows - Unaudited

(in thousands)

 

    Six Months Ended June 30,  
    2019     2018  
Cash flow from operating activities                
Net loss from continuing operations   $ (2,359 )   $ (5,666 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation expense     52       53  
Non-cash lease expense     171       (99 )
Amortization of intangible assets     2       -  
Amortization of lease incentive for tenant improvements     -       28  
Non-cash interest income     (237 )     -  
Non-cash interest expense     -       812  
Loss on extinguishment of debt     -       340  
Stock based compensation     1       34  
Change in fair value of derivative liabilities     (610 )     (2,020 )
Loss on extinguishment of derivative liabilities     -       1,252  
Loss on disposal of equipment     -       51  
Bad debt expense     9       -  
Changes in operating assets and liabilities:                
Trade accounts receivable     79       -  
Prepaid expenses and other current assets     (63 )     (76 )
Inventories     (5 )     -  
Accounts payable and accrued liabilities     (19 )     (241 )
Net cash used in operating activities - continuing operations     (2,979 )     (5,532 )
Net cash used in operating activities - discontinued operations     -       (402 )
Net cash used in operating activities     (2,979 )     (5,934 )
Cash flows from investing activities                
Purchase of property and equipment     (15 )     -  
Proceeds from notes receivable, net of imputed interest     695       -  
Purchase of intangible asset     -       (50 )
Net cash provided by (used in) investing activities – continuing operations     680       (50 )
Net cash used in investing activities – discontinued operations             (107 )
Net cash used in investing activities     680       (157 )
Cash flows from financing activities                
Proceeds from issuance of stock in connection with exercise of warrants, net of issuance costs     1       1,633  
Proceeds from issuance of common stock, net of fees ($131)     397       -  
Proceeds from issuance of preferred stock, net of issuance costs ($668)     -       6,754  
Proceeds from issuance of warrant derivative liabilities, net of issuance costs ($682)     -       7,577  
Payments on operating lease liability     (354 )     -  
Proceeds from issuance of debt     -       705  
Payments on debt     -       (2,282 )
Net cash provided by (used in) financing activities     44     14,387  
Net increase (decrease) in cash and cash equivalents     (2,255 )     8,296  
Cash and cash equivalents at beginning of period     5,447       539  
Cash and cash equivalents at end of period   $ 3,192     $ 8,835  
                 
Noncash investing and financing activities                
Right-of-use assets and assumption of operating lease liability   $ 2,704     $ -  
Reduction of derivative liability due to exercise of warrants     1       -  

Hercules and MEF I, LP/Anson Investments Debt Exchange

    -       2,265  
Issuance of common stock in exchange for reduction in debt     -       1,453  
Extinguishment of derivative liabilities through exercise of warrants     -       565  
Warrants issued in association with debt     -       98  
Supplemental cash flow information                
Cash paid for interest   $ 2     $ 337  

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

  6  
     

 

SINTX TECHNOLOGIES, INC.

(PREVIOUSLY KNOWN AS AMEDICA CORPORATION)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1. Organization and Summary of Significant Accounting Policies

 

Organization

 

SINTX Technologies, Inc. (“SINTX” or “the Company”) (previously known as Amedica Corporation) was incorporated in the state of Delaware on December 10, 1996. SINTX is an OEM ceramics company that develops and commercializes silicon nitride for medical and non-medical applications. The Company believes it is the first and only manufacturer to use silicon nitride in medical applications. The Company acquired US Spine, Inc. (“US Spine”), a Delaware spinal products corporation with operations in Florida, on September 20, 2010. The Company’s products are primarily sold in the United States.

 

As further explained in Note 12, On October 1, 2018, the Company completed the sale of its retail spine business to CTL Medical, a Dallas, Texas-based privately held medical device manufacturer. As a result of the sale, CTL Medical is now the exclusive owner of SINTX’s portfolio of metal and silicon nitride spine products, which are presently sold under the brand names of Taurus, Preference, and Valeo, with access to future silicon nitride spine technologies. Manufacturing, R&D, and all intellectual property related to the core, non-spine, biomaterial technology of silicon nitride remains with the Company. The Company will serve as CTL’s exclusive OEM provider of silicon nitride products.

 

On October 30, 2018, the Company amended its Certificate of Incorporation with the State of Delaware to change its corporate name to SINTX Technologies, Inc. in order to better reflect its focus on silicon nitride science and technologies and pipeline of silicon nitride-based products in various biomedical applications. The Company also changed its trading symbol on the NASDAQ Capital Market to “SINT”. The Company also changed the name of its wholly owned subsidiary US Spine, Inc. to “ST Sub, Inc.”

 

The previous name, Amedica, has transferred to CTL Medical, which is now CTL-Amedica. The Company’s new corporate brand reflects both the Company’s core competence in the science and production of silicon nitride ceramics, as well as encouraging prospects for the future, as an OEM supplier of spine implants to CTL-Amedica, and several opportunities outside of spine. The Company will focus on developing silicon nitride in terms of product design, and future biomaterial formulations, for a variety of OEM customers.

 

As further explained in Note 14, the Company effected a 1 for 30 reverse stock split of the Company’s common stock on July 26, 2019.

 

Basis of Presentation

 

These unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”) and include all assets and liabilities of the Company and its wholly owned subsidiary, ST Sub, Inc. All material intercompany transactions and balances have been eliminated in consolidation. SEC rules and regulations allow the omission of certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States, so long as the statements are not misleading. In the opinion of management, these financial statements and accompanying notes contain all adjustments (consisting of normal recurring adjustments) necessary to present fairly the financial position and results of operations for the periods presented herein. These condensed consolidated financial statements should be read in conjunction with the consolidated audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 11, 2019. The results of operations for the six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019. The Company’s significant accounting policies are set forth in Note 1 to the consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2018.

 

  7  
     

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the periods then ended. Actual results could differ from those estimates. The most significant estimates relate to inventory, long-lived and intangible assets and the liability for preferred stock and common stock warrants.

 

Liquidity and Capital Resources

 

The condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern within one year from the date of issuance of these condensed consolidated financial statements.

 

For the six months ended June 30, 2019 and 2018, the Company incurred net losses from continuing operations of approximately $2.4 million and $5.7 million, respectively, and used cash in continuing operations of approximately $3.0 million and $5.5 million, respectively. The Company had an accumulated deficit of approximately $232 million and $229 million as of June 30, 2019 and December 31, 2018, respectively. To date, the Company’s operations have been principally financed by proceeds received from the issuance of preferred and common stock, convertible debt and bank debt and, to a lesser extent, cash generated from product sales. It is anticipated that the Company will continue to generate operating losses and use cash in operating activities. The Company’s continuation as a going concern is dependent upon its ability to increase sales and/or raise additional funds through the capital markets. Whether and when the Company can attain profitability and positive cash flows from operating activities or obtain additional financing is uncertain.

 

The Company is actively generating additional scientific and clinical data to have it published in leading industry publications. The unique features of the Company’s silicon nitride material are not well known, and the Company believes that the publication of such data would help sales efforts as the Company approaches new prospects. The Company is also making additional changes to the sales strategy, including a focus on revenue growth by expanding the use of silicon nitride in other areas outside of spinal fusion applications.

 

  8  
     

 

The Company has common stock that is publicly traded and has been able to successfully raise capital when needed since the date of the Company’s initial public offering. In March 2018, the Company closed on gross proceeds of $1.4 million, before payment of placement agent fees and costs on a warrant reprice and exercise transaction. Additionally, on May 14, 2018, the Company closed on a public offering of units, consisting of convertible preferred stock and warrants, for gross proceeds of $15 million, which excludes underwriting discounts and commissions and offering expenses payable by the Company. On June 4, 2019, the Company entered into an Equity Distribution Agreement, (the “Distribution Agreement”), with Maxim Group LLC (“Maxim”), pursuant to which the Company may sell from time to time, shares of our common stock, having an aggregate offering price of up to $1.6 million through Maxim, as agent (the “ATM Offering”). Subject to the terms and conditions of the Distribution Agreement, Maxim will use its commercially reasonable efforts to sell the shares from time to time, based on the Company’s instructions. The Company has no obligation to sell any of the shares and may at any time suspend offers under the Distribution Agreement. The Offering will terminate upon the earlier of (i) the sale of Shares having an aggregate offering price of $1.6 million, (ii) the termination by either Maxim or the Company upon the provision of fifteen (15) days written notice, or (iii) June 4, 2020. The Company agrees to pay Maxim a transaction fee at a fixed rate of 4.25% of the gross sales price of shares sold under the Distribution Agreement and agreed to provide indemnification and contribution to Maxim with respect to certain liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended. During the three months ended June 30, 2019 the Company raised $0.397 million, net of fees through the issuance of 144,415 shares of common stock under the Distribution Agreement with Maxim. The Company is eligible to raise an additional $1.2 million under this offering. In addition, the Company converted 3,337 shares of preferred stock into 983,528 shares of common stock. The Company is engaged in discussions with investment and banking firms to examine financing alternatives, including options for a public offering of the Company’s preferred or common stock. On October 1, 2018, the Company sold the retail spine business. This sale will continue to provide cash flows from July 2019 totaling $1.4 million over the next ten months and $3.5 million for the following eighteen months. The buyer also assumed the Company’s $2.5 million related party note payable.

 

Although the Company is seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to the Company on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing is also not assured and, if available to the Company, will most likely be dilutive to its current stockholders. If the Company is not able to obtain additional debt or equity financing on a timely basis, the impact on the Company will be material and adverse.

 

These uncertainties create substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

Significant Accounting Policies

 

Except as explained below, no material changes were made to the Company’s significant accounting policies as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.

 

Accounting Pronouncements Adopted During the Quarter Ended June 30, 2019

 

In August 2016, the FASB updated accounting guidance on the following eight specific cash flow classification issues: (1) debt prepayment or debt extinguishment costs; (2) settlement of zero-coupon debt instruments or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing; (3) contingent consideration payments made after a business combination; (4) proceeds from the settlement of insurance claims; (5) proceeds from the settlement of corporate-owned life insurance policies, including bank-owned life insurance policies; (6) distributions received from equity method investees; (7) beneficial interests in securitization transactions; and (8) separately identifiable cash flows and application of the predominance principle. Under prior U.S. GAAP, there was no specific guidance on the eight cash flow classification issues aforementioned. The Company adopted the new guidance effective January 1, 2019. The guidance in this standard did not have a material impact on the financial statements of the Company upon adoption.

 

In February 2016, the FASB updated the accounting guidance related to leases as part of a joint project with the International Accounting Standards Board (“IASB”) to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The Company adopted the new guidance effective January 1, 2019 (see Note 13), using the modified retrospective approach. Adoption of the new guidance resulted in the Company being required to record an additional operating lease right-of-use asset totaling approximately $0.659 million and liability totaling approximately $0.946 million (with $0.659 million incremental to adoption of the new guidance) on the date of adoption. Subsequent to the initial adoption of the new standard the Company amended the lease (see Note 13). The standard did not materially impact the consolidated net loss and had no impact on cash flows.

 

In May 2014, in addition to several amendments issued during 2016, the FASB updated the accounting guidance related to revenue from contracts with customers, which supersedes nearly all existing revenue recognition guidance under U.S. GAAP. The Company adopted the new guidance effective January 1, 2019. The core principle of the new guidance is that a company should recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. The standard defines a five-step process to achieve this core principle and, in doing so, more judgment and estimates are often required within the revenue recognition process than were required under prior U.S. GAAP. The Company has one primary customer (see Note 12) and related contract that has one performance obligation to which revenue is allocated. Revenue under this contract is recognized when the product is shipped to the customer. The Company generally bills its customer upon shipment of the product and invoices are generally due within 30 days. The Company does provide certain rights of return, which historically have not been significant. The Company does not anticipate incurring significant incremental costs to obtain contracts with future customers. The guidance in this standard did not have a material impact on the financial statements of the Company upon adoption.

 

New Accounting Pronouncements Not Yet Adopted

 

The Company has reviewed all recently issued, but not yet adopted, accounting standards, in order to determine their effects, if any, on its results of operations, financial position or cash flows. Based on that review, the Company believes that no other pronouncements will have a significant effect on its financial statements.

 

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2. Basic and Diluted Net Loss per Common Share

 

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period that are determined to be dilutive. Common stock equivalents are primarily comprised of preferred stock, warrants for the purchase of common stock and stock options. The Company had potentially dilutive securities, totaling approximately 0.6 million and 0.7 million as of June 30, 2019 and 2018, respectively.

 

Below are basic and diluted loss per share data for the three months ended June 30, 2019, which are in thousands except for share and per share data:

 

    Basic Calculation     Effect of Dilutive Warrant Securities     Diluted Calculation  
Numerator:                        
Loss from continuing operations   $ (730 )   $ (632 )   $ (1,362 )
Deemed dividend and accretion of a discount     (2,358 )     -       (2,358 )
Net loss attributable to common stockholders   $ (3,088 )   $ (632 )   $ (3,720 )
                         
Denominator:                        
Number of shares used in per common share calculations:     931,859       -       931,859  
                         
Net loss per common share:                        
Loss from continuing operations   $ (0.78 )   $ -     $ (1.46 )
Deemed dividend and accretion of a discount     (2.53 )     -       (2.53 )
Net loss attributable to common stockholders   $ (3.31 )   $ -     $ (3.99 )

 

Below are basic and diluted loss per share data for the six months ended June 30, 2019, which are in thousands except for share and per share data:

 

    Basic Calculation     Effect of Dilutive Warrant Securities     Diluted Calculation  
Numerator:                        
Loss from continuing operations   $ (2,359 )   $ (609 )   $ (2,968 )
Deemed dividend and accretion of a discount     (2,358 )     -       (2,358 )
Net loss attributable to common stockholders   $ (4,717 )   $ (609 )   $ (5,326 )
                         
Denominator:                        
Number of shares used in per common share calculations:     829,724       -       829,724  
                         
Net loss per common share:                        
Loss from continuing operations   $ (2.84 )   $ -     $ (3.58 )
Deemed dividend and accretion of a discount     (2.84 )     -       (2.84 )
Net loss attributable to common stockholders   $ (5.68 )   $ -     $ (6.42 )

 

  10  
     

 

Below are basic and diluted loss per share data for the three months ended June 30, 2018, which are in thousands except for share and per share data:

 

    Basic Calculation     Effect of Dilutive Warrant Securities     Diluted Calculation  
Numerator:                        
Loss from continuing operations   $ (2,181 )   $ (1,610 )   $ (3,791 )
Income from discontinued operations     (131 )     -       (131 )
Deemed dividend and accretion of a discount     (7,334 )     -       (7,334 )
Net loss attributable to common stockholders   $ (9,646 )   $ (1,610 )   $ (11,256 )
                         
Denominator:                        
Number of shares used in per common share calculations:     194,933       119,421       314,354  
                         
Net loss per common share:                        
Loss from continuing operations   $ (11.19 )   $ -     $ (12.06 )
Loss from discontinued operations     (0.67 )     -       (0.42 )
Deemed dividend and accretion of a discount     (37.62 )     -       (23.33 )
Net loss attributable to common stockholders   $ (49.48 )   $ -     $ (35.81 )

 

Below are basic and diluted loss per share data for the six months ended June 30, 2018, which are in thousands except for share and per share data:

 

    Basic Calculation     Effect of Dilutive Warrant Securities     Diluted Calculation  
Numerator:                        
Loss from continuing operations   $ (5,666 )   $ (362 )   $ (6,028 )
Income from discontinued operations     (44 )     -       (44 )
Deemed dividend and accretion of a discount     (7,334 )     -       (7,334 )
Net loss attributable to common stockholders   $ (13,044 )   $ (362 )   $ (13,406 )
                         
Denominator:                        
Number of shares used in per common share calculations:     154,545       -       154,545  
                         
Net loss per common share:                        
Loss from continuing operations   $ (36.66 )   $ -     $ (39.01 )
Loss from discontinued operations     (0.28 )     -       (0.28 )
Deemed dividend and accretion of a discount     (47.46 )     -       (47.46 )
Net loss attributable to common stockholders   $ (84.40 )   $ -     $ (86.75 )

 

3. Inventories

 

Inventories consisted of the following (in thousands):

 

    June 30, 2019     December 31, 2018  
Raw materials   $ 596     $ 624  
Intermediate goods     9       -  
WIP     76       47  
Finished goods     -       5  
    $ 681     $ 676  

 

As of June 30, 2019, inventories totaling approximately $0.08 million and $0.6 million were classified as current and long-term, respectively. Inventories classified as current represent the carrying value of inventories as of June 30, 2019, that management estimates will be sold by June 30, 2020.

 

4. Intangible Assets

 

Intangible assets consisted of the following (in thousands):

 

    June 30, 2019     December 31, 2018  
Trademarks   $ 50     $ 50  
Less: accumulated amortization     (6 )     (4 )
    $ 44     $ 46  

 

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5. Fair Value Measurements

 

Financial Instruments Measured and Recorded at Fair Value on a Recurring Basis

 

The Company has issued certain warrants to purchase shares of common stock, which are considered derivative liabilities because they have registration rights which could require a cash settlement and are re-measured to fair value at each reporting period in accordance with accounting guidance. Fair value is based on the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, under a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows:

 

  Level 1 - quoted market prices for identical assets or liabilities in active markets.
     
  Level 2 - observable prices that are based on inputs not quoted on active markets but corroborated by market data.
     
  Level 3 - unobservable inputs reflecting management’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

 

The Company classifies assets and liabilities measured at fair value in their entirety based on the lowest level of input that is significant to their fair value measurement. No financial assets were measured on a recurring basis as of June 30, 2019 and December 31, 2018. The following tables set forth the financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of June 30, 2019 and December 31, 2018:

 

    Fair Value Measurements as of June 30, 2019  
Description   Level 1     Level 2     Level 3     Total  
Derivative liability                                
Common stock warrants   $ -     $ -     $ 956     $ 956  

 

    Fair Value Measurements as of December 31, 2018  
Description   Level 1     Level 2     Level 3     Total  
Derivative liability                                
Common stock warrants   $ -     $ -     $ 1,566     $ 1,566  

 

The Company did not have any transfers of assets and liabilities between Level 1 and Level 2 of the fair value measurement hierarchy during the three months ended June 30, 2019 and 2018.

 

    Common Stock
Warrants
 
Balance at December 31, 2017   $ (1,357 )
Issuances of warrants classified as derivatives     (7,577 )
Change in fair value     2,020  
Exercise of warrants     565  
Other, net     (212 )
Balance at June 30, 2018   $ (6,561 )
         
Balance at December 31, 2018   $ (1,566 )
Change in fair value     610  
Balance at June 30, 2019   $ (956 )

 

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Common Stock Warrants

 

The Company has issued certain warrants to purchase shares of common stock, which are considered derivative liabilities because they have registration rights which could require a cash settlement and are re-measured to fair value at each reporting period in accordance with accounting guidance. At June 30, 2019 and December 31, 2018, approximately $0.9 million of the derivative liability was calculated using the Black-Scholes-Merton valuation model. At June 30, 2019 and December 31, 2018, no significant amount of the derivative liability was calculated using the Monte Carlo Simulation valuation model.

 

The assumptions used in estimating the common stock warrant liability using the Black-Scholes-Merton valuation model as of June 30, 2019 and December 31, 2018 were as follows:

 

    June 30, 2019     December 31, 2018  
Weighted-average risk-free interest rate     2.23 %     2.51 %
Weighted-average expected life (in years)     4.1       0.9  
Expected dividend yield     - %     - %
Weighted-average expected volatility     68 %     157 %

 

The assumptions used in estimating the common stock warrant liability using the Monte Carlo Simulation valuation model at June 30, 2019 and December 31, 2018 were as follows:

 

    June 30, 2019     December 31, 2018  
Weighted-average risk-free interest rate     1.72 %     2.46 %
Weighted-average expected life (in years)     2.4       3.1  
Expected dividend yield     - %     - %
Weighted average expected volatility     64 %     68 %

 

In addition, if any time after the second anniversary of the issuance of the warrant, both: (1) the 30-day volume weighted average price of the Company’s stock exceeds $3.00; and (2) the average daily trading volume for such 30-day period exceeds $0.4 million, the Company may call this warrant for $0.01 per share. For those warrants that have a call provision, management believes the Monte Carlo Simulation valuation model provides a better estimate of fair value for the warrants issued during 2018 and 2017 than the Black-Scholes-Merton valuation model.

 

Other Financial Instruments

 

The Company’s recorded values of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair values based on their short-term nature. The recorded value of notes payable approximates the fair value as the interest rate approximates market interest rates.

 

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6. Accrued Liabilities

 

Accrued liabilities consisted of the following (in thousands):

 

    June 30, 2019     December 31, 2018  
Payroll and related expense   $ 413     $ 388  
Resterilization and repackaging costs     344       344  
Other     56       106  
    $ 813     $ 838  

 

7. Debt

 

L2 Capital Debt

 

On January 31, 2018, the Company signed a promissory note in the aggregate principal amount of up to $0.84 million (the “L2 Note”) for an aggregate purchase price of up to $0.75 million and warrants to purchase up to an aggregate of 68,257 shares of common stock (the “Warrants”) at an exercise price of $3.31 per share. The maturity date was six months from date of funding. The L2 Note’s interest rate was 8% per year and a default interest rate of 18% per year.

 

On May 14, 2018, the Company closed on an underwritten public offering of units, consisting of convertible preferred stock and warrants, for gross proceeds of $15.0 million. Part of the proceeds from this offering were used to pay off the outstanding debt with L2 Capital. The total payoff was $1.1 million, with $0.7 million in principal and $0.4 million in interest.

 

Hercules and MEF I, LP/Anson Investments Debt Exchange

 

On January 3, 2018, the Company entered into an Assignment Agreement (the “Assignment Agreement”) with MEF I, LP and Anson Investments Master Fund (collectively the “Assignees” and each an “Assignee”), Hercules Technology III, L.P. (“HT III”) and Hercules Capital, Inc. (“HC” and, together with HT III, “Hercules”), pursuant to which Hercules assigned to the Assignees all amounts remaining due under the Loan and Security Agreement, dated June 30, 2014, as amended, between the Company and Hercules (the “Loan and Security Agreement”) and (2) the note (the “Hercules Note”) between the Company and Hercules evidencing the amounts due under the Loan and Security Agreement. The total amount assigned by Hercules to the Assignees in the aggregate was $2.3 million and was secured by the same collateral underlying the Loan and Security Agreement. Subsequently, the Company entered into an exchange agreement pursuant to which the Assignees agreed to exchange the Hercules Term Loan obligation acquired by them for two senior secured convertible promissory notes issued by the Company, each in the principal amount of $1.1 million for an aggregate principal amount of $2.2 million, (the “Exchange Notes”). The Exchange Notes were scheduled to mature on February 3, 2019 (the “Maturity Date”). The Exchange Notes had interest at a rate of 15% per annum. The Exchange Notes were secured by a first priority security interest in substantially all of the Company assets, including intellectual property, and contains covenants restricting payments to certain of our affiliates.

 

On May 14, 2018, the Company closed on an underwritten public offering of units, consisting of convertible preferred stock and warrants, for gross proceeds of $15.0 million. Part of the proceeds from this offering were used to pay off the outstanding debt with MEF I, L.P and Anson Investments. The total payoff was $1.6 million, with $1.4 million in principal and $0.2 million in interest.

 

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North Stadium Term Loan – Related Party

 

On July 28, 2017, the Company entered into a $2.5 million term loan (the “North Stadium Loan”) with North Stadium Investments, LLC (“North Stadium”), a company owned and controlled by the Company’s Chief Executive Officer and Chairman of the Board. The North Stadium Loan bore interest at 10% per annum and required the Company to make monthly interest only payments from September 5, 2017 through July 5, 2018. All principal and unpaid interest (if any) under the North Stadium Loan was due and payable on July 28, 2018. The North Stadium Loan was secured by substantially all of the Company’s assets but was junior to security interest in assets encumbered by the Hercules Term Loan (see below). In connection with the North Stadium Loan the Company also issued North Stadium a warrant to purchase up to 1,834 shares of the Company’s common stock at a purchase price of $151.20 per share, subject to a 5-year term. The relative estimated value of the warrants on the date of grant approximated $0.2 million, which was being amortized as interest expense over the life of the term loan.

 

On October 1, 2018, CTL Medical assumed the North Stadium Term Loan debt as part of the sale of the retail spine business. As of December 31, 2018, the Company has been released by North Stadium from any and all obligations related to this debt.

 

Hercules Term Loan

 

On June 30, 2014, the Company entered into a Loan and Security Agreement with Hercules which provided the Company with a $20.0 million term loan. The Hercules Term Loan matured on January 1, 2018. The Hercules Term Loan included a $0.2 million closing fee, which was paid to Hercules on the closing date of the loan. The closing fee was recorded as a debt discount and was being amortized to interest expense over the life of the loan. The Hercules Term Loan also included a non-refundable final payment fee of $1.7 million. The final payment fee was being accrued and recorded to interest expense over the life of the loan.

 

On January 3, 2018, the Hercules Term Loan and all amounts owing thereunder was assigned to MEF I and Anson Investments. See discussion above under “ Hercules and MEF I, LP/Anson Investments Debt Exchange” for a more detailed description of that transaction.

 

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8. Equity

 

Preferred Stock Conversion

 

From July through December of 2018, Series B Convertible Preferred shareholders of the Company converted 10,926 shares of Series B Convertible Preferred Stock into 569,966 shares of common stock.

 

During May 2018 and June 2018, Series B Convertible Preferred shareholders of the Company converted a total of 4,072 shares of Series B Convertible Preferred Stock into 102,886 shares of common stock.

 

During June 2019, Series B Convertible Preferred shareholders of the Company converted 3,337 shares of Series B Convertible Preferred Stock into 983,528 shares of common stock.

 

August 2018 Warrant Exercise

 

During August 2018, pursuant to the cashless exercise provision contained in their warrant, L2 Capital exercised its warrants and was issued 8,069 shares of common stock. The L2 Capital warrant is no longer outstanding.

 

July 2018 Warrant Exercise

 

During May 2018, the Company closed on a public offering, consisting of both convertible preferred stock and warrants. During July 2018, 998 of the warrants were exercised and converted into 998 shares of common stock.

 

May 2018 Warrant Exercise (July 2016 Warrants)

 

During March 2018, the Company repriced 27,733 warrants dated July 8, 2016, from $360 to $63.75 (for further description see Warrant Reprice March 2018 below ). During May 2018, an additional 4,861 of the repriced warrants were exercised resulting in gross proceeds to the Company of $0.3 million.

 

May 2018 Unit Offering

 

On May 14, 2018, the Company closed on an underwritten public offering of units (“the Units”), consisting of convertible preferred stock and warrants, for gross proceeds of $15.0 million, which excludes underwriting discounts and commissions and offering expenses payable by SINTX. The offering was priced at a public offering price of $1,000 per unit. Each unit consisted of one share of Series B Convertible Preferred Stock, with a stated value of $1,100, and warrants to purchase up to 25 shares of common stock (the “May 2018 Warrants”). The May 2018 Warrants are initially exercisable at an exercise price of $48 per share and expire 5 years from the date of issuance. The Series B Preferred Stock is convertible into shares of common stock by dividing the stated value of $1,100 by: (i) for the first 40 trading days following the closing of this offering, $43.54 (the “Conversion Price”), (ii) after 40 trading days but prior to the 81st trading day, the lesser of  (a) the Conversion Price and (b) 87.5% of the lowest volume weighted average price for our Common Stock as reported at the close of trading on the market reporting trade prices for the Common Stock during the five trading days prior to the 41st trading day, and (iii) after 80 trading days, the lesser of  (a) the Conversion Price and (b) 87.5% of the lowest volume weighted average price for our Common Stock as reported at the close of trading on the market reporting trade prices for the Common Stock during the five trading days prior to the date of the notice of conversion. In the case of (ii)(b) and (iii)(b) above, the share price shall not be less than $2.94 (the “Floor Price”). Each of the Conversion Price and Floor Price is subject to adjustment in certain circumstances.

 

The Company raised $15.0 million associated with the issuance of the Units, with $6.8 million, net of issuance costs of $0.6 million, allocated to the preferred stock and $6.9 million, net of issuance costs of $0.7 million, allocated to the warrants. In association with the warrants that were recorded as a derivative liability, the Company immediately expensed approximately $0.7 million of issuance costs. The 15,000 preferred shares were initially convertible into 378,997 shares of common stock and had an effective conversion rate of $43.50 per share based on the proceeds that were allocated to them. The conversion price was adjusted to $19.63, effective July 12, 2018, and was adjusted again on September 7, 2018 to $14.40. During the months ended June 30, 2019 the conversion price was adjusted down on several occasions and ultimately settled at $2.94 as of June 30, 2019.

 

Warrant Reprice March 2018

 

During the six months ended June 30, 2018 the Company entered into a warrant amendment agreement (the “Amendment Agreement”) with certain holders of previously issued Series E Common Stock Purchase Warrants (collectively, “Investors”). In connection with that certain Series E Common Stock Purchase Warrant between the Company and Investors dated July 8, 2016, the Company issued to Investors warrants to purchase up to 27,733 shares of common stock (the “Warrant Shares”) at an exercise price of $360.00 per share, (the “Investors Warrants”). Under the terms of the Amendment Agreement, in consideration of Investors exercising 22,279 of the Investors Warrants (the “Warrant Exercise”), the exercise price per share of the Investors Warrants was reduced to $63.75 per share. 22,278 of the Investors Warrants were exercised resulting in gross proceeds to the Company of $1.4 million before payment of placement agent fees and costs. In addition, and as further consideration, the Company issued to Investors new warrants to purchase up to the number of shares of common stock equal to 100% of the number of Warrant Shares issued pursuant to the Warrant Exercise at an exercise price per share equal to $60.00 per share.

 

June 2019 ATM Stock Offerings

During June 2019 the Company entered into an ATM equity distribution agreement in which the Company may sell, from time to time, shares of common stock having an aggregate offering price of up to $1.6 million. The Company sold 144,415 shares in June of 2019 raising approximately $0.4 million net of issuance cost of $0.1 million. The Company is eligible to raise an additional $1.1 million under this offering.

 

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9. Stock-Based Compensation

 

A summary of the Company’s outstanding stock option activity for the six months ended June 30, 2019 is as follows:

 

    Options    

Weighted-
Average

Exercise Price

   

Weighted-

Average
Remaining
Contractual
Life
(Years)

    Intrinsic
Value
 
As of December 31, 2018     377     $ 7,653       6.0     $    -  
Granted     -       -       -       -  
Exercised     -       -       -       -  
Forfeited     -       -       -       -  
Expired     -       -       -       -  
As of June 30, 2019     377     $ 7,653       5.8     $ -  
Exercisable as of June 30, 2019     371     $ 7,551       6.3     $ -  
Expected to vest as of June 30, 2019     377     $ 7,653       5.5     $ -  

 

The Company estimates the fair value of each stock option on the grant date using the Black-Scholes-Merton valuation model, which requires several estimates including an estimate of the fair value of the underlying common stock on grant date. The expected volatility was based on an average of the historical volatility of a peer group of similar companies. The expected term was calculated utilizing the simplified method. The risk-free interest rate was based on the U.S. Treasury yield curve in effect at the time of grant for the expected term of the option.

 

10. Commitments and Contingencies

 

The Company has executed agreements with certain executive officers of the Company which, upon the occurrence of certain events related to a change in control, call for payments to the executives up to three times their annual salary and accelerated vesting of previously granted stock options.

 

From time to time, the Company is subject to various claims and legal proceedings covering matters that arise in the ordinary course of its business activities. Management believes any liability that may ultimately result from the resolution of these matters will not have a material adverse effect on the Company’s consolidated financial position, operating results or cash flows.

 

11. Note Receivable

 

On October 1, 2018, the Company completed the sale of its spine business to CTL Medical. The sale included a $6 million noninterest bearing note receivable. The 36-month term of the note receivable requires 18 payments of $138,889 followed by 18 payments of $194,444, with maturing of the note receivable on October 1, 2021. The note receivable includes an imputed interest rate of 10%, which totaled $915,725 as of October 31, 2018, and has a 36-month amortization. As of June 30, 2019, the net carrying value of the note receivable was approximately $4.3 million.

 

12. Discontinued Operations

 

As explained in Note 1, on October 1, 2018, the Company completed the sale of its retail spine business to CTL Medical. The gain on the sale of the retail spine business is estimated to approximate $1.4 million, which was recognized during the quarter ended December 31, 2018.

 

  17  
     

 

The Company and CTL Medical entered in an asset purchase agreement whereby CTL Medical agreed to acquire all of the Company’s commercial spine business for total consideration of $8.5 million, which includes a $6.0 million (including interest) note receivable (See Note 7) and CTL Medical’s assumption of the Company’s $2.5 million related party note payable to North Stadium (see Note 11). As a result of the closing, CTL Medical is now the exclusive owner of SINTX’s portfolio of metal and silicon nitride spine products, which are presently sold under the brand names of Taurus, Preference, and Valeo, with access to future silicon nitride spine technologies. The Company has agreed to pay the cost, if any, to re-sterilize and re-package select silicon nitride spinal inventories sold to CTL Medical if the sterilization date expires prior to CTL Medical selling the inventories to a third-party customer. This agreement extends for a total of 24 months, ending on September 30, 2020. The Company estimates the sterilization and repackaging cost to approximate $0.5 million. Manufacturing, R&D, and all intellectual property related to the core, non-spine, biomaterial technology of silicon nitride remains with the Company in Salt Lake City. The Company will serve as CTL’s exclusive OEM provider of silicon nitride products.

 

Operating results related to discontinued operations consisted of the following for the six months ended June 30, 2018:

 

    Six Months Ended  
    June 30, 2018  
Product revenue   $ 4,330  
Costs of revenue     1,045  
Gross profit     3,285  
Operating expenses:        
Research and development     717  
General and administrative     348  
Sales and marketing     2,264  
Total operating expenses     3,329  
Loss from discontinued operations   $ (44)  

 

During the three and six months ended June 30, 2018, the Company only recorded product revenues and cost of revenues related to the spine business. Because of the sale of the retail spine business to CTL Medical, all product revenues and costs of product revenues for this period has been removed from the condensed consolidated statements of operations.

 

13. Leases

 

The Company leases office, warehouse and manufacturing space under a single operating lease, which lease originally expired during 2019 (see Note 1 under Accounting Pronouncements Adopted During the Quarter Ended June 30, 2019). On June 7, 2019, the lease was amended to extend the rental period through 2024 and reduce the amount of space leased from 54,428 square feet to 29,534 square feet. The new rent is effective the earlier of January 1, 2020 or when the Company vacates the portion of the property that will not be part of the new lease. The amended lease has two five-year extension options. As of June 30, 2019, the operating lease right-of-use asset totaled approximately $2.5 million and the operating lease liability totaled approximately $2.6 million. Non-cash operating lease expense during the six months ended June 30, 2019, totaled approximately $0.171 million. As of June 30, 2019, the weighted-average discount rate for the Company’s operating lease totaled 6.5%. During the three months ended June 30, 2019, the Company recorded a loss of approximately $0.12 million in association with the lease amendment.

 

Leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense is recognized on a straight-line basis over the term of the lease. The Company accounts for lease components separately from the non-lease components. The depreciable life of the assets and leasehold improvements are limited by the expected lease term.

 

Operating lease future minimum payments together with the present values as of June 30, 2019, are summarized as follows:

 

    June 30, 2019  
2019   $ 490  
2020     494  
2021     509  
2022     525  
2023     540  
Thereafter     556  
Total future minimum lease payments     3,114  
Less amounts representing interests     (477 )
Present value of lease liability     2,637  
         
Current-portion of operating lease liability     587  
Long-term portion operating lease liability   $ 2,050  

 

14. Subsequent Events

 

Reverse Stock Split

 

On July 26, 2019 the Company effected a 1 for 30 reverse stock split of the Company’s common stock. The par value and the authorized shares of the common and convertible preferred stock were not adjusted as a result of the reverse stock split. All common stock shares, equivalents, and per-share amounts for all periods presented in these consolidated financial statements prior to July 26, 2019 have been adjusted retroactively to reflect the reverse stock split.

 

  18  
     

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements for the year ended December 31, 2018 and the notes thereto, along with Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2018, filed separately with the U.S. Securities and Exchange Commission. This discussion and analysis contains forward-looking statements based upon current beliefs, plans, expectations, intentions and projections that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2018, and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q.

 

Overview

 

We are an OEM ceramics company that develops and commercializes silicon nitride for medical and non-medical applications. The core strength of SINTX Technologies is the manufacturing, research, and development of silicon nitride ceramics for external partners. We believe that silicon nitride has a superb combination of properties that make it ideally suited for long-term human implantation. Other biomaterials are based on bone grafts, metal alloys, and polymers- all of which have well-known practical limitations and disadvantages. In contrast, silicon nitride has a legacy of success in the most demanding and extreme industrial environments. As a human implant material, silicon nitride offers bone ingrowth, resistance to bacterial and viral infection, ease of diagnostic imaging, resistance to corrosion, and superior strength and fracture resistance, among other advantages, all of which claims are validated in our large and growing inventory of peer-reviewed, published literature reports. We believe that our versatile silicon nitride manufacturing expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields.

 

We also believe that we are the first and only company to commercialize silicon nitride medical implants. Prior to October 1, 2018, we designed, manufactured and commercialized silicon nitride products for our own behalf in the spine implant market. Over 33,000 of our spinal implants manufactured with silicon nitride have been implanted into patients, with an excellent safety record. On October 1, 2018, we sold our spine implant business to CTL Medical and now manufacture spine implants made with silicon nitride for CTL Medical. Prior to selling our spine implant business to CTL Medical, we had received 510(k) regulatory clearance in the United States, a CE mark in Europe, ANVISA approval in Brazil, and ARTG and Prostheses approvals in Australia for a number of silicon nitride spine implant products designed for spinal fusion surgery. Spine implant products manufactured by us from silicon nitride are currently marketed and sold by CTL Medical under the Valeo® brand to surgeons and hospitals in the United States and to selected markets in Europe and South America. These implants are designed for use in cervical (neck) and thoracolumbar (lower back) spine surgery. We are collaborating with CTL Medical to establish a commercial partner in Australia and also working with other partners to obtain regulatory approval for silicon nitride implants in Japan.

 

The sale of our spine implant business to CTL Medical enables us to now focus on our core competencies. These are research and development of silicon nitride and the design and manufacture of medical and nonmedical products manufactured from silicon nitride and other ceramic materials for our own account and in collaboration with other medical device manufacturers. We are targeting original equipment manufacturer (“OEM”) – including CTL Medical - and private label partnerships in order to accelerate adoption of silicon nitride in future markets such as coating products with silicon nitride, hip and knee replacements, dental and maxillofacial implants, extremities, trauma, and sports medicine. Existing biomaterials, based on plastics, metals, and bone grafts have well-recognized limitations that we believe are addressed by silicon nitride, and we are uniquely positioned to convert existing, successful implant designs made by other companies into products manufactured with silicon nitride. OEM and private label partnerships allow us to work with a variety of partners, accelerate the adoption of silicon nitride, and realize incremental revenue at improved operating margins, when compared to the cost-intensive direct sales model.

 

We believe that silicon nitride addresses many of the biomaterial-related limitations in fields such as hip and knee replacements, dental and maxillofacial implants, sports medicine, extremities, and trauma surgery. We further believe that the inherent material properties of silicon nitride, and the ability to formulate the material in a variety of compositions, combined with precise control of the surface properties of the material, opens up a number of commercial opportunities across orthopedic surgery, neurological surgery, maxillofacial surgery, other medical disciplines, as well as commodity items such as industrial fasteners, bushings, and valves to addressing more complex demands of hypersonic missile radomes, aerospace, air-conditioning systems, beverage dispensers, touch-screen glass, and agribusiness fungicides.

 

Components of our Results of Operations

 

We manage our business within one reportable segment, which is consistent with how our management reviews our business, makes investment and resource allocation decisions and assesses operating performance.

 

  19  
     

 

Product Revenue

 

We derive our product revenue primarily from the manufacture and sale of spinal fusion products, used in the treatment of spine disorders, to CTL Medical, with whom we have a 10-year exclusive sales agreement in place. We are currently pursuing other sales opportunities for silicon nitride products outside the spinal fusion application. We generally recognize revenue from sales at the time the product is shipped. In general, our customers do not have any rights of return or exchange.

 

We believe our product revenue will increase as CTL Medical increases sales of silicon nitride spinal fusion products, as we secure other opportunities to manufacture third party products with silicon nitride, and as we continue to introduce new products into the market.

 

Cost of Revenue

 

The expenses that are included in cost of revenue include all in-house manufacturing costs for the products we manufacture.

 

Gross Profit

 

Our gross profit measures our product revenue relative to our cost of revenue. We expect our gross profit to decrease as we expand the penetration of our silicon nitride technology platform through OEM and private label partnerships, which offer additional avenues for the adoption of silicon nitride. Prior to the sale of our retail spine business, our revenues and gross profits were based on our retail sales. With the focus on OEM and private label partnerships, the margins are lower, thus causing the decrease in gross profit.

 

Research and Development Expenses

 

Our research and development costs are expensed as incurred. Research and development costs consist of engineering, product development, clinical trials, test-part manufacturing, testing, developing and validating the manufacturing process, manufacturing, facility and regulatory-related costs. Research and development expenses also include employee compensation, employee and non-employee stock-based compensation, supplies and materials, consultant services, and travel and facilities expenses related to research and development activities.

 

We expect to incur additional research and development costs as we continue to develop new spinal fusion products, our product candidates for total joint replacements, such as our total hip replacement product candidate, and dental applications which, may increase our total research and development expenses.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation for certain members of our executive team and other personnel employed in finance, compliance, administrative, information technology, customer service, executive and human resource departments. General and administrative expenses also include other expenses not part of the other cost categories mentioned above, including facility expenses and professional fees for accounting and legal services.

 

  20  
     

 

RESULTS OF OPERATIONS

 

The following is a tabular presentation of our condensed consolidated operating results for the three and six months ended June 30, 2019 and 2018 ( in thousands ):

 

   

Three Months

Ended June 30,

    $     %     Six Months
Ended June 30,
    $     %  
    2019     2018     Change     Change     2019     2018     Change     Change  
Product revenue   $ 167     $ -     $ 167       100 %   $ 264     $ -     $ 264       100 %
Cost of revenue     133       -       133       100 %     212       -       212       100 %
Gross profit     34       -       34       100 %     52       -       52       100 %
Gross profit %     20 %     - %     20 %     100 %     20 %     0 %     20 %     100 %
                                                                 
Operating expenses:                                                                
Research and development     836       956       (120 )     -13 %     1,554       1,833       (279 )     -15 %
General and administrative     615       935       (320 )     -34 %     1,586       2,242       (656 )     -29 %
Sales and marketing     105       11       94       869 %     164       58       106       184 %
Total operating expenses     1,556       1,902       (347 )     -18 %     3,304       4,133       (829 )     -20 %
Loss from operations     (1,522 )     (1,902 )     380       -20 %     (3,252 )     (4,133 )     881       -21 %
Other income (expense)     792       (279 )     1,071       384 %     893       (1,533 )     2,426       158 %
Net loss before taxes     (730 )     (2,181 )     1,451       -67 %     (2,359 )     (5,666 )     3,307       58 %
Provision for income taxes     -       -       -               -       -       -          
Loss – continuing     (730 )     (2,181 )     1,451       -67 %     (2,359 )     (5,666 )     3,307       58 %
Loss – discontinued     -       (131 )     131       -100 %     -       (44 )     44       -100 %
Net loss   $ (730 )   $ (2,312 )   $ 1,582       68 %   $ (2,359 )   $ (5,710 )   $ 3,351       59 %

 

Product Revenue

 

For the three months ended June 30, 2019, total product revenue was $0.2 million as compared to $0.0 million in the same period 2018, an increase of $0.2 million, or 100%. This increase was due to the sale of the retail spine business in October 2018 and the related restatement of revenues for the three months ended June 30, 2018 to $0.0 million as a result of the discontinued operations.

 

For the six months ended June 30, 2019, total product revenue was $0.3 million as compared to $0.0 million in the same period 2018, an increase of $0.3 million, or 100%. This increase was due to the sale of the retail spine business in October 2018 and the related restatement of revenues for the six months ended June 30, 2018 to $0.0 million as a result of the discontinued operations.

 

Cost of Revenue and Gross Profit

 

For the three months ended June 30, 2019, our cost of revenue increased $0.1 million, or 100%, as compared to the same period in 2018. Gross profit increased $0.03 million and gross margin percentage increased by 100%. Both increases are due to the discontinued operations treatment and the related sale of the retail spine business in October 2018.

 

For the six months ended June 30, 2019, our cost of revenue increased $0.2 million, or 100%, as compared to the same period in 2018. Gross profit increased $0.05 million and gross margin percentage increased by 100%. Both increases are due to the discontinued operations treatment and the related sale of the retail spine business in October 2018.

 

  21  
     

 

Research and Development Expenses

 

For the three months ended June 30, 2019, research and development expenses decreased $0.1 million, or 13%, as compared to the same period in 2018. This decrease was primarily attributable to a decrease in payroll related expenses of $0.1 million.

 

For the six months ended June 30, 2019, research and development expenses decreased $0.3 million, or 15%, as compared to the same period in 2018. This decrease was primarily attributable to a decrease in payroll related expenses of $0.3 million.

 

General and Administrative Expenses

 

For the three months ended June 30, 2019, general and administrative expenses decreased $0.3 million, or 34%, as compared to the same period in 2018. This decrease was primarily attributable to a decrease in accounting expenses of $0.1 million, legal fees of $0.1 million, and other expenses of $0.1 million.

 

For the six months ended June 30, 2019, general and administrative expenses decreased $0.7 million, or 29%, as compared to the same period in 2018. This decrease was primarily attributable to a decrease in accounting expenses of $0.2 million, legal fees of $0.2 million and other expenses of $0.3 million.

 

Sales and Marketing Expenses

 

For the three months ended June 30, 2019, sales and marketing expenses increased $0.1 million, or 869%, as compared to the same period in 2018. This increase was primarily attributable to an increase in payroll related expenses of $0.1 million.

 

For the six months ended June 30, 2019, sales and marketing expenses increased $0.1 million, or 184%, as compared to the same period in 2018. This increase was primarily attributable to an increase in payroll related expenses of $0.1 million.

 

Other Expense, Net

 

For the three months ended June 30, 2019, other income increased $1.1 million, or 384%, as compared to the same period in 2018. This increase was primarily due to a decrease in interest expense of $0.8 million, a decrease in offering costs of $0.7 million, and increase in interest income of $0.1 million, all offset by the change in the fair value of the derivative liabilities in the amount of $0.5 million.

 

For the six months ended June 30, 2019, other income increased $2.4 million, or 158%, as compared to the same period in 2018. This increase was primarily due to a decrease in the loss on the extinguishment of derivative liabilities of $1.3 million, the decrease in interest expense of $1.3 million, the decrease in the loss on extinguishment of debt of $0.3 million and the increase in interest income of $0.1 million, , a decrease in offering costs of $0.7 million, and an increase of $0.1 million on other miscellaneous accounts, all offset by the change in the fair value of the derivative liabilities in the amount of $1.4 million.

 

Liquidity and Capital Resources

 

The condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern within one year from the date of issuance of these condensed consolidated financial statements.

 

  22  
     

 

For the six months ended June 30, 2019 and 2018, the Company incurred net losses from continuing operations of approximately $2.4 million and $5.7 million, respectively, and used cash in continuing operations of approximately $3.0 million and $5.5 million, respectively. The Company had an accumulated deficit of approximately $232 million and $229 million as of June 30, 2019 and December 31, 2018, respectively. To date, the Company’s operations have been principally financed by proceeds received from the issuance of preferred and common stock, convertible debt and bank debt and, to a lesser extent, cash generated from product sales. It is anticipated that the Company will continue to generate operating losses and use cash in operating activities. The Company’s continuation as a going concern is dependent upon its ability to increase sales and/or raise additional funds through the capital markets. Whether and when the Company can attain profitability and positive cash flows from operating activities or obtain additional financing is uncertain.

 

The Company is actively generating additional scientific and clinical data to have it published in leading industry publications. The unique features of the Company’s silicon nitride material are not well known, and the Company believes that the publication of such data would help sales efforts as the Company approaches new prospects. The Company is also making additional changes to the sales strategy, including a focus on revenue growth by expanding the use of silicon nitride in other areas outside of spinal fusion applications.

 

The Company has common stock that is publicly traded and has been able to successfully raise capital when needed since the date of the Company’s initial public offering. In March 2018, the Company closed on gross proceeds of $1.4 million, before payment of placement agent fees and costs on a warrant reprice and exercise transaction. Additionally, on May 14, 2018, the Company closed on a public offering of units, consisting of convertible preferred stock and warrants, for gross proceeds of $15 million, which excludes underwriting discounts and commissions and offering expenses payable by the Company. On June 4, 2019, we entered into an Equity Distribution Agreement, (the “Distribution Agreement”), with Maxim Group LLC (“Maxim”), pursuant to which we may sell from time to time, shares of our common stock, having an aggregate offering price of up to $1.6 million through Maxim, as agent (the “ATM Offering”). Subject to the terms and conditions of the Distribution Agreement, Maxim will use its commercially reasonable efforts to sell the shares from time to time, based on our instructions. We have no obligation to sell any of the shares and may at any time suspend offers under the Distribution Agreement. The Offering will terminate upon the earlier of (i) the sale of Shares having an aggregate offering price of $1.6 million, (ii) the termination by either Maxim or us upon the provision of fifteen (15) days written notice, or (iii) June 4, 2020. We agreed to pay Maxim a transaction fee at a fixed rate of 4.25% of the gross sales price of shares sold under the Distribution Agreement and agreed to provide indemnification and contribution to Maxim with respect to certain liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended. During the three months ended June 30, 2019 the Company raised $0.4 million, net of fees through the issuance of 144,415 shares of common stock under the Distribution Agreement with Maxim. The Company is eligible to raise an additional $1.1 million under this offering. In addition, the Company converted 3,337 shares of preferred stock into 983,528 shares of common stock. The Company is engaged in discussions with investment and banking firms to examine financing alternatives, including options for a public offering of the Company’s preferred or common stock. On October 1, 2018, the Company sold the retail spine business. This sale will continue to provide cash flows from July 2019 totaling $1.4 million over the next ten months and $3.5 million for the following eighteen months. The buyer also assumed the Company’s $2.5 million related party note payable.

 

Although the Company is seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to the Company on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing is also not assured and, if available to the Company, will most likely be dilutive to its current stockholders. If the Company is not able to obtain additional debt or equity financing on a timely basis, the impact on the Company will be material and adverse.

 

These uncertainties create substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

  23  
     

 

Cash Flows

 

The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities (in thousands) – unaudited:

 

    Six Months Ended June 30,  
    2019     2018  
Net cash used in operating activities – continuing operations   $ (2,979 )   $ (5,532 )
Net cash used in operating activities – discontinued operations     -       (402 )
Net cash used in operating activities     (2,979 )     (5,934 )
Net cash provided by (used in) investing activities – continuing operations     680       (50 )
Net cash used in investing activities – discontinued operations     -       (107 )
Net cash provided by (used in) investing activities     680       (157 )
Net cash provided by (used in) financing activities     44     14,386  
Net decrease in cash used   $ (2,255 )   $ 8,295  

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities – continuing operations decreased $2.6 million to $3.0 million during the three months ended June 30, 2019, as compared to $5.5 million for the same period in 2018. The decrease in net cash used in operating activities – continuing operations is due to the decrease in the net loss and related non-cash add backs to the net loss during the six months ended June 30, 2019 as compared to the same period in 2018.

 

Net Cash Provided by Investing Activities

 

Net cash provided by investing activities – continuing operations increased $0.7 million to $0.7 million during the six months ended June 30, 2019, compared to net cash used in investing activities – continuing operations of $0.05 million for the same period in 2018. The increase in cash provided by investing activities – continuing operations during 2019 was primarily due to a $0.7 million increase in proceeds from notes receivable.

 

Net Cash Used in Financing Activities

 

Net cash provided by financing activities was $0.04 million during the six months ended June 30, 2019, compared to net cash provided by financing activities of $14.4 million during the same period in 2018. The $14.3 million decrease was primarily attributable to the $1.6 million net decrease in proceeds received from the exercise of common stock warrants, a decrease in proceeds from the issuance of debt of $0.7 million, a decrease in proceeds from capital offerings of $14.0 million, a $0.4 million increase in the payments of operating lease obligations, all offset by and a $2.3 million increase in payments for debt extinguishments.

 

Indebtedness

 

L2 Capital Debt

 

On January 31, 2018, the Company signed a promissory note in the aggregate principal amount of up to $0.84 million (the “L2 Note”) for an aggregate purchase price of up to $0.75 million and warrants to purchase up to an aggregate of 68,257 shares of common stock (the “Warrants”) at an exercise price of $3.31 per share. The maturity date was six months from date of funding. The L2 Note’s interest rate was 8% per year and a default interest rate of 18% per year. On May 14, 2018, the Company closed on an underwritten public offering of units, consisting of convertible preferred stock and warrants, for gross proceeds of $15.0 million. Part of the proceeds from this offering were used to pay off the outstanding debt with L2 Capital. The total payoff was $1.1 million, with $0.7 million in principal and $0.4 million in interest.

 

  24  
     

 

Hercules and MEF I, LP/Anson Investments Debt Exchange

 

On January 3, 2018, the Company entered into an Assignment Agreement (the “Assignment Agreement”) with MEF I, LP and Anson Investments Master Fund (collectively the “Assignees” and each an “Assignee”), Hercules Technology III, L.P. (“HT III”) and Hercules Capital, Inc. (“HC” and, together with HT III, “Hercules”), pursuant to which Hercules assigned to the Assignees all amounts remaining due under the Loan and Security Agreement, dated June 30, 2014, as amended, between the Company and Hercules (the “Loan and Security Agreement”) and (2) the note (the “Hercules Note”) between the Company and Hercules evidencing the amounts due under the Loan and Security Agreement. The total amount assigned by Hercules to the Assignees in the aggregate was $2.3 million and was secured by the same collateral underlying the Loan and Security Agreement. Subsequently, the Company entered into an exchange agreement pursuant to which the Assignees agreed to exchange the Hercules Term Loan obligation acquired by them for two senior secured convertible promissory notes issued by the Company, each in the principal amount of $1.1 million for an aggregate principal amount of $2.2 million, (the “Exchange Notes”). The Exchange Notes were scheduled to mature on February 3, 2019 (the “Maturity Date”). The Exchange Notes had interest at a rate of 15% per annum. Prior to the Maturity Date, principal and interest accrued under the Exchange Notes was payable in cash or, if certain conditions were met, payable in shares of our common stock. The Exchange Notes were secured by a first priority security interest in substantially all of the Company assets, including intellectual property, and contains covenants restricting payments to certain of our affiliates.

 

On May 14, 2018, the Company closed on an underwritten public offering of units, consisting of convertible preferred stock and warrants, for gross proceeds of $15.0 million. Part of the proceeds from this offering were used to pay off the outstanding debt with MEF I, L.P and Anson Investments. The total payoff was $1.6 million, with $1.4 million in principal and $0.2 million in interest.

 

North Stadium Term Loan – Related Party

 

On July 28, 2017, the Company entered into a $2.5 million term loan (the “North Stadium Loan”) with North Stadium Investments, LLC (“North Stadium”), a company owned and controlled by the Company’s Chief Executive Officer and Chairman of the Board. The North Stadium Loan bore interest at 10% per annum and required the Company to make monthly interest only payments from September 5, 2017 through July 5, 2018. All principal and unpaid interest (if any) under the North Stadium Loan was due and payable on July 28, 2018. The North Stadium Loan was secured by substantially all of the Company’s assets but was junior to security interest in assets encumbered by the Hercules Term Loan (see below). In connection with the North Stadium Loan the Company also issued North Stadium a warrant to purchase up to 1,834 shares of the Company’s common stock at a purchase price of $151.20 per share, subject to a 5-year term. The relative estimated value of the warrants on the date of grant approximated $0.2 million, which was being amortized as interest expense over the life of the term loan.

 

On October 1, 2018, CTL Medical assumed the North Stadium Term Loan debt as part of the sale of the retail spine business. As of December 31, 2018, the Company has been released by North Stadium from any and all obligations related to this debt.

 

Hercules Term Loan

 

On June 30, 2014, the Company entered into a Loan and Security Agreement with Hercules which provided the Company with a $20.0 million term loan. The Hercules Term Loan matured on January 1, 2018. The Hercules Term Loan included a $0.2 million closing fee, which was paid to Hercules on the closing date of the loan. The closing fee was recorded as a debt discount and was being amortized to interest expense over the life of the loan. The Hercules Term Loan also included a non-refundable final payment fee of $1.7 million. The final payment fee was being accrued and recorded to interest expense over the life of the loan.

 

On January 3, 2018, the Hercules Term Loan and all amounts owing thereunder was assigned to MEF I and Anson Investments. See discussion above under the heading “ Hercules and MEF I, LP/Anson Investments Debt Exchange”

for a more detailed description of that transaction.

 

  25  
     

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) of Regulation S-K.

 

Critical Accounting Policies and Estimates

 

A summary of our significant accounting policies and estimates is discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations and in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018. Except as referenced in New Accounting Pronouncements below, no material changes to significant accounting policies were made during the six months ended June 30, 2019. The preparation of the financial statements in accordance with U.S. generally accepted accounting principles requires us to make judgments, estimates and assumptions regarding uncertainties that affect the reported amounts of assets and liabilities. Significant areas of uncertainty that require judgments, estimates and assumptions include the accounting for income taxes and other contingencies as well as valuation of derivative liabilities, asset impairment and collectability of accounts receivable. We use historical and other information that we consider to be relevant to make these judgments and estimates. However, actual results may differ from those estimates and assumptions that are used to prepare our financial statements.

 

New Accounting Pronouncements

 

See discussion under Note 1, Organization and Summary of Significant Accounting Policies, to the Condensed Consolidated Financial Statements included in Item 1 of Part I of this Quarterly Report on Form 10-Q, for information on new accounting pronouncements.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURES

 

This Report includes the certifications of our Chief Executive Officer and Principal Financial Officer required by Rule 13a-14 of the Securities Exchange Act of 1934 (the “Exchange Act”). See Exhibits 31.1 and 31.2. This Item 4 includes information concerning the controls and control evaluations referred to in those certifications.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”), that are designed to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act, is recorded, processed, summarized, and reported within the time periods specified by the Commission’s rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act are properly recorded, processed, summarized and reported within the time periods required by the Commission’s rules and forms.

 

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (principal executive officer and principal financial officer), of the effectiveness of the design and operation of these disclosure controls and procedures, as such term is defined in Exchange Act Rule 13a-15(e), as of June 30, 2019. Based on this evaluation, the Chief Executive Officer concluded that our disclosure controls and procedures were effective as of June 30, 2019, the end of the period covered by this Quarterly Report on Form 10-Q.

 

As defined in SEC Regulation S-X, a material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Based on this assessment, management determined that, as of December 31, 2018, our internal control over financial reporting was not effective because of the material weaknesses described below.

The design and operating effectiveness of our controls were inadequate to ensure that complex accounting matters are always properly accounted for and reviewed in a timely manner, as outlined below:

Control Activities – The Company did not always have adequate control activities that were designed and operating effectively, including timely management review controls and controls to verify the completeness and adequacy of information prior to presentation of the information to the independent auditors.

Monitoring Activities – The Company did not always maintain effective monitoring controls related to the financial reporting process.

Our Chief Executive Officer continues with a review of our controls relating to complex accounting matters. Although our analysis is not complete, we have added additional resources with expertise in accounting for complex accounting matters. We are also considering redesigning controls to add additional layers of review and approval whenever entering into or subsequently converting, exercising, amending, repricing, exiting or otherwise experiencing changes in or to complex financial instruments.

Notwithstanding the identified material weaknesses, the Company believes the consolidated financial statements included in this Quarterly Report on Form 10-Q fairly represent in all material respects our financial condition, results of operations and cash flows at and for the periods presented in accordance with accounting principles generally accepted in the United States of America.

 

  26  
     

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during the second quarter of 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II

 

ITEM 1. LEGAL PROCEEDINGS

 

We are not aware of any pending or threatened legal proceeding against us that could have a material adverse effect on our business, operating results or financial condition. The medical device industry is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, we may be involved in various additional legal proceedings from time to time.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

None.

 

  27  
     

 

ITEM 6. EXHIBITS

 

Exhibit
Number
  Exhibit Description   Filed Herewith   Incorporated by Reference
herein from
Form or
Schedule
  Filing
Date
 

SEC File/

Reg. Number

10.1   Equity Distribution Agreement, dated as of June 4, 2019, by and between SINTX Technologies, Inc and Maxim Group LLC      

Form 8-K

(Exhibit 10.1)

  06/04/19   001-33624
                     
10.2   Amendment to Centrepointe Business Park Lease Agreement, dated June 7, 2019, between SINTX Technologies, Inc. and Centrepointe Properties, LLC.      

Form 8-K

(Exhibit 10.1)

  06/10/19   001-33624
                     
31.1   Certificate of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002   X            
                     
31.2   Certificate of the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   X            
                     
32   Certifications of the Chief Executive Officer and Principal Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   X            
                     
101.INS   XBRL Instance Document   X            
                     
101.SCH   XBRL Taxonomy Extension Schema Document   X            
                     
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document   X            
                     
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document   X            
                     
101.LAB   XBRL Taxonomy Extension Label Linkbase Document   X            
                     
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document   X            

 

  28  
     

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

SINTX Technologies, Inc.

(previously known as Amedica Corporation)

   
Date: August 13, 2019 /s/ B. Sonny Bal
  B. Sonny Bal
  Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer)

 

  29  
     

 

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