UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of September 2021 (Report No. 3)

 

Commission file number: 001-39957

 

NLS PHARMACEUTICS LTD.

(Translation of registrant’s name into English)

 

Alter Postplatz 2

CH-6370 Stans, Switzerland

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒       Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____

 

 

 

 

 

CONTENTS

 

This Report of Foreign Private Issuer on Form 6-K consists of (i) NLS Pharmaceutics Ltd.’s, or the Registrant’s, Condensed Financial Statements (unaudited) as of June 30, 2021, which is attached hereto as Exhibit 99.1; and (iii) the Registrant’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ended June 30, 2021, which is attached hereto as Exhibit 99.2.

 

EXHIBIT INDEX

 

Exhibit No.   Document Description
99.1   Condensed Financial Statements (Unaudited) of NLS Pharmaceutics as of and for the six months ended June 30, 2021.
99.2   Management’s Discussion and Analysis of Financial Condition and Results of Operations.
EX-101.INS   Inline XBRL Taxonomy Instance Document
EX-101.SCH   Inline XBRL Taxonomy Extension Schema Document
EX-101.CAL   Inline XBRL Taxonomy Calculation Linkbase Document
EX-101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document
EX-101.LAB   Inline XBRL Taxonomy Label Linkbase Document
EX-101.PRE   Inline XBRL Taxonomy Presentation Linkbase Document
EX-104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

1

 

 

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.

 

  NLS Pharmaceutics Ltd.
     
Date: September 28, 2021 By: /s/ Alexander Zwyer
    Name:  Alexander Zwyer
    Title: Chief Executive Officer

 

 

2

 

false --12-31 Q2 2021 2021-06-30 0001783036

Exhibit 99.1

 

 

 

 

NLS PHARMACEUTICS LTD.

UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

AS OF AND FOR THE SIX MONTHS ENDED JUNE 30, 2021 AND 2020

 

 

 

 

 

 

 

NLS PHARMACEUTICS LTD.

UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

    Page
     
Unaudited Interim Condensed Balance Sheets as of June 30, 2021 and December 31, 2020   3
Unaudited Interim Condensed Statements of Operating and Comprehensive Loss for the Six Months Ended June 30, 2021 and 2020   4
Unaudited Interim Condensed Statements of Changes in Equity for the Six Months Ended June 30, 2021 and 2020   5
Unaudited Interim Condensed Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020   6
Notes to the Unaudited Interim Condensed Financial Statements   7

 

2

 

 

NLS PHARMACEUTICS LTD.

UNAUDITED INTERIM CONDENSED BALANCE SHEETS

 

    June 30,
2021
    December 31,
2020
 
             
ASSETS            
Current assets:            
Cash and cash equivalents   $ 7,092,115     $ 93,711  
Prepaid expenses and other current assets (Note 4)     1,149,247       103,000  
Total current assets     8,241,362       196,711  
                 
Deferred offering costs    
-
      946,912  
Property and equipment (Note 5)     27,733      
-
 
Other receivables, net – related party (Note 6)    
-
      67,954  
Total assets   $ 8,269,095     $ 1,211,577  
                 
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)                
Current liabilities:                
Accounts payable, including related party of $14,547 and $454,315, as of June 30, 2021 and December 31, 2020, respectively   $ 527,203     $ 4,006,473  
Interest payable    
-
      316,174  
Convertible promissory notes – related parties (Note 7)     -       591,693  
Current portion of credit facilities, subordinated – related parties (Note 8)    
-
      150,000  
Current portion of convertible loan, including related party of $0 and $113,130 as of June 30, 2021 and December 31, 2020, respectively, net of discount of $0 and $37,362 as of June 30, 2021 and December 31, 2020, respectively (Note 9)    
-
      463,980  
Bridge loan (Note 10)    
-
      565,650  
Accrued salaries    
-
      459,195  
Other accrued liabilities, including related party of $63,859 and $40,842 as of June 30, 2021 and December 31, 2020, respectively (Note 11)     665,648       650,753  
Total current liabilities     1,192,851       7,203,918  
                 
Convertible loans, net of discount of $0 and $4,248 as of June 30, 2021 and December 31, 2020, respectively (Note 9)    
-
      32,463  
Swiss government loan (Note 12)    
-
      281,015  
Deferred revenues (Note 13)     2,499,969       2,499,969  
Accrued pension liability     327,320       178,269  
Total liabilities     4,020,140       10,195,634  
                 
Commitments and contingencies (Note 14)    
 
     
 
 
                 
Shareholders’ equity (deficit)                
Common shares, CHF 0.02 ($0.02) par value; 17,945,915 authorized; 12,068,325 and 6,960,000 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively     259,729       145,139  
Additional paid-in capital     38,532,118       20,649,882  
Accumulated deficit     (34,363,039 )     (29,759,697 )
Accumulated other comprehensive loss     (179,853 )     (19,381 )
Total shareholders’ equity (deficit)     4,248,955       (8,984,057 )
Total liabilities and shareholders’ equity (deficit)   $ 8,269,095     $ 1,211,577  

 

The accompanying notes are an integral part of these Unaudited Interim Condensed Financial Statements. 

 

3

 

 

NLS PHARMACEUTICS LTD.

UNAUDITED INTERIM CONDENSED STATEMENTS OF OPERATING AND COMPREHENSIVE LOSS

 

    For the Six Months Ended
June 30,
 
    2021     2020
(as restated)
 
             
Operating expenses:            
Research and development 1   $ 1,862,735     $ 41,421  
General and administrative 1     2,680,018       1,040,273  
Total operating expenses     4,542,753       1,081,694  
                 
   Operating loss     (4,542,753 )     (1,081,694 )
                 
Other income (expense), net     7,544       (62,193 )
Interest expense     (48,099 )     (37,094 )
Interest on related party loans     (20,034 )     (51,235 )
                 
Net loss     (4,603,342 )     (1,232,216 )
                 
Other comprehensive loss:                
Defined pension plan adjustments     (160,472 )     -  
                 
Comprehensive loss   $ (4,763,814 )   $ (1,232,216 )
                 
                 
Basic and diluted net loss per common share   $ (0.42 )   $ (0.18 )
                 
Weighted average common shares used for computing basic and diluted net loss per common share     11,069,254       6,960,000  

 

1 Comparative figures for the six months ended June 30, 2020 were restated to correct the classification of intellectual property expenses from research and development expenses to general and administrative expenses. For further information, see Note 3 “Restatement of Previously Issued Financial Statements” to the financial statements.

 

The accompanying notes are an integral part of these Unaudited Interim Condensed Financial Statements.

 

4

 

 

NLS PHARMACEUTICS LTD.

UNAUDITED INTERIM CONDENSED STATEMENTS OF CHANGES IN EQUITY

FOR THE SIX MONTHS ENDED JUNE 30, 2021 AND 2020

 

    Common Shares     Additional Paid in     Accumulated     Accumulated Other Comprehensive        
    Shares     Amount     Capital     Deficit     Loss     Total  
BALANCE, JANUARY 1, 2021     6,960,000     $ 145,139     $ 20,649,882     $ (29,759,697 )   $ (19,381 )   $ (8,984,057 )
Issuance of common shares in initial public offering, net     4,819,277       108,347       9,946,310      
-
     
-
      10,054,657  
Issuance of warrants     -      
-
      6,742,638      
-
     
-
      6,742,638  
Issuance of common shares to consultant     12,048       268       49,732      
-
     
-
      50,000  
Warrant exercises     277,000       5,975       1,143,556      
-
     
-
      1,149,531  
Defined pension plan adjustments                                     (160,472 )     (160,472 )
Net loss     -      
-
     
-
      (4,603,342 )    
-
      (4,603,342 )
BALANCE, JUNE 30, 2021     12,068,325     $ 259,729     $ 38,532,118     $ (34,363,039 )   $ (179,853 )   $ 4,248,955  

 

    Common Shares     Additional Paid in     Accumulated     Accumulated Other Comprehensive        
    Shares     Amount     Capital     Deficit     Loss     Total  
BALANCE, JANUARY 1, 2020     6,960,000     $ 145,139     $ 20,600,871     $ (26,898,262 )   $ (18,698 )   $ (6,170,950 )
Debt discount on convertible loans     -      
-
      39,496      
-
     
-
      39,496  
Debt discount on related party loans     -      
-
      30,030      
-
     
-
      30,030  
Net loss     -      
-
     
-
      (1,232,216 )    
-
      (1,232,216 )
BALANCE, JUNE 30, 2020     6,960,000     $ 145,139     $ 20,670,397     $ (28,130,478 )   $ (18,698 )   $ (7,333,640 )

 

The accompanying notes are an integral part of these Unaudited Interim Condensed Financial Statements.

 

5

 

 

NLS PHARMACEUTICS LTD.

UNAUDITED INTERIM CONDENSED STATEMENTS OF CASH FLOWS

 

    For the Six Months Ended
June 30,
 
    2021     2020  
Operating Activities:            
Net loss   $ (4,603,342 )   $ (1,232,216 )
Adjustments to reconcile net loss to net cash used in in operating activities:                
Amortization of debt discount     41,611       36,664  
Depreciation expense     5,022       -  
Provision for doubtful accounts     77,714       -  
Periodic pension costs     13,352       -  
Changes in operating assets and liabilities:                
Prepaid expenses and other current assets     (1,046,247 )     85,605  
Other receivables, net – related parties     (9,760 )     (1,719 )
Accounts payable     (3,479,270 )     246,734  
Interest payable     (313,342 )     51,789  
Other accrued liabilities     (419,073 )     280,219  
Net cash used in operating activities     (9,733,335 )     (532,924 )
                 
Investing Activities:                
Purchases of property and equipment     (32,755 )     -  
Net cash used in investing activities     (32,755 )     -  
                 
Financing Activities:                
Proceeds from the issuance of common shares in initial public offering, net     11,001,569       -  
Proceeds from the issuance of warrants     6,742,638       -  
Exercise of warrants     1,149,531       -  
Proceeds from bridge loan     108,610       -  
Payment on Swiss government loan     (277,537 )     -  
Payment on second credit facility     (150,000 )     -  
Payment on convertible loans     (420,020 )     -  
Payment on convertible loans – related party     (111,730 )     -  
Payment on bridge loan     (670,380 )     -  
Payment of shareholder loans     (583,443 )     -  
Proceeds from convertible loans     -       174,215  
Proceeds from convertible loan – related party     -       105,530  
Proceeds from Swiss government loan     -       262,137  
Deferred offering costs     -       (102,319 )
Net cash provided by financing activities     16,789,238       439,563  
                 
Effect of exchange rate on cash and cash equivalents     (24,744 )     18,498  
Change in cash and cash equivalents     6,998,404       (74,863 )
Cash and cash equivalents at the beginning of period     93,711       220,267  
Cash and cash equivalents at the end of period   $ 7,092,115     $ 145,404  
                 
Supplemental disclosure of non-cash and financing activities:                
Deferred financing costs transferred to additional paid in capital   $ 946,912     $ -  
Issuance of common shares to consultant for payment of expenses   $ 50,000     $ -  
Debt discount on convertible loans   $ -     $ 39,496  
Debt discount on convertible loan – related party   $
-
    $ 30,030  

 

The accompanying notes are an integral part of these Unaudited Interim Condensed Financial Statements. 

 

6

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

Note 1

 

Background:

 

NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) (the “Company”) is an emerging biopharmaceutical company engaged in the discovery and development of life-improving drug therapies to treat rare and complex central nervous system disorders, including narcolepsy, idiopathic hypersomnia and other rare sleep disorders, and of neurodevelopmental disorders, such as Attention Deficit Hyperactivity (“ADHD”). The Company’s lead product candidates are Quilience, to treat narcolepsy (type 1 and type 2), and Nolazol, to treat ADHD.

 

On March 12, 2019, the Company merged NLS-0 Pharma Ltd. and NLS Pharma Ltd. into NLS-1 Pharma Ltd. (the “Merger”), the predecessor of the Company, retroactively and effective on January 1, 2019 and renamed the Company NLS Pharmaceutics Ltd. Due to the high degree of common ownership among the three companies and because individual investors’ ownership is in substance the same after the transaction, this Merger was deemed to be a non-substantive merger, with no step up in basis of the assets and liabilities in the Merger. The financial statements presented were prepared as if the Merger occurred on January 1, 2019. All intercompany transactions and balances were eliminated in the Merger.

 

On February 2, 2021, the Company completed the closing of its initial public offering of 4,819,277 units at a price of $4.15 per unit. Each unit consisted of one common share and one warrant to purchase one common share (the “Warrants”). The common shares and Warrants were immediately separable from the units and were issued separately. The common shares and Warrants began trading on the Nasdaq Capital Market on January 29, 2021 under the symbols “NLSP” and “NLSPW,” respectively. The Company received net proceeds of $17 million, after deducting underwriting discounts and commissions and other estimated offering expenses. The Warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $4.15 per share. In addition, the Company granted the underwriters a 45-day option to purchase up to an additional 722,891 common shares and/or Warrants to purchase 722,891 common shares at the public offering price of $0.01 per Warrant, of which the underwriters exercised their option to purchase Warrants to purchase up to 722,891 common shares. These Warrants were issued in the Company’s initial public offering and therefore have the same exercise price of $4.15 per share.

 

Going Concern

As of June 30, 2021, the Company had an accumulated deficit of approximately $34.4 million and the Company incurred an operating loss for the six months ended June 30, 2021 of approximately $4.6 million. To date, the Company has dedicated most of its financial resources to research and development, clinical studies associated with its ongoing biopharmaceutical business and general and administrative expenses.

 

As of June 30, 2021, the Company’s cash and cash equivalents were $7.1 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund operations into the second quarter of 2022. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of these financial statements. Additionally, the Company’s operating plans may change as a result of many factors that may currently be unknown to the Company including:

 

  the length of the novel strain of coronavirus (“COVID-19”) pandemic and its impact on the Company’s planned clinical trials, operations and financial condition;
     
  the progress and costs of the Company’s pre-clinical studies, clinical trials and other research and development activities;
     
  the scope, prioritization and number of the Company’s clinical trials and other research and development programs;
     
  any cost that the Company may incur under in- and out-licensing arrangements relating to its product candidate that it may enter into in the future;

 

7

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

  the costs and timing of obtaining regulatory approval for the Company’s product candidates;
     
  the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
     
  the costs of, and timing for, strengthening the Company’s manufacturing agreements for production of sufficient clinical and commercial quantities of its product candidates;
     
  the potential costs of contracting with third parties to provide marketing and distribution services for the Company or for building such capacities internally; and
     
  the costs of acquiring or undertaking the development and commercialization efforts for additional therapeutic applications of the Company’s product candidates and the magnitude of the Company’s general and administrative expenses.

 

As a result, the Company may require additional capital to finance expenditures related to the manufacture of the Company’s product candidates for use in clinical trials, conducting clinical trials and general and administration expenses.

 

The Company has historically financed its activities primarily with cash from an initial public offering, private placement of equity and debt securities and borrowings under credit facilities, shareholder loans, Swiss Government COVID-19 loan and an upfront payment from a collaboration partner. The Company intends to raise additional capital through public offerings of debt and equity securities, private placements of debt and equity securities or through loans from third parties, but there can be no assurance that these funds will be available, or if they are available, that their availability will be on terms acceptable to the Company or in an amount sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables and indebtedness, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations or force the Company to grant rights to develop and commercialize product candidates that it would otherwise prefer to develop and commercialize on its own. There can be no assurance that such a plan will be successful.

 

Accordingly, the accompanying unaudited interim condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which contemplate continuation of the Company as a going concern for a period within one year from the issuance of these unaudited interim condensed financial statements and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in these unaudited interim condensed financial statements do not necessarily purport to represent realizable or settlement values. These unaudited interim condensed financial statements do not include any adjustment that might result from the outcome of this uncertainty.

 

Note 1A

Stock Split

 

On September 14, 2020, the Company filed an amendment to its Articles of Incorporation and effected a 5,000-for-1 stock split of its issued and outstanding common shares, CHF 0.02 ($0.02) par value, whereby 1,392 outstanding Company’s common shares were exchanged for 6,960,000 of the Company’s common shares. All per share amounts and number of shares in these unaudited condensed financial statements and related notes have been retroactively restated to reflect the stock split.

 

Note 2

Summary of Significant Accounting Policies:

 

Basis of Preparation

The unaudited interim condensed financial statements have been prepared in accordance with U.S. GAAP for interim financial information and accordingly do not include all information and disclosures as required by U.S. GAAP for complete financial statements. The year-end unaudited interim condensed balance sheet was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2020 and any public announcements made by the Company during the interim reporting period.

 

8

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

In the opinion of management, these unaudited interim condensed financial statements reflect all adjustments necessary, which are of a normal recurring nature, to fairly state the balance sheets, statements of operating and comprehensive loss, changes in equity and cash flows for the interim reporting periods presented.

 

Use of Estimates

The preparation of the unaudited interim condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect amounts reported of assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the interim reporting periods. Actual results could differ from those estimates and be based on events different from those assumptions. As part of these financial statements, the more significant estimates include (1) pension and other post-employment benefits, including certain asset values that are based on significant unobservable inputs; (2) the inputs used in determining the fair value of equity per share; (3) the beneficial conversion feature on the convertible loans and (4) valuation allowance related to the Company’s deferred tax assets.

 

Property and equipment

Property and equipment are recorded at cost, net of accumulated depreciation and any accumulated impairment losses. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. The useful lives of property and equipment are five years for furniture and fixtures and three years for software.

 

Upon retirement or sale, the cost of disposed assets and their related accumulated depreciation are removed from the balance sheet. Any resulting net gains or losses on dispositions of property and equipment are included as a component of operating expenses within the Company’s statements of operating and comprehensive loss. Repair and maintenance costs that do not significantly add value to the property and equipment, or prolong its life, are charged to operating expense as incurred.

 

Deferred Offering Costs

Specific incremental legal, accounting and other fees and costs directly attributable to a proposed or actual offering of securities may properly be deferred and charged against the gross proceeds of such an offering. In the event the Company’s planned initial public offering did not occur or was significantly delayed, all of the costs would have been expensed. As of December 31, 2020, there were $946,912 of initial public offering costs, primarily consisting of legal, accounting and printing fees, that were capitalized and included in other non-current assets on the balance sheet. The costs deferred exclude any management and general and administrative expenses and only include costs that were related to the initial public offering. The deferred offering costs were charged against the gross proceeds of the initial public offering during the six months ended June 30, 2021.

 

Earnings per Share

Basic loss per common share is computed by dividing the net loss applicable to common shareholders by the weighted-average number of common shares outstanding during the year. Diluted loss per common share is computed similar to basic loss per share, except that the denominator is increased to include the number of additional potential common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Potential common shares are excluded from the computation for a period in which a net loss is reported or if their effect is anti-dilutive. The Company’s potential common shares consist of warrants, convertible promissory notes and convertible loans with their potential dilutive effect considered using the “if-converted” method. For the six months ended June 30, 2021, 5,409,746 common shares from warrants were excluded from the computation. For the year ended December 31, 2020, 50,205 shares related to convertible loans were excluded from the computation.

 

Segment Reporting

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on developing therapeutics for the treatment of neurobehavioral and neurocognitive disorders. All of the Company’s tangible assets are held outside the United States of America.

 

9

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

 

Note 3

Restatement of Previously Issued Financial Statements

 

During the audit of the Company’s financial statements for the year ended December 31, 2020, the Company identified an error in the presentation of the intellectual property expenses, including in the six months ended June 30, 2020. The intellectual property expenses should have been classified as general and administrative expenses instead of research and development expenses.

 

This resulted in a restatement to correct previously reported amounts in the financial statements of the Company for the six months ended June 30, 2020. This reclassification of expenses had no impact on total operating expenses, net loss, loss per share or the balance sheet.

 

The following table presents the impact of the restatement in the financial statements for the six months ended June 30, 2020:

 

    For the Six Months Ended
June 30, 2020
 
    As Previously
Reported
    Adjustments     As Restated  
                   
Research and development expenses   $ 160,751     $ (119,330 )   $ 41,421  
General and administrative expenses     920,943       119,330       1,040,273  
Total operating expenses   $ 1,081,694     $
-
    $ 1,081,694  

 

Note 4

Prepaid Expenses and Other Current Assets:

 

The Company’s prepaid expenses and other current assets consisted of the following as of June 30, 2021 and December 31, 2020:

 

    June 30,
2021
    December 31,
2020
 
             
Vendor prepayments   $ 29,909     $ 27,380  
VAT recoverable and other current assets     43,079       61,207  
Prepaid insurance     1,072,501      
-
 
Prepaid expenses     3,758       14,413  
                 
Total prepaid expenses and other current assets   $ 1,149,247     $ 103,000  

 

The Company’s prepaid expenses and other current assets as of June 30, 2021 and December 31, 2020, consisted mainly of some vendor prepayments and value added tax (“VAT”) recoverable, that were returned to the Company during the following fiscal periods.

 

10

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

Note 5

Property and Equipment, net:

 

The following table shows the property and equipment acquired during the six months ended June 30, 2021 and the year ended December 31, 2020:

 

    June 30,
2021
    December 31,
2020
 
    (unaudited)        
Cost            
Furniture and fixtures   $ 6,536     $
               -
 
Software     26,219      
-
 
Total cost     32,755      
-
 
Accumulated depreciation     (5,022 )    
-
 
                 
Total property and equipment, net   $ 27,733     $
-
 

 

Deprecation and related amortization expense was $5,022 for the six months ended June 30, 2021.

 

Note 6

Other Receivables, net – Related Party

 

The Company’s majority shareholders are also majority shareholders in Pegasus Advanced Research SAS, formerly NeuroLifeScienses SAS (“Pegasus”), and as such Pegasus is considered to be a related party to the Company. In December 2015, Pegasus assigned its exclusive global license to certain compounds involving mazindol to the Company (the “License Agreement”). The License Agreement includes a royalty payment of 1.8% of the annual net sales (including sales made by sub-licensees) of the licensed compounds covered thereunder; provided, however, that such royalty payment could be further reduced to 0.9% in the event that the U.S. Patent and Trademark Officer were to issue a revised notice of allowance or expand the patent rights of certain licensed compounds or be completely cancelled in the event that a competing generic product were to reach the market during the term of the patents covering such licensed compounds. 

 

Since assigning the License Agreement to the Company, the Company and Pegasus have paid for some operating expenses for each other. The transactions between the companies are minimal and are not considered to be a funding source for either entity. The Company offsets the related receivables and payable to/from Pegasus for a combined net other long-term receivable. As of June 30, 2021, the Company evaluated the financial stability of Pegasus and the likelihood of the Company’s recovering the receivable in the near future and determined that a 100% provision for doubtful accounts was required for the balance due of $77,714. This provision was recorded to general and administrative expenses in the statement of operations and comprehensive loss during the six months ended June 30, 3021. The net receivable was $67,954 for the year ended December 31, 2020.

 

Note 7

Convertible Promissory Notes – Related Parties:

 

The following summarizes the Company’s convertible promissory notes with related parties as of December 31, 2020.

 

    December 31,
2020
 
     
     
Convertible promissory notes   $ 591,693  

 

In January 2019, the Company entered into an agreement with Magnetic Rock Investment AG (“MRI”), which is owned by certain shareholders of the Company, to loan the Company CHF 550,000 ($557,920). The loan proceeds were received in advance of the agreement, in two payments, in each of August and December 2018 in the amount of CHF 500,000 ($507,200) and CHF 50,000 ($50,720), respectively. Management determined that no separate accounting or bifurcation was required for this conversion feature as it doesn’t meet the definition of a debenture because the net settlement criterion is not met. The note accrued interest at 10% per year and had a conversion feature such that upon a capital closing (as defined), MRI had the right to require conversion of its note to equity at the same rates as the capital closing. This note had an original maturity date of April 30, 2019 at which time if it wasn’t already converted, a new maturity date would be set at the discretion of MRI. The parties had amended the agreement to extend the maturity date to March 31, 2021. The Company had accrued interest payable of $42,929 for the note as of December 31, 2020.

 

11

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

In March 2019, MRI and the Company agreed to convert an aggregate amount of CHF 526,980 ($526,769) of its loan into 40,000 of the Company’s common shares at a conversion price of approximately $13 per share. The common shares had a fair value of approximately CHF 14 ($14) per share and an aggregate fair value of $550,829, resulting in a $24,060 loss on conversion of the loan. Pursuant to an amendment to this loan, the maturity of the then remaining loan of CHF 23,020 ($24,293) was extended to March 31, 2021. The Company determined that the extension of the loan which was past due or near maturity was in substance no different than issuing new financial instruments and accordingly, the Company did not recognize a gain or loss in connection with the extension.

 

In January 2019, the Company entered into four additional convertible promissory notes, on the same terms, with certain Company shareholders. The promissory notes were for CHF 125,000 ($128,200) each, accrued interest at 10% per year and had original maturity dates of the earlier of April 30, 2019 or when any investment into the Company of CHF 500,000 ($527,650) or greater occurs. The maturity of these notes was extended to March 31, 2021. The Company had accrued interest payable of $119,045 for the notes as of December 31, 2020.

In February 2021, all of the convertible promissory notes, including accrued interest, were repaid in full.

 

Note 8

Credit Facilities, Subordinated – Related Parties:

 

The following summarizes the Company’s credit facilities with related parties as of December 31, 2020.

 

    December 31,
2020
 
       
       
Second Credit Facility   $ 150,000  
      150,000  
Less: current portion     (150,000 )
Credit facilities, long-term   $
-
 

 

In August 2015, the Company entered into a second credit facility agreement (the “Second Credit Facility”) with shareholders (the “Lenders”). The maximum borrowings under the Second Credit Facility were $500,000. The Second Credit Facility had a maturity date of December 31, 2018 and accrued interest at 0%. As the Second Credit Facility did not accrue interest, management, upon issuance of the debt, recorded total debt discount and a corresponding increase in additional paid in capital based on an imputed interest at a rate of 12%. The debt discount was amortized to interest expense using the effective interest rate method over the debt term.

 

In June 2018, the Company and the Lenders entered into a subordination agreement regarding the Second Credit Facility. The subordination agreement deferred payments on the Second Credit Facility during the term of the agreement. The agreement was to expire if (i) the Lenders irrevocably waive the subordinated claims; or (ii) if the claims are converted to share capital or participation capital of the Company.

 

The remaining balance of the Second Credit Facility of $150,000 was amended, by the parties, covering such credit facility to extend the maturity date to March 31, 2021. Additionally, the accrued interest of $85,737 on an old expired credit facility remained unpaid and the parties amended that credit facility to extend the maturity date to March 31, 2021. The Company determined that the extension of these credit facilities which were past due or near maturity was in substance no different than issuing new financial instruments and accordingly, the Company did not recognize a gain or loss in connection with the extension.

 

In February 2021, the remaining balance on the Second Credit Facility and the accrued interest on an expired credit facility were paid in full.

 

Note 9

Convertible Loans:

 

The following summarizes the Company’s convertible loans as of December 31, 2020.

 

    December 31,
2020
 
       
       
Convertible loans, net of discount of $0 and $41,611   $ 383,313  
Convertible loans – related party     113,130  
      496,443  
Less: current portion     (463,980 )
         
Convertible loans, long term   $ 32,463  

 

12

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

In December 2019, the Company entered into two loans for a total of CHF210,000 ($216,846) (the “Convertible Loans”). In February, March and June 2020, the Company entered into five additional convertible loans, on terms similar to those in December 2019, including one with a related party, for a total of CHF 265,086 ($300,480). The Convertible Loans accrued interest at 10% and had a conversion feature such that the lender could choose to convert the loan to equity at any time up to the maturity date of August 31, 2021. The conversion rate of CHF 9 ($10) per common share was at a discount to the CHF 12 ($13) per common share fair value of the Company. The beneficial conversion feature valued at CHF 63,537 ($65,608) for the December 2019 convertible loans and CHF 37,779 ($49,011) for the 2020 convertible loans was recorded as a discount to the Convertible Loans. On the date of issuance, the beneficial conversion feature value was calculated as the difference between the conversion price and the fair value per share, multiplied by the number of common shares into which the Convertible Loans are convertible. The embedded conversion feature was not bifurcated as it did not meet all of the elements of a derivative. For the six months ended June 30, 2021, amortization of $41,611 was included in interest expense. The Company had accrued interest payable of $48,634 for the Convertible Loans as of December 31, 2020.

In February 2021, all of the Convertible Loans, including accrued interest, were repaid in full.

 

Note 10

Bridge Loan:

 

In August 2020, the Company received the first tranche of CHF 300,000 ($309,780) pursuant to a bridge loan (the “Bridge Loan”). Pursuant to the Bridge Loan, the Company could borrow up to an aggregate of CHF 500,000 ($516,300), or an additional CHF 200,000 ($206,520), upon successful filing of its registration statement on Form F-1, which occurred in August 2020. The total Bridge Loan of CHF 500,000 ($527,650) carried an interest rate of 10% annually and was initially due September 30, 2020 which was amended to December 31, 2020. In January 2021, the Bridge Loan was amended two additional times. The first of the two amendments extended the maturity date to March 31, 2021, and the second amendment increased the total amount of the Bridge Loan to CHF 600,000 ($633,180).

 

In February 2021, the Bridge Loan, including accrued interest, was repaid in full.

 

Note 11

Other Accrued Liabilities:

 

Other accrued liabilities consisted of the following as of June 30, 2021 and December 31, 2020:

 

    June 30,
2021
    December 31,
2020
 
    (unaudited)        
             
Professional consultants’ expenses   $ 327,114     $ 402,691  
Vendor liabilities     177,230       177,230  
Payroll related liabilities     70,242       13,990  
Related party expenses     63,859       56,842  
Accrued board fees     56,795      
-
 
                 
Total other accrued liabilities   $ 695,240     $ 650,753  

 

Note 12

Swiss Government Loan:

 

In April 2020, in response to the COVID 19 pandemic, the Swiss Federal Council issued the COVID-19 Ordinance on Joint and Several Guarantees, according to which companies domiciled in Switzerland that are economically affected by the COVID-19 pandemic could apply for financial support in the form of emergency bank loans of up to 10% of their 2019 revenues or a maximum of CHF 20 million (the “COVID-19 Loan”). This COVID-19 Loan was secured by the Swiss Confederation. The lending banks received collateral in the form of joint and several guarantees. The Company received a COVID-19 Loan from its bank for CHF 248,400 ($281,015), which carried a 0% interest rate and was due in 60 months. The loan could be drawn down over several installments and the Company had drawn down the entire amount. Pursuant to the terms of the COVID-19 Loan, the Company could not pay any dividends until it repays such loan in full.

In February 2021, the COVID-19 loan was repaid in full.

 

13

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

Note 13

Deferred Revenues:

 

In February 2019, the Company entered into a license agreement (the “EF License Agreement”), to develop and commercialize its product candidate, Nolazol, in Latin American countries with Eurofarma, a Brazilian pharmaceutical company. The EF License Agreement covers the grant of non-transferable licenses, without the right to sublicense, to Eurofarma to develop and commercialize Nolazol in Latin America. The EF License Agreement also specifies the Company’s obligation to advance ongoing development activities with respect to Nolazol in the United States. A joint steering committee will oversee the development and regulatory activities directed towards marketing approval, manufacturing and commercialization phases. The Company believes its participation in the joint steering committee is not of material significance to the licenses in the context of the EF License Agreement on the whole and, as such, management has excluded these activities in the determination of its performance obligation(s) under the EF License Agreement.

 

The EF License Agreement provides that the parties shall enter into a separate manufacturing and supply agreement during the term of the EF License Agreement.

 

Under the EF License Agreement, the Company received a non-refundable, upfront payment of $2,500,000 and is further eligible to receive non-refundable milestone payments of up to $16,000,000, based on the achievement of milestones related to regulatory filings, regulatory approvals and the commercialization of Nolazol. The achievement and timing of the milestones depend on the success of development, approval and sales progress, if any, of Nolazol in the future. In addition, the Company is also eligible for tiered royalty payments.

 

The Company identified the licenses granted to Eurofarma and its obligation to advance development activities with respect to Nolazol in the United States as the material promises under the EF License Agreement. For purposes of identifying the Company’s performance obligations under the EF License Agreement, management believes that while the exclusive licenses were granted to Eurofarma at the outset of the EF License Agreement, the grant of those licenses does not singularly result in the transfer of the Company’s broader obligation to Eurofarma under the EF License Agreement.

 

The Company is obligated under the EF License Agreement to advance its development activities in the United States and those activities precede Eurofarma’s necessary regulatory approvals for commercialization of Nolazol, in Latin American countries. The Company intends to apply its proprietary know-how to the ongoing development activities in the United States involving its intellectual property relating to Nolazol. These development activities are specific to the Company and the Company believes they are not capable of being distinct in the context of the EF License Agreement on the whole.

 

The licenses provided to Eurofarma are not transferable and without the right to sublicense therefore Eurofarma is not presently able to monetize its investment in Nolazol as clinical development in the United States or any Latin American countries has yet to be completed and Eurofarma has yet to seek or obtain regulatory approval in any Latin American country. The licenses to Eurofarma represent rights to use the Company’s intellectual property with respect to Nolazol for which revenue is recognized at a point in time which is when Eurofarma is able to use and benefit from the licenses. The licenses are considered of limited value without the Company’s development activities with respect to Nolazol in the United States. As such, the licenses are not capable of being distinct until after successful clinical development and regulatory approval and alone do not have standalone functionality to Eurofarma. Management has determined that the licenses, while capable of being distinct, are not distinct as they do not have stand-alone value to Eurofarma without the Company’s planned development activities in the United States and the approval for sale in Latin America.

 

Bundled together with the Company’s development activities of Nolazol in the United States, the licenses granted under the EF License Agreement will enable Eurofarma to seek regulatory approvals and ultimately seek to commercialize Nolazol in Latin America. Therefore, management believes the licenses bundled together with the Company’s development activities in the United States constitute a single distinct performance obligation under the EF License Agreement for accounting purposes, or (the “License Performance Obligation”).

 

The Company has initially estimated a total transaction price of $2,500,000, consisting of the fixed upfront payment determined to be an advance on the License Performance Obligation. Upon execution of the EF License Agreement and as of June 30, 2021, variable consideration consisting of milestone payments has been constrained and excluded from the transaction price given the significant uncertainty of achievement of the development and regulatory milestones.

 

The Company has allocated the transaction price entirely to the single License Performance Obligation and recorded the $2,500,000 as deferred revenue that is expected to be recognized upon Brazilian or other Latin American market approval or, in the event marketing approval in the United States and/or Latin America is not achieved, whether by failure in clinical development or otherwise, when the Company’s performance obligations are contractually complete or the EF License Agreement is terminated.

 

Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as a current portion of deferred revenue in the accompanying condensed balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. As of June 30, 2021 and December 31, 2020, the Company has long-term deferred revenues of $2,500,000, which will be recognized when the development services of Nolazol are completed and the product candidate receives applicable regulatory approval in Latin America that allows Eurofarma to commence commercialization of Nolazol in accordance with the EF License Agreement.

 

14

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

Note 14

Commitments and Contingencies:

 

Commitments

In December 2019, the Company entered into a feasibility development agreement (the “Development Agreement”) with Adare Pharmaceuticals, Inc. (“Adare”), pursuant to which the Company intended to utilize Adare’s proprietary modified release technologies in the development of Mazindol for use in the Company’s product candidates used for the treatment of narcolepsy and ADHD. The formulation to be developed by Adare under this Development Agreement was intended to be owned solely by the Company. Upon completion of certain milestones, as defined in the Development Agreement, the Company would be obligated to pay Adare up to $840,000. In January 2021, the Company and Adare agreed to terminate the Development Agreement, effective as of December 19, 2020. The project was never started and the Company has no liability to Adare.

 

On March 10, 2021, the Company entered into a License Agreement with Novartis Pharma AG (“Novartis”), whereby the Company obtained, on an exclusive basis in the U.S., all of the available data referred to and included in the original new drug application (“NDA”) for Sanorex® (mazindol) submitted to the U.S. Food and Drug Administration (“FDA”) in February 1972. The agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 onwards. Under the Agreement, the Company has obtained the same rights on a non-exclusive basis in all territories outside of the U.S. except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. The Agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations. As consideration for the license, the Company paid Novartis $250,000 upon the signing of the agreement with milestone payments due as follows: (i) $750,000 payable following the end of a Phase II meeting with the FDA, with the amount to be reduced to $375,000 if toxicology studies must be repeated; (ii) $2 million following the earlier of FDA marketing authorization of Quilience or Nolazol; (iii) 1% of any upfront and milestone payments, if any, from any sublicensees and (iv) $3 million as a one-time payment upon the Company’s product candidate reaching $250 million in cumulative sales.

 

Litigation

The Company may become involved in miscellaneous litigation and legal actions, including product liability, consumer, commercial, tax and governmental matters, which can arise from time to time in the ordinary course of the Company’s business. Litigation and legal actions are inherently unpredictable, and excessive verdicts can result in such situations. The Company is not currently involved in any such matters.

 

COVID-19

In December 2019, COVID-19 emerged in Wuhan, China. Since then, it has spread to several other countries and infections have been reported around the world. On March 11, 2020, the World Health Organization declared the outbreak of COVID-19 a global pandemic. In response to the outbreak, governmental authorities in the United States, Canada and internationally, including in Switzerland, have introduced various recommendations and measures to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, quarantines, self-isolations, shelters-in-place and social distancing. While COVID-19 is still spreading globally, and the final implications of the pandemic are difficult to estimate at this stage, it is clear that it has affected the lives of a large portion of the global population. At this time, the pandemic has caused states of emergency to be declared in various countries, travel restrictions imposed globally, quarantines established in certain jurisdictions and various institutions and companies being closed. We are actively monitoring any developments regarding the pandemic and we are taking any necessary measures to respond to the situation in cooperation with our various stakeholders. The continued spread of COVID-19 in the United States, Canada and globally, including in Switzerland, could have an adverse impact on the Company’s business, operations and financial results, including through disruptions in the Company’s supply chains, as well as a deterioration of general economic conditions including a possible national or global recession. Shelter-in-place orders and social distancing practices designed to limit the spread of COVID-19 may affect the Company’s ability to conduct clinical studies.

 

The Company has not been adversely affected from the effects of the COVID-19 outbreak, either from any delay in its clinical development activities nor by its ability to source necessary financing to fund its operations. In view of the continuing uncertainty about the further development of COVID-19, an adverse development can be expected in 2021, but its financial impact on the Company cannot yet to be adequately and conclusively assessed.

 

Note 15

Share Capital and Public Offerings:

 

As of June 30, 2021, the Company had 12,068,325 registered and issued common shares.

 

On February 2, 2021, the Company completed the closing of its initial public offering of 4,819,277 units at a price of $4.15 per unit. Each unit consisted of one common share and one Warrant. The common shares and Warrants were immediately separable from the units and were issued separately. The common shares and Warrants began trading on the Nasdaq Capital Market on January 29, 2021 under the symbols “NLSP” and “NLSPW,” respectively. The Company received net proceeds of $17 million, after deducting underwriting discounts and commissions and other estimated offering expenses. The Warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $4.15 per share. In addition, the Company granted the underwriters a 45-day option to purchase up to an additional 722,891 common shares and/or Warrants to purchase 722,891 common shares, of which the underwriters exercised the option to purchase warrants to purchase up to 722,891 common shares. These Warrants were issued in the Company’s initial public offering and therefore have the same exercise price of $4.15 per share. The Warrants were evaluated under ASC Topic 480, “Distinguishing Liabilities from Equity” and ASC Topic 815, “Derivatives and Hedging”, and the Company determined that equity classification was appropriate. The relative fair value of the Warrants issued of $6,438,791 was allocated from the total net proceeds of the common share issuance on a relative basis to the common shares and Warrants.

 

15

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

Additionally, the Company issued 144,578 Warrants to the underwriters as compensation at 3% of the total units sold on its initial public offering and these Warrants have an exercise price of $5.1875. These Warrants were also evaluated, and the Company determined that equity classification was appropriate. The fair value of these Warrants of $303,847 was deducted from the gross proceeds received in the initial public offering.

 

The following table summarizes the common share warrant activity for the six months ended June 30, 2021:

 

Balance at January 1, 2021  
-
 
Issuances     5,686,746  
Exercises     (277,000 )
Balance at June 30, 2021     5,409,746  

 

Note 16

Related party consulting agreements:

 

In October 2019, the Company entered into a collaboration agreement with Adya Consulting, a company founded and managed by the Company’s current Chief Operating Officer, Silvia Panigone. Pursuant to the collaboration agreement, the Company agreed to pay Adya Consulting a one-time fee of CHF 2,500 ($2,705) for due diligence activities as well as a success fee of 5% for raising funds. For the six months ended June 30, 2021 and 2020, the Company recorded fees to Adya Consulting of $82,830 included in research and development expenses and $103,553 included in general and administrative expenses, respectively, on the statement of operating and comprehensive loss. Effective May 1, 2021, Ms. Panigone has entered into an employment agreement with the Company.

 

In January 2017, and as subsequently amended in October 2020, the Company entered into a consulting agreement with CHG BioVenture SA, an entity controlled by Mr. Hervé Girsault, the Company’s current Head of Business Development. Pursuant to the consulting agreement, the Company agreed to pay CHG BioVenture SA a monthly fee of CHF 17,500, as well as an opportunity for a bonus of up to 15% of the annual fee, subject to the Company’s discretion. In addition, the Company has agreed to pay CHG BioVenture SA a 1% fee tied to the net proceeds actually received by the Company in certain transactions, such as, but not limited to, an M&A transaction. The consulting agreement may be terminated by either party for any reason at the end of each calendar quarter with three months’ prior written notice, or immediately if Mr. Girsault breaches the confidentiality provision. The consulting agreement also provides for a 24-month non-competition clause. The consulting agreement also provides for standard confidentiality provisions as well as reimbursement for certain expenses. For the six months ended June 30, 2021 and 2020, the Company recorded fees to CHG BioVenture SA of $82,331 and $145,314, respectively, included in general and administrative expenses on the statement of operating and comprehensive loss.

 

16

 

 

NLS PHARMACEUTICS LTD.

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

 

The Company has entered into a new consulting agreement starting May 1, 2021 for the continuation of Mr. Girsault’s engagement with the Company in his current role. Pursuant to the new agreements, the Company has agreed to pay CHG BioVenture SA a monthly fee CHF 4’375 ($4,733) plus 7.7% VAT for his services. In addition, CHG BioVenture SA is eligible for a 1% success fee payment in the event of closing of a partnering agreement in China.

 

In March 2021, the Company entered into a consulting agreement with Mr. Subhasis Roy, the Company’s current Interim Chief Financial Officer, pursuant to which the Company agreed to pay Mr. Roy a daily rate of CHF 2,000 for his services. The consulting agreement may be terminated by either party upon 30 days’ written notice or immediately by the Company in the event of a material breach by Mr. Roy that cannot be cured. The consulting agreement contains customary confidentiality provisions and provides for an 18-month non-solicitation clause. For the six months ended June 30, 2021, the Company recorded fees to Mr. Roy of $52,298, included in general and administrative expenses on the statement of operating and comprehensive loss. The Company has entered into a new consulting agreement starting July, 2021 for the continuation of Mr. Roy’s engagement with the Company in his current role.

 

In February 2021, the Company entered into a consulting agreement with Mr. Eric Konofal, the Company’s current Chief Scientific Officer, pursuant to which the Company agreed to pay Mr. Konofal a daily rate of CHF 2,000 for his services. The consulting agreement may be terminated by either party upon 30 days’ written notice or immediately by the Company in the event of a material breach by Mr. Konofal that cannot be cured. The consulting agreement contains customary confidentiality provisions and provides for an 18-month non-solicitation clause as well as reimbursement for certain expenses. For the six months ended June 30, 2021, the Company recorded fees to Mr. Konofal of $87,107, included in research and development expenses on the statement of operating and comprehensive loss. The Company has entered a new consulting agreement starting July 1, 2021 for the continuation of Mr. Konofal’s engagement with the Company in his current role.

 

In March 2021, the Company entered into a consulting agreement with Mr. Carlos Camozzi, the Company’s current Interim Medical Director, pursuant to which the Company agreed to pay Mr. Camozzi an hourly rate of CHF 230 plus 7.7% VAT for his services. The consulting agreement may be terminated by either party upon 30 days’ written notice or immediately by us in the event of a material breach by Mr. Camozzi that cannot be cured. The consulting agreement contains customary confidentiality provisions and provides for an 18-month non-solicitation clause as well as reimbursement for certain expenses. For the six months ended June 30, 2021, the Company recorded fees to Mr. Camozzi of $53,002, included in research and development expenses on the statement of operating and comprehensive loss.

 

Note 17

Subsequent Events:

 

Subsequent to the balance sheet date of these Unaudited Interim Condensed Financial Statements, the Company has entered into a Standby Equity Distribution Agreement (“SEDA”) with a fund managed by Yorkville Advisors Global, LP (“Yorkville”). Under the SEDA, Yorkville has committed to make an upfront investment of $2,500,000 and provide up to $20,000,000 in equity financing over a 36 month period in individual tranches. In exchange for the funds to be provided, Yorkville will receive shares of the Company at a price which will be determined anew each time a SEDA tranche is called.

 

 

17

 

 

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Exhibit 99.2

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis dated September 28, 2021 should be read in conjunction with our unaudited interim condensed financial statements and related notes as of and for the six months ended June 30, 2021, included as Exhibit 99.1 to this Report on Form 6-K. This discussion and other parts of the interim report contain forward-looking statements based upon current expectations that involve risks and uncertainties. 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 but not limited to those set forth under Item 3.D. “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2020 or the Annual Report on file with the Securities and Exchange Commission (the “SEC”).

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

 

Certain information included herein may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,” “should,” “intend,” “project” or other similar words, but are not the only way these statements are identified. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

 

Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things: 

 

the regulatory pathways that we may elect to utilize in seeking European Medicines Agency, or EMA, the U.S. Food and Drug Administration, or FDA, and other regulatory approvals;

 

the use of Quilience in a compassionate use program and the results thereof;

 

obtaining EMA and FDA approval of, or other regulatory action in Europe or the United States and elsewhere with respect to, Quilience, Nolazol or other product candidates that we may seek to develop;

 

the commercial launch and future sales of Quilience, Nolazol or any other future product candidates;

 

the dosage of Quilience and Nolazol;

 

our expectations regarding the timing of commencing further clinical trials, the process entailed in conducting each such trial, including dosages, and the order of such trials with each of our product candidates or whether such trials will be conducted at all;

 

improved convenience relating to the prescription of and use of Nolazol for prescribers and patients (and their parents);

 

our expectations regarding the supply of mazindol;

 

third-party payor reimbursement for Quilience and Nolazol;

 

our estimates regarding anticipated expenses, capital requirements and our needs for additional financing;

 

changes to the narcolepsy patient market size and market adoption of Quilience by physicians and patients;

 

the timing, cost, regulatory approvals or other aspects of the commercial launch of Quilience and Nolazol;

 

 

 

 

submission of a Marketing Authorization Application and New Drug Application, with the EMA and FDA for Quilience and Nolazol, respectively;

 

completion and receiving favorable results of clinical trials for Quilience and Nolazol;

 

the issuance of patents to us by the U.S. Patent and Trademark Office and other governmental patent agencies;

 

new issuances of orphan drug designations;

 

the development and approval of the use of mazindol for additional indications other than narcolepsy and attention deficit hyperactivity disorder, or ADHD;

 

the development and commercialization, if any, of any other product candidates that we may seek to develop;

 

the use of mazindol extended release, or ER, for treatment of additional indications other than narcolepsy and ADHD;

 

the ability of our management team to lead the development of our product candidates;

 

our expectations regarding licensing, acquisitions and strategic operations; and

 

our expectations regarding the impact of the COVID-19 pandemic, including on our planned clinical trials, operations and financial position.

 

The foregoing list is intended to identify only certain of the principal factors that could cause actual results to differ. For a more detailed description of the risks and uncertainties affecting our company, reference is made to our Annual Report which was filed with the SEC, on May 14, 2021, and the other risk factors discussed from time to time by our company in reports filed or furnished to the SEC.

 

Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

Unless otherwise indicated, “we,” “us,” “our,” the “Company” and “NLS” refer, prior to the Reorganization, as defined herein, to NLS-0 Pharma AG, or NLS-0, NLS-1 Pharma AG, or NLS-1, and NLS Pharma AG, or NLS Pharma, and, after the Reorganization, to NLS Pharmaceutics Ltd. and its wholly owned subsidiary, NLS Pharmaceutics Inc., a Delaware corporation.

 

NLS-1 and NLS Pharma were incorporated in June 2015 and NLS-0 was incorporated in April 2016, each in Switzerland. In March 2019, and pursuant to Swiss law, effective as of January 1, 2019, NLS-0 and NLS Pharma each merged with and into NLS-1. We refer to these transactions collectively as the “Reorganization.” As part of the Reorganization, all assets and liabilities of NLS-0 and NLS Pharma were transferred to NLS-1 by way of universal succession (pursuant to which, under Swiss law, assets and liabilities are transferred as a whole and in one act), and NLS-1 was renamed NLS Pharmaceutics Ltd.

 

Overview

 

We are a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, which have unmet medical needs. Our lead compound mazindol, in a proprietary ER formulation, is being developed for the treatment of narcolepsy (lead indication) and ADHD (follow-on indication), and is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist. We believe that this dual mechanism of action will also give mazindol ER the potential for therapeutic benefit in other rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders.

 

2

 

 

Prior to our initial public offering in the United States, we have primarily financed our operations through the proceeds from our private placements of debt and equity securities, an upfront payment from our collaboration partner and Swiss Government COVID-19 loan. We have no product candidates approved for commercialization and have never generated any revenue from product sales. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. It may be several years, if ever, before we complete pivotal clinical studies and have a product candidate approved for commercialization and we begin to generate revenues and royalties from product sales. We have also incurred significant operating losses. For the six months ended June 30, 2021, we have an accumulated deficit of $34.3 million.

 

On February 2, 2021, we completed our initial public offering of 4,819,277 units at a price of $4.15 per unit, raising $17 million in net proceeds. Each unit consisted of one common share and one warrant to purchase one common share, or the Warrants. The common shares and Warrants were immediately separable from the units and were issued separately. The common shares and Warrants began trading on the Nasdaq Capital Market on January 29, 2021 under the symbols “NLSP” and “NLSPW,” respectively.

 

Our financial statements have been presented on the basis that we are a going concern, which contemplates the realization of revenues and the satisfaction of liabilities in the normal course of business. We have incurred losses from the inception of our operations. These factors raise substantial doubt about our ability to continue as a going concern.

 

Components of Operating Results

 

Licensing Agreement

 

In February 2019, we entered into a license agreement with Eurofarma, or the EF License Agreement, to develop and commercialize our product candidate, Nolazol, in Latin American countries with Eurofarma. The EF License Agreement covers the grant of non-transferable licenses, without the right to sublicense, to Eurofarma to develop and commercialize Nolazol in Latin America. The EF License Agreement also specifies our obligation to advance development activities with respect to Nolazol in the United States. A joint steering committee will oversee the development and regulatory activities directed towards marketing approval, manufacturing and commercialization phases. We believe that our participation in the joint steering committee is not of material significance to the licenses in the context of the EF License Agreement on the whole and, as such, management has excluded these activities in the determination of its performance obligation(s) under the EF License Agreement. The EF License Agreement also provides that the parties shall enter into a separate manufacturing and supply agreement during the term of the EF License Agreement.

 

Under the EF License Agreement, we received a non-refundable, upfront payment, of $2,500,000 and are further eligible to receive nonrefundable milestone payments of up to $16,000,000, based on the achievement of milestones related to regulatory filings, regulatory approvals and the commercialization of Nolazol. The achievement and timing of the milestones depend on the success of development, approval and sales progress, if any, of Nolazol in the future. In addition, we are also eligible for tiered royalty payments.

 

Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as a current portion of deferred revenue in the balance sheets in our financial statements included elsewhere in this annual report. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. As of June 30, 2021 and December 31, 2020, we have long-term deferred revenues of $2,500,000, which will be recognized when the development services of Nolazol are completed and the product candidate receives applicable regulatory approval in Latin America that allows Eurofarma to commence commercialization of Nolazol in accordance with the EF License Agreement.

 

3

 

 

Critical Accounting Policies

 

We describe our significant accounting policies more fully in Note 2 to our unaudited interim condensed financial statements included elsewhere in this report. We believe that the accounting policies described below and in Note 2 are critical in order to fully understand and evaluate our financial condition and results of operations.

 

We prepare our financial statements in accordance with U.S. GAAP. At the time of the preparation of the financial statements, our management is required to use estimates, evaluations, and assumptions which affect the application of the accounting policy and the amounts reported for assets, obligations, income, and expenses. Any estimates and assumptions are continually reviewed. The changes to the accounting estimates are credited during the period in which the change to the estimate is made.

 

Revenue Recognition

 

As of June 30, 2021, we have not recognized any revenue from the EF License Agreement as the upfront payment we received has been deferred. The EF License Agreement provides for the development and commercialization of our product candidate, Nolazol, in Latin American countries with Eurofarma. The EF License Agreement is within the scope of Accounting Standards Codification, or ASC, 606, “Revenue from Contract with Customers,” or ASC 606.

 

Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, we perform the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that the entity will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer.

 

Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer and are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, we consider factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on its own or whether the required expertise is readily available and whether the goods or services are integral or dependent to other goods or services in the contract.

 

We estimate the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration. At the inception of each arrangement that includes variable consideration, we evaluate the amount of potential payments and the likelihood that the payments will be received. We utilize either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration which is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.

 

4

 

 

We allocate the transaction price based on the estimated stand-alone selling price of each of the performance obligations. We must develop assumptions that require judgement to determine the stand-alone selling price for each performance obligation identified in a contract with a customer. We utilize key assumptions to determine the stand-alone selling price for service obligations, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs. Additionally, in determining the stand-alone selling price for material rights, we may reference comparable transactions, clinical trial success probabilities, and develop estimates of option exercise likelihood. Any variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated are consistent with the amounts we would expect to receive for the satisfaction of each performance obligation.

 

The consideration allocated to each performance obligation is recognized as revenue when control is transferred for the related goods or services. For performance obligations which consist of licenses and other promises, we utilize judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. We evaluate the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

 

Development and regulatory milestone payments are assessed under the most likely amount method and constrained if it is probable that a significant revenue reversal would occur. Milestone payments that are not within our control or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license revenues in the period of adjustment. To date, we have not recognized any consideration related to the achievement of development, regulatory, or commercial milestone revenue resulting from the EF License Agreement.

 

For revenue related to sales-based royalties received from licensees, including milestone payments based on the level of sales, where the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, we have not recognized any consideration related to sales-based royalty revenue resulting from any of our license agreement.

 

To the extent we receive payments, including non-refundable payments, in excess of the recognized revenue such excess is recorded as deferred revenue until we perform our obligations under these arrangements. Amounts are recorded as accounts receivable when our right to consideration is unconditional.

 

Pension Obligations

 

We have a single insurance collective pension plan that is fully insured and operated by an insurance company which covers the employee. Both we and the participants provide monthly contributions to the pension plan that are based on the covered salary. A portion of the pension contribution is credited to employees’ savings accounts which earns interest at the rate provided in the plan. The pension plan provides for retirement benefits as well as benefits on long-term disability and death. The pension plan qualifies as a defined benefit plan in accordance with U.S. GAAP. As such, the cost of the defined pension arrangement is determined based on actuarial valuations. An actuarial valuation assumes the estimation of discount rates, estimated returns on assets, future salary increases, mortality figures and future pension increases. Because of the long-term nature of these pension plans, the valuation of these is subject to uncertainties.

 

5

 

 

Income Taxation

 

We incur tax loss carryforwards generating deferred tax assets against which a valuation allowance is recorded when it is not more likely than not that the tax benefit can be realized. Significant judgement is required in determining the use of tax loss carryforwards. Management’s current judgment is that it is not more likely than not that the tax benefits can be realized and a full valuation allowance is therefore recognized.

 

Operating Expenses Overview

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the related notes included in our Annual Report, as well as our unaudited interim condensed financial statements and the related notes thereto for the six months ended June 30, 2021, included elsewhere in this Report on Form 6-K. The discussion below contains forward-looking statements that are based upon our current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from these expectations due to inaccurate assumptions and known or unknown risks and uncertainties.

 

The following financial data in this narrative are expressed in thousands of U.S. dollars, except for share and per share data or as otherwise noted.

 

Our current operating expenses consist of two components – research and development expenses and general and administrative expenses.

 

Research and Development Expenses

 

Our research and development expenses are expensed as incurred and consist primarily of, costs of third-party clinical consultants who conduct clinical and pre-clinical trials on our behalf as well as expenses related to lab supplies, materials and facility costs.

 

Clinical trial costs are a major component of research and development expenses. We accrue and expense clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. We determine the actual costs through monitoring patient enrollment and discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.

 

Our investment in research and development activities, including the clinical development of our product candidates has historically been and is projected to be substantially the majority of our total annual operating costs. Research and development expenses represent costs incurred to conduct research, such as the development of our product candidates, as well as discovery and development of new product candidates.

 

We expect that our research and development expenses will materially increase in the future as we enter into the Phase 2/3 clinical development stage of our product candidates and initiate a number of new research initiatives that are complementary to our existing and planned research initiatives and thereby recruit additional research and development employees.

 

General and Administrative Expenses

 

General and administrative expenses include payroll costs, expenses for outside professional services, and all other general and administrative expenses. Payroll costs consist of salaries, cash bonuses and benefits. Outside professional services consist of legal fees (including intellectual property and corporate matters), accounting and audit services, IT and other consulting fees. Other general and administrative expenses consist of insurances, investor and public relations and being public costs.

 

Finance Result, net

 

Other expenses include exchange rate differences and financial expenses related to credit card fees.

 

Interest expense relates to interest paid for our financing obligations.

 

6

 

 

Taxation

 

NLS Pharmaceutics is subject to corporate Swiss federal, cantonal and communal taxation, respectively in Switzerland, Canton of Nidwalden.

 

We are entitled under Swiss laws to carry forward any losses incurred for a period of seven years and can offset our losses carried forward against future taxes. As of June 30, 2021, we had tax loss carryforwards totaling $20.8 million. There is no certainty that we will make sufficient profits to be able to utilize these tax loss carryforwards in full. As such, we have recorded a 100% valuation on these tax loss carryforwards.

 

The effective corporate income tax rate (federal, cantonal and communal) where we are domiciled is currently 12%.

 

Notwithstanding the corporate income tax, the corporate capital is taxed at a rate of 0.1% (cantonal and communal tax only, as there is no federal tax on capital).

 

Value Added Tax, or VAT, is charged on all qualifying goods and services by VAT-registered businesses. An amount of 7.7% of the value of the goods or services is added to all sales invoices and is payable to the Swiss tax authorities. Similarly, VAT paid on purchase invoices is reclaimable from the Swiss tax authorities.

 

Results of Operations

 

The numbers below have been derived from our unaudited interim condensed financial statements included elsewhere in this Report on Form 6-K. The discussion below should be read along with these financial statements and it is qualified in its entirety by reference to them.

 

Comparison of the Six Months Ended June 30, 2021 and 2020

 

    For the Six Months Ended
June 30,
 
    2021     2020  
Research and development expenses   $ 1,862,735     $ 41,421  
General and administrative expenses     2,680,018       1,040,273  
Operating loss     (4,542,753 )     (1,081,694 )
Other income (expense), net     7,544       (62,193 )
Interest expense     (48,099 )     (37,094 )
Interest on related party loans     (20,034 )     (51,235 )
Net loss   $ (4,603,342 )   $ (1,232,216 )

 

Comparative figures for the six months ended June 30, 2020 were restated to correct the classification error of intellectual property expenses between research and development expenses and general and administrative expenses. For further information, see Note 3 “Restatement of Previously Issued Financial Statements” to the unaudited interim condensed financial statements.

 

Research and Development Expenses

 

Research and development activities are essential to our business, except for 2020 where we paused most of our research and development activities pending completion of our initial public offering. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using information from the clinical sites and our vendors. In addition to these arrangements, we expect that our total future research and development costs will increase over current levels in line with strategy to progress the development of our product candidates, as well as discovery and development of new product candidates.

 

7

 

 

The following table summarizes our research and development expenses during the six months ended June 30, 2021 and 2020:

 

    For the Six Months Ended
June 30,
 
    2021     2020  
             
Research and development services   $ 1,389,974     $ 32,755  
Development materials and services     263,402       8,666  
Consultants’ fees     209,359       -  
Total   $ 1,862,735     $ 41,421  

 

Our research and development expenses totaled $1,862,735 for the six months ended June 30, 2021, representing an increase of $1,821,314, or 4,397%, compared to $41,421 for the six months ended June 30, 2020. The increase in expenses was attributable to our initiation of activities related to the preparation of our upcoming Phase 2 clinical study in narcolepsy, including production of drug products for the clinical study, engagement of a clinical research organization to conduct the clinical study, preparation of documents for regulatory submission for seeking study approval as well as initiation of pre-clinical studies for the follow-on products in our pipeline.

 

General and Administrative Expenses

 

Our general and administrative expenses totaled $2,680,018 for the six months ended June 30, 2021, representing an increase of $1,639,745, or 158%, compared to $1,040,273 for the six months ended June 30, 2020. The increase was attributable to payroll costs associated with hiring of additional management and key employees, insurance costs related to D&O insurance coverage for members of board and management, provision for doubtful accounts, costs of filing and maintenance of our new and existing patents and costs related to marketing and investor relations activities following the Company’s initial public offering listing on Nasdaq.

 

Operating Loss

 

As a result of the foregoing, our operating loss totaled $4,542,753 for the six months ended June 30, 2021, representing an increase of $3,461,059, or 320%, compared to $1,081,694 for the six months ended June 30, 2020.

 

Other Income (Expense), net

 

Other income (expense) consists of exchange rate differences and financial expenses related to our credit card fees. We recognized other income of $7,544 for the six months ended June 30, 2021, representing an increase of $69,737, or 112%, compared to other expense of $62,193 for the six months ended June 30, 2020. The increase was primarily attributable to favorable exchange rate differences.

 

Interest Expense

 

Interest expense consists of interest and imputed interest expenses on certain previously outstanding convertible loans. Interest expense was $48,099, including $41,611 of amortization of debt discount, for the six months ended June 30, 2021 representing an increase of $11,005, or 30%, compared to $37,094, including $21,261 of imputed interest, for the six months ended June 30, 2020. The increase was due to additional amortization of the debt discount on the Convertible Loans as the debt discount was amortized in full as the convertible loans were repaid during the six months ended June 30, 2021.

 

Interest on Related Party Loans

 

Interest on related party loans was $20,034, for the six months ended June 30, 2021, representing a decrease of $31,201, or 61%, compared to $51,235, including $15,403 of imputed interest, for the six months ended June 30, 2020. This decrease was due to the repayment of all loans and debts in February 2021.

 

8

 

 

Net Loss

 

As a result of the foregoing, our net loss totaled $4,603,342 for the six months ended June 30, 2021, representing an increase of $3,371,126, or 274%, compared to $1,232,216 for the six months ended June 30, 2020.

 

Liquidity and Capital Resources

 

Overview

 

Since our inception through June 30, 2021, we have funded our operations principally with net proceeds of $17,744,207 from our initial public offering and $21,964,282 from the sales of our common shares and warrant exercises, convertible instruments, related party credit facilities and shareholder loans, a Swiss government loan and the EF License Agreement. As of June 30, 2021, we had $7,092,115 in cash and cash equivalents.

 

The table below summarizes our cash flows for the six months ended June 30, 2021 and 2020:

 

    For the Six Months Ended
June 30,
 
    2021     2020  
             
Net cash used in operating activities   $ (9,733,335 )   $ (532,924 )
Net cash used in investing activities     (32,755 )     -  
Net cash provided by financing activities     16,789,238       439,563  
Effect of exchange rate changes on cash and cash equivalents     (24,744 )     18,498  
                 
Net increase (decrease) in cash and cash equivalents   $ (6,998,404 )   $ (74,863 )

 

Operating Activities

 

Net cash used in operating activities was $9,733,335 for the six months ended June 30, 2021, compared with net cash used in operating activities of $532,924 for the six months ended June 30, 2020. The change in cash used in operating activities for the six months ended June 30, 2021 was due to the Company’s reporting a net loss of $4,603,342 for the six months ended June 30, 2021, compared with a net loss of $1,232,216 for the same period in 2020, driven by (i) a $1,800,000 increase in R&D costs for the six months ended June 30, 2021 and (ii) a $1,500,000 increase in payroll and general and administrative expenses for the six months ended June 30, 2021. Additionally, during the six months ended June 30, 2021, we paid $3,479,270 of accounts payable and $313,342 of accrued interest.

 

Investing Activities

 

Net cash used in investing activities of $32,755 during the six months ended June 30, 2021 was related to furniture and software purchases.

 

Financing Activities

 

Net cash provided by financing activities of $16,789,238 for the six months ended June 30, 2021, consisted of $17,744,207 of net proceeds from completion of the initial public offering, including common shares and warrants, $1,149,531 from warrant exercises and $108,610 in proceeds on the bridge loan. These proceeds were offset, in part, by payments in full on the Swiss government COVID-19 loan, the Second Credit Facility (as defined below), the convertible loans, the bridge loan and shareholder loans for a total of $2,104,500. Net cash provided by financing activities of $439,563 for the six months ended June 30, 2020, consisted of $279,745 of net proceeds from the issuance of convertible loans, including one with a related party for $105,530 and $262,137 of net proceeds from the Swiss Government COVID-19 loan, offset in part, by $102,319 of deferred offering costs relating to our initial public offering.

 

In January 2019, we issued four promissory notes, or the Notes, each for CHF 125,000 (approximately $128,200), with the Shareholders (as defined below). Each Note carried an interest rate of 10% per year, compounded annually and originally matured as of the earlier of (i) April 30, 2019 and (ii) five days following such time as we have received aggregate financing, in a sole or series of transactions, exceeding CHF 500,000 (approximately $565,650) in the form of straight equity or convertible instrument investments or other means of proceeds from third parties. Pursuant to amendments to each of the Notes, the maturity dates were extended to March 31, 2021.

 

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In August 2015, NLS Pharma Ltd. and NLS-1 Ltd., and in March 2017, NLS-0 Ltd., each entered into credit facilities providing the Company with credit lines of $150,000 (non-interest bearing), $7.1 million ($500,000 of which bears interest at an annual rate of 10%, or the Interest-Bearing Facility) and approximately $3.44 million (non-interest bearing), respectively, or the NLS Pharma Credit Facility, the NLS-1 Credit Facility and the NLS-0 Credit Facility, respectively.

 

In March 2017, we entered into a certain interest-free $2 million bridge loan, or the 2017 Bridge Loan, with the Shareholders.

 

On July 19, 2018, we issued 260,000 common shares to the shareholders, in connection with a partial conversion of $3,418,520 borrowed by us pursuant to the NLS-1 Credit Facility, at a conversion price of $13.00 per common share.

 

On March 12, 2019, simultaneously with the closing of the Reorganization, we issued an aggregate of 260,000 of our common shares to certain shareholders, specifically Messrs. Hafner, Bauer, Stein and Ödman, or the Shareholders, in exchange for the consideration of the conversion of the entire Bridge Loan and the entire borrowed amount of $1.45 million under the NLS-0 Credit Facility, at a conversion price of $13.00 per common share.

 

On March 12, 2019, we conducted the Reorganization. In connection therewith, in addition to those 260,000 common shares issued in connection with the 2017 Bridge Loan and the NLS-0 Credit Facility, we issued:

 

  an aggregate of 280,000 of our common shares to the Shareholders, in connection with the conversion of the remaining $3,681,481 borrowed by us pursuant to the NLS-1 Credit Facility, at a conversion price of $13.00 per common share;

 

  an aggregate of 40,000 of our common shares to Magnetic Rock Investment AG, or Magnetic Rock, a company that is controlled by the Shareholders, in connection with the conversion of the CHF 526,979.84 (approximately $526,769) Convertible Note at a conversion price of CHF 13 (approximately $13.00) per common share; and

 

  an aggregate of 745,000 of our common shares to those holders of NLS-0 and NLS Pharma common shares.

 

On September 16, 2019, we and the Shareholders amended the NLS Pharma Credit Facility to extend the maturity date to December 31, 2019. If we defaulted on the NLS Pharma Credit Facility, we would have been subject to a default interest rate of 5% per year. The Interest-Bearing Facility stopped accruing interest upon the Reorganization and the accrued interest stood at $85,737. The NLS-1 Credit Facility was amended to extend the maturity date covering the Interest-Bearing Facility to March 31, 2021.

 

On December 23, 2019 and in February, March and June 2020, we entered into certain convertible loans, or the Convertible Loans, one of which was with our Chief Executive Officer, in the aggregate amount of CHF 475,822 (approximately $517,326). Each Convertible Loan carried an interest rate of 10% per year, compounded annually and was scheduled to mature between June 30, 2020 and January 31, 2022, unless converted into common shares or repaid by us prior to then. If we defaulted on the Convertible Loans, we would have been subject to a default interest rate of 15% per year. During October 2020, we amended two Convertible Loans entered into during December 2019, in the aggregate amount of CHF 210,000 ($237,573), such that our optional early repayment date of the Convertible Loans has been delayed by six months, or the Convertible Loan Amendment.

 

On March 26, 2020, in response to the COVID-19 pandemic, we applied for and thereafter received a COVID-19 loan, or the COVID-19 Loan from our bank for CHF 248,400 ($262,137), with 0% interest and a term of 60 months. We have drawn down the entire amount available to us under the COVID-19 Loan.

 

In August 2020, and as subsequently amended, we entered into a certain bridge loan, or the 2020 Bridge Loan, which provided for up to CHF 600,000 ($633,180). In August 2020, we received the first tranche of CHF 300,000 ($339,390) pursuant to the 2020 Bridge Loan and received the second tranche of CHF 200,000 ($226,260) in September 2020.

 

In January 2021, we amended the 2020 Bridge Loan to an aggregate amount of CHF 600,000 and received the remaining portion of the loan. The borrowed amounts under this 2020 Bridge Loan carried an interest rate of 10% per year, compounded annually, and all borrowed sums, including interest, were scheduled to mature on March 31, 2021; provided, however, that we could repay such loan, including interest, prior to the scheduled maturity date.

 

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On February 2, 2021, we completed the closing of our initial public offering of 4,819,277 units at a price of $4.15 per unit. Each unit consisted of one common share and one Warrant to purchase one common share. The common shares and Warrants were immediately separable from the units and were issued separately. The common shares and Warrants began trading on the Nasdaq Capital Market on January 29, 2021 under the symbols “NLSP” and “NLSPW,” respectively. We received net proceeds of $17 million, after deducting underwriting discounts and commissions and other estimated offering expenses. The Warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $4.15 per share. In addition, we granted the underwriters a 45-day option to purchase up to an additional 722,891 common shares and/or Warrants to purchase 722,891 common shares, of which the underwriters exercised the option to purchase warrants to purchase up to 722,891 shares of common shares.

 

In February 2021, we repaid all outstanding loans and notes in full, including accrued interest.

 

Current Outlook

 

We have financed our operations to date primarily through proceeds from sales of our common shares and Warrants, convertible instruments, related party credit facilities and shareholder loans, the COVID-19 Loan and the EF License Agreement. In February 2021, we completed the closing of our initial public offering raising $17 million in net proceeds. We have incurred losses and generated negative cash flows from operations since inception in 2015. To date we have not generated revenues, and we do not expect to generate any significant revenue from the sale of our product candidates in the near future.

 

We expect to generate losses for the foreseeable future, and these losses could increase as we continue product development until we successfully achieve regulatory approvals for our product candidates and begin to commercialize any approved products. We are subject to all the risks pertinent to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We expect to incur additional costs associated with operating as a public company and we anticipate that we will need substantial additional funding in connection with our continuing operations. If we need to raise additional capital to fund our operations and complete our ongoing and planned clinical studies, funding may not be available to us on acceptable terms, or at all.

 

As of June 30, 2021, our cash and cash equivalents were $7.1 million. We believe that our existing cash and cash equivalents will be sufficient to fund our projected operating requirements into the second quarter of 2022. These conditions raise substantial doubt about our ability to continue as a going concern for one year from the issuance of these financial statements. Additionally, our operating plans may change as a result of many factors that may currently be unknown to us including:

 

  the length of the COVID-19 pandemic and its impact on our planned clinical trials, operations and financial condition;

 

  the progress and costs of our pre-clinical studies, clinical trials and other research and development activities;

 

  the scope, prioritization and number of our clinical trials and other research and development programs;

 

  any cost that we may incur under in- and out-licensing arrangements relating to our product candidate that we may enter into in the future;

 

  the costs and timing of obtaining regulatory approval for our product candidates;

 

  the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

 

  the costs of, and timing for, strengthening our manufacturing agreements for production of sufficient clinical and commercial quantities of our product candidates;

 

  the potential costs of contracting with third parties to provide marketing and distribution services for us or for building such capacities internally; and

 

  the costs of acquiring or undertaking the development and commercialization efforts for additional, future therapeutic applications of our product candidates and the magnitude of our general and administrative expenses.

 

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As a result, we may require additional capital to finance expenditures related to the manufacture of our product candidates for use in clinical trials, conducting clinical trials and general and administration costs.

 

Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through our existing cash, cash equivalents and short-term deposits, including the remaining net proceeds from our initial public offering, loans, debt or equity financings, or by out-licensing applications of our product candidates. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of our product candidates.

 

Off-Balance Sheet Arrangements

 

Except for standard operating leases, we have not engaged in any off-balance sheet arrangements, such as the use of unconsolidated subsidiaries, structured finance, special purpose entities or variable interest entities.

 

We do not believe that our off-balance sheet arrangements and commitments have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

 

Quantitative and Qualitative Disclosure About Market Risk

 

We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our current investment policy is to invest available cash in bank deposits with banks that have a credit rating of at least A-. Accordingly, a substantial majority of our cash and cash equivalents is held in deposits that bear interest. Given the current low rates of interest we receive, we will not be adversely affected if such rates are reduced. Our market risk exposure is primarily a result of foreign currency exchange rates, which is discussed in detail in the following paragraph.

 

Foreign Currency Exchange Risk

 

Our results of operations and cash flow are subject to fluctuations due to changes in foreign currency exchange rates. The vast majority of our liquid assets is held in U.S. dollars, and a certain portion of our expenses are denominated in CHF or EUR. For instance, during the six months ended June 30, 2021, approximately 36% of our expenses were denominated in CHF and 21% in EUR, respectively. Changes of 5% and 10% in the U.S. dollar/CHF exchange rate would have increased/decreased our operating expenses by 2% and 4%, respectively. However, these historical figures may not be indicative of future exposure, as we expect that the percentage of our CHF denominated expenses will materially decrease in the near future, therefore reducing our exposure to exchange rate fluctuations.

 

We do not hedge our foreign currency exchange risk. In the future, we may enter into formal currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations.

 

JOBS Act Accounting Election

 

Under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, an emerging growth company, or an EGC, can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected to avail ourselves of this exemption from new or revised accounting standards, and, therefore, will not be subject to the same new or revised accounting standards as public companies that are not EGCs.

 

 

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