UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

 

☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the quarterly period ended: September 30, 20222023

 

OR

 

☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the transition period from ___ to ___

Commission File Number 001-38286

ENVERIC BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware 95-4484725

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

 

4851 Tamiami Trail N, Suite 200

Naples, FL

 34103
(Address of principal executive offices) (Zip code)

 

(239)302-1707

(Registrant’s telephone number, including area code)

(239)302-1707
(Registrant’s telephone number, including area code)

 

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

 

Title of Each Class Trading Symbol(s) Name of each exchange on which registered
Common Stock, $0.01 par value per share ENVB The Nasdaq Stock Market LLC

 

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

 

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

 

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

 

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

 

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

 

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

 

As of November 11, 2022,9, 2023, there were 2,078,2712,321,315 shares outstanding of Registrant’s Common Stock (par value $0.01 per share).

 

 

 

 

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

 

FORM 10-Q

 

TABLE OF CONTENTS

 

  Page
 PART I - FINANCIAL INFORMATION 
Item 1.Financial Statements 
 Condensed Consolidated Balance Sheets as of September 30, 20222023 (Unaudited) and December 31, 2021202221
 Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 20222023 and 2021202232
 Unaudited Condensed Consolidated Statements of Changes in Stockholders’Mezzanine Equity and Shareholders’ Equity for the three and nine months ended September 30, 20222023 and 202120224-53
 Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 20222023 and 2021202265
 Notes to Unaudited Condensed Consolidated Financial Statements76
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2321
Item 3.Quantitative and Qualitative Disclosures About Market Risk3329
Item 4.Controls and Procedures3429
   
 PART II - OTHER INFORMATION 
Item 1.Legal Proceedings3530
Item 1A.Risk Factors3530
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds3630
Item 3.Defaults Upon Senior Securities3630
Item 4.Mine Safety Disclosures3630
Item 5.Other Information3630
Item 6.Exhibits3731
 Signatures3932

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

  September 30, 2023  December 31, 2022 
  (unaudited)    
ASSETS        
Current assets:        
Cash $4,266,568  $17,723,884 
Prepaid expenses and other current assets  1,560,354   708,053 
Total current assets  5,826,922   18,431,937 
         
Other assets:        
Property and equipment, net  539,152   677,485 
Right-of-use operating lease asset  —   63,817 
Intangible assets, net  253,120   379,686 
Total other assets  792,272   1,120,988 
Total assets $6,619,194  $19,552,925 
         
LIABILITIES, MEZZANINE EQUITY, AND SHAREHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $1,098,233  $463,275 
Accrued liabilities  1,533,829   1,705,655 
Current portion of right-of-use operating lease obligation  —   63,820 
Investment option liability  1,250,929   851,008 
Warrant liability  300,557   185,215 
Derivative liability  —   727,000 
Total current liabilities $4,183,548  $3,995,973 
         
Commitments and contingencies (Note 9)  -   - 
         
Mezzanine equity        
Series C redeemable preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022  —   — 
Redeemable non-controlling interest  —   885,028 
Total mezzanine equity  —   885,028 
         
Shareholders’ equity        
Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022  —   — 
Common stock, $0.01 par value, 100,000,000 shares authorized, 2,181,912 and 2,078,271 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively  21,818   20,782 
Additional paid-in capital  96,013,029   94,395,662 
Accumulated deficit  (93,063,582)  (79,207,786)
Accumulated other comprehensive loss  (535,619)  (536,734)
Total shareholders’ equity  2,435,646   14,671,924 
Total liabilities, mezzanine equity, and shareholders’ equity $6,619,194  $19,552,925 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

1

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETSSTATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 

  September 30, 2022  December 31, 2021 
  (unaudited)    
ASSETS        
Current assets:        
Cash $21,201,005  $17,355,999 
Prepaid expenses and other current assets  1,065,795   380,838 
Total current assets  22,266,800   17,736,837 
         
Other assets:        
Property and equipment, net  712,944   294,430 
Right-of-use operating lease asset  88,768   176,304 
Intangible assets, net  6,318,509   6,923,928 
Goodwill  1,468,389   1,587,634 
Total other assets  8,588,610   8,982,296 
Total assets $30,855,410  $26,719,133 
         
LIABILITIES AND SHAREHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $710,314  $683,393 
Accrued liabilities  1,113,145   1,292,721 
Current portion of right-of-use operating lease obligation  88,769   107,442 
Derivative liability  686,000   — 
Total current liabilities  2,598,228   2,083,556 
         
Non-current liabilities:        
Non-current portion of right-of-use operating lease obligation  —   68,861 
Deferred tax liability  1,486,413   1,607,122 
Investment option liability  2,514,112   — 
Warrant liability  654,937   653,674 
Total non-current liabilities  4,655,462   2,329,657 
Total liabilities $7,253,690  $4,413,213 
         
Commitments and contingencies (Note 7)  -    -  
         
Mezzanine equity        
Redeemable non-controlling interest  761,434   — 
Total mezzanine equity  761,434   — 
         
Shareholders’ equity        
Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021  —   — 
Common stock, $0.01 par value, 100,000,000 shares authorized, 2,078,271 and 651,921 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively  20,782   6,519 
Additional paid-in capital  93,989,885   83,066,656 
Accumulated deficit  (70,529,884)  (60,736,453)
Accumulated other comprehensive loss  (640,497)  (30,802)
Total shareholders’ equity  22,840,286   22,305,920 
Total liabilities, mezzanine equity, and shareholders’ equity $30,855,410  $26,719,133 
  2023  2022  2023  2022 
  For the Three Months Ended September 30,  For the Nine Months Ended September 30, 
  2023  2022  2023  2022 
Operating expenses                
General and administrative $2,010,349  $3,514,547  $7,921,340  $8,783,619 
Research and development  1,351,750   2,055,656   5,883,440   6,134,421 
Depreciation and amortization  86,296   86,646   259,300   241,413 
Total operating expenses  3,448,395   5,656,849   14,064,080   15,159,453 
                 
Loss from operations  (3,448,395)  (5,656,849)  (14,064,080)  (15,159,453)
                 
Other income (expense)                
Change in fair value of warrant liabilities  67,822   1,599,623   (115,342)  3,845,514 
Change in fair value of investment option liability  562,715   1,809,622   (399,921)  1,809,622 
Change in fair value of derivative liability  —   (231,000)  727,000   (284,000)
Interest income (expense)  2,237   (308)  3,142   (5,114)
Total other income  632,774   3,177,937   214,879   5,366,022 
                 
Net loss before income taxes  (2,815,621)  (2,478,912)  (13,849,201)  (9,793,431)
                 
Income tax expense  (6,595)  —   (6,595)  — 
                 
Net loss  (2,822,216)  (2,478,912)  (13,855,796)  (9,793,431)
Less preferred dividends attributable to non-controlling interest  —   12,603   19,041   20,411 
Less deemed dividends attributable to accretion of embedded derivative at redemption value  —   110,991   147,988   184,985 
Net loss attributable to shareholders  (2,822,216)  (2,602,506)  (14,022,825)  (9,998,827)
                 
Other comprehensive loss                
Foreign currency translation  10,433   (417,390)  1,115   (609,695)
                 
Comprehensive loss $(2,811,783) $(3,019,896) $(14,021,710) $(10,608,522)
                 
Net loss per share - basic and diluted $(1.30) $(1.46) $(6.62) $(8.11)
                 
Weighted average shares outstanding, basic and diluted  2,164,656   1,787,235   2,117,153   1,232,936 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

2

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSCHANGES IN MEZZANINE EQUITY AND COMPREHENSIVE LOSSSHAREHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

 

  2022  2021  2022  2021 
  For the Three Months Ended
September 30,		  For the Nine Months Ended
September 30,		 
  2022  2021  2022  2021 
Operating expenses                
General and administrative $3,514,547  $2,123,834  $8,783,619  $10,864,696 
Research and development  2,055,656   1,219,339   6,134,421   2,295,826 
Depreciation and amortization  86,646   173,696   241,413   484,355 
Total operating expenses  5,656,849   3,516,869   15,159,453   13,644,877 
                 
Loss from operations  (5,656,849)  (3,516,869)  (15,159,453)  (13,644,877)
                 
Other income (expense)                
Inducement expense  —   —   —   (298,714)
Change in fair value of warrant liabilities  1,599,623   804,833   3,845,514   7,077,376 
Change in fair value of investment option liability  1,809,622   —   1,809,622   — 
Change in fair value of derivative liability  (231,000)  —   (284,000)  — 
Interest expense  (308)  (370)  (5,114)  (5,191)
Total other income  3,177,937   804,463   5,366,022   6,773,471 
                 
Net loss $(2,478,912) $(2,712,406) $(9,793,431) $(6,871,406)
Less preferred dividends attributable to non-controlling interest  12,603   —   20,411   — 
Less deemed dividends attributable to accretion of embedded derivative at redemption value  110,991   —   184,985   — 
Net loss attributable to shareholders  (2,602,506)  (2,712,406)  (9,998,827)  (6,871,406)
                 
Other comprehensive loss                
Foreign currency translation  (417,390)  (6,510)  (609,695)  (4,036)
                 
Comprehensive loss $(3,019,896) $(2,718,916) $(10,608,522) $(6,875,442)
                 
Net loss per share - basic and diluted $(1.46) $(5.91) $(8.11) $(16.64)
                 
Weighted average shares outstanding, basic and diluted  1,787,235   459,289   1,232,936   413,063 
 - Shares  Amount  Equity  Shares  Amount  Capital  Deficit  Loss  

Equity

 
  Redeemable Non-controlling Interest  Total Mezzanine  Common Stock  Additional Paid-In  Accumulated  Accumulated Other Comprehensive  

Total

Shareholders’

 
  Shares  Amount  Equity  Shares  Amount  Capital  Deficit  Loss  Equity 
Balance at January 1, 2023 - 1,000  $885,028  $885,028   2,078,271  $20,782  $94,395,662  $(79,207,786) $(536,734) $14,671,924 
Stock-based compensation  —   —   —   —   —   532,835   —   —   532,835 
Preferred dividends attributable to redeemable non-controlling interest  —   12,329   12,329   —   —   (12,329)  —   —   (12,329)
Accretion of embedded derivative to redemption value  —   110,991   110,991   —   —   (110,991)  —   —   (110,991)
Foreign exchange translation gain  —   —   —   —   —   —   —   1,968   1,968 
Net loss - —   —   —   —   —   —   (4,677,527)  —   (4,677,527)
Balance at March 31, 2023 - 1,000  $1,008,348  $1,008,348   2,078,271  $20,782  $94,805,177  $(83,885,313) $(534,766) $10,405,880 
Stock-based compensation  —   —   —   —   —   879,738   —   —   879,738 
Preferred dividends attributable to redeemable non-controlling interest  —   6,712   6,712   —   —   (6,712)  —   —   (6,712)
Accretion of embedded derivative to redemption value  —   36,997   36,997   —   —   (36,997)  —   —   (36,997)
Redemption of Series A preferred stock  (1,000)  (1,052,057)  (1,052,057)  —   —   —   —   —   — 
Issuance of common shares in exchange for RSU conversions from the reduction in force  —   —   —   63,511   635   (635)  —   —   — 
Foreign exchange translation loss  —   —   —   —   —   —   —   (11,286)  (11,286)
Net loss - —   —   —   —   —   —   (6,356,053)  —   (6,356,053)
Balance at June 30, 2023-  —  $—  $—   2,141,782  $21,417  $95,640,571  $(90,241,366) $(546,052) $4,874,570 
Stock-based compensation  —   —   —   —   —   372,859   —   —   372,859 
Issuance of common shares in exchange for RSU conversions  —   —   —   40,130   401   (401)  —   —   — 
Foreign exchange translation loss  —   —   —   —   —   —   —   10,433   10,433 
Net loss - —   —   —   —   —   —   (2,822,216)  —   (2,822,216)
Balance at September 30, 2023-  —  $—  $—   2,181,912  $21,818  $96,013,029  $(93,063,582) $(535,619) $2,435,646 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

3

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS'SHAREHOLDERS’ EQUITY (DEFICIT)

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 20222023 AND 20212022

 

     Shares  Amount  Shares  Amount  Capital  Deficit  Income (Loss)  Total 
     Series B Preferred Stock  Common Stock  Additional Paid-In  Accumulated  Accumulated Other Comprehensive    
     Shares  Amount  Shares  Amount  Capital  Deficit  Income (Loss)  Total 
Balance at January 1, 2021 --- 3,275,407  $32,754   202,249  $2,022  $15,321,699  $(11,759,557) $(181,277) $3,415,641 
January 2021 registered direct offering, net of offering costs     —   —   44,427   444   4,616,643   —   —   4,617,087 
February 2021 registered direct offering, net of offering costs     —   —   60,141   601   7,015,800   —   —   7,016,401 
Stock-based compensation     —   —   —   —   3,591,565   —   —   3,591,565 
Induced conversion of stock options into restricted stock awards     —   —   —   —   298,714   —   —   298,714 
Conversion of Series B Preferred Stock     (3,275,407)  (32,754)  65,509   655   32,099   —   —   — 
Exercise of warrants     —   —   17,022   170   3,267,075   —   —   3,267,245 
Foreign exchange translation gain     —   —   —   —   —   —   35,736   35,736 
Net loss --- —   —   —   —   —   (3,250,711)  —   (3,250,711)
Balance at March 31, 2021 --- —  $—   389,348  $3,892  $34,143,595  $(15,010,268) $(145,541) $18,991,678 
Stock-based compensation     —   —   283   3   750,930   —   —   750,933 
Conversion of stock options into restricted stock     —   —   843   8   (8)  —   —   — 
Exercise of warrants     —   —   35,839   358   17,570   —   —   17,928 
Exercise of options     —   —   2,685   27   (27)  —   —   — 
Foreign exchange translation loss     —   —   —   —   —   —   (33,262)  (33,262)
Net loss --- —   —   —   —   —   (908,289)  —   (908,289)
Balance at June 30, 2021 --- —  $—   428,998  $4,288  $34,912,060  $(15,918,557) $(178,803) $18,818,988 
Consideration paid pursuant to amalgamation agreement     —   —   199,025   1,990   39,040,292   —   —   39,042,282 
Stock-based compensation     —   —   —   —   486,986   —   —   486,986 
Reserve for Ameri warrant liabilities     —   —   —   —   (262,491)  —   —   (262,491)
Foreign exchange translation loss     —   —   —   —   —   —   (6,510)  (6,510)
Net loss --- —   —   —   —   —   (2,712,406)  —   (2,712,406)
Balance at September 30, 2021 --- —  $—   628,023  $6,278  $74,176,847  $(18,630,963) $(185,313) $55,366,849 
  Shares  Amount  Shares  Amount  Equity  Shares  Amount  Capital  Deficit  Income (Loss)  

Equity

 
  Series C Preferred Stock  Redeemable Non-controlling Interest  Total Mezzanine  Common Stock  Additional Paid-In  Accumulated   Accumulated Other Comprehensive  Total Shareholders’  
  Shares  Amount  Shares  Amount  Equity  Shares  Amount  Capital  Deficit  Income (Loss)  Equity 
Balance at January 1, 2022  —  $—   —  $—   —   651,921  $6,519  $83,066,656  $(60,736,453) $(30,802) $         22,305,920 
February 2022 registered direct offering  —   —   —   —   —   400,000   4,000   5,798,464   —   —   5,802,464 
Stock-based compensation  —   —   —   —   —   —   —   768,619   —   —   768,619 
Conversion of RSUs into common shares  —   —   —   —   —   899   9   (9)  —   —   — 
Foreign exchange translation gain  —   —   —   —   —   —   —   —   —   88,709   88,709 
Net loss  —   —   —   —   —   —   —   —   (4,524,014)  —   (4,524,014)
Balance at March 31, 2022  —  $—   —  $—  $—   1,052,820  $10,528  $89,633,730  $(65,260,467) $57,907  $24,441,698 
Stock-based compensation  —   —   —   —   —   —   —   677,543   —   —   677,543 
Redeemable non-controlling interest, net of $402,000 embedded derivative and net of issuance costs of $41,962  —   —   1,000   556,038   556,038   —   —   —   —   —   — 
Issuance of redeemable non-controlling Series C preferred stock  52,685   527   —   —   527   —   —   (527)  —   —   (527)
Preferred dividends attributable to redeemable non-controlling interest  —   —   —   7,808   7,808   —   —   (7,808)  —   —   (7,808)
Accretion of embedded derivative to redemption value  —   —   —   73,994   73,994   —   —   (73,994)  —   —   (73,994)
Conversion of RSAs into common shares  —   —   —   —   —   1,223   12   (12)  —   —   — 
Foreign exchange translation gain  —   —   —   —   —   —   —   —   —   (281,014)  (281,014)
Net loss  —   —   —   —   —   —   —   —   (2,790,505)  —   (2,790,505)
Balance at June 30, 2022  52,685  $527   1,000  $637,840  $638,367   1,054,043  $10,540  $90,228,932  $(68,050,972) $(223,107) $21,965,393 
Balance  52,685  $527   1,000  $637,840  $638,367   1,054,043  $10,540  $90,228,932  $(68,050,972) $(223,107) $21,965,393 
Stock-based compensation  —   —   —   —   —   —   —   645,137   —   —   645,137 
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs  —   —   —   —   —   1,000,000   10,000   3,239,125   —   —   3,249,125 
Issuance of rounded shares as a result of the reverse stock split  —   —   —   —   —   24,228   242   (242)  —   —   — 
Preferred dividends attributable to redeemable non-controlling interest  —   —   —   12,603   12,603   —   —   (12,603)  —   —   (12,603)
Accretion of embedded derivatives to redemption value  —   —   —   110,991   110,991   —   —   (110,991)  —   —   (110,991)
Redemption of Series C preferred stock  (52,685)  (527)  —   —   (527)  —   —   527   —   —   527 
Foreign exchange translation loss  —   —   —   —   —   —   —   —   —   (417,390)  (417,390)
Net loss  —   —   —   —   —   —   —   —   (2,478,912)  —   (2,478,912)
Balance at September 30, 2022  —  $—   1,000  $761,434  $761,434   2,078,271  $20,782  $93,989,885  $(70,529,884) $(640,497) $22,840,286 
Balance  —  $—   1,000  $761,434  $761,434   2,078,271  $20,782  $93,989,885  $(70,529,884) $(640,497) $22,840,286 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

4

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS' EQUITY (DEFICIT) FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021CASH FLOWS

 

  Shares  Amount  Shares  Amount  Equity  Shares  Amount  Capital  Deficit  Income  Equity 
  Series C Redeemable Preferred Stock  Redeemable Non-controlling Interest  Total Mezzanine  Common Stock  Additional Paid-In  Accumulated  Accumulated Other Comprehensive  Total Shareholders’ 
  Shares  Amount  Shares  Amount  Equity  Shares  Amount  Capital  Deficit  Income  Equity 
Balance at January 1, 2022  —  $—   —  $—  $—-   651,921  $6,519  $83,066,656  $(60,736,453) $(30,802) $22,305,920 
February 2022 registered direct offering, net of offering costs  —   —   —   —   —   400,000   4,000   5,798,464   —   —   5,802,464 
February registered direct offering, net of offering costs  —   —   —   —   —   400,000   4,000   5,798,464   —   —   5,802,464 
Stock-based compensation  —   —   —   —   —   —   —   768,619   —   —   768,619 
Conversion of RSUs into common shares  —   —   —   —   —   899   9   (9)  —   —   — 
Foreign currency translation gain  —   —   —   —   —   —   —   —   —   88,709   88,709 
Net loss  —   —   —   —   — -  —   —   —   (4,524,014)  —   (4,524,014)
Balance at March 31, 2022  —  $—   —  $—  $— -  1,052,820  $10,528  $89,633,730  $(65,260,467) $57,907  $24,441,698 
Stock-based compensation  —   —   —   —   —   —   —   677,543   —   —   677,543 
Redeemable non-controlling interest, net of $402,000 embedded derivative and net of issuance costs of $41,962  —   —   1,000   556,038   556,038   —   —   —   —   —   — 
Issuance of redeemable Series C preferred stock  52,685   527   —   —   527   —   —   (527)  —   —   (527)
Preferred dividends attributable to redeemable non-controlling interest  —   —   —   7,808   7,808   —   —   (7,808)  —   —   (7,808)
Accretion of embedded derivative to redemption value  —   —   —   73,994   73,994   —   —   (73,994)  —   —   (73,994)
Conversion of RSAs into common shares  —   —   —   —   —   1,223   12   (12)  —   —   — 
Foreign exchange translation loss  —   —   —   —   —   —   —   —   —   (281,014)  (281,014)
Net loss  —   —   —   —   — -  —   —   —   (2,790,505)  —   (2,790,505)
Balance at June 30, 2022  52,685  $527   1,000  $637,840  $638,367 -  1,054,043  $10,540  $90,228,932  $(68,050,972) $(223,107) $21,965,393 
Beginning balance  52,685  $527   1,000  $637,840  $638,367 -  1,054,043  $10,540  $90,228,932  $(68,050,972) $(223,107) $21,965,393 
Stock-based compensation  —   —   —   —   —   —   —   645,137   —   —   645,137 
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs  —   —   —   —   —   1,000,000   10,000   3,239,125   —   —   3,249,125 
Issuance of rounded shares as a result of the reverse stock split  —   —   —   —   —   24,228   242   (242)   —   —   — 
Preferred dividends attributable to redeemable non-controlling interest  —   —   —   12,603   12,603   —   —   (12,603)  —   —   (12,603)
Accretion of embedded derivative to redemption value  —   —   —   110,991   110,991   —   —   (110,991)  —   —   (110,991)
Redemption of Series C preferred stock  (52,685)  (527)  —   —   (527)-  —   —   527   —   —   527 
Foreign exchange translation loss  —   —   —   —   —   —   —   —   —   (417,390)  (417,390)
Foreign exchange translation gain (loss)  —   —   —   —   —   —   —   —   —   (417,390)  (417,390)
Net loss  —   —   —   —   — -  —   —   —   (2,478,912)  —   (2,478,912)
Balance at September 30, 2022  —  $—   1,000  $761,434  $761,434 -  2,078,271  $20,782  $93,989,885  $(70,529,884) $(640,497) $22,840,286 
Ending balance  —  $—   1,000  $761,434  $761,434 -  2,078,271  $20,782  $93,989,885  $(70,529,884) $(640,497) $22,840,286 
  2023  2022 
  For the Nine Months Ended 
  2023  2022 
Cash Flows From Operating Activities:        
Net loss $(13,855,796) $(9,793,431)
Adjustments to reconcile net loss to cash used in operating activities        
Change in fair value of warrant liability  115,342   (3,845,514)
Change in fair value of investment option liability  399,921   (1,809,622)
Change in fair value of derivative liability  (727,000)  284,000 
Stock-based compensation  1,785,432   2,091,299 
Amortization of right-of-use asset  64,246   103,365 
Amortization of intangible assets  126,566   126,563 
Depreciation expense  132,734   114,850 
Gain on disposal of property and equipment  (4,219)  — 
Change in operating assets and liabilities:        
Prepaid expenses and other current assets  (746,033)  (758,419)
Accounts payable and accrued liabilities  429,688   (106,675)
Right-of-use operating lease liability  (64,244)  (91,022)
Net cash used in operating activities  (12,343,363)  (13,684,606)
         
Cash Flows From Investing Activities:        
Purchases of property and equipment  (5,195)  (577,972)
Proceeds from disposal of property and equipment  16,900   — 
Net cash provided by (used in) investing activities  11,705   (577,972)
         
Cash Flows From Financing Activities:        
Payment for the deferred offering costs from the equity distribution agreement  (105,000)  — 
Proceeds from sale of common stock, warrants, and investment options, net of offering costs  —   17,222,100 
Redemption of Series A Preferred Stock (see Note 8)  (1,052,057)  — 
Proceeds from the sale of redeemable non-controlling interest, net of offering  —   958,038 
Net cash (used in) provided by financing activities  (1,157,057)  18,180,138 
         
Effect of foreign exchange rate on cash  31,399   (72,554)
         
Net (decrease) increase in cash  (13,457,316)  3,845,006 
Cash at beginning of period  17,723,884   17,355,999 
Cash at end of period $4,266,568  $21,201,005 
         
Supplemental disclosure of cash and non-cash transactions:        
Cash paid for interest $—  $5,114 
Income taxes paid $6,595  $— 
Warrants issued in conjunction with common stock issuance $—  $3,595,420 
Issuance of embedded derivative $—  $402,000 
Issuance of redeemable non-controlling Series C preferred stock $—  $— 
Offering costs accrued not paid $20,800  $— 
Preferred dividends attributable to redeemable non-controlling interest $19,041  $20,411 
Accretion of embedded derivative to redemption value $147,988  $184,985 
Investment options issued in conjunction with common stock issuance $—  $4,323,734 
Modification of warrants as part of share capital raise $—  $251,357 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

5

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

  2022  2021 
  For the Nine Months Ended September 30, 
  2022  2021 
Cash Flows From Operating Activities:        
Net loss $(9,793,431) $(6,871,406)
Adjustments to reconcile net loss to cash used in operating activities        
Change in fair value of warrant liability  (3,845,514)  (7,077,376)
Change in fair value of investment option liability  (1,809,622)  — 
Change in fair value of derivative liability  284,000   — 
Stock-based compensation  2,091,299   4,829,484 
Inducement expense  —   298,714 
Amortization of right-of-use asset  103,365   — 
Amortization of intangible assets  126,563   482,115 
Depreciation expense  114,850   2,240 
Change in operating assets and liabilities:        
Prepaid expenses and other current assets  (758,419)  320,123 
Accounts payable and accrued liabilities  (106,675)  625,748 
Right-of-use operating lease liability  (91,022)  — 
Net cash used in operating activities  (13,684,606)  (7,390,358)
         
Cash Flows From Investing Activities:        
Purchases of property and equipment  (577,972)  — 
Purchase of Diverse Bio license agreement  —   (675,000)
Cash accretive acquisition of MagicMed  —   3,055,327 
Net cash (used in) provided by investing activities  (577,972)  2,380,327 
         
Cash Flows From Financing Activities:        
Proceeds from sale of common stock, warrants, and investment options, net of offering costs  17,222,100   21,614,488 
Proceeds from the sale of redeemable non-controlling interest, net of offering costs (see Note 6)  958,038   — 
Proceeds from warrant exercises, net of fees  —   3,285,164 
Net cash provided by financing activities  18,180,138   24,899,652 
         
Effect of foreign exchange rate on cash  (72,554)  (19,655)
         
Net increase in cash  3,845,006   19,869,966 
Cash at beginning of period  17,355,999   1,578,460 
Cash at end of period $21,201,005  $21,448,426 
         
Supplemental disclosure of cash and non-cash transactions:        
Cash paid for interest $5,114  $5,191 
Income taxes paid $—  $— 
Investment options issued in conjunction with common stock issuance $4,323,734  $— 
Modification of warrants as part of share capital raise $251,357  $— 
Warrants issued in conjunction with common stock issuance $3,595,420  $— 
Issuance of embedded derivative $402,000  $— 
Preferred dividends attributable to redeemable non-controlling interest $20,411  $— 
Accretion of embedded derivative to redemption value $184,985  $— 
Issuance of Common Stock pursuant to MagicMed amalgamation $—  $39,042,282 
Deferred tax liability incurred due to MagicMed amalgamation $—  $9,061,927 
Conversion of preferred stock to common stock $—  $32,754 
Fair value of warrants issued $—  $9,981,000 
Fair value of Ameri warrants $—  $262,492 

See the accompanying notes to the unaudited condensed consolidated financial statements.

6

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1. NATURE OF BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES

Nature of Operations

 

Enveric Biosciences, Inc. (“Enveric Biosciences, Inc.” “Enveric”Enveric” or the “Company”) (formerly known as Ameri Holdings, Inc.) (“Ameri”) is a pharmaceuticalbiotechnology company developing innovative, evidence-based cannabinoid medicines.novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. The head office of the Company is located in Naples, Florida. The Company has the following wholly ownedwholly-owned subsidiaries: Jay Pharma Inc. (“Jay Pharma”), 1306432 B.C. Ltd. (“HoldCo”), MagicMed Industries, Inc. (“MagicMed”), Enveric Canada Inc., and Enveric Canada. The Company has an Amalgamation AgreementTherapeutics, Pty. Ltd. (“Amalgamation Agreement”Enveric Therapeutics”) and tender agreement (“Tender Agreement”) with Jay Pharma, which were entered into in prior years..

 

On May 24, 2021,Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, the Company entered into an Amalgamation Agreement (the “Amalgamation Agreement”) with 1306432 B.C. Ltd., a corporation existing under the lawsEVM201 Series, comprises next generation synthetic prodrugs of the Provinceactive metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of British Columbia andpsychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer a wholly-owned subsidiaryfirst-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the Company (“HoldCo”), 1306436 B.C. Ltd., a corporation existing under the lawspromotion of the Province of British Columbia and a wholly-owned subsidiary of HoldCo (“Purchaser”), and MagicMed Industries Inc., a corporation existing under the laws of the Province of British Columbia (“MagicMed”), pursuant to which, among other things, the Company, indirectly through Purchaser, acquired all of the outstanding securities of MagicMed in exchange for securities of the Company by way of an amalgamation under the British Columbia Business Corporations Act, upon the terms and conditions set forthneuroplasticity without also inducing hallucinations in the Amalgamation Agreement, such that, upon completion of the Amalgamation (as defined herein), the amalgamated corporation (“Amalco”) will be an indirect wholly-owned subsidiary of the Company. The Amalgamation was completed on September 16, 2021.patient.

 

Following the Company’s amalgamation with MagicMed Industries develops and commercializes psychedelic-derived pharmaceutical candidates.completed in September 2021 (the “Amalgamation”), the Company has continued to pursue the development of MagicMed’s psychedelic derivativesproprietary Psychedelic Derivatives library, the Psybrary™, is an essential building block from which industry canthe Company believes will help to identify and develop new patented products.the right drug candidates needed to address mental health challenges, including cancer-related distress. The initial focusCompany synthesizes novel versions of classic psychedelics, such as psilocybin, DMT, mescaline and MDMA, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations and hundreds of synthesized molecules. Within the Psybrary™ the Company has three different types of molecules, Generation 1 (classic psychedelics), Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic molecular compounds and derivatives (“Psychedelic Derivatives”) on psilocybina regular basis through its work at the Company’s labs in Calgary, Alberta, Canada, where the Company has a team of PhD scientists with expertise in synthetic biology and DMT derivatives, and itchemistry. To date the Company has created over 500 molecules that are housed in the Psybrary™.

The Company screens newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary artificial intelligence (“AI”) tool. Leveraging AI systems is then expected to reduce the time and cost of pre-clinical, clinical, and commercial development. The Company believes it streamlines pharmaceutical design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological effects to help determine ideal drug candidates, tailored to each indication. Each of these molecules that the Company believes are patentable can then be expandedfurther screened to other psychedelics.see how changes to its makeup alter its effects in order to synthesize additional new molecules. New compounds of sufficient purity are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal), and ultimately clinical (human) evaluations. The Company intends to utilize the Psybrary™ and the AI tool to categorize and characterize the Psybrary™ substituents to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.

 

Akos Spin-Off

 

On May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority ownedmajority-owned subsidiary of the Company (hereafter referred to as “Akos”), which was incorporated on April 13, 2022, by way of dividend to Enveric shareholders (the “Spin-Off”). The Spin-Off will be subject to various conditions, including Akos meetingAs of May 12, 2023, the qualifications for listing on the Nasdaq Stock Market, and if successful, would result in two standalone public companies. The new company as a resultholders of the Spin-Off will be referred to as Akos. If the Spin-Off does not occur, the Company has guaranteed the redeemable non-controlling interest (“RNCI”).

On May 5, 2022, the Company andCompany’s Akos entered into a Securities Purchase Agreement (the “Akos Purchase Agreement”) with an accredited investor (the “Akos Investor”), pursuant to which Akos agreed to sell to the Akos Investor up to an aggregate of 5,000 shares of Akos’ Series A Convertible Preferred Stock (the “Akos Series A Preferred Stock”),Stock, par value $0.01 per share at a price(“Akos Series A Preferred Stock”) have exercised this right to force redemption of $1,000 per share, and warrants (the “Akos Warrants”) to purchase shares of Akos’ common stock (the “Akos Common Stock”), par value $0.01 per share, for an aggregate purchase price of up to $5,000,000 (the “Akos Private Placement”). Pursuant to the Akos Purchase Agreement, Akos has issued 1,000 sharesall of the Akos Series A Preferred Stock to the Akos Investor in exchange for $1,000,0001,000 per share, plus accrued but unpaid dividends of $52,057 for a total of $1,052,057. The Company made full payment on May 5, 2022.19, 2023. See Note 8.

 

Reverse Stock SplitAustralian Subsidiary

On March 21, 2023, the Company established Enveric Therapeutics, an Australia-based subsidiary, to support the Company’s plans to advance its lead program, the EVM201 Series, comprised of the next generation synthetic prodrugs of the active metabolite, psilocin (“EVM201 Series”), towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration (TGA), Australia’s regulatory authority.

 

6

On July 14, 2022 the Company affected a 1-for-50 reverse stock split. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the Reverse Stock Split.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Going Concern, Liquidity and Other Uncertainties

 

ForThe Company has incurred a loss since inception resulting in an accumulated deficit of $93,063,582 as of September 30, 2023, and further losses are anticipated in the development of its business. Further, the Company had operating cash outflows of $12,343,363 for the nine months ended September 30, 2022,2023. For the nine months ended September 30, 2023, the Company had a loss from operations of $15,159,453 and net cash used in operating activities of $13,684,60614,064,080. As of September 30, 2022, the Company had an accumulated deficit of $70,529,884. Since its inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements.

In assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2022,2023, the Company had cash of $21,201,0054,266,568 and working capital of $19,668,5721,643,374. The Company’s current cash on hand atis insufficient to satisfy its operating cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date is estimatedthe financial statements are issued. Management’s plan to be sufficient to fund operations, however, there can be no guarantee thatalleviate the conditions will not changethat raise substantial doubt include reducing the Company’s rate of spend, managing its cash flow, advancing its programs, and thatraising additional working capital through public or private equity or debt financings or other sources, which has included the Company will requireEquity Distribution Agreement with Canaccord for proceeds of up to $2.4 million (see Note 7) and the Purchase Agreement with Lincoln Park (see Note 10), subject to registration, and may include collaborations with additional funding, whichthird parties, as well as disciplined cash spending, to increase the Company’s cash runway. Adequate additional financing may not be available to the Company on acceptable terms, or at all, in which case significant delays or cost increases may result in material disruption to the Company’s operations. In such case,all. Should the Company wouldbe unable to raise sufficient additional capital, the Company may be required to delay, scale backundertake cost-cutting measures including delaying or eliminate some or all of its research and development programs, which would likely have a material adverse effect on the Company and its financial statements.

7

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTSdiscontinuing certain operating activities.

 

The Company’s material cash requirements consist of working capital to fund capital expenditures incurred at their research facility in Calgary and their operations, which consist primarily of, without limitation, employee related expenses, product development activities conducted by third parties, research materials and lab supplies, facility related expenses including rent and maintenance, costs associated with preclinical studies, patent related costs, costs of regulatory and public company compliance, insurance costs, audit costs, consultants and legal fees. Additionally, the Company currently utilizes third-party contract CROsresearch organizations (“CROs”) to assist with clinical development activities. If the Company obtains regulatory approval for any of their product candidates, they expect to incur significant expenses to engage third-party contract CMOsmanufacturing organizations (“CMOs”) to carry out their clinical manufacturing activities as they doit does not yet have a commercial organization,commercialization infrastructure, and incur significant expenses related to developing theirits internal commercialization capability to support product sales, marketing and distribution. The Company’s current working capital resources are sufficientinsufficient to fund these material cash requirements for the next twelve months.

 

As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the financial statements are issued. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Reduction in Force/Restructuring

In May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos cannabinoid spin-out were terminated. The Company expects to finance futurerecognized severance charges of approximately $453,059 through September 30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing cash needs through public or private equity offerings, debt financings, or business development transactions. If adequate funds are not available,flow. In June 2023, the Company may be required to delay, reducecompleted the scope of or eliminate researchreduction in force, with such severance expenses recorded in general and development programs or obtain funds through arrangements with collaborators or others that may requireadministrative accounts.

On June 16, 2023, the Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer (the “Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding restricted stock units (“RSUs”) will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits of $550,974 were accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested time-based RSUs became fully vested. The Company accelerated expense recognized related to relinquish rightsthese shares that vested was $231,273. Of the 11,278 market performance-based RSUs previously granted, 3,759 will continue to certain pipeline candidates that they might otherwise seekbe subject to develop or commercialize independently.the original terms and conditions of Mr. Kanubaddi’s employment agreement and the remainder were forfeited.

7

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SCHEDULE OF RESTRUCTURING COSTS PAYABLE

  Accrued Restructuring Costs 
January 1, 2023 Beginning balance $— 
Restructuring costs incurred  1,004,033 
Restructuring costs paid  (396,431)
September 30, 2023 ending balance $607,602 

Inflation Risks

 

Nasdaq Notice

On February 18, 2022,The Company considers the current inflationary trend existing in the North American economic environment reasonably likely to have a material unfavorable impact on results of continuing operations. Higher rates of price inflation, as compared to recent prior levels of price inflation, have caused a general increase in the cost of labor and materials. In addition, there is an increased risk of the Company receivedexperiencing labor shortages due to a letterpotential inability to attract and retain human resources due to increased labor costs resulting from the Listing Qualifications Department of the Nasdaq Stock Market indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between January 5, 2022, through February 17, 2022, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital Market (“Nasdaq”) pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or until August 17, 2022 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).

On July 29, 2022, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market stating that for the last ten consecutive business days, from July 15 to July 28, 2022, the closing bid price of the Company’s common stock had been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2).current inflationary environment.

 

NOTE 2.SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation and Principal of Consolidation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 20222023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 20212022, and related notes thereto included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2022.2023 and subsequently amended on Form 10-K/A Amendment No. 1 filed with the SEC on June 9, 2023 (as amended, the “Annual Report”).

 

The Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s consolidated financial statements for the year ended December 31, 2021.2022. There were no significant changes to these accounting policies during the three and nine months ended September 30, 2022.2023.

 

Reclassification

Certain reclassifications have been made to the prior period financial statements to conform to the current period financial statement presentation. Certain amounts related to depreciation and amortization from the prior period were reclassified from General and administrative line item to Depreciation and amortization line item on the Unaudited Condensed Consolidated Statement of Operations and Comprehensive Income (Loss). These reclassifications had no net effect on loss from operations, net loss, or cash flows as previously reported.

8

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Use of Estimates

The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions include determining the fair value of transactions involving common stock and the valuation of stock-based compensation, accruals associated with third party providers supporting research and development efforts, and estimated fair values of long liveslived assets used to record impairment charges related to intangible assets, acquired in-process research and development (“IPR&D”), and goodwill, and allocation of purchase price in business acquisitions.assets. Actual results could differ from those estimates.

 

Foreign Currency Translation

From inception through September 30, 2022,2023, the reporting currency of the Company was the United States dollar while the functional currency of certain of the Company’s subsidiaries was the Canadian dollar and Australian dollar. For the reporting periods ended September 30, 20222023 and September 30, 2021,2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the U.S.United States dollar.

 

The Company translates the assets and liabilities of its Canadian subsidiaries and Australian subsidiary into the U.S.United States dollar at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during each monthly period. Unrealized translation gains and losses are recorded as foreign currency translation gain (loss), which is included in the condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive income (loss).loss.

8

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations in the future.

 

Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive income (loss)loss in the condensed consolidated statements of operations and comprehensive income (loss)loss as incurred.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution, which at times, may exceed the federal depository insurance coverage of $250,000 in the United States and Australia and $100,000 in Canada. The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on such accounts. As of September 30, 2023, the Company had greater than $250,000 at United States financial institutions, less than $250,000 at Australian financial institutions, and greater than $100,000 at Canadian financial institutions.

Deferred Offering Costs

The Company complies with the requirements of ASC Topic 340, Other Assets and Deferred Costs (“ASC 340”) and SAB 5A - Expenses of Offering. Offering costs, which consist mainly of legal, accounting and consulting fees directly attributable to the issuance of an equity contract to be classified in equity are recorded as a reduction in equity. During September 2023, the Company incurred $125,800 in deferred offering costs in connection with the Equity Distribution Agreement (the “Distribution Agreement”), with Canaccord Genuity LLC (“Canaccord”) and the Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). These deferred offering costs will be proportionately offset against the total proceeds from the issuance of common stock available under the agreements and the Company will expense any remaining balance of deferred offering costs if the agreements are terminated. For the three and nine months ended September 30, 2023, there were no issuances of common stock under the agreements resulting in the deferral of offering costs.

 

Warrant Liability and Investment Options

 

The Company evaluates all of its financial instruments, including issued stock purchase warrants and investment options, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 “Distinguishing Liabilities from Equity” (“ASC 480”) and FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”). The Company accounts for warrants and investment options for shares of the Company’s common stock that are not indexed to its own stock as derivative liabilities at fair value on the unaudited condensed consolidated balance sheets. The Company accounts for common stock warrants and investment options with put options as liabilities under ASC 480. Such warrants and investment options are subject to remeasurement at each unaudited condensed consolidated balance sheet date and any change in fair value is recognized as a component of other expense on the unaudited condensed consolidated statements of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such common stock warrants and investment options. At that time, the portion of the warrant liability and investment options related to such common stock warrants will be reclassified to additional paid-in capital.

 

Modification of Warrants

A change in any of the terms or conditions of warrants is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant over the fair value of the original warrant immediately before its terms are modified, measured based on the fair value of the shares and other pertinent factors at the modification date. The accounting for incremental fair value of warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to equity offerings, the incremental change in fair value of the warrants are accounted for as equity issuance costs.

9

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Derivative Liability

 

The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC 815. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in the unaudited condensed consolidated statements of operations. The classification of derivative instruments, including whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the unaudited condensed consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.

 

Offering CostsIncome Taxes

 

The Company allocates offering costsfiles U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction. From a U.S. federal, state, and Canadian perspective, the years that remain open to the different componentsexamination are consistent with each jurisdiction’s statute of the capital raise on a pro rata basis. Any offering costs allocated to common stock are charged directly to additional paid-in capital. Any offering costs allocated to warrant liabilities are charged to general and administrative expenses on the Company’s unaudited condensed consolidated statement of operations.limitations.

 

9

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Net Loss per Share

Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants (using the treasury stock method). The computation of basic net loss per share for the three and nine months ended September 30, 20222023 and 20212022 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both basic and fully diluted. In accordance with ASC 260-10-45-13,260 “Earnings per Share” (“ASC 260”), penny warrants were included in the calculation of weighted average shares outstanding for the purposes of calculating basic and diluted earnings per share.

During the three and nine months ended September 30, 2022 the Company issued 767,500 pre-funded common stock warrants, which were exercised on various dates during the three and nine months ended September 30, 2022. The pre-funded common stock warrants became exercisable on July 26, 2022 based on the terms and conditions of the agreements. As the pre-funded common stock warrants are exercisable for $0.0001, these shares are considered outstanding common shares and are included in the computation of basic and diluted Earnings Per Share as the exercise of the pre-funded common stock warrants is virtually assured. The Company included these pre-funded common stock warrants in basic and diluted earnings per share when all conditions were met on July 26, 2022.

 

Potentially dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share for the three and nine months ended September 30, 20222023 and 20212022 because the effect of their inclusion would have been anti-dilutive.

SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES

 For the three and
nine months ended
September 30, 2022		  For the three and
nine months ended
September 30, 2021		  For the three and nine months ended September 30, 2023  For the three and nine months ended September 30, 2022 
Warrants to purchase shares of common stock  655,463   211,534   609,893   655,463 
Restricted stock units - vested and unissued  61,428   —   20,847   61,428 
Restricted stock units - unvested  65,117   115,504   148,251   65,117 
Restricted stock awards - vested and unissued  974   —   —   974 
Restricted stock awards - unvested  —   578 
Investment options to purchase shares of common stock  1,070,000   —   1,070,000   1,070,000 
Options to purchase shares of common stock  22,829   22,947   31,852   22,829 
Total potentially dilutive securities  1,875,811   350,563   1,880,843   1,875,811 

 

Fair Value Measurements

 

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:

 

Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.

10

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.

 

Level 3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

 

For certain financial instruments, including cash accounts receivable, and accounts payable, the carrying amounts approximate their fair values as of September 30, 20222023, and December 31, 20212022 because of their short-term nature.

 

The following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of September 30, 2023, and December 31, 2022, and indicates the fair value of the valuation inputs the Company utilized to determine such fair value of warrant liabilities, derivative liability, and investment options:

 SCHEDULE OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS

 Level  September 30, 2022  December 31, 2021  Level September 30, 2023  December 31, 2022 
Warrant liabilities - January 2021 Warrants  3  $1,011  $333,471  3 $18  $81 
Warrant liabilities - February 2021 Warrants  3   1,101   320,203  3  59   79 
Warrant liabilities - February 2022 Warrants  3   652,825   —  3  300,480   185,055 
Fair value as of September 30, 2022    $654,937  $653,674 
Warrant liabilities - fair value    $654,937  $653,674 
Fair value of warrant liability $300,557  $185,215 

 

  Level  September 30, 2022  December 31, 2021 
Derivative liability - May 2022  3  $686,000  $— 
Fair value as of September 30, 2022    $686,000  $— 
Derivative liability - fair value    $686,000  $— 
10

 

  Level  September 30, 2022  December 31, 2021 
Wainwright investment options  3  $139,314  $— 
RD investment options  3   890,549   — 
PIPE investment options  3   1,484,249   — 
Fair value as of September 30, 2022     $2,514,112  $— 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

  Level September 30, 2023  December 31, 2022 
Derivative liability - May 2022 3 $—  $727,000 
Fair value of derivative liability   $—  $727,000 

  Level September 30, 2023  December 31, 2022 
H.C. Wainwright & Co., LLC investment options 3 $70,521  $44,904 
RD investment options 3  442,653   302,289 
PIPE investment options 3  737,755   503,815 
Fair value of investment option liability   $1,250,929  $851,008 

 

The warrant liabilities, derivative liability, and investment options are all classified as Level 3, for which there is no current market for these securities such as the determination of fair value requires significant judgment or estimation. Changes in fair value measurement categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate.within other income (expense) on the condensed consolidated statements of operations and comprehensive loss.

 

InitialSubsequent measurement

The Company establishedfollowing table presents the initialchanges in fair value of its warrant liabilities at the respective dates of issuance. The Company used a Black Scholes valuation model in order to determine their value. The key inputs into the Black Scholes valuation model for the initial valuations of the warrant liabilities, derivative liability, and investment options that are below:classified as Level 3:

SCHEDULE OF BLACK SCHOLES VALUATION MODELSFAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS

  February 2022 Warrants  February 2022 Post-Modification Warrants 
  February 15, 2022  July 26, 2022 
Term (years)  5.0   5.5 
Stock price $15.75  $6.33 
Exercise price $27.50  $7.78 
Dividend yield  —%  —%
Expected volatility  74.1%  80.0%
Risk free interest rate  1.9%  2.9%
       
Number of warrants  460,000   122,000 
Value (per share) $8.00  $4.07 
  Total Warrant Liabilities 
Fair value as of December 31, 2022 $185,215 
Change in fair value  115,342 
Fair value as of September 30, 2023 $300,557 

 

  Total Derivative Liability 
Fair value as of December 31, 2022 $727,000 
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8  (727,000)
Fair value of derivative liability as of September 30, 2023 $— 

The Company established the initial fair value of its derivative liability at the respective date of issuance. The Company used a Weighted Expected Return valuation model in order to determine their value. The key inputs into the Weighted Expected Return valuation model for the initial valuations of the warrant liabilities are below:

  Total Investment Option Liability 
Fair value as of December 31, 2022 $851,008 
Change in fair value  399,921 
Fair value of investment option liability as of September 30, 2023 $1,250,929 

  May 2022 Derivative Liability 
  May 5, 2022 
Principal $1,000,000 
Dividend rate  5.0%
Market rate  4.4%

11

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Company established the initial fair value of its investment options at the respective dates of issuance. The Company used a Black Scholes valuation model in order to determine their value. The key inputs into the Black Scholes valuation model for the initial valuations of the investment options are below:

  Wainwright Options  RD Options  PIPE Options 
  July 26, 2022  July 26, 2022  July 26, 2022 
Term (years)  5.0   5.5   5.5 
Stock price $6.33  $6.33  $6.33 
Exercise price $10.00  $7.78  $7.78 
Dividend yield  —%  —%  —%
Expected volatility  80.0%  80.0%  80.0%
Risk free interest rate  2.9%  2.9%  2.9%
             
Number of investment options  70,000   375,000   625,000 
Value (per share) $3.60  $4.07  $4.07 

Subsequent measurement

The following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options:

SCHEDULE OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS

  Total Warrant Liabilities 
Fair value as of December 31, 2021 $653,674 
Issuance of February 2022 warrants  3,595,420 
Issuance  3,595,420 
Change in fair value due to modification of February 2022 warrants as part of July 2022 raise  251,357 
Change in fair value  (3,845,514)
Fair value as of September 30, 2022 $654,937 

  Total Derivative Liability 
Fair value as of December 31, 2021 $— 
Issuance of May 2022 convertible preferred stock  402,000 
Change in fair value  284,000 
Fair value as of September 30, 2022 $686,000 

  Total Investment Options 
Fair value as of December 31, 2021 $— 
Issuance of July 2022 investment options  4,323,734 
Change in fair value  (1,809,622)
Fair value as of September 30, 2022 $2,514,112 

12

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 20222023 are below:

SCHEDULE OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS

  January 2021 Warrants  February 2021 Warrants  February 2022 Warrants  February 2022 Post-Modification Warrants 
Term (years)  2.3   2.4   3.4   4.3 
Stock price $2.38  $2.38  $2.38  $2.38 
Exercise price $247.50  $245.00  $27.50  $7.78 
Dividend yield  —%  —%  —%  —%
Expected volatility  80.0%  85.0%  96.0%  94.0%
Risk free interest rate  5.00%  4.90%  4.80%  4.70%
Number of warrants  36,429   34,281   338,000   122,000 
Value (per share) $—  $—  $0.46  $1.18 

  January 2021 Warrants  February 2021 Warrants  February 2022 Warrants  February 2022 Post-Modification Warrants 
Term (years)  3.3   3.4   4.4   5.3 
Stock price $4.22  $4.22  $4.22  $4.22 
Exercise price $247.50  $245.00  $27.50  $7.78 
Dividend yield  —%  —%  —%  —%
Expected volatility  78.0%  78.0%  80.0%  79.0%
Risk free interest rate  4.20%  4.20%  4.10%  4.00%
                 
Number of warrants  36,429   34,281   338,000   122,000 
Value (per share) $0.03  $0.03  $1.07  $2.37 

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:

  H.C. Wainwright & Co., LLC Options  RD Offering Options  PIPE Offering Options 
Term (years)  3.8   4.3   4.3 
Stock price $2.38  $2.38  $2.38 
Exercise price $10.00  $7.78  $7.78 
Dividend yield  —%  —%  —%
Expected volatility  97.0%  94.0%  94.0%
Risk free interest rate  4.70%  4.70%  4.70%
Number of investment options  70,000   375,000   625,000 
Value (per share) $1.01  $1.18  $1.18 

 

The key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of September 30, 2022redemption, are below:

 

  May 2022 Derivative Liability 
Principal $1,000,000 
Dividend rate  5.0%
Market rate  6.8%
May 2022 Derivative Liability
Principal$—
Dividend rate—%
Market rate—%

 

The key inputs intoAt the Black Scholes valuation model for the Level 3 valuationsdate of the investment options asredemption of September 30, 2022 are below:the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the probability of a spin-off occurring was zero. See Note 8

 

  Wainwright Options  RD Options  PIPE Options 
Term (years)  4.8   5.3   5.3 
Stock price $4.22  $4.22  $4.22 
Exercise price $10.00  $7.78  $7.78 
Dividend yield  —%  —%  —%
Expected volatility  78.0%  79.0%  79.0%
Risk free interest rate  4.10%  4.00%  4.00%
             
Number of investment options  70,000   375,000   625,000 
Value (per share) $1.99  $2.37  $2.37 

Leases

Operating lease assets are included within right-of-use operating lease asset and operating lease liabilities are included in current portion of right-of-use operating lease obligation and non-current portion of right-of-use operating lease obligation on the consolidated balance sheet as of September 30, 2022. The Company has elected not to present short-term leases as these leases have a lease term of 12 months or less at lease inception and do not contain purchase options or renewal terms that the Company is reasonably certain to exercise. All other lease assets and lease liabilities are recognized based on the present value of lease payments over the lease term at commencement date. Because most of the Company’s leases do not provide an implicit rate of return, the Company used an incremental borrowing rate based on the information available at adoption date in determining the present value of lease payments.

13

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Redeemable Non-controlling Interest

 

In connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement (as defined below in Note 8) and certificate of designation contain a put right guaranteed by the Company as defined in Note 6.8. Applicable accounting guidance requires an equity instrument that is redeemable for cash or other assets to be classified outside of permanent equity if it is redeemable (a) at a fixed or determinable price on a fixed or determinable date, (b) at the option of the holder, or (c) upon the occurrence of an event that is not solely within the control of the issuer. As a result of this feature, the Company recorded the non-controlling interests as redeemable non-controlling interests and classified them in temporarymezzanine equity within its unaudited condensed consolidated balance sheet initially at its acquisition-date estimated redemption value or fair value. In addition, the Company has elected to recognize changes in the redemption value immediately as they occur and adjust the carrying amount of the instrument by accreting the embedded derivative at each reporting period over 12 months.

 

TheIn May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, provides that upon the earlier of (i) the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall haveexercised the right (the “Put Right”), but not the obligation, to causePut Right (as defined below) requiring Akos to purchaseforce redemption of all or a portion of the Akos Series A Preferred Stock for a purchase price equal to $1,000 per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of Designations, plus all the accrued but unpaid dividends per share. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment of the purchase price for the shares purchased under the Put Right.Stock. See Note 8.

 

12

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Segment Reporting

 

The Company determines its reporting units in accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”). The Company evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates each operating segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines if the segments are economically similar and, if so, the operating segments are aggregated. The Company has multiple operations related to psychedelics and cannabinoids. Both of these operations exist under one reporting unit: Enveric. The Company has one operating segment and reporting unit. The Company is organized and operated as one business. Management reviews its business as a single operating segment, using financial and other information rendered meaningful only by the fact that such information is presented and reviewed in the aggregate.

 

Recent Accounting Pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company early adopted ASU 2020-06 effective January 1, 2023, and has determined that the adoption of this guidance had no impact on its condensed consolidated financial statements.

NOTE 3.PREPAID EXPENSES AND OTHER CURRENT ASSETS

As of September 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS

  September 30, 2023  December 31, 2022 
Prepaid research and development $651,623  $268,686 
Prepaid value-added taxes  229,909   159,782 
Prepaid professional fees  74,500   — 
Prepaid insurance  332,508   174,406 
Prepaid other  146,014   105,179 
Deferred offering costs  125,800   — 
Total prepaid expenses and other current assets $1,560,354  $708,053 

NOTE 4. INTANGIBLE ASSETS AND GOODWILL

 

As of September 30, 2022,2023, the Company’s intangible assets consisted of:

 SCHEDULE OF GOODWILL INDEFINITE AND FINITE LIVED INTANGIBLE ASSETS

Definite lived intangible assets    
Balance at December 31, 2022 $379,686 
Amortization  (126,566)
Balance at September 30, 2023 $253,120 

Goodwill    
Balance at December 31, 2021 $1,587,634 
Loss on currency translation  (119,245)
Balance at September 30, 2022 $1,468,389 
     
Indefinite lived intangible assets    
Balance at December 31, 2021 $6,375,492 
Loss on currency translation  (478,856)
Balance at September 30, 2022 $5,896,636 
     
Definite lived intangible assets    
Balance at December 31, 2021 $548,436 
Amortization  (126,563)
Balance at September 30, 2022 $421,873 
13

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

For goodwill, identified indefinite lived assets, and identified definite lived intangible assets, there was no impairment expense during the three and nine months ended September 30, 20222023 and 2021.2022. For identified definite lived intangible assets, amortization expense amounted to $42,18742,191 and $170,692 during the three months ended September 30, 20222023, and 2021,2022, respectively. For identified definite lived intangible assets, amortization expense amounted to $126,563126,566 and $482,115126,563 during the nine months ended September 30, 20222023 and 2021, respectively.2022.

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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Company amortizes definite lived intangible assets on a straight-line basis over their estimated useful lives. Amortization expense of identified intangible assets based on the carrying amount as of September 30, 2022 is as follows:

SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS AMORTIZATION EXPENSES

Year ending December 31,   
2022 (excluding the nine months ended September 30) $42,187 
2023  168,750 
2024  168,750 
2025  42,186 
Finite lived Assets Amortization Expense  $421,873 

 

4.NOTE 5. PROPERTY AND EQUIPMENT

 

Property and equipment consists of the following assets which are located in Calgary, Canada and placed in service by Enveric Biosciences Canada, IncInc. (“EBCI”), with all amounts translated into U.S. dollars:

 SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION

 September 30, 2022  December 31, 2021  September 30, 2023  December 31, 2022 
Lab equipment $819,988  $310,957  $818,460  $831,123 
Computer equipment  24,841   10,818 
Property and Equipment, gross        
Computer equipment and leasehold improvements  27,759   25,137 
Less: Accumulated depreciation  (131,885)  (27,345)  (307,067)  (178,775)
Property and equipment, net of accumulated depreciation $712,944  $294,430  $539,152  $677,485 

 

Depreciation expense was $44,45844,105 and $2,24044,458 for the three months ended September 30, 20222023, and 2021,2022, respectively. Depreciation expense was $114,850132,734 and $2,240114,850 for the nine months ended September 30, 20222023 and 2021,2022, respectively.

 

5.NOTE 6. ACCRUED LIABILITIES

As of September 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:

SCHEDULE OF ACCRUED LIABILITIES

  September 30, 2023  December 31, 2022 
Product development $94,663  $195,104 
Accrued salaries and wages  729,616   1,175,963 
Professional fees  74,499   83,255 
Accrued restructuring costs  607,602   — 
Accrued franchise taxes  9,449   — 
Patent costs  18,000   251,333 
Total accrued expenses $1,533,829  $1,705,655 

NOTE 7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS

Authorized Capital

The holders of the Company’s common stock are entitled to one vote per share.share. Holders of common stock are entitled to receive ratably such dividends, if any, as may be declared by the Board of Directors out of legally available funds. Upon the liquidation, dissolution, or winding up of the Company, holders of common stock are entitled to share ratably in all assets of the Company that are legally available for distribution. As of September 30, 2022,2023, 100,000,000 shares of common stock and 20,000,000 shares of Preferred Stock were authorized under the Company’s articles of incorporation.

 

On December 30, 2020, the Company amended its articles of incorporation to designate and authorize 20,000,000 shares of preferred stock. The Company issued Series B preferred stock (“Series B Preferred Stock), which has a certificate of designation authorizing issuance of 3,600,000 preferred shares. During the three months ended March 31, 2021, holders of an aggregate of 65,509 shares of Series B Preferred Stock converted their shares into 65,509 shares of common stock. Following those conversions, no Series B Preferred stock shares remain outstanding.Equity Distribution Agreement

 

Series C Preferred Shares

On May 3, 2022,September 1, 2023, the BoardCompany entered into the Distribution Agreement, with Canaccord, pursuant to which the Company may offer and sell from time to time, through Canaccord as sales agent and/or principal, shares of Directors (the “Board”) declared a dividend of one one-thousandth of a sharecommon stock of the Company’s Series C Preferred Stock (“Series C Preferred Stock”) for each outstandingCompany, par value $0.01 per share having an aggregate offering price of up to $10.0 million. Due to the offering limitations applicable to the Company and in accordance with the terms of the Company’sDistribution Agreement, the Company may offer Common Stock having an aggregate gross sales price of up to $2,392,514 pursuant to the prospectus supplement dated September 1, 2023 (the “Common Stock”) held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (the “Record Date”“Prospectus Supplement”). This dividend was based onSubject to the numberterms and conditions of outstanding sharesthe Distribution Agreement, Canaccord may sell the Common Stock by any method permitted by law deemed to be an “at-the-market offering”. The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the Common Stock sold through Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses. The Company may also sell Common Stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale. Any sale of Common Stock priorto Canaccord as principal would be pursuant to the Reverse Stock Split. The outstanding sharesterms of Series C Preferred Stock were entitled to vote together witha separate terms agreement between the outstanding shares of the Company’s Common Stock, as a single class, exclusively with respect to a proposal giving the Board the authority, as it determines appropriate, to implement a reverse stock split within twelve months following the approval of such proposal by the Company’s stockholders (the “Reverse Stock Split Proposal”), as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split Proposal (the “Adjournment Proposal”).Company and Canaccord.

 

1514

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The Company held a special meeting of stockholders on July 14, 2022 (the “Special Meeting”) forDuring the purpose of voting on, among other proposals, a Reverse Stock Split Proposalthree and an Adjournment Proposal. All shares of Series C Preferred Stock that were not present in person or by proxy at the Special Meeting were automatically redeemed bynine months ended September 30, 2023, the Company immediately prior to the opening of the polls at Special Meeting (the “Initial Redemption”). All shares that were not redeemed pursuant to the Initial Redemption were redeemed automatically upon the approval by the Company’s stockholders of the Reverse Stock Split Proposal at the Special Meeting (the “Subsequent Redemption” and, together with the Initial Redemption, the “Redemption”). Each share of Series C Preferred Stock was entitled to receive $0.10 in cash for each 10 whole shares of Series C Preferred Stock immediately prior to the Redemption. As of June 30, 2022, there were 52,684.548 shares of Series C Preferred Stockhas issued and outstanding. As of September 30, 2022, both the Initial Redemption and the Subsequent Redemption have occurred. As a result, no shares of Series C Preferred Stock remain outstanding.common stock through the Distribution Agreement. The Company had capitalized deferred offering costs of $125,800 related to establishing the Distribution Agreement with Canaccord and the Purchase Agreement with Lincoln Park and no reductions to additional paid in capital.

 

Common Stock Activity

 

On February 15, 2022, the Company completed a public offering of 400,000 shares of Common Stock and warrants to purchase up to 400,000 shares of Common Stock for gross proceeds of approximately $1010.0 million, before deducting underwriting discounts and commissions and other offering expenses. A.G.P./Alliance Global Partners acted as sole book-running manager for the offering. In addition, Enveric granted the underwriter a 45-day option to purchase up to an additional 60,000 shares of Common Stock and/or warrants to purchase up to an additional 60,000 shares of Common Stock at the public offering price, which the underwriter has partially exercised for warrants to purchase up to 60,000 shares of common stock. At closing, Enveric received net proceeds from the offering of approximately $9.1 million, after deducting underwriting discounts and commissions and estimated offering expenses with $5.8 million allocated to equity, $3.6 million to warrant liability and the remaining $0.3 million recorded as an expense.

 

On July 22, 2022, the Company entered into a securities purchase agreement (the “Registered Direct Securities Purchase Agreement”) with an institutional investor for the purchase and sale of 116,500shares of the Company’s common stock, pre-funded warrants to purchase up to 258,500shares of common stock (the “RD Pre-Funded Warrants”), and unregistered preferred investment options (the “RD Preferred Investment Options”) to purchase up to 375,000shares of common stock (the “RD Offering”). The gross proceeds from the RD Offering were approximately $3,000,000. Subject to certain ownership limitations, the RD Pre-Funded Warrants became immediately exercisable at an exercise price equal to $0.0001per share of common stock. On August 3, 2022, all of the issued RD Pre-Funded Warrants were exercised.

 

Concurrently with the RD Offering, the Company entered into a securities purchase agreement (the “PIPE Securities Purchase Agreement”) with institutional investors for the purchase and sale of 116,000shares of common stock, pre-funded warrants to purchase up to 509,000shares of common stock (the “PIPE Pre-Funded Warrants”), and preferred investment options (the “PIPE Preferred Investment Options”) to purchase up to 625,000shares of the common stock in a private placement (the “PIPE Offering”). The gross proceeds from the PIPE Offering were approximately $5,000,000. Subject to certain ownership limitations, the PIPE Pre-Funded Warrants became immediately exercisable at an exercise price equal to $0.0001per share of common stock. All of the issued PIPE Pre-Funded Warrants were exercised on various dates prior to August 18, 2022.

 

The RD offeringOffering and PIPE Offering closed on July 26, 2022, with aggregate gross proceeds of approximately $8 million. The aggregate net proceeds from the offerings, after deducting the placement agent fees and other estimated offering expenses, were approximately $7.1 million, with $3.2 million allocated to equity, $4.3 million to investment option liability, and the remaining $0.4 million recorded as an expense.

 

During the nine months ended September 30, 2023, a total of 103,641 shares of Common Stock were issued pursuant to the conversion of restricted stock units. During the nine months ended September 30, 2022, a total of 2,122 shares of Common Stock were issued pursuant to the conversion of restricted stock units.

 

16

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Stock Options

Amendment to 2020 Long-Term Incentive Plan

On May 3, 2022, our Boardboard of directors (“Board”) adopted the First Amendment (the “Plan Amendment”) to the Enveric Biosciences, Inc. 2020 Long-Term Incentive Plan (the “Incentive Plan”) to (i) increase the aggregate number of shares available for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such issuance date. The Plan Amendment was approved by the Company’s stockholdersshareholders at a special meeting of the Company’s stockholdersshareholders held on July 14, 2022.2022.

15

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

A summary of activity under the Company’s incentive plan for the nine months ended September 30, 20222023, is presented below:

 SCHEDULE OF STOCK OPTION

  Number of Shares  Weighted Average Exercise Price  Weighted Average Grant Date Fair Value  Weighted Average Remaining Contractual Term (years)  Aggregate Intrinsic Value 
Outstanding at December 31, 2021  23,829  $79.00  $103.50   5.3  $34,333 
Forfeited  (1,000) $175.00  $140.50   —   — 
Outstanding at September 30, 2022  22,829  $75.00  $101.50   4.3  $— 
                     
Exercisable at September 30, 2022  19,690  $74.93  $101.00   3.8  $— 
  Number of Shares  Weighted Average Exercise Price  Weighted Average Grant Date Fair Value  Weighted Average Remaining Contractual Term (years)  Aggregate Intrinsic Value 
Outstanding at December 31, 2022  48,329  $37.05  $44.82   4.1  $    — 
Forfeited  (16,476) $5.79  $5.80   —  $— 
Outstanding at September 30, 2023  31,852  $53.18  $74.04   3.4  $— 
Exercisable at September 30, 2023  24,626  $63.72  $86.52   3.0  $— 

 

The Company’s stock basedstock-based compensation expense, recorded within general and administrative expense in the condensed consolidated statement of operations and comprehensive loss, related to stock options for the three months ended September 30, 20222023, and 20212022 was $48,69744,606 and $4,68348,697, respectively. The Company’s stock basedstock-based compensation expense, recorded within general and administrative expense, related to stock options for the nine months ended September 30, 20222023 and 20212022 was $134,383147,067 and $4,683134,383, respectively. As of September 30, 2022,2023, the Company had $222,50193,697 in unamortized stock option expense, which will be recognized over a weighted average period of 1.31 years.

During the nine months ended September 30, 2021, the Company exchanged options to purchase 11,209 shares of common stock for 6,509 restricted stock units and 843 restricted stock awards. In connection with this exchange, the Company recognized $298,714 in inducement expense related to the increase in fair value of the new awards over the old awards, which is included in other expenses on the Company’s consolidated statement of operations and comprehensive income (loss).year.

 

Restricted Stock Awards

 

The Company’s activity in restricted common stock was as follows for the nine months ended September 30, 2022:

SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY

  Number of shares  Weighted average fair value 
Non-vested at December 31, 2021  1,031  $141.50 
Forfeited  (700) $146.50 
Vested  (331) $130.40 
Non-vested at September 30, 2022  —  $— 

For the three months ended September 30, 20222023, and 2021,2022, the Company recorded $6,2500 and $23,9956,250, respectively, in stock-based compensation expense within general and administrative expense, related to restricted stock awards. For the nine months ended September 30, 20222023 and 2021,2022, the Company recorded $24,3630 and $80,10924,363, respectively, in stock-based compensation expense within general and administrative expense, related to restricted stock awards. As of September 30, 2022,2023, there were no unamortized stock-based compensation costs related to restricted share awards. The balanceDuring the three months ended September 30, 2023, the Company settled the 708 vested and unissued shares for cash of Common Shares related to the vested restricted stock awards as$14,250. As of September 30, 2022 will be issued during the 2022 calendar year. There2023, there are 9740 vested and unissued shares of restricted stock awards as of September 30, 2022.awards.

 

1716

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Issuance of Restricted Stock Units

 

The Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2022:2023:

SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY

 Number of shares  Weighted average fair value  Number of shares  Weighted average
fair value		 
Non-vested at December 31, 2021  62,013  $126.00 
Non-vested at December 31, 2022  64,053  $92.57 
Granted  37,445  $33.50   182,500  $2.73 
Vested  (62,636) $19.80 
Forfeited  (26,772) $79.64   (35,666) $27.45 
Vested  (7,569) $140.60 
Non-vested at September 30, 2022  65,117  $92.02 
Non-vested at September 30, 2023  148,251  $28.39 

 

For the three months ended September 30, 20222023, and 2021,2022, the Company recorded $590,190328,253 and $458,308590,190, respectively, in stock-based compensation expense related to restricted stock units. For the nine months ended September 30, 20222023 and 2021,2022, the Company recorded $1,932,5531,638,365 and $4,710,2251,932,553, respectively, in stock-based compensation expense related to restricted stock units, which is a component of both general and administrative and research and development expenses in the unaudited condensed consolidated statement of operations.

operations and comprehensive loss. As of September 30, 2022,2023, the Company had unamortized stock-based compensation costs related to restricted stock units of $5,858,0482,388,221 which will be recognized over a weighted average period of 3.02.3 years and unamortized stock-based costs related to restricted stock units which will be recognized upon achievement of specified milestones.

As of September 30, 2022,2023, 1,856 shares of Common Stock have been issued in relation to vested restricted stock units and 61,42820,847 restricted stock units are vested without shares of Common Stockcommon stock being issued.issued, with all of these shares due as of September 30, 2023.

 

The following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:

SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS

Stock-based compensation for RSU 2022  2021  2022  2021 
  Three months ended September 30,  Nine months ended September 30, 
Stock-based compensation for RSU 2022  2021  2022  2021 
General and administrative $357,756  $315,929  $1,138,080  $4,592,748 
Research and development  232,434   118,474   794,473   118,474 
Total $590,190  $434,403  $1,932,553  $4,711,222 

Warrants

On February 11, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with A.G.P./Alliance Global Partners (the “Underwriter”). Pursuant to the Underwriting Agreement, the Company agreed to sell, in a firm commitment offering, 400,000 shares of the Company’s Common Stock and accompanying warrants to purchase up to an aggregate of 400,000 shares of its common stock (“February 2022 Warrants”), as well as up to 60,000 additional shares of common stock and/or warrants to purchase an aggregate of up to 60,000 shares of its common stock that may be purchased by the Underwriter pursuant to a 45-day option granted to the Underwriter by the Company (the “Offering”). Each share of common stock was sold together with a common warrant to purchase one share of common stock, at an exercise price of $27.50 per share. Such common warrants were immediately exercisable and will expire five years from the date of issuance. There is not expected to be any trading market for the common warrants issued in the Offering. The combined public offering price of each share of common stock and accompanying common warrant sold in the Offering was $25.00. On February 14, 2022, the Underwriter exercised its option to purchase an additional 60,000 warrants.

In connection with the Registered Direct (“RD”) Offering and the Private Investment in Public Entity (“PIPE”) Offering entered into on July 22, 2022, the Company entered into Warrant Amendment (the “Warrant Amendments”) with the investors in both offerings to amend certain existing warrants to purchase up to an aggregate of 122,000 shares of Common Stock that were previously issued to the investors, with an exercise price of $27.50 per share (subsequent to the 1-for-50 reverse stock split that occurred on July 14, 2022) and expiration date of February 15, 2027. Pursuant to the Warrant Amendments, the previously issued warrants were amended, effective upon the closing of the offerings, so that the amended warrants have a reduced exercise price of $7.78 per share and expire five and one-half years following the closing of the offerings. In connection with this transaction, the Company determined the fair value of the February 2022 Warrants immediately prior to the Warrant Amendment and the fair value of the amended warrants immediately after the Warrant Amendment. The incremental change in fair value was deemed to be $251,357, which was included as equity issuance costs related to the RD and PIPE financing transactions.

18

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

  2023  2022  2023  2022 
  Three months ended
September 30,		  Nine months ended
September 30,		 
  2023  2022  2023  2022 
Stock-based compensation expense for RSUs:                
General and administrative $101,607  $357,756  $946,851  $1,138,080 
Research and development  226,646   232,434   691,514   794,473 
Total $328,253  $590,190  $1,638,365  $1,932,553 

 

Preferred Investment OptionsWarrants

In connection with the Registered Direct Securities Purchase Agreement the Company issued unregistered preferred investment options to purchase up to 375,000 shares of common stock. Subject to certain ownership limitations, the RD Preferred Investment Options became immediately exercisable at an exercise price equal to $7.78 per share of common stock. The RD Preferred Investment Options are exercisable for five and one-half years from the date of issuance.

In connection with the PIPE Securities Purchase Agreement the Company issued unregistered preferred investment options to purchase up to 625,000 shares of the common stock. Subject to certain ownership limitations, PIPE Preferred Investment Options became immediately exercisable at an exercise price equal to $7.78 per share of common stock. The PIPE Preferred Investment Options are exercisable for five and one-half years from the date of issuance

On July 26, 2022, in connection with the RD Offering and PIPE Offering, the Company issued preferred investment options (the “Placement Agent Preferred Investment Options”) to an entity to purchase up to 70,000 shares of the common stock for acting as a placement agent. The Placement Agent Preferred Investment Options have substantially the same terms as the RD Preferred Investment Options and the PIPE Preferred Investments Options, except the Placement Agent Preferred Investment Options have an exercise price of $10.00 per share. The Placement Agent Preferred Investment Options are exercisable for five years from the date of the commencement of the RD Offering and PIPE Offering.

 

The following table summarizes information about shares issuable under warrants outstanding aton September 30, 2022:2023:

SCHEDULE OF WARRANTS AND INVESTMENT OPTIONSOUTSTANDING

  Warrant shares outstanding  Weighted average exercise price  Weighted average remaining life  Intrinsic value 
Outstanding at December 31, 2021  195,463  $131.00   3.4  $801,024 
Issued  1,227,500  $10.31      $— 
Exercised  (767,500) $—   —  $— 
Outstanding at September 30, 2022  655,463  $58.36   3.8  $5,514 
                 
Exercisable at September 30, 2022  655,463  $58.36   3.8  $5,514 
  Warrant shares outstanding  Weighted average exercise price  Weighted average remaining life  Intrinsic value 
Outstanding at December 31, 2022  655,463  $58.36   3.6  $5,514 
Expired  (45,570) $111.50   —  $— 
Outstanding at September 30, 2023  609,893  $50.46   2.9  $— 
Exercisable at September 30, 2023  609,893  $50.46   2.9  $— 

 

The warrants assumed pursuant to the acquisition of MagicMed contain certain down round features, which were not triggered by the February 2022 public offering or theand July 2022 public offering,RD Offering, that would require adjustment to the exercise price upon certain events when the offering price is less than the stated exercise price.

 

The following table summarizes information about investment options outstanding at September 30, 2022:

  Investment options outstanding  Weighted average exercise price  Weighted average remaining life  Intrinsic value 
Outstanding at January 1, 2021  —  $—   —  $— 
Issued  1,070,000  $7.93   5.5   — 
Outstanding at September 30, 2021  1,070,000  $7.93   5.3  $— 
                 
Exercisable at September 30, 2021  1,070,000  $7.93   5.3  $— 

1917

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

6.Preferred Investment Options

The following table summarizes information about investment options outstanding on September 30, 2023:

SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS

  Investment options outstanding  Weighted average exercise price  Weighted average remaining life  Intrinsic value 
Outstanding at December 31, 2022  1,070,000  $7.93   5.1  $— 
Outstanding at September 30, 2023  1,070,000  $7.93   4.3  $— 
Exercisable at September 30, 2023  1,070,000  $7.93   4.3  $— 

NOTE 8. REDEEMABLE NON-CONTROLLING INTEREST

Spin-Off and Related Private Placement

In connection with the planned Spin-Off, on May 5, 2022, Akos and the Company entered into the Akosinto a Securities Purchase Agreement (the “Akos Purchase Agreement”) with the Akos Investor,an accredited investor (the “Akos Investor”), pursuant to which Akos agreed to sell up to an aggregate of 5,000 shares of Akos Series A Preferred Stock, at price of $1,000 per share, and warrants (the “Akos Warrants”) Akos Warrants to purchase shares of Akos’ common stock, par value $0.01 per share (the “Akos Common Stock”), for an aggregate purchase price of up to $5,000,000 (the “Akos Private Placement”). The Akos Purchase Agreement iswas guaranteed by the Company. Pursuant to the Akos Purchase Agreement, Akos has issued 1,000 shares of the Akos Series A Preferred Stock to the Akos Investor in exchange for $1,000,000 on May 5, 2022. The additional $4,000,000 willwas to be received on or immediately prior to the Spin-Off. The issuance of the Akos Series A Preferred Stock results in RNCI (see Note 2). Palladium Capital Advisors, LLC (“Palladium”) acted as placement agent for the Akos Private Placement. Pursuant to the Akos Purchase Agreement, Akos hashad agreed to pay Palladium a fee equal to 9% of the aggregate gross proceeds raised from the sale of the shares of the Akos Series A Preferred Stock and a non-accountable expense allowance of 1% of the aggregate gross proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement. The fee due in connection with the Akos Private Placement shallto be paid to Palladium in the form of convertible preferred stock and warrants was on similar terms to the securities issued in the Akos Private Placement. As of June 30, 2022, there have been no accruals recorded for the fees or warrants since the closing of the spin-off is not probable. Palladium iswas also entitled to warrants to purchase Akos Common Stock in an amount up to 8% of the number of shares of Akos Common Stock underlying the shares issuable upon conversion of the Akos Series A Preferred Stock. As of September 30, 2023, no accruals are required to be recorded for the fees or warrants since the Akos Series A Preferred Stock has been redeemed.

 

Terms of Akos Series A Preferred Stock

 

Under the Certificate of the Designations, Preferences, and Rights of Series A Convertible Preferred Stock of Akos (the “Akos Series A Preferred Certificate of Designations”), on or immediately prior to the completion of the spin-off of Akos into an independent, separately traded public company listed on the Nasdaq Stock Market, the outstanding Akos Series A Preferred Stock will be automatically converted into a number of shares of Akos Common Stock equal to 25% of the then issued and outstanding Akos Common Stock, subject to the Beneficial Ownership Limitation (as defined in the Akos Purchase Agreement). Cumulative dividends on each share of Akos Series A Preferred Stock accrue at the rate of 5% annually.

 

The Akos Series A Preferred Certificate of Designations providesprovided that upon the earlier of (i) the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall have the right (the “Put Right”), but not the obligation, to cause Akos to purchase all or a portion of the Akos Series A Preferred Stock for a purchase price equal to $1,000per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of Designations (the “Stated Value”), plus all the accrued but unpaid dividends per share. In addition, after the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred and Akos is not in material default of any of the transaction documents, Akos may, at its option, at any time and from time to time, redeem the outstanding shares of Akos Series A Preferred Stock, in whole or in part, for a purchase price equal to the aggregate Stated Value of the shares of Akos Series A Preferred Stock being redeemed and the accrued and unpaid dividends on such shares. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment of the purchase price for the shares purchased under the Put Right.

 

The Akos Series A Preferred Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of Akos Common Stock upon conversion of the Akos Series A Preferred Stock that would result in the number of shares of Akos Common Stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of Akos Common Stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to Akos, the holder may increase or decrease the limit of the amount of ownership of outstanding shares of Akos Common Stock after converting the holder’s shares of Akos Series A Preferred Stock, provided that any change in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to Akos.

 

2018

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Redemption of Akos Series A Preferred Stock

In May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid dividends of approximately $52,000 for a total of approximately $1,052,000. The Company had 20 days following the receipt of the Put Exercise Notice to make the payment and made payment on May 19, 2023. Upon redemption in May 2023, the Company revalued the derivative liability and the Company recognized a change in fair value of the derivative liability on the Company’s condensed consolidated statement of operations during the second quarter of 2023 of $714,000.

The Company, Akos, and the Akos Investor have terminated the Akos Purchase Agreement in connection with the planned Spin-Off and certain registration rights agreement in connection with the Akos Private Placement.

Accounting for Akos Series A Preferred Stock

 

Since the shares of Akos Series A Preferred Stock arewere redeemable at the option of the holder and the redemption is not solely in the control of the Company, the shares of Akos Series A Preferred Stock arewere accounted for as a redeemable non-controlling interest and classified within temporarymezzanine equity in the Company’s condensed consolidated balance sheets. The redeemable non-controlling interest was initially measured at fair value. Dividends on the shares of Akos Series A Preferred Stock arewere recognized as preferred dividends attributable to redeemable non-controlling interest in the Company’s unaudited condensed consolidated statement of operations.operations and comprehensive loss.

 

The table below presents the reconciliation of changes in redeemable non-controlling interest:

SCHEDULE OF RECONCILIATION CHANGE IN REDEEMBALEREDEEMABLE NONCONTROLLING INTEREST

Balance at December 31, 2021 $— 
Redeemable non-controlling interest, net of initial value embedded derivative of $402,000 and net of issuance costs of $41,962  556,038 
Preferred dividends attributable to redeemable non-controlling interest  20,411 
Accretion of embedded derivative and transaction costs to redemption value  184,985 
Balance at September 30, 2022 $761,434 
Balance at December 31, 2022 $885,028 
Preferred dividends attributable to redeemable non-controlling interest  19,041 
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred  147,988 
Redemption of Akos Series A Preferred Stock  (1,052,057)
Balance at September 30, 2023 $— 

 

AsIn May 2023, the Akos Series A Preferred Stock was redeemed for a total of September 30, 2022,$1,052,057, and the redemption valuebalance of the redeemable non-controlling interest is $1,000,0000 plus cumulative dividends which accrue at the rateas of 5% annually, or approximately $1,020,000. The Company has guaranteed this redemption on behalf of Akos. September 30, 2023.

 

7.NOTE 9. COMMITMENTS AND CONTINGENCIES

 

The Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s financial position, results of operations or cash flows.

Australian Subsidiary Research and Development

On March 23, 2023, the Company issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase 1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. Under the agreement, Avance Clinical will manage the Phase 1 clinical trial of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s Therapeutic Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract is approximately 3,000,000 AUD, which translates to approximately $2,000,000 USD as of September 30, 2023. As of September 30, 2023, the Company has paid approximately $950,997 of the Avance Clinical contract costs and has $549,713 recorded as prepaid assets within prepaid and other current assets on the accompanying condensed consolidated balance sheet. For the three and nine months ended September 30, 2023, the Company has expensed $157,117 and $401,284 in research and development expenses, respectively, within the accompanying condensed consolidated statement of operations.

19

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Development and Clinical Supply Agreement

 

On February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “PureForm Agreement”) with PureForm Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”) for the Company’s development plans for cancer treatment and supportive care. Under the terms of the PureForm Agreement, PureForm has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term of the Agreement (contingent upon an initial minimum order of 1 kilogram during the first thirty (30) days from the effective date) and has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties. All inventions that are developed jointly by the parties in the course of performing activities under the PureForm Agreement will be owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information to the Company.

 

The initial term of the PureForm Agreement is three (3) years commencing on the effective date of the PureForm Agreement, subject to extension by mutual agreement of the parties. The PureForm Agreement may be terminated by either party upon thirty (30) days written notice of an uncured material breach or immediately in the event of bankruptcy or insolvency. The PureForm Agreement contains, among other provisions, representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for an agreement of this nature.

 

The Company has met the minimum purchase requirement of 1 kilogram during the first thirty days of the PureForm Agreement’s effectiveness.

 

21

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan

On December 26, 2017, Jay Pharma entered into a purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan (the “Vogel-Nathan Purchase Agreement”), pursuant to which Jay Pharma was assigned ownership rights to certain patents, which were filed and unissued as of the date of the Vogel-Nathan Purchase Agreement. The Vogel-Nathan Purchase Agreement includes a commitment to pay a one-time milestone totaling $200,000 upon the issuance of a utility patent in the United States or by the European Patent Office, as defined in the agreement. The Company has accrued such amount as of December 31, 2021, as a result of the milestone criteria being achieved. Payment was made during January 2022. In addition, a milestone payment totaling $300,000 is due upon initiation of a Phase II(b) study. Research activities related to the relevant patents are still in pre-clinical stage, and accordingly, this milestone has not been achieved. The Vogel-Nathan Purchase Agreement contains a commitment for payment of royalties equaling 2%2% of the first $20$20 million in net sales derived from the commercialization of products utilizing the relevant patent. As these products are still in the preclinical phase of development, no royalties have been earned.

 

Agreement with Tikkun

License Agreement

Jay Pharma, Tikkun Olam LLC (“TO LLC”) and Tikkun Olam Hemp LLC (“TOH”) entered into a license agreement dated on January 10, 2020, pursuant to which Jay Pharma would acquire certain in-licensed and owned intellectual property rights related to the cannabis products in the United States (presently excluding the state of New York) from TO LLC and TOH, each of which is an affiliate of TO Holdings Group LLC, in exchange for royalty payments of (i) four percent (4.0%) of net sales of OTC cancer products made via consumer channels; and (ii) five percent (5.0%) of net sales of beauty products made via consumer channels; and (iii) three percent (3.0%) of net sales of OTC cancer products made via professional channels, along with a minimum net royalty payment starting in January 1, 2022 and progressively increasing up to a cap of $400,000 maximum each year for the first 10 years, then $600,000 maximum each year for the next 5 years, and an annual maximum cap of $750,000 each year thereafter during the term of the agreement. The licensed intellectual property rights relate to beauty products and OTC cancer products, and branding rights related thereto. The beauty products include any topical or transdermal cannabis-containing or cannabis-derived (including hemp-based) skin care or body care beauty products, and the OTC cancer products means any cancer-related products, in each case excluding those regulated as a drug, medicine, or controlled substance by the FDA or any other relevant governmental authority, such as the USDA.

On August 12, 2020, Jay Pharma, TO LLC and TOH entered into the First Amendment to the License Agreement, pursuant to which all references to the Original Amalgamation Agreement and the amalgamation were revised to be references to the Tender Agreement and the Offer, as applicable.

On October 2, 2020, Jay Pharma, TO LLC and TOH entered into the Second Amendment to the License Agreement, pursuant to which the effective date of the transactions was revised to occur as of October 2, 2020.

Other Consulting and Vendor Agreements

The Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services, with terms ranging between 1 and 1518 months. These agreements, in aggregate, commit the Company to approximately $2.41.2 million in future cash.cash payments.

 

8.NOTE 10. INCOME TAXESSUBSEQUENT EVENTS

Lincoln Park Equity Line

 

On September 16, 2021,November 3, 2023, the Company acquired MagicMed. In connectionentered into a Purchase Agreement and a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock, par value $0.01 per share subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement.

Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the “Purchase Shares”). However, such sales of Common Stock by the Company, if any, will be subject to important limitations set forth in the Purchase Agreement, including limitations on number of shares that may be sold. Sales may occur from time to time, at the Company’s sole discretion, over the 24-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase Agreement are satisfied, including that a registration statement on Form S-1 covering the resale of the shares of our Common Stock that have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company has filed with the acquisition,SEC pursuant to the Company recorded intangible assets from IPR&D valued at $Registration Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC.

35,500,000

, which wouldBecause the purchase price per share to be tested for impairment for book purposes, but without a tax basis, creating a deferred tax liability of $9,061,927. The deferred tax liability decreased to $1,607,122 due to an impairment on intangible assets of $29,048,164and an impairment of goodwill of $8,225,862 paid by Lincoln Park for the year ended December 31, 2021. Asshares of September 30, 2022,Common Stock that we may elect to sell to Lincoln Park under the balancePurchase Agreement, if any, will fluctuate based on the market prices of our Common Stock at the deferred tax liabilitytime we elect to sell shares to Lincoln Park pursuant to the Purchase Agreement, if any, it is $not possible for us to predict the number of shares of Common Stock that we will sell to Lincoln Park under the Purchase Agreement, the purchase price per share that Lincoln Park will pay for shares purchased from us under the Purchase Agreement, or the aggregate gross proceeds that we will receive from those purchases by Lincoln Park under the Purchase Agreement.

1,486,413

For additional details, please refer to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2023.

.

2020 Long-Term Incentive Plan Amended

On November 2, 2023, the shareholders approved the amendments to the 2020 Long-Term Incentive Plan, which was approved by the Board on August 8, 2023 (the “Amended Incentive Plan”). The Amended Incentive Plan increased the number of authorized shares reserved for issuance under the Amended Incentive Plan to a maximum of 350,000, subject to adjustment.

2220

 

 

Item 2. Management’s discussion and analysis of financial condition and results of operations

 

The information set forth below should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company” and similar terms refer to Enveric Biosciences, Inc., a Delaware corporation.

Cautionary Note Regarding Forward-Looking Statements

 

This quarterly report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that,” “may,” “plans,” “seeks,” “projects,” “targets,” and “would” or the negative of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, future financial and operating results, the company’s plans, objectives, expectations and intentions and other statements that are not historical facts. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from our historical experience and our present expectations, or projections described under the sections in this Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These risks and uncertainties include, but are not limited to:

 

●our dependence on the success of our prospective product candidates, which are in the early stages of development and may not reach a particular stage in development, receive regulatory approval, or be successfully commercialized;
●potential difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical development and investigational new drug (“IND”) application filings and into clinical development;
●the risk that the cost savings, synergies and growth from our combination with MagicMed Industries Inc. and the successful use of the rights and technologies acquired in the combination may not be fully realized or may take longer to realize than expected;
●the ongoing impact of the novel coronavirus (COVID-19) on our business, including our current plans for product development, as well as any currently ongoing preclinical studies and clinical trials and any future studies or other development or commercialization activities;
●the limited study on the effects of medical cannabinoids and psychedelics, and the chance that future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of cannabinoids or psychedelics;
●the expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing interpretations;
●the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;
●the fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing the applicable developmental and regulatory prerequisites;
●our ability to effectively and efficiently build, maintain and legally protect our molecular derivatives library so that it can be an essential building block from which those in the biotech industry can develop new patented products;
●our ability to establish or maintain collaborations on the development of therapeutic candidates;
●our ability to obtain appropriate or necessary governmental approvals to market potential products;
●our ability to manufacture product candidates on a commercial scale or in collaborations with third parties;
●our significant and increasing liquidity needs and potential requirements for additional funding;
●our ability to obtain future funding for developing products and working capital and to obtain such funding on commercially reasonable terms;
●legislative changes related to and affecting the healthcare system, including, without limitation, changes and proposed changes to the Patient Protection and Affordable Care Act (“PPACA”);Act;
●the intense competition we face, often from companies with greater resources and experience than us;
●our ability to retain key executives and scientists;
●the ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection;
●political, economic, and military instability in Israel which may impede our development programs;
●our ability to successfully spin off our cannabinoid assets;
●the effect that the reverse stock split of our common stock effected on July 14, 2022 may have on the price of our common stock; and
●our success at managing the risks involved in the foregoing.foregoing; and
●the risk of loss in excess of insurance limitations on funds help in U.S Banking Institutions.

21

 

For a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item 1A of this Form 10-Q and Part I, Item 1A of the annual report on Form 10-K filed with the SEC on March 31, 2022.Annual Report. Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. We undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise, except as required by law.

 

23

Business Overview

We are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, depression, and addiction disorders. We seek to improveLeveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust intellectual property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, the livesEVM201 Series, comprises next generation synthetic prodrugs of patients sufferingthe active metabolite, psilocin. Enveric is developing the first product from cancer, initially by developing palliative and supportive care productsthe EVM201 Series – EB-373 – for people suffering from certain side effectsthe treatment of cancer and cancer treatment such as pain or skin irritation. We currently intendpsychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer such palliative and supportive care productsa first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the United States, following approval through established regulatory pathways.patient.

 

Psychedelics

 

Following our amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), we have continued to pursue the development of MagicMed’s proprietary psychedelic derivativesPsychedelic Derivatives library, the Psybrary™ which we believe will help us to identify and develop the right drug candidates needed to address mental health challenges, including cancer-related distress. We synthesize novel versions of classic psychedelics, such as psilocybin, N-dimethyltryptamine (DMT), mescaline and MDMA, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations and hundreds of synthesized molecules. Within the Psybrary™ we have three different types of molecules, Generation 1 (classic psychedelics), Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic molecular compounds and derivatives (“Psychedelic Derivatives”)Derivatives on a regular basis through our work at Enveric Labs in Calgary, Alberta, Canada, where we have a team of PhD scientists with expertise in synthetic biology and chemistry. To date we have created over 500 molecules that are housed in the Psybrary.

 

We screen newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary artificial intelligence (AI)AI tool. Leveraging AI systems is expected to reduce the time and cost of pre-clinical, clinical, and commercial development. We believe it streamlines pharmaceutical design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological effects to help determine ideal drug candidates, tailored to each indication. Each of these molecules that we believe are patentable can then be further screened to see how changes to its makeup alter its effects in order to synthesize additional new molecules. New compounds of sufficient purity are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal), and ultimately clinical (human) evaluations. We intend to utilize our Psybrary™ and the AI tool to categorize and characterize the Psybrary™ substituents to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.

 

22

Cannabinoids

 

We are also aimingaim to advance a pipeline of novel cannabinoid combination therapies for the side effects of cancer treatments, such as chemotherapy and radiotherapy.

 

We intend to bring together leading oncology clinicians, researchers, academic and industry partners to develop both external proprietary products and a robust internal pipeline of product candidates aimed at improving quality of life and outcomes for cancer patients. We intend to evaluate options to out-license our proprietary technology as it moves along the regulatory pathway.

 

In developing our product candidates, we intend to focus on cannabinoids derived from non-hemp botanical sources, and synthetic materials containing no tetrahydrocannabinol (THC)(“THC”) in order to comply with U.S. federal regulations. Of the potential cannabinoids to be used in therapeutic formulations, THC, which is responsible for the psychoactive properties of marijuana, can result in undesirable mood effects. Selected cannabidiol (CBD) and cannabigerol (CBG) candidates, on the other hand, have amounts of THC well below 0.1% and are not psychotropic and therefore more attractive candidates for translation into therapeutic practice. Drugs with less than 0.1% THC have a history, when approved as drugs by FDA,the Food and Drug Administration “FDA”, of being able to be rescheduled by DEA from Schedule I to Schedule V, as in the case of Epidiolex and Marinol. In the future, we may utilize cannabinoids that are derived from cannabis plants, which may contain higher amounts of THC; however, we only intend to do so in jurisdictions where THC is legal. However, synthetic THC is a Schedule I controlled substance; so, the use of any APIs (Active Pharmaceutical Ingredients) containing synthetic THC (or naturally derived THC in concentrations greater than 0.3%) may increase regulatory scrutiny and require additional expenses and authorizations. All current and future product candidates that we are developing or may develop will be tested for safety and efficacy under an IND application and subject to the Food and Drug Administration (“FDA”)FDA pre-market approval process for new drugs.

 

While we continue to pursue the development of our cannabinoid-based product candidates, our principal focus is on the development of psychedelic-based treatments.

 

On May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets (the “Spin-Off”) to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority owned subsidiary of the Company (“Akos”). In connection with the Spin-Off, the Company would transfer its cannabinoid clinical development pipeline assets to Akos, while retaining its psychedelics clinical development pipeline assets.

24

Recent Developments

Reverse Stock Split

On July 14, 2022, the Company filed a Certificate of Amendment of Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of State of Delaware The Spin-Off was subject to effect a 1-for-50 reverse stock split of the shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”), either issued and outstanding or held by the Company as treasury stock, effective as of 4:05 p.m. (New York time) on July 14, 2022 (the “Reverse Stock Split”). The Company held a special meeting of stockholders (the “Special Meeting”), during which the Company’s stockholders approved the amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect a reverse stock split of the Company’s common stock at a ratio in the range of 1-for-10 to 1-for-100, with such ratio to be determined by the Company’s board of directors (the “Board”) and included in a public announcement. Following thevarious conditions, including Akos meeting the Board determined to effect the Reverse Stock Split at a ratio of 1-for-50 and approved the corresponding final form of the Certificate of Amendment.

As a result of the Reverse Stock Split, every 50 shares of issued and outstanding Common Stock were automatically combined into one issued and outstanding share of Common Stock, without any change in the par value per share. No fractional shares were issued as a result of the Reverse Stock Split. Any fractional shares that would otherwise have resulted from the Reverse Stock Split were rounded up to the next whole number. The Reverse Stock Split reduced the number of shares of Common Stock outstanding from 52,684,548 shares to 1,054,043 shares. The number of authorized shares of Common Stock under the Certificate of Incorporation remained unchanged at 100,000,000 shares. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the Reverse Stock Split described above.

Proportionate adjustments were made to the per share exercise price and the number of shares of Common Stock that may be purchased upon exercise of outstanding stock options granted by the Company, and the number of shares of Common Stock reservedqualifications for future issuance under the Company’s 2020 Long-Term Incentive Plan.

February 2022 Offering

On February 15, 2022, we completed a public offering of 400,000 shares of Common Stock and warrants to purchase up to 20,000,000 shares of Common Stock for gross proceeds of approximately $10 million, before deducting underwriting discounts and commissions and other offering expenses. A.G.P./Alliance Global Partners acted as sole book-running manager for the offering. In addition, we granted the underwriter a 45-day option to purchase up to an additional 60,000 shares of common stock and/or warrants to purchase up to an additional 60,000 shares of common stock at the public offering price, which the underwriter has partially exercised for warrants to purchase up to 60,000 shares of common stock. At closing, we received net proceeds from the offering of approximately $9.1 million, after deducting underwriting discounts and commissions and estimated offering expenses with $5.8 million allocated to equity, $3.6 million to warrant liability and the remaining $0.3 million recorded as an expense.

Series C Preferred Shares

On May 3, 2022, the Board of Directors (the “Board”) declared a dividend of one one-thousandth of a share of the Company’s Series C Preferred Stock (“Series C Preferred Stock”) for each outstanding share of the Company’s Common Stock (the “Common Stock”) held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (the “Record Date”). This dividend was basedlisting on the number of outstanding shares of CommonNasdaq Stock prior to the Reverse Stock Split. The outstanding shares of Series C Preferred Stock were entitled to vote together with the outstanding shares of the Company’s Common Stock, as a single class, exclusively with respect to a proposal giving the Board the authority, as it determines appropriate, to implement a reverse stock split within twelve months following the approval of such proposal by the Company’s stockholders (the “Reverse Stock Split Proposal”), as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split Proposal (the “Adjournment Proposal”).

The Company held a special meeting of stockholders on July 14, 2022 (the “Special Meeting”) for the purpose of voting on, among other proposals, a Reverse Stock Split ProposalMarket, and an Adjournment Proposal. All shares of Series C Preferred Stock that were not presentif successful, would result in person or by proxy at the Special Meeting were automatically redeemed by the Company immediately prior to the opening of the polls at Special Meeting (the “Initial Redemption”). All shares that were not redeemed pursuant to the Initial Redemption were redeemed automatically upon the approval by the Company’s stockholders of the Reverse Stock Split Proposal at the Special Meeting (the “Subsequent Redemption” and, together with the Initial Redemption, the “Redemption”). Each share of Series C Preferred Stock was entitled to receive $0.10 in cash for each 10 whole shares of Series C Preferred Stock immediately prior to the Redemption. As of August 12, 2022, both the Initial Redemption and the Subsequent Redemption occurred. As a result, as of September 30, 2022, no shares of Series C Preferred Stock remain outstanding.

25

The Company was not solely in control of redemption of the shares since the holders had the option of deciding whether to return a proxy card for the Special Meeting, which determine whether a given holder’s shares of Series C Preferred Stock were redeemed in the Initial Redemption or the Subsequent Redemption. Since the redemption of the Series C Preferred Stock was not solely in the control of the Company, the preferred shares are classified within temporary equity in the Company’s unaudited condensed consolidated balance sheets. The preferred shares were initially measured at redemption value. As of September 30, 2022, no shares of Series C Preferred Stock are outstanding.

Spin-Off and Related Private Placementtwo standalone public companies.

 

In connection with the planned Spin-Off, on May 5, 2022, Akos and the Company entered into a Securities Purchase Agreement (the “Akos Purchase Agreement”) with an accredited investor (the “Akos Investor”),2023, pursuant to which Akos agreed to sell up to an aggregate of 5,000 shares of Akos’ Series A Convertible Preferred Stock, par value $0.01 per share (the “Akos Series A Preferred Stock”), at price of $1,000 per share, and warrants (the “Akos Warrants”) to purchase shares of Akos’ common stock, par value $0.01 per share (the “Akos Common Stock”), for an aggregate purchase price of up to $5,000,000 (the “Akos Private Placement”). The Akos Purchase Agreement is guaranteed by the Company. Pursuant to the Akos Purchase Agreement, Akos has issued 1,000 shares of the Akos Series A Preferred Stock to the Akos Investor in exchange for $1,000,000 on May 5, 2022. The additional $4,000,000 will be received on or immediately prior to the Spin-Off. The issuance of the Akos Series A Preferred Stock results in a non-controlling interest (“NCI”) (see Note 2). Palladium Capital Advisors, LLC (“Palladium”) acted as placement agent for the Private Placement. Pursuant to the Akos Purchase Agreement, Akos has agreed to pay Palladium a fee equal to 9% of the aggregate gross proceeds raised from the sale of the shares of the Akos Series A Preferred Stock and a non-accountable expense allowance of 1% of the aggregate gross proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement. The fee due in connection with the Akos Private Placement shall be paid to Palladium in the form of convertible preferred stock and warrants on similar terms to the securities issued in the Akos Private Placement. As of September 30, 2022, there have been no accruals recorded for the fees or warrants since the closing of the spin-off is not probable. Palladium is also entitled to warrants to purchase Akos Common Stock in an amount up to 8% of the number of shares of Akos Common Stock underlying the shares issuable upon conversion of the Akos Series A Preferred Stock.

Under the Certificate of the Designations, Preferences and Rights of Series A Convertible Preferred Stock of Akos (the “Akos Series A Preferred Certificate of Designations”), on or immediately prior to the completion of the Spin-Off, the outstanding Akos Series A Preferred Stock will be automatically converted into a number of shares of Akos Common Stock equal to 25% of the then issued and outstanding Akos Common Stock, subject to the Beneficial Ownership Limitation (as defined below).

The Akos Series A Preferred Certificate of Designations, provides that upon the earlier of (i) the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall have the right (the “Put Right”), but not the obligation, to causeexercised their Put Right requiring Akos to purchaseredeem all or a portion of the Akos Series A Preferred Stock for a purchase price equal to $1,000 per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of Designations (the “Stated Value”), plus all the accrued but unpaid dividends per share. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment of the purchase price for the shares purchased under the Put Right. In addition, after the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred and Akos is not in material default of any of the transaction documents, Akos may, at its option, at any time and from time to time, redeem the outstanding shares of Akos Series A Preferred Stock in whole or in part,for $1,000 per share, plus accrued but unpaid dividends of approximately $52,000 for a purchase price equaltotal redemption amount of approximately $1,052,000. The Company completed the redemption May 19, 2023. The Company now plans to the aggregate Stated Value of the shares of Akos Series A Preferred Stock being redeemedengage with strategic advisors to identify and the accrued and unpaid dividends on such shares. The Akos Series A Preferred Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of Akos Common Stock upon conversion of the Akos Series A Preferred Stock that would result in the number of shares of Akos Common Stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of Akos Common Stock outstanding immediately after giving effectpursue alternative routes to the conversion (the “Beneficial Ownership Limitation”), except that upon noticecapture value from the holder to Akos, the holder may increase or decrease the limit of the amount of ownership of outstanding shares of Akos Common Stock after converting the holder’s shares of Akos Series A Preferred Stock, provided that any change in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to Akos.cannabinoid assets.

 

In connectionRecent Developments

Australian Subsidiary

On March 21, 2023, the Company established Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”), an Australia-based subsidiary, to support the Company’s plans to advance its EVM201 Series towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the Spin-Off,local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration (“TGA”), Australia’s regulatory authority.

On March 23, 2023, the Company would transfer its cannabinoidissued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase 1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. Under the agreement, Avance Clinical will manage the Phase 1 clinical trial of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s TGA and is currently in preclinical development pipeline assetstargeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract is approximately 3,000,000 AUD, which translates to Akos, while retaining its psychedelics clinical development pipeline assets.approximately $2,000,000 as of September 30, 2023. As of September 30, 2022, there is no accrual recorded since2023, the closingCompany has paid $950,997 of the spin-off is not probable.Avance Clinical contract costs and has $549,713 recorded as prepaid assets. For the three and nine months ended September 30, 2023, the Company has expensed $157,117 and $401,284 in research and development expenses, respectively.

 

2623

 

 

AmendmentReduction in Force/Restructuring

In May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees to 2020 Long-Term Incentive Planstreamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos cannabinoid spin-out were terminated. The Company recognized severance charges of approximately $453,059 through September 30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing cash flow. As of September 30, 2023, the Company has completed the reduction in force, with such severance expenses recorded in salaries and wages and legal accounts.

 

On May 3, 2022, our Board adoptedJune 16, 2023, the First AmendmentCompany entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer (the “Plan Amendment”“Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits of $550,974 was accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested time-based RSU’s became fully vested. The Company accelerated expense recognized related to these shares that vested upon termination of $231,273. Of the 11,278 market performance-based RSUs, 3,759 will continue to be subject to the Enveric Biosciences, Inc. 2020 Long-Term Incentive Plan (the “Incentive Plan”) to (i) increaseoriginal terms and conditions of Mr. Kanubaddi’s employment agreement and the aggregate number of shares available for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such issuance date. The Plan Amendment was approved by the Company’s stockholders at a special meeting of the Company’s stockholders held on July 14, 2022.remainder were forfeited.

 

July 2022 OfferingsEquity Distribution Agreement

On September 1, 2023, the Company entered into the Distribution Agreement, with Canaccord, pursuant to which the Company may offer and sell from time to time, through Canaccord as sales agent and/or principal, shares of common stock of the Company, par value $0.01 per share having an aggregate offering price of up to $10.0 million. Due to the offering limitations applicable to the Company and in accordance with the terms of the Distribution Agreement, the Company may offer Common Stock having an aggregate gross sales price of up to $2,392,514 pursuant to the prospectus supplement dated September 1, 2023 (the “Prospectus Supplement”). Subject to the terms and conditions of the Distribution Agreement, Canaccord may sell the Common Stock by any method permitted by law deemed to be an “at-the-market offering”. The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the Common Stock sold through Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses. The Company may also sell Common Stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale. Any sale of Common Stock to Canaccord as principal would be pursuant to the terms of a separate terms agreement between the Company and Canaccord.

 

On July 22, 2022,During the three and nine months ended September 30, 2023, the Company entered into a securities purchase agreement (the “Registered Direct Securities Purchase Agreement”) with an institutional investor for the purchase and sale of 116,500 shares of the Company’s common stock, pre-funded warrants to purchase up to 258,500has issued no shares of common stock and unregistered preferred investment options (the “RD Preferred Investment Options”) to purchase up to 375,000 shares of common stock (the “RD Offering”). The gross proceeds fromthrough the RD Offering were approximately $3,000,000. Shares of common stock and RD Pre-Funded Warrants issued in the RD Offering were offered pursuant to a “shelf” registration statement on Form S-3 previously filed with the SEC on July 2, 2021. Subject to certain ownership limitations, the PIPE Pre-Funded Warrants became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. There is not expected to be any trading market for the common warrants issued in the RD Offering. On August 3, 2022, all of the issued RD Pre-Funded Warrants were exercised. Subject to certain ownership limitations, the RD Preferred Investment Options became immediately exercisable at an exercise price equal to $7.78 per share of common stock. The RD Preferred Investment Options are exercisable for five and one-half years from the date of issuance.Distribution Agreement.

Concurrently with the RD Offering, the Company entered into a securities purchase agreement (the “PIPE Securities Purchase Agreement”) with institutional investors for the purchase and sale of 116,000 shares of common stock, pre-funded warrants to purchase up to 509,000 shares of common stock, and preferred investment options (the “PIPE Preferred Investment Options”) to purchase up to 625,000 shares of the common stock in a private placement (the “PIPE Offering”). The gross proceeds from the PIPE Offering were approximately $5,000,000. Subject to certain ownership limitations, the PIPE Pre-Funded Warrants became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. There is not expected to be any trading market for the common warrants issued in the PIPE Offering. All of the issued PIPE Pre-Funded Warrants were exercised on various dates prior to August 18, 2022. Subject to certain ownership limitations, PIPE Preferred Investment Options became immediately exercisable at an exercise price equal to $7.78 per share of common stock. The PIPE Preferred Investment Options are exercisable for five and one-half years from the date of issuance.

The RD offering and PIPE Offering closed on July 26, 2022, with aggregate gross proceeds of approximately $8 million. The aggregate net proceeds from the offerings, after deducting the placement agent fees and other estimated offering expenses, were approximately $7.1 million.

On July 26, 2022, in connection with the RD Offering and PIPE Offering, the Company issued preferred investment options (the “Placement Agent Preferred Investment Options”) to an entity to purchase up to 70,000 shares of the common stock for acting as a placement agent. The Placement Agent Preferred Investment Options have substantially the same terms as the RD Preferred Investment Options and the PIPE Preferred Investments Options, except the Placement Agent Preferred Investment Options have an exercise price of $10.00 per share. The Placement Agent Preferred Investment Options are exercisable for five years from the date of issuance.

In connection with the RD Offering and the PIPE, the Company entered into Warrant Amendment Agreements (the “Warrant Amendments”) with the investors in both offerings to amend certain existing warrants to purchase up to an aggregate of 122,000 shares of Common Stock that were previously issued to the investors on February 15, 2022, with an exercise price of $27.50 per share and expiration date of February 15, 2027. Pursuant to the Warrant Amendments, the previously issued warrants were amended, effective upon the closing of the offerings, so that the amended warrants have a reduced exercise price of $7.78 per share and expire five and one-half years following the closing of the offerings. The Company determined the fair value of the February 2022 Warrants immediately prior to the Warrant Amendment and the fair value of the amended warrants immediately after the Warrant Amendment. The incremental change in fair value was deemed to be $251,357, which was included as equity issuance costs related to the RD and PIPE financing transactions.

 

2724

 

Results of Operations

 

The following table sets forth information comparing the components of net loss for the three months ended September 30, 20222023, and 2021:2022:

 

 For the Three Months Ended September 30,  

For the Three Months Ended September 30,

 
 2022  2021  2023  2022 
Operating expenses                
General and administrative $3,514,547  $2,123,834  $2,010,349  $3,514,547 
Research and development  2,055,656   1,219,339   1,351,750   2,055,656 
Depreciation and amortization  86,646   173,696   86,296   86,646 
Total operating expenses  5,656,849   3,516,869   3,448,395   5,656,849 
                
Loss from operations  (5,656,849)  (3,516,869)  (3,448,395)  (5,656,849)
                
Other income (expense)                
Change in fair value of warrant liabilities  1,599,623   804,833   67,822   1,599,623 
Change in fair value of investment option liability  1,809,622   —   562,715   1,809,622 
Change in fair value of derivative liability  (231,000)  —   —   (231,000)
Interest expense  (308)  (370)
Interest income (expense)  2,237   (308)
Total other income  3,177,937   804,463   632,774   3,177,937 
Net loss before income taxes $(2,815,621) $(2,478,912)
        
Income tax expense  (6,595)  — 
                
Net loss  (2,478,912)  (2,712,406) $(2,822,216) $(2,478,912)
Less preferred dividends attributable to non-controlling interest  12,603   — 
Less deemed dividends attributable to accretion of embedded derivative at redemption value  110,991   — 
Net loss attributable to shareholders  (2,602,506)  (2,712,406)
        
Other comprehensive loss        
Foreign currency translation  (417,390)  (6,510)
        
Comprehensive loss $(3,019,896) $(2,718,916)
        
Net loss per share - basic and diluted $(1.46) $(5.91)
        
Weighted average shares outstanding, basic and diluted  1,787,235   459,289 

General and Administrative Expenses

 

Our general and administrative expenses increaseddecreased to $2,010,349 for the three months ended September 30, 2023 from $3,514,547 for the three months ended September 30, 2022, from $2,123,834 for the three months ended September 30, 2021, an increasea decrease of $1,390,713,$1,504,198, or 65%43%. This change was primarily driven by an increase in marketing fees of $143,578, an increase in professional fees of $234,911, and an increasea decrease in transaction expenses from liability classified equity offerings of $704,092.$704,094, stock based compensation of $329,178, directors and officer insurance of $252,097, and marketing of $201,862.

 

Research and Development Expenses

 

Our research and development expense for the three months ended September 30, 20222023 was $2,055,656$1,351,750 as compared to $1,219,339$2,055,656 for the three months ended September 30, 2021 an increase2022 with a decrease of $836,317,$703,906, or 69%approximately 34%. This increasechange was primarily driven by increasedthe change in strategy and cost reduction plan resulting in a decrease of payroll and consulting fees of $804,023, scientific advisory board fees of $41,198 and product development activities duringexpense of $151,989, offset by the current year, as compared to the prior year, in particular, research relating to psychedelic molecules, activities which the Company was not engaged in during the comparable periodincrease of the prior year. In addition, there was an increase in research and development stock-based compensationAvance clinical contract of $113,960 during the three months ended September 30, 2022 as compared to the same period in 2021.$290,797.

 

28

Depreciation and Amortization Expense

Depreciation and amortization expense for the three months ended September 30, 20222023 was $86,646$86,296 as compared to $173,696 for the three months ended September 30, 2021, a decrease of $87,050, or approximately 50%. The decrease in amortization is due to amortization of approximately $128,511 recorded for the Skincare license during the three months ended September 30, 2021. The Skincare license was subsequently fully impaired in the fourth quarter of 2021, resulting in no amortization of the Skincare license during 2022. This decrease was offset by an increase in depreciation of $42,218 during the three months ended September 30, 2022 as compared to the three months ended September 30, 2021.

Change in Fair Value of Warrant Liabilities

The Company’s change in fair value warrant liabilities was increased by $794,790$86,646 for the three months ended September 30, 2022, as compared towith a decrease of $350. Depreciation and amortization expense was substantially similar for the three months ended September 30, 2021, due primarily to a decrease in2023 compared with the Company’s stock price in the current period.three months ended September 30, 2022.

 

Change in Fair Value of Investment Option LiabilityWarrant Liabilities

The Company’s changeChange in fair value of investment option liability was $1,809,622warrant liabilities for the three months ended September 30, 2023 resulted in income of $67,822 as compared to income of $1,599,623 for the three months ended September 30, 2022. The change in fair value of warrant liabilities is significantly influenced by the change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock. The Company’s stock price was $2.38 as of September 30, 2023, $3.37 as of June 30, 2023, $4.22 as of September 30, 2022 and $10.70 as of June 30, 2022. The stock price of the Company did not have any outstanding investment option liabilitiesdecreased approximately 29% during the three months ended September 30, 2021.2023 compared to a decrease of approximately 61% during the three months ended September 30, 2022. The significant percentage change in the Company’s stock price during the three months ended September 30, 2023 compared to the three months ended September 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.

25

Change in Fair Value of Investment Option Liability

Change in fair value of investment option liability for the three months ended September 30, 2023 resulted in income of $562,715, as compared to $1,809,622 during the three months ended September 30, 2022. The change in fair value is due to the significant decrease in the Company’s stock price betweenfor the issuance of the investment option liability andthree months ended September 30, 2022.2023. The Company’s stock price was $6.33 on July 26, 2022 (the date of issuance) and $4.22$2.38 on September 30, 2022,2023 and $3.37 on June 30, 2023, a decrease of approximately 29% during that time compared to a decrease of approximately 33% during that time.the three months ended September 30, 2022.

 

Change in Fair Value of Derivative Liability

The Company’s change in fair value of derivative liability increased byexpense was $231,000 for the three months ended September 30, 2022, as compared to $0 for the three months ended September 30, 2021,2023 due primarily to the announcementredemption of the plannedredeemable stock in May 2023 and therefore no probability of occurrence of the Akos spin-off as of Akos.

Foreign Currency Translation

Our foreign currency translation loss was $417,390 for the three months ended September 30, 20222023 as compared to a loss of $6,510 for the three months ended SeptemberJune 30, 2021, for a change in loss of $410,880. The increase in foreign exchange loss is primarily due to the U.S. Dollar fluctuating against the Canadian Dollar and the conversion of the Canadian Dollars into United States Dollars for payment of United States Dollar denominated expenses. In addition, the Company engaged in a significantly higher number of transactions denominated in Canadian dollars during the three months ended September 30, 2022, as compared to the three months ended September 30, 2021, resulting in a much larger effect of foreign currency translation on the Company’s operations.2023.

29

 

The following table sets forth information comparing the components of net loss for the nine months ended September 30, 20222023 and the comparable period in 2021:2022:

 

 For the Nine Months Ended September 30,  For the Nine Months Ended September 30, 
 2022  2021  2023  2022 
Operating expenses                
General and administrative $8,783,619  $10,864,696  $7,921,340  $8,783,619 
Research and development  6,134,421   2,295,826   5,883,440   6,134,421 
Depreciation and amortization  241,413   484,355   259,300   241,413 
Total operating expenses  15,159,453   13,644,877   14,064,080   15,159,453 
                
Loss from operations  (15,159,453)  (13,644,877)  (14,064,080)  (15,159,453)
                
Other income (expense)                
Inducement expense  —   (298,714)
Change in fair value of warrant liabilities  3,845,514   7,077,376   (115,342)  3,845,514 
Change in fair value of investment option liability  1,809,622   —   (399,921)  1,809,622 
Change in fair value of derivative liability  (284,000)  —   727,000   (284,000)
Interest expense  (5,114)  (5,191)
Interest income (expense)  3,142   (5,114)
Total other income  5,366,022   6,773,471   214,879   5,366,022 
                
Net loss before income taxes $(13,849,201) $(9,793,431)
Income tax expense  (6,595)  — 
Net loss $(9,793,431) $(6,871,406) $(13,855,796) $(9,793,431)
Less preferred dividends attributable to non-controlling interest  20,411   — 
Less deemed dividends attributable to accretion of embedded derivative at redemption value  184,985   — 
Net loss attributable to shareholders  (9,998,827)  (6,871,406)
        
Other comprehensive loss        
Foreign currency translation  (609,695)  (4,036)
        
Comprehensive loss $(10,608,522) $(6,875,442)
        
Net loss per share - basic and diluted $(8.11) $(16.64)
        
Weighted average shares outstanding, basic and diluted  1,232,936   413,063 

General and Administrative Expenses

 

Our general and administrative expenses decreased to $7,921,340 for the nine months ended September 30, 2023 from $8,783,619 for the nine months ended September 30, 2022, from $10,864,696 for the nine months ended September 30, 2021, a decrease of $2,081,077,$862,279, or 19%10%. This change was primarily driven by a decrease in stock-basedtransaction expenses from liability classified equity offerings of $823,970, directors and officers insurance of $780,797, stock based compensation of $3,532,658,$202,908 and marketing of $274,814, partially offset by an increase in transaction expenses from equity offerings of $823,970 and an increase in professionalconsulting fees of $630,195.$626,382, accounting fees of $310,797 and franchise taxes of $307,644.

 

26

Research and Development Expenses

Our research and development expense for the nine months ended September 30, 20222023 was $6,134,421$5,883,440 as compared to $2,295,826 for the nine months ended September 30, 2021 with an increase of $3,838,595, or approximately 167%. This increase was primarily driven by increased product development activities during the current year, as compared to the prior year, in particular, research relating to psychedelic molecules, activities which the Company was not engaged in during the comparable quarter of the prior year. In addition, $794,473 of stock-based compensation expense was allocated to research and development$6,134,421 for the nine months ended September 30, 2022 compared to $118,474with a decrease of $250,981, or approximately 4%. This change was primarily driven by increase of the Avance clinical contract of $646,029 and product development of $141,085 offset by payroll and consulting fees of $1,021,851 for the nine months ended September 30, 2021.change in strategy and reduction in workforce as part of the cost reduction plan.

 

30

Depreciation and Amortization Expense

Depreciation and amortization expense for the nine months ended September 30, 20222023 was $241,413$259,300 as compared to $484,355$241,413 for the nine months ended September 30, 2021,2022, with a decreasean increase of $242,942,$17,887, or approximately 50%7%. The decrease in amortizationThis increase is due to amortization of approximately $396,981 recorded for the Skincare license during the three months ended September 30, 2021. The Skincare license was subsequently fully impaired in the fourth quarter of 2021, resulting in no amortization of the Skincare license during 2022. This decrease was offset by an increase in depreciation of $112,610 and an increase in amortization of the Diverse Bio license of $28,125fixed asset additions during the nine months ended September 30, 2022 aswhich only incurred partial depreciation, compared to a full nine months’ of depreciation during the nine months ended September 30, 2021.2023.

 

Change in Fair Value of Warrant Liabilities

The Company’s change in gainChange in fair value of warrant liabilities decreased by $3,231,862the nine months ended September 30, 2023 resulted in expense of $115,342 as compared to income of $3,845,514 for the nine months ended September 30, 20222022. The change in fair value of warrant liabilities is significantly influenced by the change in the closing price of Common Stock at the end of each period, as compared to $7,077,376 for the nine months endedclosing price of Common Stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock. The Company’s stock price per share was $2.38 as of September 30, 2021, primarily due to a change in2023, $2.08 as of December 31, 2022, $4.22 as of September 30, 2022 and $46.50 as of December 31, 2021. The stock price of the Company’s stock priceCompany increased approximately 14% during the nine months ended September 30, 2022 as2023 compared to the same period in 2021. The Company’s stock price was $4.22 at September 30, 2022, as compared to $46.50 at December 31, 2021, a decrease of approximately 91% during the nine months ended September 30, 2022. The Company’s stock price was $103.50 at September 30, 2021, as compared to $74.00 at December 31, 2020, an increase of approximately 40% during the nine months ended September 30, 2021. The significant percentage change in the Company’s stock price during the nine months ended September 30, 20222023 compared to the same period in 2021,nine months ended September 30, 2022, resulted in the significant decreaseincrease to the change in fair value of warrant liabilities.

Change in Fair Value of Investment Option Liability

Change in fair value of investment option liability during the nine months ended September 30, 2023 resulted in expense of $399,921, as compared to $1,809,622 during the nine months ended September 30, 2022. The change in fair value is due to the significant increase in the Company’s stock price the nine months ended September 30, 2023. The Company’s stock price per share was $2.08 on December 31, 2022 and $2.38 on September 30, 2023, an increase of approximately 14% during that time, compared to a decrease of approximately 33% during the nine months ended September 30, 2022. The significant percentage change in the Company’s stock price during the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.

 

Change in Fair Value of Derivative Liability

The Company’s change in fair value of investment optionderivative liability was increased by $1,809,622 for the nine months ended September 30, 2022 as compared to for the nine months ended September 30, 2021, due to the significant decrease in the Company’s stock price between the issuanceexpense of the investment option liability and September 30, 2022. The Company’s stock price was $6.33 on July 26, 2022 (the date of issuance) and $4.22 on September 30, 2022, a decrease of approximately 33% during that time.

Change in Fair Value of Derivative Liability

The Company’s change in fair value of derivative liability increased by $284,000 for the nine months ended September 30, 2022 as compared to income of $727,000 for the nine months ended September 30, 2021,2023, due primarily to the announcementMay 2023 redemption which ceased the probability of occurrence of the plannedAkos spin-off and Akos Series A Preferred Stock redemption as of Akos.

Inducement ExpenseSeptember 30, 2023 as compared to December 31, 2022.

 

Inducement expense was $0Going Concern, Liquidity and Capital Resources

The Company has incurred a loss since inception resulting in an accumulated deficit of $93,063,582 as of September 30, 2023 and further losses are anticipated in the development of its business. Further, the Company had operating cash outflows of $12,343,363 for the nine months ended September 30, 2022 as compared to $298,714 for the nine months ended September 30, 2021, representing a decrease of 100%. The expenses recorded in 2021 were related to inducement incurred related to the conversion of warrants and options. The Company did not incur such expenses in the current period.

Foreign Currency Translation

Our foreign currency translation loss was $609,695 for the nine months ended September 30, 2022 as compared to a loss of $4,036 for the nine months ended September 30, 2021, for a change of $605,659. The increase in foreign exchange loss is primarily due to the U.S. Dollar fluctuating against the Canadian Dollar and the conversion of the Canadian Dollars into United States Dollars for payment of United States Dollar denominated expenses. In addition, the Company engaged in a significantly higher number of transactions denominated in Canadian dollars during the nine months ended September 30, 2022, as compared to the nine months ended September 30, 2021, resulting in a much larger effect of foreign currency translation on the Company’s operations.

Liquidity and Capital Resources

2023. For the nine months ended September 30, 2022,2023, the Company had a loss from operations of $15,159,453 and net cash used in operating activities of $13,684,606. As of September 30, 2022, the Company had an accumulated deficit of $70,529,884.$14,064,080. Since inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements.

In assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2022,2023, the Company had cash of $21,201,005$4,266,568 and working capital of $19,668,572.$1,643,374. The Company’s current cash on hand atis insufficient enough to satisfy its operating cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date is estimatedthe financial statements are issued. Management’s plan to be sufficient to fund operations, however, there can be no guarantee thatalleviate the conditions will not changethat raise substantial doubt include reducing the Company’s rate of spend, managing its cash flow, advancing its programs, and thatraising additional working capital through public or private equity or debt financings or other sources, which has included the Company will requireEquity Distribution Agreement with Canaccord for proceeds of up to $2.4 million and the Purchase Agreement with Lincoln Park, which may include collaborations with third parties as well as disciplined cash spending, to increase the Company’s cash runway. Adequate additional funding, whichfinancing may not be available to the Company on acceptable terms, or at all, in which case significant delays or cost increases may result in material disruption to the Company’s operations. In such case,all. Should the Company wouldbe unable to raise sufficient additional capital, the Company may be required to delay, scale backundertake cost-cutting measures including delaying or eliminate some or all of its research and development programs, which would likely have a material adverse effect on the Company and its financial statements.discontinuing certain operating activities.

 

The Company’s material cash requirements consist of working capital to fund capital expenditures incurred at their research facility in Calgary and their operations, which consist primarily of, without limitation, employee related expenses, product development activities conducted by third parties, research materials and lab supplies, facility related expenses including rent and maintenance, costs associated with preclinical studies, patent related costs, costs of regulatory and public company compliance, insurance costs, audit costs, consultants and legal fees. Additionally, the Company currently utilizes third-party contract CROs to assist with clinical development activities. If the Company obtains regulatory approval for any of their product candidates, they expect to incur significant expenses to engage third-party contract CMOs to carry out their clinical manufacturing activities as they do not yet have a commercial organization, and incur significant expenses related to developing their internal commercialization capability to support product sales, marketing and distribution. The Company’s current working capital resources are sufficient to fund these material cash requirements for the next twelve months.

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In May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos cannabinoid spin-out will be terminated. Additionally, on June 16, 2023, the Company entered into the Kanubaddi Separation Agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer. In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits was accrued and will be paid out in twelve equal monthly installments beginning in July 2023. The Company expects to finance futurerecognized severance charges of approximately $1,004,033 through September 30, 2023, with $396,431 of these charges paid as of September 30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing cash needs through public or private equity offerings, debt financings, or business development transactions. If adequate funds are not available,flow. As of September 30, 2023, the Company may be required to delay, reducehas completed the scope of or eliminate researchreduction in force, with such severance expenses recorded in salaries and development programs or obtain funds through arrangements with collaborators or others that may require the Company to relinquish rights to certain pipeline candidates that they might otherwise seek to develop or commercialize independently.

On February 15, 2022, the Company completed a registered direct offering of 400,000 shares of Common Stock at approximately $25.00 per share for gross proceeds of approximately $10.0 million. The net proceeds to the Company after deducting financial advisory feeswages and other costs and expenses were approximately $9.1 million.legal accounts.

 

On July 26, 2022, the Company completed a registered direct offering for the purchase and sale of 116,500 shares of the Company’s Common Stock, pre-funded warrants to purchase up to 258,500 shares of Common Stock and unregistered preferred investment options (the “RD Preferred Investment Options”) to purchase up to 375,000 shares of Common Stock (collectively, the “RD Offering”). The combined purchase price for one share of Common Stock and associated RD Preferred Investment Option is $8.00. The gross proceeds from the RD Offering were approximately $3.0 million.

Concurrently with the RD Offering, the Company completed a registered direct offering for the purchase and sale of 116,000 shares of Common Stock, pre-funded warrants to purchase up to 509,000 shares of Common Stock (the “PIPE Pre-Funded Warrants”) and preferred investment options (the “PIPE Preferred Investment Options”) to purchase up to 625,000 shares of the Common Stock in a private placement (the “PIPE”). The combined purchase price for one share of Common Stock and associated PIPE Preferred Investment Option is $8.00. The gross proceeds from the PIPE were approximately $5.0 million. The aggregate net proceeds from the RD Offering and the PIPE, after deducting the placement agent fees and other estimated offering expenses, were approximately $7.1 million.

We believe that, asAs a result of February and July offerings, we currently have sufficient cash and financing commitments to meet our funding requirements overthese factors, management has concluded that there is substantial doubt about the next year. Notwithstanding, we expect that we will need to raise additional financing to accomplish our development plan over the next several years. We may seek to obtain additional funding through debt or equity financing in the future. There are no assurances that we will be able to raise capital on terms acceptable to us or at all, or that cash flows generated from our operations will be sufficient to meet our current operating costs. OurCompany’s ability to obtain additional capital may depend on prevailing economic conditions andcontinue as a going concern for a period of one year after the date of the financial business and other factors beyond our control.statements are issued. The COVID-19 pandemic has caused an unstable economic environment globally. Disruptions inCompany’s condensed consolidated financial statements do not include any adjustments that might result from the global financial markets may adversely impact the availability and costoutcome of credit, as well as our ability to raise money in the capital markets. Current economic conditions have been and continue to be volatile. Continued instability in these market conditions may limit our ability to access the capital necessary to fund and grow our business. If we are unable to obtain sufficient amounts of additional capital, we may be required to reduce the scope of our planned development, which could harm our financial condition and operating results.this uncertainty.

Cash Flows

 

Since inception, we have primarily used our available cash to fund our product development and operations expenditures.

 

Cash Flows for the Nine Months Ended September 30, 20222023 and 20212022

The following table sets forth a summary of cash flows for the periodsyears presented:

 

  For the Nine Months Ended September 30, 
  2022  2021 
Net cash used in operating activities $(13,684,606) $(7,390,358)
Net cash (used in) provided by investing activities  (577,972)  2,380,327 
Net cash provided by financing activities  18,180,138   24,899,652 
Effect of foreign exchange rate on cash  (72,554)  (19,655)
Net increase in cash $3,845,006  $19,869,966 
  For the Nine Months Ended September 30, 
  2023  2022 
Net cash used in operating activities $(12,343,363) $(13,684,606)
Net cash provided by (used in) investing activities  11,705   (577,972)
Net cash (used in) provided by financing activities  (1,157,057)  18,180,138 
Effect of foreign exchange rate on cash  31,399   (72,554)
Net (decrease) increase in cash $(13,457,316) $3,845,006 

Operating Activities

Net cash used in operating activities was $12,343,363 during the nine months ended September 30, 2023, which consisted primarily of a net loss adjusted for non-cash items of $11,962,774, an increase in prepaid expenses of $746,033, and an increase in accounts payable and accrued liabilities of $429,688.

 

Net cash used in operating activities was $13,684,606 during the nine months ended September 30, 2022, which consisted primarily of a net loss adjusted for non-cash items of $9,793,431,$12,728,490, increase in prepaid expenses and other current assets of $758,419, changeand a decrease in fair value of warrantaccounts payable and accrued liabilities of $3,845,514, and change in fair value of investment option liability of $1,809,622, offset by stock based compensation of $2,091,299.$106,675.

 

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Investing Activities

Net cash used in operatingprovided by investing activities was $7,390,358$11,705 during the nine months ended September 30, 2021,2023, which consisted primarily of a net lossthe purchase of $6,871,406property and change in fair value of warranty liability of $7,077,376equipment, offset by stock-based compensationproceeds from sale of $4,829,484.

Investing Activitiesproperty and equipment.

 

Net cash used in investing activities was $577,972 during the nine months ended September 30, 2022, which consisted of the purchase of property and equipment.

 

Financing Activities

Net cash provided by investingused in financing activities was $2,380,327$1,157,057 during the nine months ended September 30, 2021,2023, which consisted of cash accretive acquisitionthe redemption of MagicMedredeemable non-controlling interest and payment of $3,055,327, offset by the acquisition of intellectual property from Diverse Biotech, Inc. of $675,000.

Financing Activitiesdeferred offering costs.

 

Net cash provided by financing activities was $18,180,138 during the nine months ended September 30, 2022, which consisted of $17,222,100 in net proceeds from the sale of common stock and warrants and $958,038 in proceeds from the sale of redeemable non-controlling interest, net of offering costs, of $958,038.

Net cash provided by financing activities was $24,899,652 during the nine months ended September 30, 2021, which consisted of $21,614,488 in net proceeds from the sale of common stock and proceeds from the exercise of warrants of $3,285,164.interest.

 

Critical Accounting Policies and Significant Judgments and Estimates

The Company’s accounting policies are fundamental to understanding its management’s discussion and analysis. The Company’s significant accounting policies are presented in Note 2 to its financial statements for the year ended December 31, 20212022, and included in the Annual Report on Form 10-K filed with the SEC on March 31, 2022.Report. The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by U.S. GAAP. However, in the opinion of the management of the Company, all adjustments necessary for a fair presentation of the financial position and operating results have been included in the Company’s unaudited condensed consolidated financial statements.

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Warrant Liability and Preferred Investment Options

The Company accounts for warrants and preferred investment options for shares of the Company’s common stock that are not indexed to its own stock as liabilities at fair value on the balance sheet. Such warrants and preferred investment options are subject to remeasurement at each balance sheet date and any change in fair value is recognized as a component of other expense on the statement of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such common stock warrants and preferred investment options. At that time, the portion of the liability related to such common stock warrants and preferred investment options will be reclassified to additional paid-in capital.

Foreign Currency Risk

The reporting currency of the Company is the United States dollar, while the functional currency of our subsidiaries, Enveric Biosciences Canada Inc. and Jay Pharma, Inc., is the Canadian dollar. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and the United States dollar.

The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency fluctuations in the future.

Item 3. Quantitative and qualitative disclosures about market riskQualitative Disclosures About Market Risk

From inception through September 30, 2022,2023, the Company’s reporting currency of the Company is the United States dollar while the functional currency of certain of the Company’s Canadian subsidiaries iswere the Canadian dollar and Australian dollar. For the reporting periods ended September 30, 2023 and September 30, 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the U.S. dollar.

33

 

The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations in the future.

 

Item 4. Controls and proceduresProcedures

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures designed to ensure that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified under the rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The matters that management identified in our Annual Report on Form 10-K for the year ended December 31, 2021, filed on March 31, 2022, continued to exist and were still considered material weaknesses in our internal control over financial reporting at September 30, 2022.2023.

 

As required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive) and Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2022.2023. Based on this evaluation, and in light of the material weaknesses found in our internal controls over financial reporting, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and 15d-15 under the Exchange Act) were not effective as of September 30, 2022.2023.

 

Management’s Remediation Plan

 

As previously discussed in our Annual Report on Form 10-K for the year ended December 31, 2021, filed on March 31, 2022, management had concluded that our internal control over financial reporting was not effective as of December 31, 2021,2022, because management identified inadequate segregation of duties to ensure the processing, review, and authorization of all transactions, including non-routine transactions resulting in deficiencies, which, in aggregate, amounted to a material weakness in the Company’s internal control over financial reporting.

 

As of September 30, 2022,2023, there were control deficiencies whichthat constituted a material weakness in our internal control over financial reporting. Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure controls.

 

While we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve the overall effectiveness of our internal controls over financial reporting.

 

Changes in Internal Control over Financial Reporting

 

Other than the changes discussed above in the Remediation Plan, there have been no other changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during quarter ending September 30, 2022,2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1. Legal proceedingsProceedings

The Company is periodically involved in legal proceedings, legal actions and claims arising in the ordinary course of business. WeOther than as described below, we do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material adverse effect on our financial position, results of operations or cash flows.

 

Item 1A. Risk factorsFactors

The following descriptionFactors that could cause our actual results to differ materially from those in this Quarterly Report are any of risk factors includes any material changes to, and supersedes the description of, risk factors associated with our business, financial condition and results of operations previously disclosedrisks described in “Item 1A. Risk Factors” of our Annual Report for the year ended December 31, 2021Company’s annual report on Form 10-K as filed with the SEC on March 31, 2022. Our business, financial condition2023, as amended on June 9, 2023 and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause our actual financial conditionquarterly reports on Form 10-Q as filed with the SEC on May 15, 2023 and operating results to vary materially from past, or from anticipated future, financial condition and operating results.August 11, 2023. Any of these factors could result in a significant or material adverse effect on our results of operations of financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations.

The following discussion As of the date of this Quarterly Report, there have been no material changes to the risk factors contains forward-looking statements. These risk factors may be important to understanding other statementsdisclosed in thisthe Company’s annual report on Form 10-Q. The following information should be read in conjunction10-K as filed with the condensed consolidated financial statementsSEC on March 31, 2023, as amended on June 9, 2023 and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Form 10-Q.

Certain directors who serve on our Board of Directors may also serve as directors of Akos, and ownership of shares of Akos common stock by our directors and executive officers may create, or appear to create, conflicts of interest.

Certain of our directors who serve on our Board of Directors may also serve on the board of directors of Akos. This may create, or appear to create, conflicts of interest when our, or Akos’ management and directors could face decisions that could have different implications for us and Akos, including the resolution of any dispute regarding the terms of the agreements governing the Spin-Off and the relationship between us and Akos after the Spin-Off or any other commercial agreements entered into in the future between us and the spun-off business and the allocation of such directors’ time between us and Akos. The continued or future ownership of such common stock by our directors and executive officers following the Spin-Off may create the appearance of a conflict of interest when these directors and executive officers are faced with decisions that could have different implications for us and Akos.

The Reverse Stock Split may decrease the liquidity of the shares of our common stock.

The liquidity of the shares of our common stock may be affected adversely by the Reverse Stock Split given the reduced number of shares that are outstanding following the Reverse Stock Split. In addition, the Reverse Stock Split would have increased the number of stockholders who own odd lots (less than 100 shares) of our common stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

35

We may not meet the continued listing requirements of the Nasdaq Capital Market, which could result in a delisting of our common stock.

Our common stock is listed on the Nasdaq Capital Market. We have in the past, and may in the future, be unable to comply with certain of the listing standards that we are required to meet to maintain the listing of our common stock on the Nasdaq Capital Market. For instance, on February 18, 2022, we received a letter from the Listing Qualifications Department of Nasdaq Stock Market (the “Staff”) indicating that, based upon the closing bid price of our common stock for the 30 consecutive business day period between January 5, 2022, through February 17, 2022, we did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). On July 29, 2022, we received a letter from the Staff stating that for the last 10 consecutive business days, from July 15 to July 28, 2022, the closing bid price of our common stock had been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2).

In the event that we fail to satisfy any of the listing requirements of the Nasdaq Capital Market, our common stock may be delisted. If we are unable to list on the Nasdaq Capital Market, it would likely be more difficult to trade in or obtain accurate quotations as to the market price of our common stock. If our common stock is delisted from trading on the Nasdaq Capital Market, and we are not able to list our common stock on another exchange or to have it quoted on the Nasdaq Capital Market, our securities could be quoted on the OTC Bulletin Board or on the “pink sheets.” As a result, we could face significant adverse consequences including, without limitation,

●a limited availability of market quotations for our securities;
●a determination that our common stock is a “penny stock” which will require brokers trading in our

common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities

●a limited amount of news and analyst coverage for our Company; and
●a decreased ability to issue additional securities (including pursuant to short-form registration

statementsquarterly reports on Form S-3 or obtain additional financing in10-Q as filed with the future).SEC on May 15, 2023 and August 11, 2023.

 

Item 2. Unregistered salesSales of equity securitiesEquity Securities and useUse of proceedsProceeds

 

None.

Item 3. Defaults upon senior securitiesUpon Senior Securities

 

None.

 

Item 4. Mine safety disclosuresSafety Disclosures

 

Not applicable.

 

Item 5. Other informationInformation

 

None.In May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid dividends of approximately $50,000 for a total of approximately $1,052,057. The Company has 20 days following the receipt of the Put Exercise Notice to make the payment and made payment on May 19, 2023.

The Company, Akos, and the Akos Investor intend to terminate the Akos Purchase Agreement in connection with the planned Spin-Off and that certain registration rights agreement in connection with the Akos Private Placement.

In May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos cannabinoid spin-out will be terminated. The Company recognized severance charges of approximately $1,004,033 through September 30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing cash flow. As of September 30, 2023, the Company has completed the reduction in force, with such severance expenses recorded in salaries and wages and legal accounts.

 

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Item 6. Exhibits

INDEX TO EXHIBITS

Exhibit No.Description
2.110.1Share PurchaseEquity Distribution Agreement, dated January 10, 2020,as of September 1, 2023, by and between AMERI Holdings,Enveric Biosciences, Inc. and Ameri100, Inc.Cannacord Genuity LLC (incorporated by reference to Exhibit 2.11.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 13, 2020)
2.2Tender Offer Support Agreement and Termination of Amalgamation Agreement, dated August 12, 2020, by and among AMERI Holdings, Inc., Jay Pharma Merger Sub, Inc., Jay Pharma Inc., 1236567 B.C. Unlimited Liability Company and Barry Kostiner, as the Ameri representative (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on August 12, 2020)
2.3Amendment No.September 1, To Tender Offer Support Agreement and Termination of Amalgamation Agreement, dated December 18, 2020, by and among Ameri, Jay Pharma Merger Sub, Inc., Jay Pharma Inc., 1236567 B.C. Unlimited Liability Company and Barry Kostiner, as the Ameri representative (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on December 18, 2020)
2.4Amalgamation Agreement, dated May 24, 2021, by and among Enveric Biosciences, Inc., 1306432 B.C. LTD., 1306436 B.C. LTD., and MagicMed Industries, Inc. (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the Commission on May 24, 2021)
3.1Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.2Certificate of Amendment to Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.3Certificate of Designations of Series B Preferred Stock of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.4Amended and Restated Bylaws of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.4 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.5Amendment to the Amended and Restated Bylaws of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on November 18, 2021)
3.6Certificate of Designation of the Series C Preferred Stock of the Company, dated May 4, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form 8-A, filed with the Securities and Exchange Commission on May 4, 2022, File No. 000-26460)
3.7Certificate of Amendment of Certificate of Designation of the Series C Preferred Stock of the Company, dated May 17, 2022 (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form 8-A/A, filed with the Securities and Exchange Commission on May 17, 2022, File No. 000 26460)
3.8Certificate of Amendment of Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 14, 2022)
4.1Form of Pre-Funded Warrant (issued in connection with January 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 12, 2021)
4.2Form of Warrant (issued in connection with January 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the Commission on January 12, 2021)
4.3Form of Warrant (issued in connection with February 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on February 11, 2021)
4.4Form of Series B Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Annual Report on Form 10-K filed with the Commission on April 1, 2021)
4.5Form of MagicMed Warrant Certificate (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 17, 2021)
4.6Form of Common Stock Purchase Warrant (in connection with February 2022 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on February 15, 2022)

2023)

37

4.7Form of RD Pre-Funded Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.8Form of PIPE Pre-Funded Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.9Form of RD Preferred Investment Option (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.10Form of PIPE Preferred Investment Option (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.11Form of Wainwright Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.5 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.1

First Amendment to the Enveric Biosciences, Inc. 2020 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 14, 2022)#

10.2Form of Warrant Amendment (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.3Form of Securities Purchase Agreement (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.4Form of Securities Purchase Agreement (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.5Form of Registration Rights Agreement (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
31.131.1* Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer*
31.231.2* Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Financial and Accounting Officer*
3232.1** Certification pursuant to Section 906 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer, Principal Financial and Accounting Officer**
101.INS101.INS* Inline XBRL Instance Document*
101.SCH101.SCH* Inline XBRL Taxonomy Extension Schema*
101.CAL101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB101.LAB* Inline XBRL Taxonomy Extension Labels Linkbase Document*
101.PRE101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document*
104104* Cover Page Interactive Data File (embedded within the(formatted as Inline XBRL document)document and contained in Exhibit 101)

*Filed herewith.
**

Furnished herewith.

#Management contract or compensatory plan or arrangement.

 

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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.

 

 ENVERIC BIOSCIENCES, INC
November 14, 2022
13, 2023  
 By:/s/ Dr. Joseph Tucker
 Dr. Joseph Tucker
 Chief Executive Officer
 (Principal Executive Officer)
   
November 14, 2022
13, 2023  
 By:/s/ Robert DickeyKevin Coveney
 Robert DickeyKevin Coveney
 Interim Chief Financial Officer
 (Principal Financial and Accounting Officer)

 

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