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Table of Contents
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
 
 
FORM
10-Q
 
 
 
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended November 30, 2020
 
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1933
For the transition period from
    
    
    
    
to
    
    
    
    
Commission File Number:
000-49908
 
 
CYTODYN INC.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware
 
83-1887078
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer or
Identification No.)
1111 Main Street, Suite 660
Vancouver, Washington
 
98660
(Address of principal executive offices)
 
(Zip Code)
(360980-8524
(Registrant’s telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year, if changed since last report)
 
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of Each Class
 
Trading
Symbol(s)
 
Name of Each Exchange
on Which Registered
None.
 
None.
 
None.
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 for such shorter period that the registrant was required to submit such files).    Yes  ☒    No  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, 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  
On December 31, 2020, there were 598,132,866 shares outstanding of the registrant’s $0.001 par value common stock.
 
 
 

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2

Table of Contents
PART I. Financial Information
Item 1. Consolidated Financial Statements
CytoDyn Inc.
Consolidated Balance Sheets
(Unaudited)
(In thousands, except per share data)
 
     November 30, 2020
(unaudited)
    May 31, 2020
(audited)
 
Assets
                
Current assets:
                
Cash
   $ 29,407     $ 14,282  
Restricted cash
     —         10  
Inventories
     99,071       19,147  
Prepaid expenses
     900       498  
Prepaid service fees
     1,416       2,890  
    
 
 
   
 
 
 
Total current assets
     130,794       36,827  
Operating leases
right-of-use
asset
     391       176  
Property and equipment, net
     115       55  
Intangibles, net
     12,462       13,456  
    
 
 
   
 
 
 
Total assets
   $ 143,762     $ 50,514  
    
 
 
   
 
 
 
Liabilities and Stockholders’ (Deficit) Equity
                
Current liabilities:
                
Accounts payable
   $ 46,083     $ 29,479  
Accrued liabilities and compensation
     15,911       6,879  
Accrued interest on convertible notes
     1,133       292  
Accrued dividends on convertible preferred stock
     1,816       981  
Current portion of operating leases payable
     111       115  
Current portion of long-term convertible notes payable, net
     50,676       6,745  
Warrant exercise proceeds held in trust
     —         10  
    
 
 
   
 
 
 
Total current liabilities
     115,730       44,501  
    
 
 
   
 
 
 
Long-term liabilities:
                
Convertible notes payable, net
     —         8,431  
Operating leases liability
     286       63  
Accounts payable
 
 
34,280
 
 
 
—  
 
    
 
 
   
 
 
 
Total long-term liabilities
     34,566       8,494  
    
 
 
   
 
 
 
Total liabilities
     150,296       52,995  
    
 
 
   
 
 
 
Commitments and Contingencies (Note 10)
            
Stockholders’ (Deficit) Equity
                
Preferred Stock, $0.001 par value; 5,000 shares authorized
                
Series D convertible preferred stock, $0.001 par value; 12 authorized; 9 issued and outstanding at November 30, 2020 and May 31, 2020, respectively
     —         —    
Series C convertible preferred stock, $0.001 par value; 8 authorized; 8 issued and outstanding at November 30, 2020 and May 31, 2020, respectively
     —         —    
Series B convertible preferred stock, $0.001 par value; 400 shares authorized, 87 and 92 shares issued and outstanding at November 30, 2020 and May 31, 2020, respectively
     —         —    
Common stock, $0.001 par value; 800,000 shares authorized, 590,279 and 519,261 issued and
589,837 and 518,976 outstanding at November 30, 2020 and May 31, 2020, respectively
     590       519  
Additional
paid-in
capital
     414,463       351,711  
Accumulated (deficit)
     (421,587     (354,711
Less: Treasury stock, $0.001 par value (442 and 286 shares at November 30, 2020 and May 31,2020, respectively)
     —         —    
    
 
 
   
 
 
 
Total stockholders’ (deficit) equity
     (6,534     (2,481
    
 
 
   
 
 
 
Total liabilities and stockholders’ (deficit) equity
   $ 143,762     $ 50,514  
 
  
 
 
   
 
 
 
See accompanying notes to consolidated financial statements.
 
3

Table of Contents
CytoDyn Inc.
Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
 
     Three Months Ended November 30,     Six Months Ended November 30,  
     2020     2019     2020     2019  
Operating expenses:
        
General and administrative
   $ 7,551     $ 3,094     $ 17,426     $ 6,140  
Research and development
     16,446       8,527       31,738       17,582  
Amortization and depreciation
     506       500       1,011       1,031  
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating expenses
     24,503       12,121       50,175       24,753  
  
 
 
   
 
 
   
 
 
   
 
 
 
Operating loss
     (24,503     (12,121     (50,175     (24,753
Interest income
     —         2       —         2  
Change in fair value of derivative liabilities
     —         203       —         829  
Loss on extinguishment of convertible note
     (4,169     —         (4,169     —    
Interest expense:
        
Finance charges
     (231     (1,549     (137     (1,558
Amortization of discount on convertible notes
     (1,243     (439     (2,582     (1,470
Amortization of debt issuance costs
     (15     (120     (19     (404
Inducement interest expense
     (3,758     (283     (7,103     (2,713
Interest on convertible notes payable
     (1,047     (553     (1,613     (957
  
 
 
   
 
 
   
 
 
   
 
 
 
Total interest expense
     (6,294     (2,944     (11,454     (7,102
  
 
 
   
 
 
   
 
 
   
 
 
 
Loss before income taxes
     (34,966     (14,860     (65,798     (31,024
Income tax benefit
     —         —         —         —    
  
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
   $ (34,966   $ (14,860   $ (65,798   $ (31,024
  
 
 
   
 
 
   
 
 
   
 
 
 
Basic and diluted loss per share
   $ (0.06   $ (0.04   $ (0.12   $ (0.08
  
 
 
   
 
 
   
 
 
   
 
 
 
Basic and diluted weighted average common shares outstanding
     577,945       389,138       566,677       376,822  
  
 
 
   
 
 
   
 
 
   
 
 
 
See accompanying notes to consolidated financial statements.
 
4

Table of Contents
CytoDyn Inc.
Consolidated Statement of Changes in Stockholders’ (Deficit)/ Equity
(Unaudited)
(In thousands, expect per share data)
 
     Preferred Stock      Common Stock      Treasury Stock  
     Shares      Amount      Shares      Amount      Shares      Amount  
Balance May 31, 2019
     95      $ —          329,554      $ 330        159      $ —    
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
First Quarter Fiscal Year Ended May 31, 2020
                                                     
Issuance of stock for convertible note repayment
     —          —          3,014        3        —          —    
Proceeds from registered direct offering ($0.50
 
per share)
     —          —          5,640        6        —          —    
Offering costs related to registered direct offering
     —          —          —          —          —          —    
Proceeds from public warrant tender offers
     —          —          45,376        45        —          —    
Offering costs related to public warrant tender offers
     —          —          —          —          —          —    
Inducement interest expense - tender offers and debt conversions
     —          —          —          —          —          —    
Proceeds from Series C preferred stock offering
     2        —          —          —          —          —    
Offering costs related to Series C preferred stock offering
     —          —          —          —          —          —    
Dividends on Series C preferred stock
     —          —          —          —          —          —    
Legal fees in connection with equity offerings
     —          —          —          —          —          —    
Stock-based compensation
     —          —          —          —          —          —    
Net Loss August 31, 2019
     —          —          —          —          —          —    
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Balance August 31, 2019
     97      $ —          383,584      $ 384        159      $ —    
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Second Quarter Fiscal Year Ended May 31, 2020
                                                     
Issuance of stock for convertible note repayment
     —          —          2,270        2        —          —    
Note conversion and extension fees
     —          —          —          —          —          —    
Proceeds from registered direct offering ($0.50
 per share)
     —          —          13,461        13        —          —    
Offering costs related to registered direct offering
     —          —          —          —          —          —    
Proceeds from public warrant tender offers
     —          —                              —          —    
Offering costs related to public warrant tender offers
     —          —          —          —          —          —    
Inducement interest expense - debt conversion
     —          —          —          —          —          —    
Proceeds from Series C preferred stock offering
     3        —          —          —          —          —    
Offering costs related to Series C preferred stock offering
     —          —          —          —          —          —    
Exercise of option to repurchase common stock
     —          —          —          —          —          —    
Dividends on Series C preferred stock
     —          —          —          —          —          —    
Legal fees in connection with equity offerings
     —          —          —          —          —          —    
Stock-based compensation
     —          —          —          —          —          —    
Net Loss November 30, 2019
     —          —          —          —          —          —    
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Balance November 30, 2019
     100      $ —          399,315      $ 399        159      $ —    
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
See accompanying notes to consolidated financial statements.
 
5

Table of Contents
CytoDyn Inc.
Consolidated Statement of Changes in Stockholders’ (Deficit)/ Equity
(Unaudited)
(In thousands, except per share data)
 
     Additional
Paid-In Capital
    Accumulated
Deficit
    Total     Fiscal Year
To Date
 
Balance May 31, 2019
   $ 220,120     $ (229,364   $ (8,914   $ (8,914
  
 
 
   
 
 
   
 
 
   
 
 
 
First Quarter Fiscal Year Ended May 31, 2020
                                
Issuance of stock for convertible note repayment
     1,002       —         1,005       1,005  
Proceeds from registered direct offering ($0.50
 per share)
     2,250       —         2,256       2,256  
Offering costs related to registered direct offering
     (260     —         (260     (260
Proceeds from public warrant tender offers
     11,855       —         11,900       11,900  
Offering costs related to public warrant tender offers
     (1,058     —         (1,058     (1,058
Inducement interest expense - tender offers and debt conversions
     2,430       —         2,430       2,430  
Proceeds from Series C preferred stock offering
     1,754       —         1,754       1,754  
Offering costs related to Series C preferred stock offering
     (198     —         (198     (198
Dividends on Series C preferred stock
     —         (110     (110     (110
Legal fees in connection with equity offerings
     (16     —         (16     (16
Stock-based compensation
     581       —         581       581  
Net Loss August 31, 2019
     —         (16,164     (16,164     (16,164
    
 
 
   
 
 
   
 
 
   
 
 
 
Balance August 31, 2019
   $ 238,460     $ (245,638   $ (6,794   $ (6,794
  
 
 
   
 
 
   
 
 
   
 
 
 
Second Quarter Fiscal Year Ended May 31, 2020
                                
Issuance of stock for convertible note repayment
     738       —         740       1,745  
Note conversion and extension fees
     (217     —         (217     (217
Proceeds from registered direct offering ($0.50
 per share)
     4,396       —         4,409       6,665  
Offering costs related to registered direct offering
     (74     —         (74     (334
Proceeds from public warrant tender offers
     —         —         —         11,900  
Offering costs related to public warrant tender offers
     —         —         —         (1,058
Inducement interest expense - debt conversion
     283       —         283       2,713  
Proceeds from Series C preferred stock offering
     2,788       —         2,788       4,542  
Offering costs related to Series C preferred stock offering
     (182     —         (182     (380
Exercise of option to repurchase common stock
     (8     —         (8     (8
Dividends on Series C preferred stock
     —         (151     (151     (261
Legal fees in connection with equity offerings
     —         —         —         (16
Stock-based compensation
     434       —         434       1,015  
Net Loss November 30, 2019
     —         (14,860     (14,860     (31,024
    
 
 
   
 
 
   
 
 
   
 
 
 
Balance November 30, 2019
   $ 246,618     $ (260,649   $ (13,632   $ (13,632
    
 
 
   
 
 
   
 
 
   
 
 
 
See accompanying notes to consolidated financial statements.
 
6

Table of Contents
CytoDyn Inc.
Consolidated Statement of Changes in Stockholders’ (Deficit)/ Equity
(Unaudited)
(In thousands, except per share data)
 
     Preferred Stock      Common Stock      Treasury Stock  
     Shares     Amount      Shares      Amount      Shares      Amount  
Balance May 31, 2020
     109     $ —          519,261      $ 519        286      $ —    
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
First Quarter Fiscal Year Ended May 31, 2021
                                                    
Issuance of stock for convertible note repayment
     —         —          2,119        2        —          —    
Issuance of legal settlement shares
     —         —          4,000        4        —          —    
Exercise of stock options
     —         —          100        —          —          —    
Stock issued for incentive compensation and tendered for income tax
     —         —          323        —          156        —    
Conversion of Series B preferred stock to common stock
     (5     —          50        —          —          —    
Private warrant exchange
     —         —          16,544        17        —          —    
Exercise of warrants
     —         —          27,928        28        —          —    
Inducement interest expense related to private warrant exchange
     —         —          —          —          —          —    
Offering costs related to private warrant exchange
     —         —          —          —          —          —    
Dividend declared and paid on Series B preferred stock
($0.25 per share)
     —         —          —          —          —          —    
Dividends accrued on preferred stock
     —         —          —          —          —          —    
Stock-based compensation
     —         —          —          —          —          —    
Net loss August 31, 2020
     —         —          —          —          —          —    
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Balance August 31, 2020
     104     $ —          570,325      $ 570        442      $ —    
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Second Quarter Fiscal Year Ended May 31, 2021
                                                    
Issuance of stock for convertible note repayment
     —         —          4,293        4        —          —    
Exercise of stock options
     —         —          10        —          —          —    
Stock issued for incentive compensation and tendered for income tax
     —         —          —          —          —          —    
Stock issued for private offering ($1.50
 
per share)
     —         —          667        1        —          —    
Private warrant exchange
     —         —          12,480        13        —          —    
Exercise of warrants
     —         —          2,504        2        —          —    
Inducement interest expense related to private warrant exchange
     —         —          —          —          —          —    
Offering costs related to private warrant exchange
     —         —          —          —          —          —    
Dividend declared and paid on Series B preferred stock
($0.25 per share)
     —         —          —          —          —          —    
Dividends accrued on preferred stock
     —         —          —          —          —          —    
Stock-based compensation
     —         —          —          —          —          —    
Net loss November 30, 2020
     —         —          —          —          —          —    
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Balance November 30, 2020
     104     $ —          590,279      $ 590        442      $ —    
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
See accompanying notes to consolidated financial statements.
 
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CytoDyn Inc.
Consolidated Statement of Changes in Stockholders’ (Deficit)/ Equity
(Unaudited)
(In thousands, except per share data)
 
     Additional
Paid-In Capital
    Accumulated
Deficit
    Total     Fiscal Year
To Date
 
Balance May 31, 2020
   $ 351,711     $ (354,711   $ (2,481   $ (2,481
    
 
 
   
 
 
   
 
 
   
 
 
 
First Quarter Fiscal Year Ended May 31, 2021
                                
Issuance of stock for convertible note repayment
     9,535       —         9,537       9,537  
Issuance of legal settlement shares
     (4     —         —         —    
Exercise of stock options
     39       —         39       39  
Stock issued for incentive compensation and tendered for income tax
     828       —         828       828  
Conversion of Series B preferred stock to common stock
     —         —         —         —    
Private warrant exchange
     7,787       —         7,804       7,804  
Exercise of warrants
     13,441       —         13,469       13,469  
Inducement interest expense related to private warrant exchange
     3,345       —         3,345       3,345  
Offering costs related to private warrant exchange
     (364     —         (364     (364
Dividend declared and paid on Series B preferred stock
($0.25 per share)
     —         (243     (243     (243
Dividends accrued on preferred stock
     —         (420     (420     (420
Stock-based compensation
     2,086       —         2,086       2,086  
Net loss August 31, 2020
     —         (30,832     (30,832     (30,832
    
 
 
   
 
 
   
 
 
   
 
 
 
Balance August 31, 2020
   $ 388,404     $ (386,206   $ 2,768     $ 2,768  
    
 
 
   
 
 
   
 
 
   
 
 
 
Second Quarter Fiscal Year Ended May 31, 2021
                                
Issuance of stock for convertible note repayment
     11,549       —         11,553       21,090  
Exercise of stock options
     10       —         10       49  
Stock issued for incentive compensation and tendered for income tax
     —         —         —         828  
Stock issued for private offering ($1.50
 per share)
     999       —         1,000       1,000  
Private warrant exchange
     4,583       —         4,596       12,400  
Exercise of warrants
     1,737       —         1,739       15,208  
Inducement interest expense related to private warrant exchange
     3,758       —         3,758       7,103  
Offering costs related to private warrant exchange
              —                  (364
Dividend declared and paid on Series B preferred stock
($0.25 per share)
     —         —         —         (243
Dividends accrued on preferred stock
     —         (415     (415     (835
Stock-based compensation
     3,423       —         3,423       5,509  
Net loss November 30, 2020
     —         (34,966     (34,966     (65,798
    
 
 
   
 
 
   
 
 
   
 
 
 
Balance November 30, 2020
   $ 414,463     $ (421,587   $ (6,534   $ (6,534
    
 
 
   
 
 
   
 
 
   
 
 
 
See accompanying notes to consolidated financial statements.
 
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CytoDyn Inc.
Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
 
     Six Months Ended November 30,  
     2020     2019  
Cash flows from operating activities:
    
Net loss
   $ (65,798   $ (31,024
Adjustments to reconcile net loss to net cash used in operating activities:
    
Amortization and depreciation
     1,011       1,031  
Amortization of debt issuance costs
     19       404  
Amortization of discount on convertible notes
     2,582       1,470  
Inducement interest expense
     7,103       2,713  
Interest expense associated with accretion of convertible notes payable
     —         688  
Change in fair value of derivative liabilities
     —         (829
Stock-based compensation
     7,115       1,015  
Loss on extinguishment of convertible note
     4,169       —    
Changes in operating assets and liabilities:
    
(Increase) in inventories
     (79,924     —    
Decrease (increase) in prepaid expenses
     1,072       (228
Increase in accounts payable and accrued expenses
     61,532       2,785  
  
 
 
   
 
 
 
Net cash used in operating activities
     (61,119     (21,975
  
 
 
   
 
 
 
Cash flows from investing activities:
    
Furniture and equipment purchases
     (77     (14
  
 
 
   
 
 
 
Net cash used in investing activities
     (77     (14
  
 
 
   
 
 
 
Cash flows from financing activities:
    
Proceeds from warrant transactions, net of offering costs
     12,035      
10,506
 
Proceeds from sale of common stock and warrants
     1,000       6,665  
Proceeds from exercise of warrants
     15,209        
Proceeds from sale of preferred stock, net of offering costs
     —         4,149  
Proceeds from registered direct financing held in trust
     —         791  
Payment on convertible notes
     (950     (1,310
Exercise of option to repurchase shares held in escrow
     —         (8
Release of funds held in trust for warrant tender offer
     (10     (854
Proceeds from exercise of stock options
     48       —    
Payment of payroll witholdings related to tender of common stock for income tax withholding
     (778     —    
Proceeds from convertible notes payable, net
     50,000       —    
Payment of convertible notes conversion offering costs
     —         (217
Dividend declared and paid on Series B preferred stock
     (243     —    
  
 
 
   
 
 
 
Net cash provided by financing activities
     76,311       19,722  
  
 
 
   
 
 
 
Net change in cash
     15,115       (2,267
Cash, beginning of period
     14,292       3,467  
  
 
 
   
 
 
 
Cash, end of period
   $ 29,407     $ 1,200  
  
 
 
   
 
 
 
Supplemental disclosure of cash flow information:
    
Cash paid during the period for interest
   $ 138     $ 255  
  
 
 
   
 
 
 
Non-cash
investing and financing transactions:
    
Conversion of principal and interest of convertible notes to common stock
   $ 16,922     $ 1,899  
  
 
 
   
 
 
 
Accrued dividends on convertible preferred stock
   $ 835     $ 261  
  
 
 
   
 
 
 
See accompanying notes to consolidated financial statements.
 
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CYTODYN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
AS OF NOVEMBER 30, 2020
(UNAUDITED)
Note 1. Organization
CytoDyn Inc. (the “Company”) was originally incorporated under the laws of Colorado on May 2, 2002 under the name RexRay Corporation (its previous name) and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. Leronlimab is in a class of therapeutic monoclonal antibodies designed to address unmet medical needs in the areas of Human Immunodeficiency Virus (“HIV”), Cancer, Immunology, and novel coronavirus disease (“COVID-19”).
With respect to HIV, the CCR5 receptor appears to play a key role in the ability of HIV to enter and infect healthy
T-cells.
The Company’s lead product candidate, leronlimab, belongs to a class of HIV therapies known as entry inhibitors. These therapies block HIV from entering into and infecting certain cells.
With respect to Cancer and Immunology, the CCR5 receptor also appears to be implicated in human metastasis and in immune-mediated illnesses such as triple-negative breast cancer, other metastatic solid tumor cancers,
graft-vs-host
disease (“GvHD”), and
Non-Alcoholic
Steatohepatitis (“NASH”).
More recently, the Company expanded its clinical focus with leronlimab to include evaluating its effectiveness in multiple other autoimmune indications where CCR5 antagonism has shown initial promise, as well as
COVID-19.
The Company targets leronlimab treatment as a therapy for patients who experience respiratory complications as a result of contracting
COVID-19.
The Company believes leronlimab provides therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in patients experiencing this syndrome.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated interim financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect all adjustments, which consist solely of typical recurring adjustments, needed to fairly present the financial results of the periods presented. The consolidated financial statements and notes thereto are presented as prescribed by
Form 10-Q. Accordingly,
certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted.
The accompanying consolidated financial statements should be read in conjunction with the financial statements for the fiscal years ended May 31, 2020 and 2019 and notes thereto in the Company’s Annual Report on
Form 10-K for
the fiscal year ended May 31, 2020, filed with the Securities and Exchange Commission on August 14, 2020. Operating results for the three and six months ended November 30, 2020 are not necessarily indicative of the results that may be expected for the entire year. In the opinion of management, all adjustments have been made, which consist only of normal recurring adjustments necessary for a fair statement of (a) the results of operations for the three and six months ended November 30, 2020 and November 30, 2019, (b) the financial position at November 30, 2020 and (c) cash flows for the six month periods ended November 30, 2020 and November 30, 2019.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, CytoDyn Operations Inc. and Advanced Genetic Technologies, Inc. (“AGTI”), of which AGTI is a dormant entity. All intercompany transactions and balances are eliminated in consolidation.
Reclassifications
Certain prior year amounts shown in the accompanying consolidated financial statements have been reclassified to conform to the current period presentation. These reclassifications did not have any effect on total current assets, total assets, total current liabilities, total liabilities, total stockholders’ (deficit) equity, net loss or loss per share.
 
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Going Concern
The consolidated accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of $65.8 million for the six months ended November 30, 2020 and has an accumulated deficit of $421.6 million as of November 30, 2020. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.
The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to obtain additional operating capital, complete development of its product candidate, obtain U.S. Food & Drug Administration (“FDA”) approval, outsource manufacturing of the product candidate, and ultimately achieve initial revenues and attain profitability. The Company is currently engaging in significant research and development activities related to its product candidate for multiple indications, and expects to incur significant research and development expenses in the future primarily related to its clinical trials. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs largely from the sale of equity and debt securities, combined with additional funding from other traditional sources. There can be no assurance, however, that the Company will be successful in these endeavors.
Use of Estimates
The preparation of the consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of consolidated financial statements and the reported amounts of expenses during the reporting period. Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the impact that the recent coronavirus disease could have on our significant accounting estimates and assumptions. The Company’s estimates are based on historical experience and on various market and other relevant, appropriate assumptions. Actual results could differ from these estimates.
Cash
Cash is maintained at federally insured financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances. Balances in excess of federally insured limits at November 30, 2020 and May 31, 2020 approximated $29.2 million and $14.0 million, respectively.
Identified Intangible Assets
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 350
Intangibles-Goodwill and Other
, which establishes accounting standards for the impairment of long-lived assets such as intangible assets subject to amortization. The Company reviews long-lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. If the sum of the undiscounted expected future cash flows over the remaining useful life of a long-lived asset group is less than its carrying value, the asset is considered impaired. Impairment losses are measured as the amount by which the carrying amount of the asset group exceeds the fair value of the asset. There were no impairment charges for the six months ended November 30, 2020 and 2019. The value of the Company’s patents would be significantly impaired by any adverse developments as they relate to the clinical trials pursuant to the patents acquired as discussed in Note
8
.
Research and Development
Research and development costs are expensed as incurred. Clinical trial costs incurred through third parties are expensed as the contracted work is performed. Contingent milestone payments that are due to third parties under research and development collaboration arrangements or other contractual agreements are expensed when the milestone conditions are probable and the amount of payment is reasonably estimable, see further discussion in Note 9 and 10.
Inventory
The Company values inventory at the lower of cost or net realizable value using the average cost method. Inventories consist of raw materials, bulk drug substance, and drug product in unlabeled vials to be used for commercialization of the Company’s biologic, leronlimab, which is in the regulatory approval process. The consumption of raw materials during production is classified as
work-in-progress
until saleable. Once it is determined to be in saleable condition following regulatory approval, inventory is classified as finished goods. Inventory is evaluated for recoverability by considering the likelihood that revenue will be obtained from the future sale of the related inventory, in light of the status of the product within the regulatory approval process.
 
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The Company evaluates its inventory levels on a quarterly basis and writes down inventory that has become obsolete, or has a cost in excess of its expected net realizable value, and inventory quantities in excess of expected requirements. In assessing the lower of cost or net realizable value
for
pre-launch
inventory, the Company relies on independent analyses provided by third parties knowledgeable of the range of likely commercial prices comparable to current comparable commercial product.
Inventories Procured or Produced in Preparation for Product Launches
The Company capitalizes inventories procured or produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when the results of clinical trials have reached a status sufficient to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced, and the Company has determined it is probable that these capitalized costs will provide some future economic benefit in excess of capitalized costs. The material factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and the compilation of the regulatory application. The Company closely monitors the status of the product within the regulatory review and approval process, including all relevant communication with regulatory authorities. If the Company is aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory may no longer qualify for capitalization.
Anticipated future sales, shelf lives, and expected approval date are taken into account when evaluating realizability of capitalized inventory. The shelf life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize
pre-launch
inventory, the Company considers the product stability data of all of the
pre-approval
inventory procured or produced to date to determine whether there is adequate shelf life.
Fair Value of Financial Instruments
The Company’s financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued liabilities, and short-term and long-term debt. As of November 30, 2020, the carrying value of the Company’s cash, accounts payable, and accrued liabilities approximate their fair value due to the short-term maturity of the instruments. Short-term and long-term debt are reported at amortized cost in the Consolidated Balance Sheets. The remaining financial instruments are reported in the Consolidated Balance Sheets at amounts that approximate current fair values.
During the fiscal year ending May 31, 2020, the Company carried derivative financial instruments at fair value as required by U.S. GAAP. Derivative financial instruments consist of financial instruments that contain a notional amount and one or more underlying variables (e.g., interest rate, security price, variable conversion rate or other variables), require no initial net investment and permit net settlement. Derivative financial instruments may be free-standing or embedded in other financial instruments. The Company follows the provisions of ASC 815,
Derivatives and Hedging,
as their instruments are recorded as a derivative liability, at fair value, and ASC 480,
Distinguishing Liabilities from Equity,
as it relates to warrant liability, with changes in fair value reflected in the Consolidated Statement of Operations.
The fair value hierarchy specifies three levels of inputs that may be used to measure fair value as follows:
 
   
Level 1. Quoted prices in active markets for identical assets or liabilities.
 
   
Level 2. Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. Level 2 inputs also
include non-binding market
consensus prices that can be corroborated with observable market data, as well as quoted prices that were adjusted for security-specific restrictions.
 
   
Level 3. Unobservable inputs to the valuation methodology which are significant to the measurement of the fair value of assets or liabilities. These Level 3 inputs also
include non-binding market
consensus prices
or non-binding broker
quotes that cannot be corroborated with observable market data.
The Company did not have any assets or liabilities measured at fair value using Level 1 or 2 of the fair value hierarchy as of November 30, 2020 and May 31, 2020. As of November 30, 2020, there were no assets or liabilities measured at fair value using Level 3 inputs; previous outstanding derivative warrants and related convertible debt had been converted prior to May 31, 2020 according to the terms of the agreements.
 
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A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurements. These instruments are not quoted on an active market. During the 2020 fiscal year, the Company used a Binomial Lattice Model to estimate the value of the warrant derivative liability and a Monte Carlo Simulation to value the derivative liability of the redemption provision within a convertible promissory note. These valuation models were used because management believes they reflect all the assumptions that market participants would likely consider in negotiating the transfer of the instruments.
The Company’s derivative liabilities were classified within Level 3 of the fair value hierarchy because certain unobservable inputs were used in the valuation models.
The following is a reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) from inception to the year ended May 31, 2020 (in thousands):
 
Investor warrants issued with registered direct equity offering
   $ 4,360  
Placement agent warrants issued with registered direct equity offering
     819  
Fair value adjustments
     (3,855
  
 
 
 
Balance at May 31, 2018
     1,324  
Inception date value of redemption provisions
     2,750  
Fair value adjustments—convertible notes
     (745
Fair value adjustments—warrants
     (922
  
 
 
 
Balance at May 31, 2019
     2,407  
Fair value adjustments—convertible notes
     (2,005
Fair value adjustments—warrants
     11,547  
Exercise of derivative warrants
     (11,949
  
 
 
 
Balance at May 31, 2020
   $ —  
  
 
 
 
Operating Leases
Operating leases are included in operating lease
right-of-use
(“ROU”) assets, current portion of operating leases payable and operating leases liabilities in the Consolidated Balance Sheets.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and
non-lease
components, which are generally accounted for separately.
Stock-Based Compensation
U.S. GAAP requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award (requisite service period), when designated milestones have been achieved or when pre-defined performance conditions are met.
The Company accounts for stock-based awards established by the fair market value of the instrument using the Black-Scholes option pricing model utilizing certain weighted average assumptions including stock price volatility, expected term and risk-free interest rates, as of the grant date. The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected term of the stock-based award. The expected volatility is based on the historical volatility of the Company’s common stock on monthly intervals. The computation of the expected option term is based on the “simplified method,” as the Company issuances are considered “plain vanilla” options. For stock-based awards with defined vesting, the Company recognizes compensation expense over the requisite service period, when designated milestones have been achieved or when pre-defined performance conditions are met. The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent periods, if actual forfeitures differ from those estimates. Based on limited historical experience of forfeitures, the Company estimated future unvested forfeitures at 0% for all periods presented. Periodically, the Company will issue restricted common stock to executives or third parties as compensation for services rendered. Such stock awards are valued at fair market value on the effective date of the Company’s obligation.
 
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The Company periodically issues stock options or warrants to consultants for various services. The Black-Scholes option pricing model, as described more fully above, is utilized to measure the fair value of the equity instruments on the date of issuance. The Company recognizes the compensation expense associated with the equity instruments over the requisite service or vesting period.​​​​​​​
Debt
The Company has historically issued promissory notes at a discount and
has
incurred direct debt issuance costs. Debt discount and issuance costs are capitalized and amortized over the life of the convertible promissory note in accordance with ASC
470-35
Debt Subsequent Measurement
.
Offering Costs
The Company periodically incurs direct incremental costs associated with the sale of equity securities as fully described in Note
11
. The costs are recorded as a component of equity upon receipt of the proceeds.
Loss per Common Share
Basic loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted loss per share would include the weighted average common shares outstanding and potentially dilutive common stock equivalents. Because of the net losses for all periods presented, the basic and diluted weighted average shares outstanding are the same since including the additional shares would have an anti-dilutive effect on the loss per share.
For this reason, the following options, warrants, unvested restricted stock units, convertible preferred stock including undeclared dividends and share reservations for convertible notes, which are issuable into common stock were not included in the computation of basic and diluted weighted average number of shares of common stock outstanding for the six months ended November 30, 2020 and November 30, 2019 (in thousands), respectively:
 
    
Six Months Ended November 30,
 
    
2020
    
2019
 
Stock options, warrants & unvested restricted stock
     82,796        177,457  
Convertible notes payable
     12,000        10,048  
Convertible preferred stock
     31,490        17,550  
Income Taxes
Deferred taxes are provided on the asset and liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax basis. Future tax benefits for net operating loss carryforwards are recognized to the extent that realization of these benefits is considered more likely than not. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The Company follows the provisions of FASB ASC
740-10,
Uncertainty in Income Taxes
. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there are no unrecognized benefits for all periods presented. The Company has not recognized interest expense or penalties as a result of the implementation of ASC
740-10.
If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefit in interest expense and penalties in operating expenses.
In accordance with Section 15 of the Internal Revenue Code, the Company utilized a federal statutory rate of 21% for the six months ended November 30, 2020 and November 30, 2019. The net tax expense for the
six
months ended November 30, 2020 and 2019, was
zero
. The Company had a full valuation allowance as of November 30, 2020 and May 31, 2020, as management does not consider it more than likely than not that the benefits from the deferred taxes will be realized.
Recent Accounting Pronouncements
Recent accounting pronouncements, other than below, issued by the FASB (including its EITF), the AICPA and the SEC did not or are not believed by management to have a material effect on the Company’s present or future consolidated financial statements.
 
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In December 2019, the FASB issued ASU
No. 2019-12,
Simplifying the Accounting for Income Taxes (Topic 740)
. The objective of the standard is to improve areas of U.S. GAAP by removing certain exceptions permitted by ASC 740 and clarifying existing guidance to facilitate consistent application. The standard will become effective for the Company beginning on January 1, 2021. The Company is currently evaluating the new standard to determine the potential impact on its financial condition, results of operations, cash flows, and financial statement disclosures.
In August 2020, the FASB issued ASU
No. 2020-06,
Debt with Conversion and Other Options (Subtopic
470-20)
and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic
815-40)
which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition is permissible for the adoption of this standard. Update
No. 2020-06
is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted no earlier than the fiscal year beginning after December 15, 2020. The Company is currently evaluating the potential impact, if any, on its consolidated financial statements.
Note 3. Inventories
The Company’s inventory as of November 30, 2020 and May 31, 2020 was $99.1 million and $19.1 million, respectively. Inventory as of November 30, 2020 consisted of raw materials purchased for future commercial production and work-in-progress inventory related to the substantially completed commercial production of
pre-launch inventories
of leronlimab to support the Company’s expected approval of the product as a combination therapy for HIV patients in the United States.
Work-in-progress
consists of bulk drug substance, which is the manufactured drug stored in bulk storage, and drug product, which is the manufactured drug in unlabeled vials. Bulk drug substance and drug product comprised approximately $41.1 million and $29.7 million, respectively, of
work-in-progress
inventory.
The Company believes that material uncertainties related to the ultimate regulatory approval of leronlimab for commercial sale have been significantly reduced based on positive data from the Phase 3 clinical trial results, and information gathered from
pre-filing
meetings with the FDA for the BLA. The last two portions of the BLA (clinical and manufacturing) were submitted with the FDA in April 2020 and the BLA submission was completed on May 11, 2020. In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA filing requesting additional information. In August and September 2020, the FDA provided written responses to the Company’s questions and met telephonically with Company key personnel and its clinical research organization concerning its recent BLA for this HIV combination therapy to expedite the resubmission of its BLA filing for this indication. The Company is working diligently to resubmit the BLA, which it expects to file in the first half of calendar year 2021.
Inventories as of November 30, 2020 and May 31, 2020 are presented below (in thousands):
    
November 30, 2020
    
May 31, 2020
 
Raw materials
   $ 28,294      $ 19,147  
Work-in-progress
     70,777        —    
    
 
 
    
 
 
 
Total
   $ 99,071      $ 19,147