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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2022

 

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 001-38185

 

PRESSURE BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Massachusetts   04-2652826
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)

 

14 Norfolk Avenue

South Easton, Massachusetts

  02375
(Address of principal executive offices)   (Zip Code)

 

(508) 230-1828

(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
N/A   N/A   N/A

 

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 (§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, or a smaller reporting 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. (Check one):

 

  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 Exchange Act Rule 12b-2 of the Exchange Act).

 

☐ Yes ☒ No

 

The number of shares outstanding of the Issuer’s common stock as of May 13, 2022 was 8,788,098.

 

 

 

 

 

 

TABLE OF CONTENTS

 

  Page
   
PART I - FINANCIAL INFORMATION 3
   
Item 1. Unaudited Financial Statements 3
   
Consolidated Balance Sheets as of March 31, 2022 and December 31, 2021 3
   
Consolidated Statements of Operations for the Three months Ended March 31, 2022 and 2021 4
   
Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2022 and 2021 5
   
Consolidated Statements of Changes in Stockholders’ Deficit for the Three Months Ended March 31, 2022 and 2021 6
   
Notes to Unaudited Consolidated Financial Statements 8
   
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 26
   
Item 3. Quantitative and Qualitative Disclosure About Market Risk 30
   
Item 4. Controls and Procedures 30
   
PART II - OTHER INFORMATION 31
   
Item 1. Legal Proceedings 31
   
Item 1A. Risk Factors 31
   
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 32
   
Item 3. Defaults Upon Senior Securities 32
   
Item 4. Mine Safety Disclosures 32
   
Item 5. Other Information 32
   
Item 6. Exhibits 33
   
SIGNATURES 34

 

2

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

 

  

March 31,

2022

  

December 31,

2021

 
ASSETS          
CURRENT ASSETS          
Cash and cash equivalents  $118,803   $132,311 
Accounts receivable   291,846    154,746 
Inventories, net of $342,496 reserve at March 31, 2022 and December 31, 2021   1,360,539    1,147,554 
Prepaid expenses and other current assets   184,936    422,617 
Total current assets   1,956,124    1,857,228 
Investment in equity securities   79,114    59,976 
Property and equipment, net   103,520    115,846 
Right of use asset leases   369,006    395,565 
Intangible assets, net   382,211    403,846 
TOTAL ASSETS  $2,889,975   $2,832,461 
LIABILITIES AND STOCKHOLDERS’ DEFICIT          
CURRENT LIABILITIES          
Accounts payable  $665,228   $527,924 
Accrued employee compensation   170,212    117,680 
Accrued professional fees and other   2,133,392    1,955,672 
Other current liabilities   8,304,648    7,757,217 
Deferred revenue   45,806    37,124 
Convertible debt, net of unamortized discounts of $813,478 and $1,536,649, respectively   14,290,657    12,839,813 
Other debt, net of unamortized discounts of $11,670 and $0, respectively   1,311,495    1,256,840 
Operating lease liability   135,810    132,996 
Other related party debt   195,250    - 
Total current liabilities   27,252,498    24,625,266 
LONG TERM LIABILITIES          
Long term debt   150,000    150,000 
Operating lease liability – long term   233,196    262,569 
Deferred revenue   2,592    3,587 
TOTAL LIABILITIES   27,638,286    25,041,422 
COMMITMENTS AND CONTINGENCIES (Note 4)   -    - 
STOCKHOLDERS’ DEFICIT          
Series D Convertible Preferred Stock, $.01 par value; 850 shares authorized; 300 shares issued and outstanding on March 31, 2022 and December 31, 2021, respectively (Liquidation value of $300,000)   3    3 
Series G Convertible Preferred Stock, $.01 par value; 240,000 shares authorized; 80,570 shares issued and outstanding on March 31, 2022 and December 31, 2021, respectively   806    806 
Series H Convertible Preferred Stock, $.01 par value; 10,000 shares authorized; 10,000 shares issued and outstanding on March 31, 2022 and December 31, 2021, respectively   100    100 
Series H2 Convertible Preferred Stock, $.01 par value; 21 shares authorized; 21 shares issued and outstanding on March 31, 2022 and December 31, 2021, respectively   -    - 
Series J Convertible Preferred Stock, $.01 par value; 6,250 shares authorized; 3,458 shares issued and outstanding on March 31, 2022 and December 31, 2021, respectively   35    35 
Series K Convertible Preferred Stock, $.01 par value; 15,000 shares authorized; 6,880 shares issued and outstanding on March 31, 2022 and December 31, 2021, respectively   68    68 
Series AA Convertible Preferred Stock, $.01 par value; 10,000 shares authorized; 8,649 shares issued and outstanding on March 31, 2022 and December 31, 2021, respectively   87    87 
Common stock, $.01 par value; 100,000,000 shares authorized; 10,194,136 and 9,120,526 shares issued and outstanding on March 31, 2022 and December 31, 2021 respectively   101,942    91,206 
Warrants to acquire common stock   31,974,888    31,715,154 
Additional paid-in capital   63,867,846    64,261,048 
Accumulated deficit   (120,694,086)   (118,277,468)
Total stockholders’ deficit   (24,748,311)   (22,208,961)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT  $2,889,975   $2,832,461 

 

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

 

3

 

 

PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

   2022   2021 
  

For the Three Months Ended

March 31,

 
   2022   2021 
Revenue:          
Products, services, other  $480,000   $559,874 
Total revenue   480,000    559,874 
           
Costs and expenses:          
Cost of products and services   314,363    226,275 
Research and development   281,589    299,943 
Selling and marketing   66,462    93,328 
General and administrative   903,885    1,015,430 
Total operating costs and expenses   1,566,299    1,634,976 
           
Operating loss   (1,086,299)   (1,075,102)
           
Other (expense) income:          
Interest expense, net   (2,579,161)   (4,668,064)
Unrealized (loss) gain on investment in equity securities   19,138    (107,903)
Loss on extinguishment of liabilities   (589,850)   (725,159)
Other income (expense)   (3,513)   (1,359)
Total other expense   (3,153,386)   (5,502,485)
           
Net loss   (4,239,685)   (6,577,587)
Deemed dividends on beneficial conversion feature   -    (57,884)
Preferred stock dividends   (432,149)   (403,215)
Net loss attributable to common stockholders  $(4,671,834)  $(7,038,686)
Basic and diluted net loss per share attributable to common stockholders  $(0.48)  $(1.45)
           
Weighted average common stock shares outstanding used in the basic and diluted net loss per share calculation   9,695,189    4,865,826 

 

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

 

4

 

 

PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

   2022   2021 
   For the Three Months Ended 
   March 31, 
   2022   2021 
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss  $(4,239,685)  $(6,577,587)
Adjustments to reconcile net loss to net cash used in operating activities:          
Gain on loan forgiveness   (10,000)   (367,039)
Non-cash lease expense   26,559    15,576 
Common stock and warrants issued for interest and extension fees   1,173,458    2,622,078 
Depreciation and amortization   35,096    27,190 
Accretion of interest and amortization of debt discount   817,877    2,165,780 
Loss on extinguishment of accrued liabilities and debt   589,570    - 
Stock-based compensation expense   64,483    61,237 
(Gain) loss on investment in equity securities   (19,138)   107,903 
Common stock and warrants issued for services   117,461    238,512 
Changes in operating assets and liabilities:          
Accounts receivable   (137,100)   (373,268)
Inventories   (212,985)   33,402 
Prepaid expenses and other assets   237,681    43,291 
Accounts payable   137,304    (60,613)
Accrued employee compensation   52,532    42,702 
Operating lease liability   (26,559)   (15,576)
Deferred revenue and other accrued expenses   637,164    799,397 
Net cash used in operating activities   (756,282)   (1,237,015)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchases of property plant and equipment   (1,135)   (3,962)
Net cash used in investing activities   (1,135)   (3,962)
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Net proceeds from Series AA Convertible Preferred Stock   -    100,000 
Proceeds from stock option exercises   -    14,773 
Net proceeds from convertible debt   806,000    730,000 
Net proceeds from non-convertible debt – third party   351,150    854,538 
Net proceeds from non-convertible debt – related party   195,250    85,000 
Payments on convertible debt   (324,350)   (191,250)
Payments on non-convertible debt – related party   -    (70,000)
Payments on non-convertible debt   (284,141)   (250,094)
Net cash provided by financing activities   743,909    1,272,967 
           
NET INCREASE IN CASH AND CASH EQUIVALENTS   (13,508)   31,990 
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR   132,311    18,540 
CASH AND CASH EQUIVALENTS AT END OF PERIOD  $118,803   $50,530 
           
SUPPLEMENTAL INFORMATION          
Interest paid in cash  $120,436   $37,375 
NON CASH TRANSACTIONS:          
Common stock issued with debt   142,480    - 
Discount from warrants issued with debt   87,436    162,654 
Common stock issued in lieu of cash for dividend   64,256    - 
Early adoption of ASU 2020-06   473,027    - 
Preferred stock dividends   432,149    403,215 
Conversion of debt and interest into common stock   350,500    118,000 
Discount due to beneficial conversion feature   -    53,777 
Deemed dividend - beneficial conversion feature   -    57,884 

 

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

 

5

 

 

PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

(UNAUDITED)

 

    Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Warrants     Capital     Deficit     Deficit  
    Series D
Preferred Stock
    Series G
Preferred Stock
    Series H
Preferred Stock
    Series H(2)
Preferred Stock
    Series J
Preferred Stock
    Series K
Preferred Stock
    Series AA
Preferred Stock
    Common Stock     Stock     Additional Paid-In     Accumulated     Total
Stockholders’
 
    Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Warrants     Capital     Deficit     Deficit  
BALANCE, December 31, 2021   300   $3    80,570   $806    10,000   $100    21   $-    3,458   $35    6,880   $68    8,649   $87    9,120,526   $91,206   $31,715,154   $64,261,048   $(118,277,468)  $(22,208,961)
Early adoption of ASU 2020-06   -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    (2,728,243)   2,255,216    (473,027)
Stock-based compensation   -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    64,483    -    64,483 
Series AA Preferred Stock dividend   -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    (432,149)   (432,149)
Issuance of common stock for services   -    -    -    -    -    -    -    -    -    -    -    -    -    -    37,000    370    -    77,330    -    77,700 
Issuance of common stock warrants for services   -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    39,761    -    -    39,761 
Warrants issued for debt extension   -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    132,537    -    -    132,537 
Common stock issued for debt extension   -    -    -    -    -    -    -    -    -    -    -    -    -    -    214,500    2,145    -    470,755    -    472,900 
Conversion of debt and interest for common stock   -    -    -    -    -    -    -    -    -    -    -    -    -    -    140,200    1,402    -    349,098    -    350,500 
Issuance of common stock for dividends paid-in-kind   -    -    -    -    -    -    -    -    -    -    -    -    -    -    31,810    318    -    63,938    -    64,256 
Issuance of common stock for interest paid-in-kind   -    -    -    -    -    -    -    -    -    -    -    -    -    -    558,100    5,581    -    1,167,877    -    1,173,458 
Stock issued with debt   -    -    -    -    -    -    -    -    -    -    -    -    -    -    92,000    920    -    141,560    -    142,480 
Warrants issued with debt   -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    87,436    -    -    87,436 
Net loss   -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    -    (4,239,685)   (4,239,685)
BALANCE, March 31, 2022   300   $3    80,570   $806    10,000   $100    21   $-    3,458   $35    6,880   $68    8,649   $87    10,194,136   $101,942   $31,974,888   $63,867,846   $(120,694,086)  $(24,748,311)

 

6

 

 

    Series D
Preferred Stock
    Series G
Preferred Stock
    Series H
Preferred Stock
    Series H(2)
Preferred Stock
    Series J
Preferred Stock
    Series K
Preferred Stock
    Series AA
Preferred Stock
    Common Stock     Stock     Additional Paid-In     Accumulated     Total
Stockholders’
 
    Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Warrants     Capital     Deficit     Deficit  
                                                                                                                                                                 
BALANCE, December 31, 2020     300     $ 3       80,570     $ 806       10,000     $ 100       21     $ -       3,458     $ 35       6,880     $ 68       8,043       81       4,168,324     $ 41,683     $ 29,192,471     $ 50,312,968     $ (96,465,807 )   $ (16,917,592 )
Stock-based compensation     -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       61,237       -       61,237  
Stock option exercise     -       -       -       -       -       -       -       -       -       -       -       -       -       -       21,411       214       -       14,559       -       14,773  
Series AA Preferred Stock dividend     -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       (403,215 )     (403,215 )
Issuance of warrants for interest paid-in-kind     -       -       -       -       -     -       -       -       -       -       -       -       -       -       -       -       600,298       -       -       600,298  
Issuance of common stock for services     -       -       -       -       -       -       -       -       -       -       -       -       -       -       112,400       1,124               237,388       -       238,512  
Beneficial conversion feature on debt     -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       53,777       -       53,777  
Series AA Preferred Stock offering     -        -        -        -        -        -        -        -        -        -        -        -        40       -       -       -       49,884       50,116       -       100,000  
Beneficial conversion option on convertible preferred stock     -        -        -        -        -        -        -        -        -        -        -        -        -        -        -       -       -       57,884       -       57,884  
Deemed dividend on convertible preferred stock     -        -        -        -        -        -        -        -        -        -        -        -        -        -        -       -       -       (57,884 )     -       (57,884 )
Conversion of debt and interest for common stock     -        -        -        -        -        -        -        -        -        -        -        -        -        -        47,200       472       -       117,528       -       118,000  
Issuance of common stock for interest paid in kind     -        -        -        -        -        -        -        -        -        -        -        -        -        -        922,372       9,224       -       2,012,556       -       2,021,780  
Warrants issued with debt     -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       162,654       -       -       162,654  
Net loss     -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       -       (6,577,587 )     (6,577,587 )
BALANCE, March 31, 2021     300     $ 3       80,570     $ 806       10,000     $ 100       21     $ -       3,458     $ 35       6,880     $ 68       8,083     $ 81       5,271,707     $ 52,717     $ 30,005,307     $ 52,860,129     $ (103,446,609 )   $ (20,527,363 )

  

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

 

7

 

 

PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2022

(UNAUDITED)

 

  1) Business Overview, Liquidity and Management Plans

 

Pressure Biosciences, Inc. (“we”, “our”, “the Company”) develops and sells innovative, broadly enabling, high pressure-based platform technologies and related consumables for the worldwide life sciences, agriculture, food and beverage, and other key industries. Our solutions are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or “PCT”) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Historically, our primary focus has been in the development of PCT-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, soil & plant biology, forensics, and counter-bioterror applications. In more recent years, major new market opportunities have emerged in the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired, patented technology from BaroFold, Inc. (the “BaroFold” technology) to allow entry into the bio-pharma contract services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (“UST”) platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.

 

On February 8, 2021, PBI announced plans to acquire the assets of a global eco-friendly agrochemical supplier. On April 14, 2021, PBI finalized terms and executed a new letter of intent to purchase the assets of the agrochemical supplier. This opportunity is attractive as it has the potential of readily producing significant revenue, as well as the potential to apply the UST technology to improve some of the product line. In July 2021, a newly-formed subsidiary of PBI, PBI Agrochem, leased a warehouse in Carson City, NV, and hired a warehouse manager.

 

  2) Going Concern

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the liquidation of liabilities in the normal course of business. However, we have experienced losses from operations and negative cash flows from operations with respect to our pressure cycling technology business since our inception. As of March 31, 2022, we do not have adequate working capital resources to satisfy our current liabilities and as a result, there is substantial doubt regarding our ability to continue as a going concern. We have been successful in raising debt and equity capital in the past and as described in Notes 5 and 6. In addition we raised debt and equity capital after March 31, 2022 as described in Note 7. We have financing efforts in place to continue to raise cash through debt and equity offerings. Although we have successfully completed financings and reduced expenses in the past, we cannot assure you that our plans to address these matters in the future will be successful. These financial statements do not include any adjustments that might result from this uncertainty.

 

8

 

 

  3) Summary of Significant Accounting Policies

 

Basis of Presentation

 

The unaudited interim financial statements of Pressure BioSciences, Inc. and its consolidated subsidiaries (collectively, the “Company”) included herein have been prepared by the Company in accordance with the instructions to Form 10-Q and the rules and regulations of the U.S. Securities and Exchange Commission. Under these rules and regulations, some information and footnote disclosures normally included in financial statements prepared under accounting principles generally accepted in the United States of America have been shortened or omitted. Management believes that all adjustments necessary for a fair statement of the financial position and the results of operations for the periods shown have been made. All adjustments are normal and recurring. These financial statements should be read together with the Company’s audited financial statements included in its Form 10-K for the fiscal year ended December 31, 2021. Operating results for the three months ended March 31, 2022 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2022.

 

Use of Estimates

 

The Company’s consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America, which require the use of estimates, judgements and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. Global concerns about the COVID-19 pandemic have adversely affected, and we expect will continue to adversely affect, our business, financial condition and results of operations including the estimates and assumptions made by management. Significant estimates and assumptions include valuations of share-based awards, investments in equity securities and intangible asset impairment. Actual results could differ from the estimates, and such differences may be material to the Company’s consolidated financial statements.

 

Recent Accounting Pronouncements

 

In August 2020, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes the beneficial conversion separation model for convertible debt. As a result, after adopting the guidance, entities will no longer account for beneficial conversion features in equity. The guidance is effective for public business entities, other than small reporting companies financial statements starting January 1, 2022, with early adoption permitted. The Company is a small reporting company and early adopted the new guidance on January 1, 2022 using the modified retrospective approach and recorded a cumulative effect of adoption equal to a $2,728,243 decrease in additional paid in capital and a $2,255,216 decrease in accumulated deficit. There is no expected material impact to the Company’s statements of operations or cash flows as the result of the adoption of ASU 2020-06.

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of Pressure BioSciences, Inc., and its wholly owned subsidiaries PBI BioSeq, Inc and PBI Agrochem, Inc. All intercompany accounts and transactions have been eliminated in consolidation.

 

9

 

 

Revenue Recognition

 

We recognize revenue in accordance with FASB ASC 606, Revenue from Contracts with Customers, and ASC 340-40, Other Assets and Deferred Costs—Contracts with Customers. Revenue is measured based on a consideration specified in a contract with a customer, and excludes any sales incentives and amounts collected on behalf of third parties. We enter into sales contracts that may consist of multiple distinct performance obligations where certain performance obligations of the sales contract are not delivered in one reporting period. We measure and allocate revenue according to ASC 606-10.

 

We identify a performance obligation as distinct if both the following criteria are true: the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Determining the standalone selling price (“SSP”) and allocation of consideration from a contract to the individual performance obligations, and the appropriate timing of revenue recognition, is the result of significant qualitative and quantitative judgments. Management considers a variety of factors such as historical sales, usage rates, costs, and expected margin, which may vary over time depending upon the unique facts and circumstances related to each performance obligation in making these estimates. While changes in the allocation of the SSP between performance obligations will not affect the amount of total revenue recognized for a particular contract, any material changes could impact the timing of revenue recognition, which would have a material effect on our financial position and result of operations. This is because the contract consideration is allocated to each performance obligation, delivered or undelivered, at the inception of the contract based on the SSP of each distinct performance obligation.

 

Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by the Company from a customer, are excluded from revenue.

 

Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are in included in cost of revenues as consistent with treatment in prior periods.

 

Our current Barocycler® instruments require a basic level of instrumentation expertise to set-up for initial operation. To support a favorable first experience for our customers, upon customer request, and for an additional fee, we will send a highly trained technical representative to the customer site to install Barocyclers® that we sell, lease, or rent through our domestic sales force. The installation process includes uncrating and setting up the instrument, followed by introductory user training. Our sales arrangements do not provide our customers with a right of return. Any shipping costs billed to customers are recognized as revenue.

 

The majority of our instrument and consumable contracts contain pricing that is based on the market price for the product at the time of delivery. Our obligations to deliver product volumes are typically satisfied and revenue is recognized when control of the product transfers to our customers. Concurrent with the transfer of control, we typically receive the right to payment for the shipped product and the customer has significant risks and rewards of ownership of the product. Payment terms require customers to pay shortly after delivery and do not contain significant financing components.

 

Revenue from scientific services customers is recognized upon completion of each stage of service as defined in service agreements.

 

We apply ASC 845, “Accounting for Non-Monetary Transactions”, to account for products and services sold through non-cash transactions based on the fair values of the products and services involved, where such values can be determined. Non-cash exchanges would require revenue to be recognized at recorded cost or carrying value of the assets or services sold if any of the following conditions apply:

 

  a) The fair value of the asset or service involved is not determinable.
     
  b) The transaction is an exchange of a product or property held for sale in the ordinary course of business for a product or property to be sold in the same line of business to facilitate sales to customers other than the parties to the exchange.
     
  c) The transaction lacks commercial substance.

 

We recognize revenue for non-cash transactions at recorded cost or carrying value of the assets or services sold.

 

We account for lease agreements of our instruments in accordance with ASC 842, Leases. We record revenue over the life of the lease term, and we record depreciation expense on a straight-line basis over the thirty-six-month estimated useful life of the Barocycler® instrument. The depreciation expense associated with assets under lease agreement is included in the “Cost of PCT products and services” line item in our accompanying consolidated statements of operations. Many of our lease and rental agreements allow the lessee to purchase the instrument at any point during the term of the agreement with partial or full credit for payments previously made. We pay all maintenance costs associated with the instrument during the term of the leases.

 

Deferred revenue represents amounts received from service contracts for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. Revenue from service contracts is recorded ratably over the length of the contract.

 

10

 

 

Disaggregation of revenue

 

In the following table, revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition.

 

In thousands of US dollars ($) 

Three Months Ended

March 31,

 
Primary geographical markets  2022   2021 
North America  $318   $208 
Europe   46    84 
Asia   116    268 
   $480  $560 

 

  

Three Months Ended

March 31,

 
Major products/services lines  2022   2021 
Hardware  $284   $377 
Consumables   40    102 
Contract research services   15    6 
Sample preparation accessories   31    29 
Agrochem products   83    - 
Technical support/extended service contracts   17    24 
Shipping and handling   10    19 
Other   -    3 
   $480   $560 

 

11

 

 

  

Three Months Ended

March 31,

 
Timing of revenue recognition  2022   2021 
Products transferred at a point in time  $448   $538 
Services transferred over time   32    22 
   $480  $560 

 

Contract balances

 

In thousands of US dollars ($) 

March 31,

2022

  

December 31,

2021

 
Receivables, which are included in ‘Accounts Receivable’  $292   $155 
Contract liabilities (deferred revenue)   48    41 

 

Transaction price allocated to the remaining performance obligations.

 

The following table includes estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied (or partially unsatisfied) at the end of the reporting period.

 

In thousands of US dollars ($)  2022   2023   Total 
Extended warranty service  $46   $3   $49 

 

All consideration from contracts with customers is included in the amounts presented above.

 

Contract Costs

 

The Company recognizes the incremental costs of obtaining contracts as an expense when incurred if the amortization period of the assets that the Company otherwise would have recognized is one year or less. These costs are included in selling, general, and administrative expenses. The costs to obtain a contract are recorded immediately in the period when the revenue is recognized either upon shipment or installation. The costs to obtain a service contract are considered immaterial when spread over the life of the contract so the Company records the costs immediately upon billing.

 

12

 

 

Concentrations

 

Credit Risk

 

Our financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash, cash equivalents, and trade receivables. We have cash investment policies which, among other things, limit investments to investment-grade securities. We perform ongoing credit evaluations of our customers, and the risk with respect to trade receivables is further mitigated by the fact that many of our customers are government institutions, large pharmaceutical and biotechnology companies, and academic laboratories.

 

The following table illustrates the level of concentration as a percentage of total revenues during the three months ended March 31, 2022 and 2021.

 

   For the Three Months Ended 
   March 31, 
   2022   2021 
Top Five Customers   73%   88%
Federal Agencies   0%   1%

 

The following table illustrates the level of concentration as a percentage of net accounts receivable balance as of March 31, 2022 and December 31, 2021. The Top Five Customers category may include federal agency receivable balances if applicable.

 

   March 31,
2022
   December 31,
2021
 
Top Five Customers   88%   82%
Federal Agencies   3%   5%

 

Product Supply

 

In recent years we utilized a contract assembler for our Barocycler® 2320EXT. They provided us with precision manufacturing services that included management support services to meet our specific application and operational requirements. Among the services provided to us were:

 

  CNC Machining
     
  Contract Assembly & Kitting
     
  Component and Subassembly Design
     
  Inventory Management
     
  ISO certification

 

Beginning in July 2021, we brought the assembly of our Barocycler 2320EXT instruments in-house. This became necessary when our independent contract assembler (CBM Industries) informed us that they were about to need 100% of their assembly space for one of their customers, who was in fact one of the largest life science instrument manufacturers in the U.S. We worked with our notified body to gain approval to use both the CE and CSA marks on the instrument, which we received during Q3 2021. Until further notice, we expect to continue to assemble our Barocycler 2320EXT instrument at our South Easton, MA location.

 

We currently manufacture and assemble the Barocycler®, HUB440, HUB880, the SHREDDER SG3, and most of our consumables at our South Easton, MA facility. We will regularly reassess the tradeoffs between in-house assembly versus the benefits of outsourced relationships for of the entire Barocycler® product line, and future instruments.

 

13

 

 

Investment in Equity Securities

 

As of March 31, 2022, we held 100,250 shares of common stock of Nexity Global SA, (a Polish publicly traded company).

 

We account for this investment in accordance with ASC 320 “Investments — Debt and Equity Securities”. ASC 320 requires equity investments with readily determinable fair values to be measured at fair value with changes in fair value recognized in net income.

 

As of March 31, 2022, our consolidated balance sheet reflected the fair value, determined on a recurring basis based on Level 1 inputs of our investment in Nexity, to be $79,114. We recorded $19,138 as an unrealized gain during the three months ended March 31, 2022 for changes in market value.

 

Computation of Loss per Share

 

Basic loss per share is computed by dividing loss available to common shareholders by the weighted average number of common shares outstanding. Diluted loss per share is computed by dividing loss available to common shareholders by the weighted average number of common shares outstanding plus additional common shares that would have been outstanding if dilutive potential common shares had been issued. For purposes of this calculation, convertible preferred stock, common stock dividends, and warrants and options to acquire common stock, are all considered common stock equivalents in periods in which they have a dilutive effect and are excluded from this calculation in periods in which these are anti-dilutive to our net loss.

 

The following table illustrates our computation of loss per share for the three months ended March 31, 2022 and 2021:

 

   2022   2021 
   For the Three Months Ended 
   March 31, 
   2022   2021 
Numerator:        
Net loss attributable to common stockholders  $(4,671,834)  $(7,038,686)
           
Denominator for basic and diluted loss per share:          
Weighted average common stock shares outstanding   9,695,189    4,865,826 
           
Loss per common share – basic and diluted  $(0.48)  $(1.45)

 

14

 

 

The following table presents securities that could potentially dilute basic loss per share in the future. For all periods presented, the potentially dilutive securities were not included in the computation of diluted loss per share because these securities would have been anti-dilutive to our net loss. The Series D Convertible Preferred Stock, Series G Convertible Preferred Stock, Series H and H2 Convertible Preferred Stock, Series J Convertible Preferred Stock, Series K Convertible Preferred Stock, and Series AA Convertible Preferred Stock are presented below as if they were converted into common shares according to the conversion terms.

 

   As of March 31, 
   2022   2021 
Stock options   1,307,822    1,358,490 
Convertible debt   5,668,816    4,757,701 
Common stock warrants   16,350,438    14,901,211 
Convertible preferred stock:          
Series D Convertible Preferred Stock   25,000    25,000 
Series G Convertible Preferred Stock   26,857    26,857 
Series H Convertible Preferred Stock   33,334    33,334 
Series H2 Convertible Preferred Stock   70,000    70,000 
Series J Convertible Preferred Stock   115,267    115,267 
Series K Convertible Preferred Stock   229,334    229,334 
Series AA Convertible Preferred Stock   8,649,000    8,083,000 
    32,475,868    29,600,194 

 

Accounting for Stock-Based Compensation Expense

 

We maintain equity compensation plans under which incentive stock options and non-qualified stock options are granted to employees, independent members of our Board of Directors and outside consultants. We recognize stock-based compensation expense over the requisite service period using the Black-Scholes formula to estimate the fair value of the stock options on the date of grant.

 

Determining Fair Value of Stock Option Grants

 

Valuation and Amortization Method - The fair value of each option award is estimated on the date of grant using the Black-Scholes pricing model based on certain assumptions. The estimated fair value of employee stock options is amortized to expense using the straight-line method over the vesting period.

 

Expected Term - The Company uses the simplified calculation of expected life, as the Company does not currently have sufficient historical exercise data on which to base an estimate of expected term. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted.

 

Expected Volatility - Expected volatility is based on the Company’s historical stock volatility data over the expected term of the award.

 

Risk-Free Interest Rate - The Company bases the risk-free interest rate used in the Black-Scholes valuation method on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent remaining term.

 

Forfeitures - The Company records stock-based compensation expense only for those awards that are expected to vest. The Company estimated a forfeiture rate of 5% for awards granted based on historical experience and future expectations of options vesting. The Company used this historical rate as our assumption in calculating future stock-based compensation expense.

 

15

 

 

The Company recognized stock-based compensation expense of $64,483 and $61,237 for the three months ended March 31, 2022 and 2021, respectively. The following table summarizes the effect of this stock-based compensation expense within each of the line items of our costs and expenses within our Consolidated Statements of Operations:

 

   For the Three Months Ended 
   March 31, 
   2022   2021 
Cost of sales  $4,349   $5,053 
Research and development   18,909    25,862 
Selling and marketing   9,050    4,595 
General and administrative   32,175    25,727 
Total stock-based compensation expense  $64,483   $61,237 

 

Fair Value of Financial Instruments

 

Due to their short maturities, the carrying amounts for cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and debt approximate their fair value. The carrying amount of long-term debt approximates fair value due to interest rates that approximate prevailing market rates.

 

Fair Value Measurements

 

The Company follows the guidance of FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”) as it related to all financial assets and financial liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis.

 

The Company generally defines fair value 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 (exit price). The Company uses a three-tier fair value hierarchy, which classifies the inputs used in measuring fair values. These tiers include: Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. A slight change in an unobservable input like volatility could have a significant impact on fair value measurement.

 

Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company has determined that its financial assets are classified within Level 1 in the fair value hierarchy. The development of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s management.

 

16

 

 

The following tables set forth the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of March 31, 2022:

 

      

Fair value measurements at

March 31, 2022 using:

 
  

March 31,

2022

  

Quoted

prices in

active

markets

(Level 1)

  

Significant

other

observable

inputs

(Level 2)

  

Significant

unobservable

inputs

(Level 3)

 
Equity Securities  $79,114   $79,114    -    - 
Total Financial Assets  $79,114   $79,114   $-   $- 

 

The following tables set forth the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of December 31, 2021: