UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For
the quarterly period ended
or
For the transition period from _____________ to _____________
Commission
File Number
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
(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.
☒
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).
☒
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 | ☐ | |
| ☒ | 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 ☒
The number of shares outstanding of the Issuer’s common stock as of November 10, 2023 was .
TABLE OF CONTENTS
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 2 |
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
| September 30, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable | ||||||||
| Inventories, net of $ | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Investment in equity securities | ||||||||
| Property and equipment, net | ||||||||
| Right of use asset operating leases | ||||||||
| Intangible assets, net | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued employee compensation | ||||||||
| Accrued professional fees and other | ||||||||
| Accrued interest and dividends payable | ||||||||
| Deferred revenue | ||||||||
| Convertible debt, net of unamortized debt discounts of $ | ||||||||
| Other debt, net of unamortized discounts of $ | ||||||||
| Related party, net of unamortized debt discount of $ | ||||||||
| Right of use operating lease liability | ||||||||
| Total current liabilities | ||||||||
| LONG TERM LIABILITIES | ||||||||
| Long term debt | ||||||||
| Right of use operating lease liability long term | ||||||||
| Deferred revenue | ||||||||
| TOTAL LONG TERM LIABILITIES | ||||||||
| TOTAL LIABILITIES | ||||||||
| COMMITMENTS AND CONTINGENCIES (Note 4) | ||||||||
| STOCKHOLDERS’ DEFICIT | ||||||||
| Series D, G, H, H2, J, K, AA, BB, CC Convertible Preferred Stock, $ par value (Note 6) | ||||||||
| Common stock, $ par value; shares authorized; and shares issued and outstanding on September 30, 2023 and December 31, 2022, respectively | ||||||||
| Warrants to acquire common stock | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| TOTAL STOCKHOLDERS’ DEFICIT | ( | ) | ( | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 3 |
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue: | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Total revenue | ||||||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of products and services | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating costs | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest expense, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Unrealized gain (loss) on investment in equity securities | ( | ) | ( | ) | ( | ) | ||||||||||
| Gain (loss) on extinguishment of liabilities | ( | ) | ( | ) | ||||||||||||
| Other income (expense) | ( | ) | ( | ) | ||||||||||||
| Total other expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Deemed dividends on extension of warrants | ( | ) | ||||||||||||||
| Preferred stock dividends | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss attributable to common shareholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Basic and diluted net loss per share attributable to common shareholders | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average common shares outstanding used in the basic and diluted net loss per share calculation | ||||||||||||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 4 |
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2023 | 2022 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| (Gain) on extinguishment of debt | ( | ) | ( | ) | ||||
| Non-cash lease expense | ||||||||
| Common stock and warrants issued for interest | ||||||||
| Depreciation and amortization | ||||||||
| Accretion of interest and amortization of debt discount | ||||||||
| Loss on extinguishment of accrued liabilities and debt | ||||||||
| Common stock and warrants issued for debt extension | ||||||||
| Preferred stock issued for debt extension | ||||||||
| Stock-based compensation expense | ||||||||
| (Gain)/Loss on investment in equity securities | ( | ) | ||||||
| Common stock and warrants issued for services | ||||||||
| Preferred stock issued for services | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Inventories | ( | ) | ||||||
| Prepaid expenses and other assets | ||||||||
| Accounts payable | ||||||||
| Accrued employee compensation | ||||||||
| Operating lease liability | ( | ) | ( | ) | ||||
| Deferred revenue and other accrued expenses | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchases of property plant and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Sale of common stock for cash | ||||||||
| Proceeds from stock option exercises | ||||||||
| Net proceeds from convertible debt | ||||||||
| Net proceeds from non-convertible debt - third party | ||||||||
| Net proceeds from debt - related party | ||||||||
| Payments on convertible debt | ( | ) | ( | ) | ||||
| Payments on debt - related party | ( | ) | ( | ) | ||||
| Payments on non-convertible debt | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | ||||||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | ||||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 5 |
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2023 | 2022 | |||||||
| CASH FLOWS SUPPLEMENTAL INFORMATION | ||||||||
| Interest paid in cash | $ | $ | ||||||
| NON CASH TRANSACTIONS: | ||||||||
| Early adoption of ASU 2020-06 | ||||||||
| Common stock issued with debt | ||||||||
| Discount from warrants issued with debt | ||||||||
| Common stock issued in lieu of cash for dividend | ||||||||
| Preferred stock issued with debt | ||||||||
| Preferred stock dividends | ||||||||
| Conversion of preferred stock for common stock | ||||||||
| Conversion of debt, interest, preferred stock dividend for preferred stock | ||||||||
| Conversion of debt and interest into common stock | ||||||||
| Conversion of common stock for preferred stock | ||||||||
| Extension of warrants for Series AA preferred stock | ||||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 6 |
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND SEPTEMBER 30, 2022
(UNAUDITED)
| Combined Preferred Stock | Common Stock | Stock | Additional Paid In | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Warrants | Capital | Deficit | Deficit | |||||||||||||||||||||||||
| BALANCE, December 31, 2022 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
| Stock option exercise | - | |||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Series AA Preferred Stock dividend | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of common stock for services | - | |||||||||||||||||||||||||||||||
| Issuance of common stock warrants for services | - | - | ||||||||||||||||||||||||||||||
| Conversion of debt and interest for common stock | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for dividends paid-in-kind | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for interest paid-in-kind | - | |||||||||||||||||||||||||||||||
| Common stock issued for debt extension | - | |||||||||||||||||||||||||||||||
| Stock issued with debt | - | |||||||||||||||||||||||||||||||
| Conversion of preferred stock for common stock | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Sale of Common Stock | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, March 31, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
| Series AA/CC Preferred Stock dividend | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock for services | - | |||||||||||||||||||||||||||||||
| Extension of warrants for Series AA Preferred stock | - | - | ( | ) | ||||||||||||||||||||||||||||
| Common stock issued for debt extension | - | |||||||||||||||||||||||||||||||
| Conversion of preferred stock for common stock | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Conversion of debt, accrued interest and accrued dividend for preferred stock | - | |||||||||||||||||||||||||||||||
| Conversion of common stock to preferred stock | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Issuance of common stock for dividends paid-in-kind | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for interest paid-in-kind | - | |||||||||||||||||||||||||||||||
| Stock issued with debt | - | |||||||||||||||||||||||||||||||
| Sale of Common Stock | - | |||||||||||||||||||||||||||||||
| Issuance of preferred stock for services | - | |||||||||||||||||||||||||||||||
| Issuance of Preferred stock for debt extension | - | |||||||||||||||||||||||||||||||
| Preferred stock issued with debt | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| BALANCE, June 30, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Series AA/CC Preferred Stock dividend | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of common stock for services | - | |||||||||||||||||||||||||||||||
| Common stock issued for debt extension | - | |||||||||||||||||||||||||||||||
| Conversion of preferred stock for common stock | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of common stock for interest paid-in-kind | - | |||||||||||||||||||||||||||||||
| Stock issued with debt | - | |||||||||||||||||||||||||||||||
| Issuance of preferred stock for services | - | |||||||||||||||||||||||||||||||
| Issuance of Preferred stock for debt extension | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| BALANCE, September 30, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 7 |
| Combined Preferred Stock | Common Stock | Stock | Additional Paid In | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Warrants | Capital | Deficit | Deficit | |||||||||||||||||||||||||
| BALANCE, December 31, 2021 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
| Early adoption of ASU 2020-06 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Series AA Preferred Stock dividend | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of common stock for services | - | |||||||||||||||||||||||||||||||
| Issuance of common stock warrants for services | - | - | ||||||||||||||||||||||||||||||
| Warrants issued for debt extension | - | - | ||||||||||||||||||||||||||||||
| Common stock issued for debt extension | - | |||||||||||||||||||||||||||||||
| Conversion of debt and interest for common stock | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for dividends paid-in-kind | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for interest paid-in-kind | - | |||||||||||||||||||||||||||||||
| Stock issued with debt | - | |||||||||||||||||||||||||||||||
| Warrants issued with debt | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| BALANCE, March 31, 2022 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Stock option exercise | - | |||||||||||||||||||||||||||||||
| Series AA Preferred Stock dividend | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of common stock for services | - | |||||||||||||||||||||||||||||||
| Common stock issued for debt extension | - | |||||||||||||||||||||||||||||||
| Conversion of preferred stock for common stock | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of common stock for dividends paid-in-kind | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for interest paid-in-kind | - | |||||||||||||||||||||||||||||||
| Stock issued with debt | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| BALANCE, June 30, 2022 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock for interest paid-in-kind | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for dividends paid-in-kind | - | |||||||||||||||||||||||||||||||
| Issuance of common stock for services | - | |||||||||||||||||||||||||||||||
| Series AA Preferred Stock dividend | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Common stock issued for debt extension | - | |||||||||||||||||||||||||||||||
| Warrants issued for services | - | - | ||||||||||||||||||||||||||||||
| Stock issued with debt | - | |||||||||||||||||||||||||||||||
| Stock warrants issued | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| BALANCE, September 30, 2022 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 8 |
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2023
(UNAUDITED)
1) Business Overview, Liquidity and Management Plans
Pressure BioSciences, Inc. (OTCQB: PBIO) (the “Company”) is a leader in the development & sale of innovative, enabling, high pressure technology-based instruments, consumables, and services for the life sciences and other industries worldwide. Our products/services are based on three patented, high-pressure platforms: (i) Ultra Shear Technology™ (“UltraShear™” or “UST™”), (ii) BaroFold Technology™ (“BaroFold™”), and (iii) Pressure Cycling Technology™ (“PCT™”)
The Company was founded on the belief that its PCT platform had the potential to significantly increase the quality of sample preparation in both research and clinical settings. This premise has been well proven and PBI has been successful in installing its PCT platform in the laboratories of key opinion leaders worldwide. Although developed subsequently, the Company now assesses that the commercial potential for its UST platform across diverse multi-billion-dollar markets far exceeds the potential of the PCT platform. Consequently, in January 2022, PBI made the critical strategy decision to immediately shift its primary business focus from PCT to its innovative UST Platform.
The UST Platform (8 issued patents) is based on the use of intense shear forces from ultra-high-pressure discharge (greater than 20,000 psi) through a dynamically controlled nano-gap valve under precisely controlled temperatures. UST has been shown to turn hydrophobic (water-repelling) oil-based supplements (e.g., CBD, curcumin, astaxanthin), therapeutics (e.g., prednisone), and other active ingredients (e.g., retinol) into long-term stable, effectively water-soluble, highly bioavailable, oil-in-water nanoemulsion formulations. The Company first introduced the UST Platform in May 2022 through participation in several cannabis/health & wellness meetings combined with a free-sample program. Executed agreements were subsequently announced with six CBD companies and one cosmeceutical/skincare company for full commercialization in Q3 202 3. The Company began shipping Nano CBD topical spray on October 2, 2023.
The BaroFold Platform (14 issued patents) can be used to significantly improve the quality and production costs of protein biotherapeutics. It employs high pressure manipulations for the disaggregation, unfolding and controlled refolding of proteins to their desired native structures at yields and efficiencies not achievable using existing technologies. The BaroFold Platform has been shown to remove protein aggregates in biotherapeutic drug manufacturing, thereby improving product efficacy, safety, and cost for both new-drug entities and biosimilar (follow-on biologic) products. It is scalable and practical for standard manufacturing processes.
The PCT Platform (17 issued patents) uses alternating cycles of hydrostatic pressure between ambient and ultra-high pressures to control bio-molecular interactions safely and reproducibly in sample preparation (e.g., the critical steps performed by tens of thousands of scientists worldwide prior to analytical measurements, such as cell lysis and biomolecule extraction from tissue samples). Our focus for PCT is on making, GMP-compliant, next generation PCT-based Barocycler EXTREME system available globally to biopharmaceutical drug manufacturers for use in the design, development, characterization, and quality control of biotherapeutic drugs. We currently have over 350 PCT Systems placed in approximately 250 academic, government, pharmaceutical, and biotech research laboratories worldwide. There are currently over 200 independent publications highlighting the advantages of using the PCT Platform in scientific research & clinical laboratories.
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 operationing business since our inception. As of September 30, 2023, 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 as described in Notes 5 and 6. In addition, we raised debt and equity capital after September 30, 2023, 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.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 9 |
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, 2022. Operating results for the nine months ended September 30, 2023 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2023.
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 company’s 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 $
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses, which requires measurement and recognition of expected credit losses for financial assets held. We adopted this new accounting guidance effective January 1, 2023. The adoption did not have a material impact on our consolidated financial statements and disclosures and did not significantly impact the Company’s accounting policies or estimation methods related to the allowance for doubtful accounts. The Company does not have any reserve for doubtful accounts due to its customers being distributors, universities, research organizations and government agencies. In the past several years, all its customers have paid in full without any need for a write-down.
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.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 10 |
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 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 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.
Most 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 takes on the 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.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 11 |
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.
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 September 30, | Nine Months Ended September 30, | ||||||||||||||
| Primary geographical markets | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| North America | $ | $ | $ | $ | ||||||||||||
| Europe | ||||||||||||||||
| Asia | ( | ) | ||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| Major products/services lines | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Hardware | $ | $ | $ | $ | ||||||||||||
| Consumables | ||||||||||||||||
| Contract research services | - | |||||||||||||||
| Sample preparation accessories | ||||||||||||||||
| Technical support/extended service contracts | ||||||||||||||||
| Agrochem Products | ||||||||||||||||
| Shipping and handling | ||||||||||||||||
| Other | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| Timing of revenue recognition | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Products transferred at a point in time | $ | $ | $ | $ | ||||||||||||
| Services transferred over time | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
Contract balances
| In thousands of US dollars ($) | September 30, 2023 | December 31, 2022 | ||||||
| Receivables, which are included in ‘Accounts Receivable’ | $ | $ | ||||||
| Contract liabilities (deferred revenue) | ||||||||
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 12 |
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 ($) | 2023 | 2024 | Total | |||||||||
| Extended warranty service | $ | $ | $ | |||||||||
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.
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 and nine months ended September 30, 2023 and 2022.
| Three Months Ended September 30, | Nine months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Top five customers | % | % | % | % | ||||||||||||
| Federal agencies | % | % | % | % | ||||||||||||
The following table illustrates the level of concentration as a percentage of net accounts receivable balance as of September 30, 2023 and December 31, 2022. The Top Five Customers category may include federal agency receivable balances if applicable.
| September 30, 2023 | December 31, 2022 | |||||||
| Top five customers | % | % | ||||||
| Federal agencies | % | % | ||||||
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 |
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 13 |
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 (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.
Investment in Equity Securities
As of September 30, 2023, we held 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 September 30, 2023, 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 $
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.
| For the Three Months Ended September 30, | For the Nine months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Numerator: | ||||||||||||||||
| Net loss attributable to common shareholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator for basic and diluted loss per share: | ||||||||||||||||
| Weighted average common stock shares outstanding | ||||||||||||||||
| Loss per common share - basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 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, Series AA Convertible Preferred Stock, Series BB Convertible Stock and Series CC Convertible Preferred Stock are presented below as if they were converted into common shares according to the conversion terms.
| As of September 30, | ||||||||
| 2023 | 2022 | |||||||
| Stock options | ||||||||
| Convertible debt | ||||||||
| Common stock warrants | ||||||||
| Convertible preferred stock: | ||||||||
| Series D Convertible Preferred Stock | ||||||||
| Series G Convertible Preferred Stock | ||||||||
| Series H Convertible Preferred Stock | ||||||||
| Series H2 Convertible Preferred Stock | ||||||||
| Series J Convertible Preferred Stock | ||||||||
| Series K Convertible Preferred Stock | ||||||||
| Series AA Convertible Preferred Stock | ||||||||
| Series BB Convertible Preferred Stock | ||||||||
| Series CC Convertible Preferred Stock | ||||||||
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
The following table summarizes the assumptions we utilized for grants of stock options to the three sub-groups of our stock option recipients during the nine months ended September 30, 2023:
| Assumptions | CEO, other Officers and Employees | |||
| Expected life | (yrs) | |||
| Expected volatility | % | |||
| Risk-free interest rate | % | |||
| Forfeiture rate | to | % | ||
| Expected dividend yield | % | |||
Valuation and Amortization Method - The fair value of each option award is estimated on the date of the 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 the 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.
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 15 |
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
All of the outstanding non-qualified options had an exercise price that was at or above the Company’s common stock share price at time of issuance.
The Company recognized stock-based compensation expense of $ and $ for the three months ended September 30, 2023 and 2022, respectively. The company recognized stock-based compensation expense of $ and $ for the nine months ended September 30, 2023 and 2022, respectfully. 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 | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Cost of sales | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
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.
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 September 30, 2023:
Fair value measurements at September 30, 2023 using: | ||||||||||||||||
| September 30, 2023 | Quoted prices in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | |||||||||||||
| Equity Securities | $ | $ | ||||||||||||||
| Total Financial Assets | $ | $ | $ | $ | ||||||||||||
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, 2022:
Fair value measurements at December 31, 2022 using: | ||||||||||||||||
December 31, 2022 | Quoted prices in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | |||||||||||||
| Equity Securities | ||||||||||||||||
| Total Financial Assets | $ | $ | $ | $ | ||||||||||||
4) Commitments and Contingencies
Operating Leases
The
Company accounts for its leases under ASC 842. The Company has elected to apply the short-term lease exception to leases of one year
or less. Our corporate office is currently located at 14 Norfolk Avenue, South Easton, Massachusetts 02375. We are currently paying $
We
extended our lease for our space in Medford, MA (the “Medford Lease”) from December 30, 2020 to December 30, 2023. The lease
required monthly payments of $
The
Company accounted for the lease extension of our Medford Lease as a lease modification under ASC 842. At the effective date of modification,
the Company recorded an adjustment to the right-of-use asset and lease liability in the amount of $
The
Company accounted for the Sparks Lease as an operating lease under ASC 842. Upon the commencement of the lease, the Company recorded
a right-of-use asset and lease liability in the amount of $
Following is a schedule by years of future minimum rental payments required under operating leases with initial or remaining non-cancelable lease terms in excess of one year as of September 30, 2023:
| Year | Total | |||
| October 1 – December 31, 2023 | $ | |||
| 2024 | ||||
| 2025 | ||||
| 2026 | ||||
| Total future undiscounted lease payments | ||||
| Less imputed interest | ( | ) | ||
| Present value of lease liabilities | $ | |||
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 16 |
The
operating cash flows from the operating leases were $
Below is a table for the right of use asset and the corresponding lease liability in the consolidated balance sheets:
| Operating Leases | September 30, 2023 | December 31, 2022 | ||||||
| Right of use asset | $ | $ | ||||||
| Right of use liability, current | $ | $ | ||||||
| Right of use liability, long term | $ | $ | ||||||
| Total lease liability | $ | $ | ||||||
The
weighted-average discount rate is
The Company had no financing leases during the nine months ended September 30, 2023 and 2022.
The components of lease cost for operating leases for the nine months ended September 30, 2023 and 2022 are as follows:
| September 30, 2023 | September 30, 2022 | |||||||
| Operating lease cost | $ | $ | ||||||
| Short-term lease cost | ||||||||
| Total lease cost | $ | $ | ||||||
Battelle Memorial Institute
In
December 2008, we entered into an exclusive patent license agreement with the Battelle Memorial Institute (“Battelle”).
The licensed technology is the subject of a patent application filed by Battelle in 2008 and relates to a method and a system for improving
the analysis of protein samples, including through an automated system utilizing pressure and a pre-selected agent to obtain a digested
sample in a significantly shorter period of time than current methods, while maintaining the integrity of the sample throughout the preparatory
process. In addition to royalty payments on net sales on “licensed products,” we are obligated to make minimum royalty payments
for each year that we retain the rights outlined in the patent license agreement and we are required to have our first commercial sale
of the licensed products within one year following the issuance of the patent covered by the licensed technology. After re-negotiating
the terms of the contract in 2013, the minimum annual royalty was $
Target Discovery Inc.
In March 2010, we signed a strategic product licensing, manufacturing, co-marketing, and collaborative research and development agreement with Target Discovery Inc. (“TDI”), a related party. Under the terms of the agreement, we have been licensed by TDI to manufacture and sell an innovative line of chemicals used in the preparation of tissues for scientific analysis (“TDI reagents”). The TDI reagents were designed for use in combination with our pressure cycling technology. The companies believe that the combination of PCT and the TDI reagents can fill an existing need in life science research for an automated method for rapid extraction and recovery of intact, functional proteins associated with cell membranes in tissue samples. We did not incur any royalty obligation under this agreement in 2023 or 2022.
In
April 2012, we signed a non-exclusive license agreement with TDI to grant the non-exclusive use of our pressure cycling technology. We
executed an amendment to this agreement on October 1, 2016 wherein we agreed to pay a monthly fee of $
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 17 |
Severance and Change of Control Agreements
Each of Mr. Schumacher, and Drs. Ting, and Lazarev, executive officers of the Company, are entitled to receive a severance payment if terminated by the Company without cause. The severance benefits would include a payment in an amount equal to one year of such executive officer’s annualized base salary compensation plus accrued paid time off. Additionally, the officer will be entitled to receive medical and dental insurance coverage for one year following the date of termination.
Each of these executive officers, other than Mr. Schumacher, is entitled to receive a change of control payment in an amount equal to one year of such executive officer’s annualized base salary compensation, accrued paid time off, and medical and dental coverage, in the event of their termination upon a change of control of the Company. In the case of Mr. Schumacher, this payment would be equal to two years of annualized base salary compensation, accrued paid time off, and two years of medical and dental coverage. The severance payment is meant to induce the aforementioned executives to remain in the employ of the Company, in general, and particularly in the occurrence of a change in control, as a disincentive to the control change.
5) Debt
Convertible Debt
On
various dates during the nine months ended September 30, 2023, the Company issued convertible notes for net proceeds of approximate total
of $
For
the nine months ended September 30, 2023, deferred financing costs and OID issued with the debt are $
The
summary of specific terms of the convertible notes and outstanding balances as of September 30, 2023, and December 31, 2022, are listed
in the tables below. The convertible notes are from numerous parties and with original issue dates from July 2019 to September 2023
and maturity dates from
| September 30, 2023 | December 31, 2022 | |||||||||||||||||||||||
| Holders | Interest Rate | Conversion Price | Principal | Interest Rate | Conversion Price | Principal | ||||||||||||||||||
| Main Investor | % | $ | $ | % | $ | ) | $ | |||||||||||||||||
| Others | % | $ | % | $ | ||||||||||||||||||||
| Totals | ||||||||||||||||||||||||
| Discount | ||||||||||||||||||||||||
| Net | $ | $ | ||||||||||||||||||||||
Notes:
| (1) | ||
| (2) |
| a. | Notes
are convertible before maturity at $ |
| Pressure BioSciences, Inc. | September 30, 2023 10Q Report | 18 |
| b. | Notes
are convertible upon an Event of Default at | |
| c. | Notes
are convertible at $ | |
| d. | Notes
can be voluntary converted at lower of 1) $ |