Subsequent Events | 7) Subsequent Events From October 1, 2023, through November 10, 2023, the Company issued seven (7) convertible loan with a principal balance of $ 439,000 . The terms of the convertible notes were 15 days to 12 months with interest rates of 10 - 120 % and convertible into the Company’s common stock at a fixed rate of $ 2.50 per share. In this time the Company also issued 278,500 shares of common stock for new convertible debt loans in the third quarter, 455,350 shares of common stock for accrued interest paid-in-kind, 310,000 shares of common stock for debt extensions, 505,000 shares of common stock from the conversion of Series BB preferred stock, 145,809 shares of common stock for Series AA preferred dividends and 40 Series BB preferred stock for professional services. On October 18, 2023, the Board of Directors (the “Board”) of Pressure BioSciences, Inc. (the “Company”) approved an amendment (the “Amendment”) to the Pressure BioSciences, Inc. 2021 Equity Incentive Plan (the “Plan”). The Plan originally provided that no one person could be granted awards pursuant to the Plan during any one fiscal year to purchase more than 300,000 0.01 500,000 On the same date, the Board granted a total of 1,500,000 0.25 25 25 3 In addition, on the same date, the Board approved the repricing of all outstanding options (including those held by the Board members and the named executive officers) to $ 0.25 0.69 1.50 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, forward-looking statements are identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. Such statements include, without limitation, statements regarding: ● our need for, and our ability to raise, additional equity or debt financing on acceptable terms, if at all; ● our need to take additional cost reduction measures, cease operations or sell our operating assets, if we are unable to obtain sufficient additional financing; ● our belief that we will have sufficient liquidity to finance normal operations for the foreseeable future; ● the options we may pursue in light of our financial condition; ● the potential applications for Ultra Shear Technology ( UST ● the potential applications of the BaroFold high-pressure protein refolding and disaggregation technology ● the amount of cash necessary to operate our business; ● the anticipated uses of grant revenue and the potential for increased grant revenue in future periods; ● our plans and expectations with respect to our continued operations; ● the expected number of Pressure Cycling Technology (“PCT”) and Constant Pressure (“CP”) based units that we believe will be installed and the expected revenues from the sale of consumable products, extended service contracts, and biopharma contract services; ● our belief that PCT has achieved initial market acceptance in the mass spectrometry and other markets; ● the expected development and success of new instrument and consumables product offerings; ● the potential applications for our instrument and consumables product offerings; ● the expected expenses of, and benefits and results from, our research and development efforts; ● the expected benefits and results from our collaboration programs, strategic alliances and joint ventures; ● our expectations of the results of our development activities funded by government research grants; ● the potential size of the market for biological sample preparation, biopharma contract services and Ultra Shear Technology; ● general economic conditions; ● the anticipated future financial performance and business operations of our company; ● our reasons for resources expended in the market for genomic, proteomic, lipidomic and small molecule sample preparation; ● the importance of mass spectrometry as a laboratory tool; ● the advantages of PCT over other current technologies as a method of biological sample preparation and protein characterization in biomarker discovery, forensics, and histology, as well as for other applications; ● the capabilities and benefits of our PCT Sample Preparation System, consumables and other products; ● our belief that laboratory scientists will achieve results comparable with those reported to date by certain research scientists who have published or presented publicly on PCT and our other products and services; ● our ability to retain our core group of scientific, administrative and sales personnel; and ● our ability to expand our customer base in sample preparation and for other applications of PCT, as well as for our other products and services in both the BaroFold and Ultra Shear Technology areas. These forward-looking statements are only predictions and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements, expressed or implied, by such forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this Quarterly Report on Form 10-Q. Except as otherwise required by law, we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this Quarterly Report on Form 10-Q to reflect any change in our expectations or any change in events, conditions or circumstances on which any of our forward-looking statements are based. Factors that could cause or contribute to differences in our future financial and other results include those discussed in the risk factors set forth in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022 and in this Report. We qualify all of our forward-looking statements by these cautionary statements. Pressure BioSciences, Inc. (OTCQB: PBIO 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 The BaroFold Platform The PCT Platform 2023 Key Accomplishments From January 1, 2023 to September 30, 2023, we announced the following key accomplishments: ● September 22: ● September 21: ● September 8: ● August 30: ● August 22: ● August 9: . ● July 26: ● July 25: ● July 17: ● July 10: ● July 6: ● July 5: ● June 13: ● June 1: ● May 22: ● May 16: ● May 9: ● April 26: ● April 21, 2023: ● April 18: ● April 14: ● April 6, 2023: ● March 28: ● March 22: ● March 1: ● February 1: ● January 27: ● January 19: Results of Operations The following disclosure compares the results of operations for the quarter ended September 30, 2023 (“Q2 2023”) with September 30, 2022 (“Q2 2022”) and compares the nine months ended September 30, 2023 with September 30, 2022. Products and Services Revenue We recognized total revenue of $413,009 for Q3 2023 compared to $144,032 for Q3 2022, a 187% increase. For the year-to-date periods ending September 30, 2023 and September 30, 2022, we recognized revenue of $1,665,412 and $1,122,169 respectively, a 48% increase. This increase in revenue was primarily attributable to a $506,828 increase in PCT instrumentation and consumable sales, a $30,295 increase in technical support services and an $87,378 increase in Agrochem products, offset by a decrease of $89,350 in scientific services. Cost of Products and Services The cost of products and services was $229,457 for Q3 2023 compared to $126,203 for Q3 2022. For the year-to-date periods ending September 30, 2023 and September 30, 2022 our cost of products and services were $844,684 and $742,707, respectively. Gross profit margin on products and services increased to 49% in the year-to-date period ended September 30, 2023 from 34% in the same period ended September 30, 2022. The increase in gross profit margin was attributable to $180,670 of Agrochem products sold in 2023 at no cost due to 2022 inventory write-off and a $79,901 instrument non-monetary exchange sale in 2022 was recorded at no profit. Research and Development Research and development expenses were $288,345 for Q3 2023 compared to $262,370 for Q3 2022. For the year-to-date periods ending September 30, 2023 and September 30, 2022, these expenses were $1,004,437 and $716,685, respectively, a 40% increase. The reported increase was due to a $71,777 reclass of salaries to COGS for a non-monetary instrument exchange in 2022 and $241,585 of stock-based compensation expense for employee stock options issued in 2023. Selling and Marketing Selling and marketing expenses were $157,773 for Q3 2023 compared to $226,526 for Q3 2022. For the year-to-date periods ending September 30, 2023 and September 30, 2022, these expenses were $537,802 and $422,422, respectively a 27% increase The reported increase was primarily attributable to the hiring of a Marketing FTE in Q2 2023 and $102,675 of stock-based compensation expense for employee stock options issued in 2023. General and Administrative General and administrative expenses were $1,030,244 for Q3 2023 compared to $892,293 for Q3 2022. For the year-to-date periods ending September 30, 2023 and September 30, 2022, these expenses were $5,290,564 and $2,591,644, respectively, a 104% increase. The increase was primarily due to approximately $2.0 million common stock and warrants issued for services, approximately $1.3 million of stock-based compensation expense for employee, BOD and financial consultant stock options issued in 2023, and approximately $132,000 of financial consulting expenses in 2023, offset by an approximately $423,000 decrease in IR expenses. Operating Loss Operating loss was $1,292,809 for Q3 2023 compared to $1,363,360 for Q3 2022. For the year-to-date periods ending September 30, 2023 and September 30, 2022, the operating loss was $6,012,075 and $3,551,289 respectively, a 79% increase. This increase was primarily due to $2.0 millions in common stock and warrants issued for services and $1.7 million of stock-based compensation expense for employee, BOD financial consultant stock options issued in 2023, offset by an approximate $423,000 decrease in IR expenses. Interest Expense, net Interest expense was $4,338,759 for Q3 2023 compared to $2,034,021 for Q3 2022. For the year-to-date periods ending September 30, 2023 and September 30, 2022, these expenses were $14,112,098 and $6,448,771, respectively, a 119% increase. This increase was attributable to an increase in convertible debt and merchant cash loans, in addition to stock issuances for interest paid in kind and stock issued for debt extensions. Unrealized gain on investment in equity securities Unrealized loss on investments in equity securities was $5,965 for Q3 2023 compared to an unrealized loss of $8,675 for Q3 2022. For the nine months ended September 30, 2023, the unrealized gain on investment in equity securities was $14,280 as compared to an unrealized loss of $8,047 for the nine months ended September 30, 2022. The reported change was attributable to movement in the market price of the Company’s investment in Nexity. Loss on extinguishment of liabilities In connection with debt extensions and forgiveness, we recognized a net gain of $0 for Q3 2023 compared to $1,054,122 of losses for Q3 2022. For the nine months ended September 30, 2023 the recognized net gain of $687,591 as compared to a net loss of $1,809,249 for the nine months ended September 30, 2022. The increase/decline in gains/losses was attributable to decreased extension and forgiveness activity. Net loss attributable to common stockholders Net loss attributable to common stockholders was $6,261,999 ($0.29 per share) for Q3 2023 compared to $4,893,946 ($0.44 per share) for Q3 2022. For the nine months ended September 30, 2023, the net loss attributable to common stock was $24,666,565 ($1.21 per share) as compared to $12,913,826 ($1.24 per share). Liquidity and Financial Condition We have experienced negative cash flows from operations since our inception. As of September 30, 2023, we did not have adequate working capital resources to satisfy our current liabilities and as a result, we have substantial doubt regarding our ability to continue as a going concern. As described in Notes 5 and 6 of the accompanying consolidated financial statements, we have been successful in raising debt and equity capital. We received approximately $6.5 million in net proceeds from loans in the nine months ended September 30, 2023. We have efforts in place to continue to raise cash through debt and equity offerings. (See Note 7 to the financial statements) We will need substantial additional capital to fund our operations in future periods. If we are unable to obtain financing on acceptable terms, or at all, we will likely be required to cease our operations, pursue a plan to sell our operating assets, or otherwise modify our business strategy, which could materially harm our future business prospects. Net cash used in operations for the nine months ended September 30, 2023 was $2,053,823 as compared to $3,051,257 for the nine months ended September 30, 2022. Net cash used in investing activities for the nine months ended September 30, 2023 was $7,495 compared to $20,754 in the nine months ended September 30, 2022. Net cash provided by financing activities for the nine months ended September 30, 2023 was $2,062,716 as compared to $3,170,580 for the nine months ended September 30, 2022. This Item 3 is not applicable to us as a smaller reporting company and has been omitted. We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Securities Exchange Act of 1934 filings are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our President and Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed to do, and management was necessarily required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. As of September 30, 2023, we carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934. Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were not effective. Our conclusion that our disclosure controls and procedures were not effective as of September 30, 2023 is due to the continued presence of the material weaknesses in our internal control over financial reporting identified in our Annual Report on Form 10-K for the year ended December 31, 2022. These material weaknesses are the following: ● We identified a lack of sufficient segregation of duties. Specifically, this material weakness is such that the design over these areas relies primarily on detective controls and could be strengthened by adding preventative controls to properly safeguard Company assets. ● Management has identified a lack of sufficient personnel in the accounting function due to our limited resources with appropriate skills, training, and experience to perform the review processes to ensure the complete and proper application of generally accepted accounting principles, particularly as it relates to valuation of warrants and other complex debt /equity transactions. Specifically, this material weakness resulted in audit adjustments to the annual consolidated financial statements and revisions to related disclosures, valuation of warrants and other equity transactions. ● Limited policies and procedures that cover recording and reporting of financial transactions. ● Lack of multiple levels of review over the financial reporting process We continue to plan to remediate those material weaknesses as follows: ● Improve the effectiveness of the accounting group by augmenting our existing resources with additional consultants or employees to assist in the analysis and recording of complex accounting transactions, and to simultaneously achieve desired organizational structuring for improved segregation of duties. We plan to mitigate this identified deficiency by hiring an independent consultant once we generate significantly more revenue or raise significant additional working capital. ● Improve expert review and achieve desired segregation procedures by strengthening cross approval of various functions including quarterly internal audit procedures where appropriate once we generate significantly more revenue or raise significantly more working capital. During the period covered by this Report, we implemented and performed additional substantive procedures, such as supervisory review of work papers and consistent use of financial models used in equity valuations, to ensure our consolidated financial statements as of and for the six-month period ended September 30, 2023, are fairly stated in all material respects in accordance with GAAP. We have not, however, been able to fully remediate the material weaknesses due to our limited financial resources. Our remediation efforts are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner. Except as described above, there have been no changes in our internal controls over financial reporting that occurred during the period ended September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting. We are not currently involved in any litigation that we believe could have a material adverse effect on our financial condition or results of operations. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of our company or any of our subsidiaries, threatened against or affecting our company, our common stock, any of our subsidiaries or of our companies or our subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect. Factors that could cause or contribute to differences in our future financial and operating results include those discussed in the risk factors set forth in Item 1 of our Annual Report on Form 10-K for the year ended December 31, 2022 and, in this Item, 1A. The risks described in our Form 10-K and this Report are not the only risks that we face. Additional risks not presently known to us or that we do not currently consider significant may also have an adverse effect on the Company. If any of the risks occur, our business, results of operations, cash flows or financial condition could suffer. There have been no material changes to the risk factors set forth in Item 1A of our 10-K for the year ended December 31, 2022. Except where noted, all the securities discussed in this Part II, Item 2 were issued in reliance on the exemption under Section 4(a)(2) of the Securities Act. On various dates in the nine months ended September 30, 2023 the Company issued a total of 9,917,035 of its common shares, 953 shares of Series BB preferred stock and 401 shares of Series CC preferred stock as follows: ● 117,552 shares from option exercises; ● 1,630,500 shares for professional services; ● 1,346,800 shares for debt extensions; ● 203,613 shares for conversion of debt and interest; ● 142,767 shares for dividends paid-in-kind; ● 4,094,121 shares for interest paid-in-kind; ● 1,258,742 shares for shares issued with debt; ● 60,000 shares from sale of common shares; ● 95 shares of Series BB preferred stock was converted to common stock; ● 92 shares of Series BB preferred stock for professional services; ● 741 shares of Series BB preferred stock for debt extensions; ● 58 shares of Series BB preferred stock issued with debt; ● 401 shares of Series CC preferred stock for conversion of debt/accrued interest and dividends, and ● 62 shares of Series BB preferred stock for the conversion of common stock. None. Not applicable. None. Exhibits 21.1* Securities Issuance and Exchange Agreement 31.1* Certification by the Principal Executive Officer of Registrant pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Rule 13a-14(a) or Rule 15d-14(a)) 31.2* Certification by the Principal Financial Officer of Registrant pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Rule 13a-14(a) or Rule 15d-14(a)) 32.1** Certification by the Principal Executive Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* 32.2** Certification by the Principal Financial Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* 101.INS* Inline XBRL Instance Document 101.SCH* Inline XBRL Taxonomy Extension Schema Document 101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) * Filed herewith. ** In accordance with SEC Release 33-8238, Exhibits 32.1 and 32.2 are furnished and not filed. Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned thereunto duly authorized. PRESSURE BIOSCIENCES, INC. Date: November 20, 2023 By: /s/ Richard T. Schumacher Richard T. Schumacher President & Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |