Vicapsys Life Sciences, Inc 10-Q for FY2024 Q3
Vicapsys Life Sciences, Inc. (VICP)
About this 10-Q
Vicapsys Life Sciences, Inc filed this 10-Q on January 10, 2025, covering the quarter ended September 30, 2024 (FY2024 Q3).
Headline figures
Quarter ended September 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $235.51K
- compared with a net loss of $240.34K a year earlier
- Diluted EPS
- -$0.01
- compared with -$0.01 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
For
the quarterly period ended
For the transition period from __________ to __________
Commission
file number:
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| Incorporation or Organization) | Identification Number) |
| (Address of Principal Executive Offices) | (Zip Code) |
(Registrant’s Telephone Number, Including Area Code)
(Former name, former address and former fiscal year, if changed since last report)
Securities registered under Section 12(b) of the Act: None
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| N/A | N/A | N/A |
Indicate
by check mark whether the issuer (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 has 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
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
| Smaller
reporting company | |
| Emerging
growth company |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares outstanding of the registrant’s $ par value common stock as of November 18, 2024, was ).
Vicapsys Life Sciences, Inc.
TABLE OF CONTENTS
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains certain forward-looking statements that are subject to various risks and uncertainties. Forward-looking statements are generally identifiable by use of forward-looking terminology such as “may,” “will,” “should,” “potential,” “intend,” “expect,” “outlook,” “seek,” “anticipate,” “estimate,” “approximately,” “believe,” “could,” “project,” “predict,” or other similar words or expressions. Forward-looking statements are based on certain assumptions, discuss future expectations, describe future plans and strategies, contain financial and operating projections or state other forward-looking information. Our ability to predict results or the actual effect of future events, actions, plans or strategies is inherently uncertain. Although we believe that the expectations reflected in our forward-looking statements are based on reasonable assumptions, our actual results and performance could differ materially from those set forth or anticipated in our forward-looking statements. Factors that could have a material adverse effect on our forward- looking statements and upon our business, results of operations, financial condition, funds derived from operations, cash available for dividends, cash flows, liquidity and prospects include, but are not limited to, the factors referenced in this document, including those set forth below:
| ● | our lack of an operating history; | |
| ● | the net losses that we expect to incur as we develop our business; | |
| ● | Obtaining U.S. Food and Drug Administration (“FDA”) or other regulatory approvals or clearances for our technology; | |
| ● | implementing and achieving successful outcomes for clinical trials of our products; | |
| ● | convincing physicians, hospitals and patients of the benefits of our technology and to convert from current technology; | |
| ● | the ability of users of our products (when and as developed) to obtain third-party reimbursement; | |
| ● | any failure to comply with rigorous FDA and other government regulations; and | |
| ● | securing, maintaining and defending patent or other intellectual property protections for our technology. |
Forward-looking statements include risks and uncertainties and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These factors, risks and uncertainties can be found in Company’s Annual Report filed on Form 10-K filed with the Securities and Exchange Commission on October 21, 2024, (the “Form 10-K”) for the fiscal year ended December 31, 2023, as the same may be updated from time to time, including in Part II, Item 1A, “Risk Factors,” of this Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any of these forward-looking statements, which reflect our views as of the date of this document. The matters discussed herein and elsewhere in this document could cause our actual results and performance to differ materially from those set forth or anticipated in forward-looking statements. Accordingly, we cannot guarantee future results or performance. Furthermore, except as required by law, we are under no duty to, and we do not intend to, update any of our forward-looking statements after the date of this document, whether as a result of new information, future events or otherwise.
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VICAPSYS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| September 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | $ | ||||||
| Prepaid Expenses | ||||||||
| Total Current Assets | ||||||||
| Total Assets | $ | $ | ||||||
| Liabilities and Stockholders’ Deficit | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accounts payable, related parties | ||||||||
| Accounts payable | ||||||||
| Accrued salaries, related party | ||||||||
| Short-term note payable | ||||||||
| Short-term promissory note | ||||||||
| Convertible notes payable | ||||||||
| Total Current Liabilities | ||||||||
| Stockholders’ Deficit: | ||||||||
| Series A Convertible Preferred Stock; par value $; shares authorized; -- shares issued and outstanding | |
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| Series B Convertible Preferred Stock; par value $; shares authorized; -- shares issued and outstanding | |
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| Convertible Preferred Stock, value | |
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| Common Stock, par value $; shares authorized; and shares issued and outstanding, respectively | |
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| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Stockholders’ Deficit | ( | ) | ( | ) | ||||
| Total Liabilities and Stockholders’ Deficit | $ | $ | ||||||
See accompanying condensed notes to unaudited consolidated financial statements.
| 3 |
VICAPSYS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Personnel costs | ||||||||||||||||
| Research and development expenses, related party | ||||||||||||||||
| Professional fees | ||||||||||||||||
| General and administrative expenses | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other Expenses: | ||||||||||||||||
| Interest expense | ||||||||||||||||
| Loss on debt extinguishment | ||||||||||||||||
| Financing costs | ||||||||||||||||
| Total other expenses | ||||||||||||||||
| Income (loss) before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income taxes | ||||||||||||||||
| Net income (loss) available to common shareholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net income (loss) per common share: | ||||||||||||||||
| Basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic and diluted | ||||||||||||||||
See accompanying condensed notes to unaudited consolidated financial statements.
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VICAPSYS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
For the Three and Nine Months Ended September 30, 2024 and 2023
(Unaudited)
| Shares | Amount | Shares | Amount | Capital | Deficit | (Deficit) | ||||||||||||||||||||||
| Common Stock | Common Stock to be Issued | Additional Paid-in | Accumulated | Stockholders’ Equity | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | (Deficit) | ||||||||||||||||||||||
| Balance December 31, 2022 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Stock-based compensation expense | - | - | ||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance March 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Common stock to be issued pursuant to private placement completed in April 2023 | - | |||||||||||||||||||||||||||
| Common stock to be issued per loan commitment | - | |||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance June 30, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Common stock issued from common stock to be issued | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||
| Common stock cancelled fom common stock to be issued | - | ( | ) | ( | ) | |||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance September 30, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Balance December 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance March 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance June 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Balance | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Common stock issued per loan commitment | - | |||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance September 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Balance | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
See accompanying condensed notes to unaudited consolidated financial statements.
| 5 |
VICAPSYS LIFE SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| 2024 | 2023 | |||||||
| For the Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net (loss) | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net (loss) to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Amortization of debt discount | ||||||||
| Loss on debt extinguishment | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid Expenses | ( | ) | ||||||
| Accounts payable | ||||||||
| Accounts payable, related parties | ||||||||
| Net Cash Used in Operating Activities | ( | ) | ( | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Short-term note payable | ( | ) | ||||||
| Proceeds from the exercise of warrants | ||||||||
| Proceeds from private placement | ||||||||
| Proceeds from short-term note payable | ||||||||
| Proceeds from convertible note | ||||||||
| Deferred offering costs | ( | ) | ||||||
| Net Cash Provided By Financing Activities | ||||||||
| Net (decrease) in Cash | ||||||||
| Cash, Beginning of period | ||||||||
| Cash, End of period | $ | $ | ||||||
| Supplementary Cash Flow Information | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for taxes | $ | $ | ||||||
| Non-cash investing and financing activities | ||||||||
| Commitment Fee | $ | $ | ||||||
| Discount on debt | $ | $ | ||||||
See accompanying condensed notes to unaudited consolidated financial statements.
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VICAPSYS LIFE SCIENCES, INC.
NOTES TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 - ORGANIZATION
Business
Vicapsys Life Sciences, Inc. (“VLS”) was incorporated in the State of Florida on July 8, 1997 under the name All Product Distribution Corp. On August 19, 1998, the Company changed its name to Phage Therapeutics International, Inc. On November 13, 2007, the Company changed its name to SSGI, Inc. On December 22, 2017, pursuant to a Share Exchange Agreement (the “Exchange Agreement”) by and among VLS, Michael W. Yurkowsky, ViCapsys, Inc. (“VI”) and the shareholders of VI, a private company, VI became a wholly owned subsidiary of VLS. We refer to VLS and VI together as the “Company”. VLS serves as the holding company for VI. Other than its interest in VI, VLS does not have any material assets or operations.
The Company’s strategy is to develop and commercialize, on a worldwide basis, various intellectual property rights (patents, patent applications, know how, etc.) relating to a series of encapsulated products that incorporate proprietary derivatives of the chemokine CXCL12 for creating a zone of immunoprotection around cells, tissues, organs and devices for therapeutic purposes. The product name VICAPSYN™ is the Company’s proprietary product line that is applied to transplantation therapies and related stem-cell applications in the transplantation field.
NOTE 2 – GOING CONCERN AND MANAGEMENT’S PLANS
The
accompanying unaudited consolidated financial statements have been prepared assuming the Company will continue as a going concern, which
assumes the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company experienced
a net loss of $
In
July 2024, entered into a promissory note agreement for the principal amount of $
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING PRINCIPLES
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements in this report have been prepared by the Company without audit. In the opinion of management, all adjustments necessary to present the financial position, results of operations and cash flows for the stated periods have been made. Except as described below, these adjustments consist only of normal and recurring adjustments. Certain information and note disclosures normally included in the Company’s consolidated annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted.
| 7 |
These unaudited consolidated financial statements should be read in conjunction with a reading of the Company’s consolidated audited financial statements and notes thereto for the year ended December 31, 2023, filed with the Company’s annual report on Form 10-K with the Securities and Exchange Commission (the “SEC”) on October 21, 2024. Interim results of operations for the three and nine months ended September 30, 2024, and 2023, are not necessarily indicative of future results for the full year. The unaudited consolidated financial statements of the Company include the consolidated accounts of VLS and its wholly owned subsidiary VI. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reported period. Actual results could differ from those estimates. Significant estimates included in the financial statements, include useful the life of intangible assets, valuation allowance for deferred tax assets and non-cash equity transactions and stock-based compensation.
Cash
The
Company considers all highly liquid investments with an original term of three months or less to be cash equivalents. The Company held
Fair Value of Financial Instruments
ASC 825, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of fair value information about financial instruments. ASC 820, “Fair Value Measurements” defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of September 30, 2024 and December 31, 2023.
The carrying amounts of the Company’s financial assets and liabilities, such as cash, prepaid expenses, accounts payable and accrued liabilities, payables with related parties, and debt discounts approximate their fair values because of the short maturity of these instruments.
Revenue Recognition
Revenue recognition is accounted for under ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”) and all the related amendments. The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under U.S. GAAP including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation.
The Company’s contracts with customers are generally on a contract and work order basis and represent obligations that are satisfied at a point in time, as defined in the new guidance, generally upon delivery or has services are provided. Accordingly, revenue for each sale is recognized when the Company has completed its performance obligations. Any costs incurred before this point in time, are recorded as assets to be expensed during the period the related revenue is recognized. The Company did not generate any revenue for the three and nine months ended September 30, 2024, and 2023.
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Stock-Based Compensation
Stock-based compensation is accounted for based on the requirements of ASC 718 – “Compensation –Stock Compensation,” which requires recognition in the financial statements of the cost of employee, director and non-employee services received in exchange for an award of equity instruments over the period the employee, director, or non-employee is required to perform the services in exchange for the award (presumptively, the vesting period). The ASC also requires measurement of the cost of employee, director, and non-employee services received in exchange for an award based on the grant-date fair value of the award. The Company has elected to recognize forfeitures as they occur as permitted under the FASB’s Accounting Standards Update ASU 2016-09 Improvements to Employee Share-Based Payment.
Research and Development
Costs
and expenses that can be clearly identified as research and development are charged to expense as incurred. The Company incurred $
Income Taxes
The Company accounts for income taxes in accordance with ASC 740-10, Income Taxes. Deferred tax assets and liabilities are recognized to reflect the estimated future tax effects, calculated at the tax rate expected to be in effect at the time of realization. A valuation allowance related to a deferred tax asset is recorded when it is more likely than not that some portion of the deferred tax asset will not be realized. Deferred tax assets and liabilities are adjusted for the effects of the changes in tax laws and rates of the date of enactment.
ASC 740-10 prescribes a recognition threshold that a tax position is required to meet before being recognized in the financial statements and provides guidance on recognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure, and transition issues. Interest and penalties are classified as a component of interest and other expenses. To date, the Company has not been assessed, nor paid, any interest or penalties.
Uncertain tax positions are measured and recorded by establishing a threshold for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Only tax positions meeting the more-likely-than-not recognition threshold at the effective date may be recognized or continue to be recognized.
The Company reports earnings (loss) per share in accordance with ASC 260, “Earnings per Share.” Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during each period. Diluted earnings per share is computed by dividing net loss by the weighted-average number of shares of common stock, common stock equivalents and other potentially dilutive securities outstanding during the period using the treasury stock method and as-if converted method. As of September 30, 2024, and 2023, the Company’s dilutive securities are convertible into and , respectively, shares of common stock, respectively, which are not included in the computation of dilutive loss per share because their impact is antidilutive.
SCHEDULE OF ANTIDILUTIVE SECURITIES OF EARNINGS PER SHARE
| September 30, 2024 | September 30, 2023 | |||||||
| Stock options | ||||||||
| Convertible Debt | ||||||||
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Recent Accounting Pronouncements
Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material effect on the accompanying unaudited consolidated financial statements for the three and nine months ended September 30, 2024, and 2023.
NOTE 4 – RELATED PARTY TRANSACTIONS
Consulting Agreements
On
November 5, 2021, the Company entered into a Consulting Agreement (the “Poznansky Agreement”) with Mark Poznansky, MD, a
minority stockholder and former Director. The Company engaged Dr. Poznansky to render consulting services with respect to informing,
guiding, and supervising the development of antagonists to immune repellents or anti-fugetaxins for the treatment of cancer. The initial
term of the Poznansky Agreement was for six months (the “Initial Term”), which was extended indefinitely, and the Company
agreed to pay the Consultant $
MGH License Agreement
On May 8, 2013, VI and MGH, a principal stockholder (see Note 5), entered into the License Agreement, pursuant to which MGH granted to the Company, in the field of coating and transplanting cells, tissues and devices for therapeutic purposes, on a worldwide basis: (i) an exclusive, royalty-bearing license under its rights in Patent Rights (as defined in the License Agreement) to make, use, sell, lease, import and transfer Products and Processes (each as defined in the License Agreement); (ii) a non-exclusive, sub-licensable (solely in the License Field and License Territory (each as defined in the License Agreement)) royalty-bearing license to Materials (as defined in the License Agreement) and to make, have made, use, have used, Materials for only the purpose of creating Products, the transfer of Products and to use, have used and transfer processes; (iii) the right to grant sublicenses subject to and in accordance with the terms of the License Agreement, and (iv) the nonexclusive right to use technological information (as defined in the License Agreement) disclosed by MGH to the Company under the License Agreement, all subject to and in accordance with the License Agreement (the “License”).
As amended by the Ninth Amendment to the License Agreement on May 30, 2023 (“Effective Date”), which adds to the due diligence requirements as amended by Eighth Amendment to the License Agreement, requires that within one year of the Ninth Amendment Effective Date, the Company shall submit a research and development plan for the patent rights associated with MGH 24644 with mutually acceptable diligence requirements to be added by amendment to the Agreement for development of the product or process for the therapy and/ or prophylaxis of a human disorder in the license field.
As amended by the Eighth Amendment to the License Agreement on March 14, 2022 (“Effective Date”), which replaces the prior pre-sales due diligence requirements in their entirety, the License Agreement requires that the Company satisfy the following requirements prior to the first sale of Products (“MGH License Milestones”), by certain dates.
Pre-Sales Diligence Requirement:
| (x) | The Company shall provide a detailed business plan and development plan by June 1st, 2022. As of the date of this filing the Company has yet to submit the business and development plan and is negotiating the extension of this requirement with MGH. | |
| (xi) | The
Company shall raise $ |
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| (xii) | The
Company shall raise an additional $ | |
| (xiii) | The Company shall initiate research regarding the role of CXCL12 in beta cell function and differentiation by January 1st, 2023. | |
| (xiv) | The Company shall initiate diabetic non-human primate studies using cadaveric islets encapsulated in the CXCL12 technology by March 1st, 2023. | |
| (xv) | The Company shall initiate research regarding other applications of the CXCL12 platform by June 1st, 2023. As of the date of this filing the Company has yet to initiate research regarding other applications of the CXCL12 platform and is negotiating the extension of this requirement with MGH.. | |
| (xvi) | The Company shall initiate a Phase I clinical trial of a Product or Process by March 1st, 2024. | |
| (xvii) | The Company shall initiate a Phase II clinical trial of a Product or Process within thirteen (13) years from Effective Date. | |
| (xviii) | The Company shall initiate Phase III clinical trial of a Product or Process within sixteen (16) years from Effective Date. |
Additionally, as amended by the Eighth Amendment to the License Agreement on March 14, 2022, which replaces the prior post-sales due diligence requirements in their entirety, the License Agreement requires that the Company satisfy the following requirements post-sales of Products (“MGH License Milestones”), by certain dates.
Post-Sales Diligence Requirements:
| (i) | The Company shall itself or through an Affiliate or Sublicensee make a First Commercial Sale within the following countries and regions in the License Territory within eighteen (18) years after the Effective Date of this Agreement: US and Europe and China or Japan. | |
| (ii) | Following the First Commercial Sale in any country in the License Territory, Company shall itself or through its Affiliates and/or Sublicensees use commercially reasonable efforts to continue to make Sales in such country without any elapsed time period of one (1) year or more in which such Sales do not occur due to lack such efforts by Company. |
In consideration of the update to the diligence milestones, the Company shall pay the following Annual Minimum Royalty payments:
| (i) | Prior
to the First Commercial Sale, the Company shall pay to MGH a non-refundable annual license fee of ten thousand dollars ($ | |
| (ii) | Following
the First Commercial Sale, Company shall pay MGH a non-refundable annual minimum royalty in the amount of one hundred thousand dollars
United States Dollars ($ |
The
License Agreement also requires VI to pay to MGH a
| 11 |
The License Agreement expires on the later of (i) the date on which all issued patents and filed patent applications within the Patent Rights have expired (November 2033) or have been abandoned, and (ii) one year after the last sale for which a royalty is due under the License Agreement.
The License Agreement also grants MGH the right to terminate the License Agreement if VI fails to make any payment due under the License Agreement or defaults in the performance of any of its other obligations under the License Agreement, subject to certain notice and rights to cure set forth therein. MGH may also terminate the License Agreement immediately upon written notice to VI if VI: (i) shall make an assignment for the benefit of creditors; or (ii) or shall have a petition in bankruptcy filed for or against it that is not dismissed within 60 days of filing. As of the date of this filing, this License Agreement remains active and the Company has not received any termination notice from MGH.
VI may terminate the License Agreement prior to its expiration by giving 90 days’ advance written notice to MGH, and upon such termination shall, subject to the terms of the License Agreement, immediately cease all use and sales of Products and Processes.
The
Company incurred costs to MGH of $
During the three and nine months ended September 30, 2024, and 2023, there have not been any sales of Product or Process under this License Agreement.
Accounts Payable, related parties and Accrued Salaries, related party
The
Company incurred director fees of $
The
Company incurred consulting fees of $
In
August 2020, Frances Tonneguzzo, the Company’s Chief Executive Officer (the “former CEO”) tendered her resignation
as CEO. For the three and nine months ended September 30, 2024 and 2023, the Company did not incur any expenses to the former CEO. As
of September 30, 2024, and December 31, 2023, $
NOTE 5 – COMMITMENTS AND CONTINGENCIES
Legal Matters
The Company is not aware of any material, existing or pending legal proceedings against the Company, nor is it involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial shareholder, is an adverse party or has a material interest adverse to our interest.
| 12 |
MGH License Agreement
As
discussed in Note 4,
The
License Agreement also requires VI to pay to MGH a
Consulting Agreements
On
January 12, 2022, the Company entered into a Consulting Agreement (the “Donohoe Agreement”) with Donohoe Advisory
Associates, LLC. (the “Consultant”). The Company engaged the Consultant to provide assistance and advice to the Company
in support of the Company’s efforts to obtain a listing on a national securities exchange. The Company agreed to pay the
Consultant a retainer fee of $
On
March 7, 2022, the Company entered into a Consulting Agreement (the “Consulting Agreement”) with Alpha IR Group, LLC. (the
“Consultant”). The Company engaged the Consultant to provide consulting, investor relations, and corporate and transaction
communication related services. The initial term of the Consulting Agreement was for three months (the “Initial Term”) beginning
March 1, 2022, and the Company agreed to pay compensation equal to the sum of $
| 13 |
On
January 1, 2022, the Company entered into a consulting agreement (the “Toneguzzo Agreement”) with Frances Toneguzzo, Ph.D.,
the Company’s former CEO. Pursuant to the one-year term of the Toneguzzo Agreement in exchange for services in leading the research
and development teams and laboratory work, the consultant received $
Employment Agreement
The
Company has an employment agreement with Federico Pier, the Company’s Chief Executive Officer and Chairman of the Board. Pursuant
to the terms of the employment agreement, Mr. Pier will receive a $ one-time cash bonus if the Company’s common stock is
up listed to NASDAQ or the New York Stock Exchange, or the Company secures and receives financing of at least $
NOTE 6 – SHORT-TERM LIABILITIES
Convertible Note Payable 1
As
discussed in Note 2, on June 27, 2023, the Board of Directors approved a resolution authorizing the Company to obtain a secured six-month
term loan for the principal amount of $
Original Issuance Discount
The
principal face value of the loan is $
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Debt Amendments
To
secure the convertible note, the Company paid a commitment fee of $
Debt Modification
On
December 26, 2023, the Company and the note holder entered into a letter agreement under which an agreement was made to extend the maturity
date of the Note to
On
February 6, 2024, the Company and convertible note holder entered into a letter agreement under which an agreement was made to extend
the maturity date of the note to
On
March 26, 2024, the Company and the note holders entered into a letter agreement under which an agreement was made to extend the
maturity date of the note to
In
April 2024, the note holders agreed to extend the maturity date of the convertible note to
As of the date of this filing, the Company subsequently failed to repay the convertible note on or before October 31, 2024, and failed to file the resale registration statement on or before October 31, 2024. In December 2024, the note holder agreed to and issued a one-time waiver applicable to the default and failure to comply with the purchase agreement debt modifications through December 31, 2024.
| 15 |
Convertible Note Payable 2
As
discussed in Note 2, on July 17, 2024, the Board of Directors approved a resolution authorizing the Company to obtain a secured six-month
term loan for the principal amount of $
Issuance Discount 2
The
principal face value of the loan is $
Debt Discount 2
To
secure the convertible note, the Company paid a commitment fee of $
Short-Term Note Payable
The
Company entered into a commercial insurance premium finance and security agreement in May 2023. The agreement finances the Company’s
annual D&O insurance premium. Payments are due in monthly installments of approximately $
The
Company had an outstanding premium balance of approximately $
As of the date of this filing the Company is in default of the commercial premium finance agreement and the D&O insurance policy is no longer in effect.
Short-Term Promissory Note
In
August 2024, the Company entered into a promissory note agreement for the principal sum of $
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NOTE 7 – STOCKHOLDERS’ EQUITY (DEFICIT)
Preferred Stock
The Company has authorized shares of preferred stock, $ par value per share.
Series A Preferred Stock
On
December 19, 2017, the Company amended its articles of incorporation by filing a certificate of designation with the Secretary of State
of Florida therein designating a class of preferred stock as Series A Preferred Stock, $ par value per share, consisting of million
() shares.
In
the event of liquidation, dissolution or winding up of the Company, either voluntarily or involuntarily, the holders of Series A Preferred
Stock shall be entitled to receive, prior and in preference to any common stock holders, distribution of any surplus funds equal to the
greater of (i) the sum of $
Pursuant to the Articles of Incorporation, the shares of Series A Preferred Stock automatically converted into shares of common stock to be issued on February 12, 2021, (the one-year anniversary of the initial filing by the Company of the Form 10 filed with the SEC). The common stock shares for the conversion of the Series A Preferred Stock were issued on January 13, 2022.
As of September 30, 2024, and December 31, 2023, there were -- shares of Series A Preferred Stock issued and outstanding.
Series B Preferred Stock
On December 19, 2017, the Company amended the articles of incorporation by filing a certificate of designation with the Secretary of State of Florida therein designating a class of preferred stock as Series B Preferred Stock, $ par value per share, consisting of million () shares (the “Series B Preferred Stock Certificate of Designation”).
| 17 |
As of September 30, 2024, and December 31, 2023, there were -- shares of Series B Preferred Stock issued and outstanding.
Common Stock
The Company has authorized shares of common stock, $ par value per share. As of September 30, 2024, and December 31, 2023, there were and , respectively, shares of common stock issued and outstanding.
Common Stock Issuances
In
connection with the convertible promissory note as discussed in Note 6, to secure the note, the Company paid a commitment fee by issuing
In
April 2023, the Company entered into Security Purchase Agreements (“SPA’s) with select accredited investors in connection
with a private offering. The Company raised an aggregate amount of $
In
connection with the convertible promissory note as discussed in Note 6, to secure the note, the Company paid a commitment fee by issuing
Stock Option-Based Compensation Plan
On August 10, 2022, the Board of Directors of the Company approved and adopted the Vicapsys Life Sciences, Inc., 2022 Omnibus Equity Incentive Plan (the “Plan”). The material terms of the 2022 Plan are set forth below:
| ● | The Board or a committee established by the Board will administer the 2022 Plan. |
| ● | . |
| ● | Eligible recipients of awards include an employee, director or independent contractor of the Company who has been selected as an eligible participant by the Administrator, subject to certain limitations relating to Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”). |
| ● | No
non-employee director may be granted awards under the 2022 plan during any calendar year if such awards and cash fees paid for serving
as a non-employee director would exceed $ |
| ● | In
no event shall the exercise price of an option issued pursuant to the 2022 Plan be less than one hundred percent ( |
The purposes of the Plan are to (i) provide an additional incentive to selected employees, directors, and independent contractors of the Company or its Affiliates whose contributions are essential to the growth and success of the Company, (ii) strengthen the commitment of such individuals to the Company and its Affiliates, (iii) motivate those individuals to faithfully and diligently perform their responsibilities and (iv) attract and retain competent and dedicated individuals whose efforts will result in the long-term growth and profitability of the Company. To accomplish these purposes, the Plan provides that the Company may grant Options, Stock Appreciation Rights, Restricted Stock, Restricted Stock Units, Other Stock-Based Awards or any combination of the foregoing.
Stock Option Activity
SCHEDULE OF STOCK OPTIONS ACTIVITY
| Number of Options | Weighted- Average Exercise Price per Share | Weighted- Average Remaining Life (Years) | Aggregate Intrinsic Value (Per Option) | |||||||||||||
| Outstanding at December 31, 2022 | $ | $ | ||||||||||||||
| Outstanding at September 30, 2023 | $ | $ | ||||||||||||||
| Exercisable at September 30, 2023 | $ | $ | ||||||||||||||
| Number of Options | Weighted- Average Exercise Price per Share | Weighted- Average Remaining Life (Years) | Aggregate Intrinsic Value (Per Option) | |||||||||||||
| Outstanding at December 31, 2023 | $ | | $ | |||||||||||||
| Outstanding at September 30, 2024 | $ | $ | ||||||||||||||
| Exercisable at September 30, 2024 | $ | $ | ||||||||||||||
The Company did not grant any options to purchase shares of common stock during the three and nine months ended September 30, 2024 and 2023. As of September 30, 2024, there were shares of fully vested stock options. The Company did t incur any stock compensation expense for the three and nine months ended September 30, 2024. The Company recorded stock compensation expense of $ and $, respectively, for the three and nine months ended September 30, 2023.
NOTE 8 – SUBSEQUENT EVENTS
As of the date of this filing the Company is in default with the terms of the convertible notes discussed in Note 6. The Company intends to honor the notes and all liabilities as it perseveres in its mission to raise funds for the Company’s growth. Despite the default, the Company anticipates continuing its collaboration with the noteholder.
| 18 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited consolidated financial statements and the notes thereto appearing in Part I, Item 1 of this Quarterly Report. Historical results and trends that might appear in this Quarterly Report should not be interpreted as being indicative of future operations.
Overview
Vicapsys Life Sciences, Inc. (“VLS”) was incorporated in the State of Florida on July 8, 1997 under the name All Product Distribution Corp. On August 19, 1998, the Company changed its name to Phage Therapeutics International, Inc. On November 13, 2007, the Company changed its name to SSGI, Inc. On December 22, 2017, pursuant to a Share Exchange Agreement (the “Exchange Agreement”) by and among VLS, Michael W. Yurkowsky, ViCapsys, Inc. (“VI”) and the shareholders of VI, a private company, VI became a wholly owned subsidiary of VLS. We refer to VLS and VI together as the “Company”.
The Company’s strategy is to develop and commercialize, on a worldwide basis, various intellectual property rights (patents, patent applications, know how, etc.) relating to a series of encapsulated products that incorporate proprietary derivatives of the chemokine CXCL12 for creating a zone of immuno protection around cells, tissues, organs and devices for therapeutic purposes. The product name VICAPSYN™ is the Company’s proprietary product line that is applied to transplantation therapies and related stem-cell applications in the transplantation field.
Results of Operations – Three and Nine Months Ended September 30, 2024 and 2023
Revenues
The Company did not have any revenues for the three and nine months ended September 30, 2024 and 2023.
Operating Expenses
We classify our operating expenses into four categories: personnel costs, research and development expenses, professional fees, and general and administrative expenses. The Company’s total operating expenses for the three and nine months ended September 30, 2024, were $198,862 and $584,958, respectively, compared to $175,423 and $519,771 for the three and nine months ended September 30, 2023.
Personnel costs remained consistent at $62,500 and $187,500, respectively, for the three and nine months ended September 30, 2024, compared to $69,181 and $200,125, respectively, for the three and nine months ended September 30, 2023. We incurred $3,746 and $14,090 in research and development expenses during the three and nine months ended September 30, 2024, respectively, related to a ninth amendment license fee and also an annual royalty fee we agreed to pay upon execution of the Eighth Amendment to the License Agreement with MGH. We incurred $3,267 and $15,267 in research and development expenses during the three and nine months ended September 30, 2023, respectively. Research and development expenses remained consistently low as the Company continued ongoing financing efforts. The decrease in general and administrative costs to $4,116 and $41,819 for the three and nine months ended September 30, 2024, respectively, from $26,925 and $64,076 for the three and nine months ended September 30, 2023, respectively, was primarily due to the cancellation of the D&O insurance policy in March 2024. The overall increase in professional fees of $128,500 and $341,549 for the three and nine months ended September 30, 2024, from $76,050 and $240,303 for the three and nine months ended September 30, 2023, was primarily attributable to consulting costs incurred in 2024.
Funding Requirements
We anticipate that substantial additional equity or debt financings or funding from collaborative agreements or from foundations, government grants or other sources, will be needed to complete preclinical and animal testing necessary to file an Investigational New Drug Application with the U.S. Food and Drug Administration, and that further funding beyond such amounts will be required to commence trials and other activities necessary to begin the process of development and regulatory approval of a product for the continued growth of the Company.
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Additional capital will also be required for the clinical development of the recently discovered anti-fibrotic applications and corporate partnerships will be necessary to move Company products into advanced clinical development and commercialization. We also anticipate our cash expenditures will increase as we continue to operate as a publicly traded entity.
Liquidity and Capital Resources
At September 30, 2024, we had a cash balance of $89,569 and an accumulated deficit of $17,052,745.
We do not believe that we have enough cash on hand to operate our business during the next 12 months. We anticipate we will need to raise an additional $1 million through the issuance of debt or equity securities to sustain base operations during the next 12 months, excluding development work. There can be no assurance that we will be able to obtain additional funding on commercially reasonable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends.
If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, products or therapeutic candidates or to grant licenses on terms that may not be favorable to us.
To date, we have financed our operations through our sale of equity and debt securities. Failure to generate revenue or to raise funds could cause us to go out of business, which would result in the complete loss for investors in our Company.
To date, we have generated no revenues, and no substantial revenues are anticipated until we have implemented our full plan of operations. To implement our strategy to grow and expand per our business plan, we intend to generate working capital via a private placement of equity or debt securities, or to secure a loan. If we are unsuccessful in raising capital or securing a loan, we could be required to cease business operations and investors would lose all of their investment.
In April 2023, the Company entered into Security Purchase Agreements (“SPA’s) with select accredited investors in connection with a private offering by the Company to raise a maximum of $300,000 through the sale of shares of common stock at $0.25 per share. The Company has raised an aggregate amount of $100,000 as of the date of these consolidated financial statements.
In June 2023, the Board of Directors approved a resolution authorizing the Company to obtain a six-month term loan for the principal amount of $330,000. In connection therewith, the Company entered into a Securities Purchase Agreement with selected accredited investors whereby the Company secured a convertible promissory note in the amount of $330,000, which was issued with an original issuance discount of $26,400 and resulted in aggregate proceeds of $303,600. The Company received aggregate proceeds of $290,350, net of issuance costs.
As of the date of this filing, the Company is in default of the terms of the six-month term loan purchase agreement as the Company failed to repay the convertible note on or before October 31, 2024, and also failed to file the resale registration statement on or before October 31, 2024 per the terms of the debt modification agreement. In December 2024, the note holder agreed to and issued a one-time waiver applicable to the default and failure to comply with the purchase agreement debt modifications through December 31, 2024
In July 2024, entered into a convertible promissory note agreement for the principal amount of $95,000. The Note is convertible upon an event of default into shares of common stock, $0.001 par value per share.
In August 2024, the Company entered into a promissory note agreement for the principal sum of $55,000. The maturity date on the promissory note is May 10, 2025 and carries an annual interest rate of 10%.
Additionally, we will have to meet all the financial disclosure and reporting requirements associated with being a publicly reporting company. Our management will have to spend additional time on policies and procedures to make sure our Company is compliant with various regulatory requirements.
| 20 |
This additional corporate governance time required of management could limit the amount of time management has to implement our business plan and may impede the speed of our operations.
Working Capital Deficit
| September 30, 2024 | December 31, 2023 | |||||||
| Current Assets | $ | 89,569 | $ | 39,656 | ||||
| Current Liabilities | 2,735,297 | 1,968,337 | ||||||
| Working Capital Deficit | $ | (2,645,728 | ) | $ | (1,928,681 | ) | ||
Cash Flows
Cash activity for the nine months ended September 30, 2024 and 2023 is summarized as follows:
Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Net cash used in operating activities | $ | (43,687 | ) | $ | (335,470 | ) | ||
| Net cash provided by financing activities | 123,834 | 374,905 | ||||||
| Net increase (decrease) in cash | $ | 80,147 | $ | 39,435 | ||||
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Regulation S-K Item 303(a)(4) during the periods presented, investments in special-purpose entities or undisclosed borrowings or debt. Additionally, we are not a party to any derivative contracts or synthetic leases.
Contractual Obligations
MGH License Agreement
The Company has executed a License Agreement with MGH. Prior to the first commercial sale, the License Agreement requires the Company to pay MGH a non-refundable annual license fee of $10,000 by June 30, 2022, and on each subsequent anniversary of the Effective Date thereafter. The first non-refundable annual license fee was paid on July 1, 2022. Additionally, following the first commercial sale, the License agreement requires the Company to pay MGH a non-refundable annual minimum royalty in the amount of $100,000 per year within sixty days after each annual anniversary of the Effective Date.
The License Agreement also requires VI to pay to MGH a 1% royalty rate on net sales related to the first license sub-field, which is the treatment of T1D. Future sub-fields shall carry a reasonable royalty rate, consistent with industry standards, to be negotiated at the time the first such royalty payment shall become due with respect to the applicable Products and Processes (as defined in the License Agreement).
The License Agreement additionally requires VI to pay to MGH a $1.0 million “success payment” within 60 days after the first achievement of total net sales of Product or Process equal or exceeding $100,000,000 in any calendar year and $4,000,000 within 60 days after the first achievement of total net sales of Product or Process equal to or exceeding $250,000,000 in any calendar year. The Company is also required to reimburse MGH’s expenses in connection with the preparation, filing, prosecution and maintenance of all Patent Rights.
As of the date of this filing the Company is in default of the pre-sales diligence requirements and is negotiating the extension of the requirements outlined in the License Agreement with MGH.
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The Company entered into a consulting agreement with Donohoe Advisory Associates, LLC to provide assistance and advice to the Company in support of the Company’s efforts to obtain a listing on a national securities exchange. The Company will be obligated to pay a “success fee” to the Consultant of either $10,000 or that number of registered common shares equivalent to $10,000 divided by the closing price of the Company’s common stock on the last day of trading on the OTC Market. The form of the success fee will be determined by the Company.
Employment Agreement
The Company has an employment agreement with Federico Pier, the Company’s Chief Executive Officer and Chairman of the Board. Pursuant to the terms of the employment agreement, Mr. Pier will receive a $100,000 one-time cash bonus if the Company’s common stock is up listed to NASDAQ or the New York Stock Exchange, or the Company secures and receives financing of at least $8 million. Additionally, the Company shall issue Mr. Pier, pursuant to the Company’s equity incentive plan, a restricted stock unit award containing the following terms: Mr. Pier shall receive shares of common stock of the Company (i) representing 1% of the Company’s fully diluted equity as of the payment date (the “Initial Equity Payment”) if the Company achieves a market capitalization of at least $250 million for sixty consecutive days during the Term (the “Initial Market Capitalization Target”); and (ii) representing the difference between 2% of the Company’s fully diluted equity as of the payment date and the amount of Initial Equity Payment (the “Subsequent Equity Payment” and, together with Initial Equity Payment, “Equity Payments”) if the Company achieves a market capitalization of at least $500 million for sixty consecutive days during the Term (the “Subsequent Market Capitalization Target” and, together with Initial Market Capitalization Target, “Market Capitalization Targets”), such that Mr. Pier has, in the aggregate, received shares of common stock of the Company representing 2% of the Company’s fully diluted equity as of the date of payment of Subsequent Equity Payment. The Company will use issue such Equity Payments within seventy-three days after the attainment of the applicable Market Capitalization Target. Mr. Pier shall remain eligible to receive additional equity-based compensation awards as the Company may grant from time to time.
Critical Accounting Policies and Estimates
Our discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities. We evaluate, on an ongoing basis, our estimates and judgments, including those related to the useful life of the assets. We base our estimates on historical experience and assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
The methods, estimates and judgments we use in applying our most critical accounting policies have a significant impact on the results that we report in our consolidated financial statements. The Securities and Exchange Commission (the “SEC”), considers an entity’s most critical accounting policies to be those policies that are both most important to the portrayal of a company’s financial condition and results of operations and those that require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about matters that are inherently uncertain at the time of estimation.
We believe the following critical accounting policies, among others, require significant judgments and estimates used in the preparation of our interim consolidated financial statements.
Our significant accounting policies are described in more detail in the notes to our consolidated financial statements for the fiscal year ended December 31, 2023, included in the Company’s Annual Report filed on Form 10-K with the SEC on October 21, 2024.
Recent Accounting Pronouncements
Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material effect on the accompanying unaudited consolidated financial statements.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Pursuant to Item 305(e) of Regulation S-K (§ 229.305(e)), the Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined by Rule 229.10(f)(1).
ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
The Company maintains “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act is 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 the Company’s management, including its Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures.
In designing and evaluating the Company’s disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired objectives, and the Company necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.
The Company’s management, including its Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of September 30, 2024, and concluded that the Company’s disclosure controls and procedures were not effective as of September 30, 2024, due to a material weakness in the Company’s internal control over financial reporting.
The Company has an ineffective control environment due to a lack of internal resources with expertise to determine entries and disclosures related to some of the Company’s more complex equity transactions. Management believes this lack of internal expertise has been historically mitigated by continuing to retain consultants with this expertise when needed. The Company expects that this material weakness will be further remediated with future capital raises.
Changes in Internal Control Over Financial Reporting
There were no changes in the Company’s internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) identified in connection with the evaluation during the quarter ended September 30, 2024 that have materially affected, or that are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
The Company is not a party to any pending legal proceeding, nor is the Company’s property the subject of a pending legal proceeding. None of the Company’s directors, officers or affiliates are involved in a proceeding adverse to our business or has a material interest adverse to the Company’s business.
ITEM 1A. RISK FACTORS.
Not required for smaller reporting companies.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION.
None.
ITEM 6. EXHIBITS.
| Exhibit No. | Description | |
| 31.1 | Section 302 Certification of Principal Executive Officer* | |
| 31.2 | Section 302 Certification of Principal Financial Officer* | |
| 32.1 | Section 906 Certification of Principal Executive Officer and Principal Financial Officer*** | |
| 101.INS | Inline XBRL Instance Document * | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document * | |
| 101.CAL | Inline XBRL Taxonomy Calculation Linkbase Document ** | |
| 101.LAB | Inline XBRL Taxonomy Labels Linkbase Document * | |
| 101.PRE | Inline XBRL Taxonomy Presentation Linkbase Document ** | |
| 101.DEF | Inline XBRL Definition Linkbase Document * | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document)* |
| * | Filed herewith. |
| ** | This certification is being furnished solely to accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, and it is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
| 24 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: January 10, 2025
| Vicapsys Life Sciences, Inc. | ||
| By: | /s/ Federico Pier | |
| Federico Pier | ||
| Chief Executive Officer and Executive Chairman of the Board | ||
| (Principal Executive Officer) | ||
| By: | /s/ Jeffery Wright | |
| Jeffery Wright | ||
| Chief Financial Officer | ||
| (Principal Financial Officer and | ||
| Principal Accounting Officer) | ||
| 25 |
EXHIBIT 31.1
CERTIFICATIONS
I, Federico Pier, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q for the quarter ended September 30, 2024, of Vicapsys Life Sciences, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: January 10, 2025 | /s/ Federico Pier |
| Federico Pier, | |
| Chief Executive Officer and Executive Chairman of the Board (principal executive officer) |
EXHIBIT 31.2
CERTIFICATIONS
I, Jeffery Wright, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q for the quarter ended September 30, 2024, of Vicapsys Life Sciences, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: January 10, 2025 | /s/ Jeffery Wright |
| Jeffery Wright, | |
| Chief Financial Officer (principal financial officer) |
EXHIBIT 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
CHIEF FINANCIAL OFFICER PURSUANT TO RULE 13a-14(b) UNDER
THE SECURITIES EXCHANGE ACT OF 1934 AND SECTION 1350 OF
CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE
Each of the undersigned, Federico Pier and Jeffery Wright, certifies pursuant to Rule 13a-14(b) under the Securities Exchange Act of 1934 and Section 1350 of Chapter 63 of Title 18 of the United States Code, that (1) this quarterly report on Form 10-Q for the quarter ended September 30, 2024, of Vicapsys Life Sciences, Inc. (the “Company”) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, and (2) the information contained in this report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: January 10, 2025
| /s/ Federico Pier | |
| Federico Pier, | |
| Chief Executive Officer and Executive Chairman of the Board (principal executive officer) | |
| /s/ Jeffery Wright | |
| Jeffery Wright, | |
| Chief Financial Officer (principal financial officer) |
This certification accompanies this Quarterly Report on Form 10-Q pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.