VICP 10-K

Vicapsys Life Sciences, Inc. (VICP)

10-K 2022-03-16 For: 2021-12-31

View Original

Added on April 06, 2026

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
N/A		N/A		N/A

		Page
	PART I

Item 1	Business	4
Item 1A	Risk Factors	23
Item 1B	Unresolved Staff Comments	23
Item 2	Properties	23
Item 3	Legal Proceedings	23
Item 4	Mine Safety Disclosures	23
	PART II

Item 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	24
Item 6	Selected Financial Data	25
Item 7	Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
Item 7A	Quantitative and Qualitative Disclosures About Market Risk	31
Item 8	Financial Statements and Supplementary Data	31
Item 9	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	31
Item 9A	Controls and Procedures	31
Item 9B	Other Information	33
Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	33

	PART III

Item 10	Directors, Executive Officers and Corporate Governance	33
Item 11	Executive Compensation	36
Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	37
Item 13	Certain Relationships and Related Transactions, and Director Independence	39
Item 14	Principal Accountant Fees and Services	40
	PART IV

Item 15	Exhibits and Financial Statement Schedules	40
Item 16	Form 10-K Summary	41
	Signatures	42

	(i)	The Company shall provide a detailed business plan and development plan by June 1^st, 2022.
	(ii)	The Company shall raise $2 million in financing by December 1^st, 2022.
	(iii)	The Company shall raise an additional $8 million in financing by December 1^st, 2023.
	(iv)	The Company shall initiate research regarding the role of CXCL12 in beta cell function and differentiation by January 1^st, 2023.
	(v)	The Company shall initiate diabetic non-human primate studies using cadaveric islets encapsulated in the CXCL12 technology by March 1^st, 2023.
	(vi)	The Company shall initiate research regarding other applications of the CXCL12 platform by June 1^st, 2023.
	(vii)	The Company shall initiate a Phase I clinical trial of a Product or Process by March 1^st, 2024.
	(viii)	The Company shall initiate a Phase II clinical trial of a Product or Process within thirteen (13) years from Effective Date.
	(ix)	The Company shall initiate Phase III clinical trial of a Product or Process within sixteen (16) years from Effective Date.

	(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.

	(i)	Prior to the First Commercial Sale, the Company shall pay to Hospital a non-refundable annual license fee of ten thousand dollars ($10,000) by June 30, 2022, and on each subsequent anniversary of the Eighth Amendment Effective Date thereafter.
	(ii)	Following the First Commercial Sale, Company shall pay Hospital a non-refundable annual minimum royalty in the amount of one hundred thousand dollars United States Dollars ($100,000) per year within sixty (60) days after each annual anniversary of the Effective Date. The annual minimum royalty shall be credited against royalties subsequently due on Net Sales made during the same calendar year, if any, but shall not be credited against royalties due on Net Sales made in any other year.

	●	T1D cases among African American children increased by 20% with 20.8 children diagnosed per 100,000
	●	T1D cases among Hispanic children increased nearly 20% with 16.3 per 100,000
	●	T1D cases among Asian / Pacific Island children increased 19% with 9.4 per 100,000
	●	White children are the slowest growing demographic with a 14% increase, yet remain the most impacted group with 27.3 T1D cases per 100,000

	●	ViaCyte Inc. develops human embryonic stem cells that differentiate into pancreatic progenitor cells. We believe they are one of our most significant and advanced competitors, as they announced on August 1, 2017 that the first patients have been implanted with the PEC-Direct™ product candidate, an islet cell replacement therapy in development as a functional cure for patients with T1D who are at high risk for acute life-threatening complications. ViaCyte has established a collaboration with W.L. Gore & Associates, the makers of Goretex to created devices for implantation and protection of transplanted islets. ViaCyte is currently recruiting for a Phase 1/II clinical trial (NCT03163511).

	●	Sernova Corp. is a microcap company trading on the Toronto, Canada exchange that has developed a macro-cell pouch system for encapsulating cadaveric (allo-) islets that is currently in a Phase 1/II clinical trial. In July 2019, Sernova reported interim analysis demonstrating the cell pouch transplanted with islet cells showed initial safety as well as key efficacy measures.

	●	Beta O2 Technologies Ltd. (Rosh-Haayin, Israel). A biomedical company developing an implantable device, the BetaAir, to encapsulate islet cells for the treatment of T1D. They are in the process of changing from a device that requires external infusion of oxygen into their encapsulation device containing islet cells. Last public information was in 2015. The current status of Beta O2 Technologies Ltd. is unclear.

	●	DefyMed (Strasbourg, France): Defymed was founded in 2011 to develop implantable bio-artificial medical devices for diverse therapeutic applications, with a first focus on T1D. The diabetes product, named MAILPAN® (Macro- encapsulation of PANcreatic Islets), is a result of work done by the Centre Europeen d’etude du Diabete (CeeD), STATICE and the Centre de Transfert de Technologies du Mans (CTTM). The Mailpan system which is still in preclinical development uses non-biodegradable, biocompatible membranes for selective diffusion of insulin and glucose while protecting implanted stem-cell derived beta cells.

	●	Sigilon Therapeutics is a discovery-based platform combines cell engineering and its proprietary Afibromer™ technology, a new class of implantable biomaterials that do not trigger fibrosis. The company will develop products that emerge from its discovery platform to treat serious hematologic, enzyme deficiency and endocrine disorders –including T1D. Sigilon partnered with Lilly on the T1D indication in April 2018 but no recent information is available on the status of the partnership.

	●	Novo Nordisk has a stem cell line that differentiates into beta cells and one of the largest diabetes franchises in the world. In collaboration with Cornell researchers they have developed a hydrogel-based nanofiber encapsulation device with macroscopic dimensions. Currently appears to be in pre-clinical development.

	●	Sanofi and Evotec formed a partnership to jointly develop a beta cell replacement therapy for the treatment of diabetes in a deal that could reach more than 300 million Euros in potential milestone payments. Evotec achieved a milestone in 2018 for a manufacturing process for generation of iPSC-derived beta cells including scale-up. Collaboration is still in the pre-clinical phase.

	●	Baxter Healthcare has been marketing Adept®, a liquid solution for adhesion reduction, for gynecologic laparoscopic adhesiolysis indications since 2006. Baxter’s Adept solution has been extensively studied and its ability to prevent adhesions is controversial. Baxter Healthcare also markets COSEAL®, a synthetic hydrogel used in patients undergoing cardiac or abdomino-pelvic surgery to prevent or reduce the incidence, severity and extent of postsurgical adhesion formation. In February 2020, Baxter acquired the Sanofi franchise for Seprafilm Adhesion Barrier, a mechanical bioresorbable adhesion barrier that is indicated for the reduction in the incidence, extent, and severity of postoperative adhesions in patients undergoing abdominal or pelvic laparotomy. While Seprafilm is regarded as an effective barrier, challenges with respect to placement remain and limit its widespread use.

	●	Gynecare Worldwide, a division of Ethicon, Inc., a Johnson & Johnson company, markets Interceed®, a sheet adhesion barrier similar in intended use to Seprafilm but is indicated only for selected open gynecological indications.

	●	FzioMed, Inc. has received CE Mark approval in the European Union for Oxiplex®/AP Gel, an adhesion barrier for abdominal/pelvic surgery, and is conducting a clinical trial in the U.S., which is expected to be completed by December 2020. Fziomed has announced a global distribution agreement with Ethicon for distribution of Oxiplex/AP Gel.

	●	Covidien introduced SprayShield®, an adhesion barrier used in abdominopelvic procedures, that is approved for sale in Europe. In 2013, Covidien sold the SprayShield product line to Integra Life Sciences.

	●	preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;
	●	submission to the FDA of an Investigational New Drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin;
	●	approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated, or by a central IRB if appropriate;
	●	performance of adequate and well-controlled human clinical trials to establish the safety, potency, and purity of the product candidate for each proposed indication, in accordance with the FDA’s Good Clinical Practice, or GCP, regulations;
	●	preparation and submission to the FDA of a Biologics License Application, or BLA, for a biologic product requesting marketing for one or more proposed indications, including submission of detailed information on the manufacture and composition of the product and proposed labeling;
	●	review of the product by an FDA advisory committee, where appropriate or if applicable;
	●	satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the product’s identity, strength, quality, and purity, and, if applicable, the FDA’s current good tissue practice, or CGTP, for the use of human cellular and tissue products;
	●	satisfactory completion of any FDA audits of the nonclinical study and clinical trial sites to assure compliance with GLPs and GCPs, respectively, and the integrity of clinical data in support of the BLA;
	●	payment of user fees and securing FDA approval of the BLA;
	●	compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, adverse event reporting, and compliance with any post-approval studies required by the FDA; and
	●	Preclinical Studies and Investigational New Drug Application.

	●	*Phase 1* clinical trials are initially conducted in a limited population to test the product candidate for safety, including adverse effects, dose tolerance, absorption, metabolism, distribution, excretion, and pharmacodynamics in healthy humans or, on occasion, in patients, such as cancer patients.

	●	*Phase 2* clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, evaluate the efficacy of the product candidate for specific targeted indications and determine dose tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and costlier Phase 3 clinical trials.

	●	*Phase 3* clinical trials are undertaken within an expanded patient population to further evaluate dosage and gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

	●	restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

	●	fines, untitled or warning letters or holds on post-approval clinical trials;

	●	refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

	●	product seizure or detention, or refusal to permit the import or export of products; or

	●	injunctions or the imposition of civil or criminal penalties.

	●	the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;

	●	the federal civil and criminal false claims laws, including the civil U.S. False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious, or fraudulent or knowingly making, using, or causing to be made or used a false record or statement to avoid, decrease, or conceal an obligation to pay money to the federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the U.S. False Claims Act;

	●	the federal false statements statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items, or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

	●	the anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program;

	●	the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, (collectively “HIPAA”) which imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program (including private payors) or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services;

	●	HIPAA, which impose obligations with respect to safeguarding the privacy, security, and transmission of individually identifiable information that constitutes protected health information, including mandatory contractual terms and restrictions on the use and/or disclosure of such information without proper authorization;

	●	the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the U.S. Patient Protection and Affordable Care Act, as amended by the U.S. Health Care and Education Reconciliation Act, collectively, the Affordable Care Act (the “ACA”), which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the U.S. Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, and requires certain manufacturers and applicable group purchasing organizations to report ownership and investment interests held by physicians or their immediate family members;

	●	federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

	●	33.5% were ages 10-14
	●	27% were 5-9

	●	federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

	●	The Foreign Corrupt Practices Act, or FCPA, prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment; and

	●	analogous laws and regulations in other national jurisdictions and states, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.

	●	an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic products, apportioned among these entities according to their market share in certain government healthcare programs, although this fee would not apply to sales of certain products approved exclusively for orphan indications;

	●	expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;

	●	expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices and extending rebate liability to prescriptions for individuals enrolled in Medicare Advantage plans;

	●	addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for products that are inhaled, infused, instilled, implanted or injected;

	●	expanded the types of entities eligible for the 340B drug discount program;

	●	established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount off the negotiated price of applicable products to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient products to be covered under Medicare Part D;

	●	a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and

	●	established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription product spending. Funding has been allocated to support the mission of the Center for Medicare and Medicaid Innovation from 2011 to 2019.

Period Fiscal Year 2021	High		Low
First Quarter (January 1, 2021 – March 31, 2021)	$	2.00	$	1.50
Second Quarter (April 1, 2021 – June 30, 2021)	$	2.05	$	1.11
Third Quarter (July 1, 2021 – September 30, 2021)	$	1.43	$	0.0001
Fourth Quarter (October 1, 2021 – December 31, 2021)	$	2.00	$	0.25

Period Fiscal Year 2020	High		Low
First Quarter (January 1, 2020 – March 31, 2020)	$	2.50	$	1.50
Second Quarter (April 1, 2020 – June 30, 2020)	$	2.50	$	2.50
Third Quarter (July 1, 2020 – September 30, 2020)	$	2.50	$	0.10
Fourth Quarter (October 1, 2020 – December 31, 2020)	$	2.15	$	1.50

	December 31, 2021		December 31, 2020
Common stock to be issued		11,067,281		651,281
Convertible preferred stock		-		10,440,000
Stock options		1,900,000		1,900,000
Warrants to purchase common stock		4,060,000		4,146,725
		17,027,281		17,138,006

	●	Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and disposition of our assets;
	●	Provide reasonable assurance our transactions are recorded as necessary to permit preparation of our financial statements in accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
	●	Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

Name	Age	Position(s) and Office(s) Held
Federico Pier	54	Chief Executive Officer (Principal Executive Officer) and Executive Chairman of the Board of Directors
Jeffery Wright	39	Chief Financial Officer (Principal Financial and Accounting Officer)
Michael Yurkowsky	50	Director
John Potts	90	Director
Dorothy Jordan	65	Director

	(i)	our principal executive officer or other individual serving in a similar capacity during the fiscal year ended December 31, 2021;

	(ii)	our two most highly compensated executive officers other than our principal executive officers who were serving as executive officers at December 31, 2021 whose compensation exceed $100,000; and

	(iii)	up to two additional individuals for whom disclosure would have been required but for the fact that the individual was not serving as an executive officer at December 31, 2021.

Name	Year		Salary ($)		Bonus ($)		All Other Compensation ($)		Total ($)
Federico Pier		2021	$	-	$	-	$	-	$	-
Chief Executive Officer (1)		2020	$	-	$	-	$	-	$	-

Jeffrey Wright		2021	$	60,000	$	-	$	-	$	60,000
Chief Financial Officer		2020	$	60,000	$	-	$	-	$	60,000

	●	each person, or group of affiliated persons, known to us to beneficially own more than 5% of our common stock;

	●	each of our directors;

	●	each of our named executive officers; and

	●	all of our directors and executive officers as a group.

Name	Class of Security	Amount and Nature of Beneficial Ownership			Percent of Class (1)
*Executive Officers and Directors:*

Federico Pier	Common Stock		855,785	(2)		2.8	%

Jeffery Wright	Common Stock		-			-	%

Michael Yurkowsky	Common Stock		5,104,781	(3)		15.8	%

John Potts	Common Stock		225,000			*	%

Dorothy Jordan	Common Stock		112,500			*	%

All Executive Officers and Directors as a group (5 persons)	Common Stock		6,298,066	(4)		19.3	%

*More than 5% Beneficial Owners:*

Bonderman Family Limited Partnership (5)	Common Stock		6,800,000	(6)		21.8	%

ADEC Private Equity Investments LLC (7)	Common Stock		3,600,000	(8)		11.7	%

Steve Gorlin	Common Stock		2,112,850			7.0	%

Massachusetts General Hospital (9)	Common Stock		3,582,880			11.9	%

YPH LLC (10)	Common Stock		3,320,000	(11)		10.3	%

	(1)	Based on 30,241,550 shares of common stock outstanding as of March 14, 2022.
	(2)	Includes 250,000 shares of common stock issuable upon the exercise of vested options.
	(3)	Includes 250,000 shares of common stock issuable upon the exercise of vested options.
	(4)	Includes (i) 589,138 shares of common stock owned by YP Holdings, LLC (“YP”), (ii) 1,200,000 shares of common stock owned by YPH, LLC (“YPH”), (iii) 2,120,000 shares of common stock issuable upon the exercise of warrants owned by YPH, and (iv) 1,188,043 shares of common stock owned by Ypsilon Biotech 2, LLC (“Ypsilon”). YP, YPH and Ypsilon are entities controlled by Mr. Yurkowsky.
	(5)	Leonard Potter has voting and dispositive control over shares of the Company’s common stock held by the Bonderman Family Limited Partnership. The address of the Bonderman Family Limited Partnership is 301 Commerce Street, Suite 3300, Fort Worth, TX 76102.
	(6)	Includes 1,000,000 shares of common stock issuable upon the exercise of warrants.
	(7)	E. Burke Ross has voting and dispositive control over shares of the Company’s common stock held by the ADEC Private Equity Investments, LLC.
	(8)	Includes 600,000 shares of common stock issuable upon the exercise of warrants.
	(9)	Emile Braun has voting control and dispositive control over shares of the Company’s common stock held by Massachusetts General Hospital.
	(10)	Michael Yurkowsky has voting and dispositive control over shares of the Company’s common stock held by YPH LLC.
	(11)	Includes 1,200,000 shares of common stock issuable upon the exercise of warrants.

	Year Ended December 31, 2021		Year Ended December 31, 2020
Audit Fees⁽¹⁾	$	40,000	$	35,000
Audit-Related Fees		—		—
Tax Fees		—		—
All Other Fees		—		—
Total Fees	$	40,000	$	35,000

(a)	1.	Financial Statements

		The financial statements and Report of Independent Registered Public Accounting Firm are listed in the “Index to Financial Statements and Schedules” on page F-1 and included on pages F-2 to F-21 of this annual report on Form 10-K

	2.	Financial Statement Schedules

		All schedules for which provision is made in the applicable accounting regulations of the Securities and Exchange Commission (the “Commission”) are either not required under the related instructions, are not applicable (and therefore have been omitted), or the required disclosures are contained in the financial statements included herein.

	3.	Exhibits (including those incorporated by reference).

Exhibit No.		Description
2.1		Investment and Restructuring Agreement, dated April 11, 2019, by and among ViCapsys Life Sciences, Inc., ViCapsys, Inc, YPH, LLC, Stephen McCormack, Steve Gorlin, Charles Farrahar, Athens Encapsulation Inc., and the Additional Investors (incorporated by reference to Exhibit 2.1 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
3.1		Articles of Incorporation of the Registrant filed on July 8, 1997 (incorporated by reference to Exhibit 3.1 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.2		Articles of Amendment to the Articles of Incorporation of the Registrant, dated August 19, 1998 (incorporated by reference to Exhibit 3.2 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.3		Articles of Amendment to the Articles of Incorporation of the Registrant, dated March 18, 1999 (incorporated by reference to Exhibit 3.3 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.4		Articles of Amendment to the Articles of Incorporation of the Registrant, dated November 13, 2007 (incorporated by reference to Exhibit 3.4 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.5		Articles of Amendment to the Articles of Incorporation of the Registrant filed on January 15, 2008 (incorporated by reference to Exhibit 3.5 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.6		Amended and Restated Articles of Incorporation of the Registrant filed on April 28, 2009 (incorporated by reference to Exhibit 3.6 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.7		Amendment to Restated Articles of Incorporation of the Registrant filed on September 13, 2017 (incorporated by reference to Exhibit 3.7 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.8		Amendment with Certificate of Designations for Series A Convertible Preferred Stock and Series B Convertible Preferred Stock filed on December 17, 2017 (incorporated by reference to Exhibit 3.8 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020)
3.9		Articles of Correction filed on December 27, 2017 (incorporated by reference to Exhibit 3.9 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
3.10		Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.10 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.1		Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.1 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.2		First Amendment, dated January 22, 2014, to the Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.2 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.3		Second Amendment, dated May 6, 2014, to the Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.3 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.4		Third Amendment, dated August 25, 2014, to the Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.4 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.5		Fourth Amendment, dated December 1, 2014, to the Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.5 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.6		Fifth Amendment, dated October 22, 2016, to the Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.6 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.7		Sixth Amendment, dated February 16, 2017, to the Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.7 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.8		Seventh Amendment, dated December 22, 2017, to the Exclusive Patent License Agreement, dated May 8, 2013, between ViCapsys, Inc. and The General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 10.8 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
10.9		Share Exchange Agreement, dated December 22, 2017, by and among ViCapsys Life Sciences, Inc., Michael W. Yurkowsky, ViCapsys, Inc., and the shareholders of ViCapsys, Inc. (incorporated by reference to Exhibit 10.9 to the registrant’s registration statement on Form 10 filed with the Commission on February 12, 2020).
21.1*		List of Subsidiaries
31.1*		Certification of Chief Executive Officer required by Rule 13a-14(1) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*		Certification of Chief Financial Officer required by Rule 13a-14(1) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**		Certification of Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and Section 1350 of 18 U.S.C. 63

101.INS*		XBRL Instance Document
101.SCH*		XBRL Taxonomy Extension Schema Document
101.CAL*		XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*		XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*		XBRL Taxonomy Extension Label Linkbase Document
101.PRE*		XBRL Taxonomy Extension Presentation Linkbase Document
104*		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

	VICAPSYS LIFE SCIENCES, INC.

Date: March 16, 2022	By:	/s/ Federico Pier
		Federico Pier Chief Executive Officer

Date: March 16, 2022	By:	/s/ Federico Pier
		Federico Pier Chief Executive Officer (principal executive officer) and Executive Chairman of the Board of Directors

Date: March 16, 2022	By:	/s/ Jeffery Wright
		Jeffery Wright
		Chief Financial Officer (principal financial officer and principal accounting officer)

Date: March 16, 2022	By:	/s/ Michael Yurkowsky
		Michael Yurkowsky Director

Date: March 16, 2022	By:	/s/ John Potts, M.D.
		John Potts, M.D. Director

Date: March 16, 2022	By:	/s/ Dorothy Jordan
		Dorothy Jordan Director

	Page
Report of Independent Registered Public Accounting Firm	F-2

Consolidated Balance Sheets as of December 31, 2021 and 2020	F-3

Consolidated Statements of Operations for the years ended December 31, 2021 and 2020	F-4

Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2021 and 2020	F-5

Consolidated Statements of Cash Flows for the years ended December 31, 2010 and 2020	F-6

Notes to Consolidated Financial Statements	F-7-F-17