10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2020

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________ to ___________

Commission file number 000-30156

RENOVACARE, INC.

(Exact name of registrant as specified in its charter)

Nevada	98-0170247
(State or other jurisdiction of incorporation)	(I.R.S. Employer Identification No.)

4 Becker Farm Road, Suite 105

Roseland, NJ 07068

(Address of principal executive offices)

888-398-0202

(Registrant's telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act: None

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

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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	☐
Non-accelerated filer	☒
Smaller reporting company	☒	Emerging Growth Company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in 12b-2 of the Exchange Act):

Yes ☐ No ☒

As of November 12, 2020, the registrant had 87,352,364 shares of its common stock, par value $0.00001 per share, issued and outstanding.

RENOVACARE, INC.

FORM 10-Q

For The Quarter Ended September 30, 2020

TABLE OF CONTENTS

		Page #
PART I - FINANCIAL INFORMATION
Item 1.	Financial Statements
	Condensed Consolidated Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019	1
	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019 (unaudited)	2
	Condensed Consolidated Statements of Stockholders’ Equity for the Nine Months Ended September 30, 2020 and 2019 (unaudited)	3
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019 (unaudited)	4
	Notes to Condensed Consolidated Financial Statements	5
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	12
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	21
Item 4.	Controls and Procedures	21
PART II - OTHER INFORMATION
Item 1.	Legal Proceedings	22
Item 1A.	Risk Factors	22
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	22
Item 6.	Exhibits	23
Signatures		24

PART I

Item 1. Financial Statements

RENOVACARE, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

AS OF SEPTEMBER 30, 2020 (Unaudited) AND DECEMBER 31, 2019

	September 30,			December 31,
	2020			2019
ASSETS
Current assets
Cash and cash equivalents	$	8,671,295		$	12,185,248
Other current assets		273,606			102,500
Total current assets		8,944,901			12,287,748
Fixed Assets, net		40,965			-
Right of use asset		86,587			-
Security deposit		7,995			-
Prepaid R&D – noncurrent		159,498			-
Intangible assets		152,854			152,854
Total assets	$	9,392,800		$	12,440,602
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses	$	585,089		$	169,044
Accounts payable - related parties		132,371			111,696
Operating lease liability		44,458			-
Total current liabilities		761,918			280,740
Operating lease liability		42,233			-
Total liabilities		804,151			280,740
Commitments and contingencies
Stockholders' equity
Preferred stock: $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding		-			-
Common stock: $0.00001 par value; 500,000,000 shares authorized, 87,352,364 shares issued and outstanding at September 30, 2020 and December 31, 2019		874			874
Additional paid-in capital		35,811,930			32,378,833
Retained deficit		(27,224,155	)		(20,219,845	)
Total stockholders' equity		8,588,649			12,159,862
Total liabilities and stockholders' equity	$	9,392,800		$	12,440,602

(The accompanying notes are an integral part of these condensed consolidated financial statements)

1

RENOVACARE, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019

(Unaudited)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
Revenue	$	-		$	-		$	-		$	-
Operating expense
Research and development		1,551,989			130,467			3,091,383			504,169
General and administrative		1,290,890			1,070,314			4,024,317			1,944,111
Total operating expense		2,842,879			1,200,781			7,115,700			2,448,280
Loss from operations		(2,842,879	)		(1,200,781	)		(7,115,700	)		(2,448,280	)
Other income (expense)
Interest income		24,915			84,731			111,390			265,460
Total other income (expense)		24,915			84,731			111,390			265,460
Net loss	$	(2,817,964	)	$	(1,116,050	)	$	(7,004,310	)	$	(2,182,820	)
Basic and Diluted Loss per Common Share	$	(0.03	)	$	(0.01	)	$	(0.08	)	$	(0.03	)
Weighted average number of common shares outstanding - basic and diluted		87,352,364			87,243,352			87,352,364			87,198,132

(The accompanying notes are an integral part of these condensed consolidated financial statements)

2

RENOVACARE, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019

(Unaudited)

					Additional						Total
	Common Stock				Paid-in			Retained			Stockholders'
	Shares		Amount		Capital			Deficit			Equity
Balance, January 1, 2020		87,352,264	$	874	$	32,378,833		$	(20,219,845	)	$	12,159,862
Stock based compensation		-		-		465,763			-			465,763
Net loss		-		-		-			(1,174,753	)		(1,174,753	)
Balance, March 31, 2020		87,352,264		874		32,844,596			(21,394,598	)		11,450,872
Stock based compensation		-		-		1,586,522			-			1,586,522
Net loss		-		-					(3,011,593	)		(3,011,593	)
Balance, June 30, 2020		87,352,264		874		34,431,118			(24,406,191	)		10,025,801
Stock based compensation		-		-		1,119,815			-			1,119,815
Stock based compensation issued for prepaid services		-		-		260,997			-			260,997
Net loss		-		-		-			(2,817,964	)		(2,817,964	)
Balance, September 30, 2020		87,352,264	$	874	$	35,811,930		$	(27,224,155	)	$	8,588,649
Balance, January 1, 2019		87,175,522	$	872	$	32,187,580		$	(16,861,763	)	$	15,326,689
Stock based compensation		-		-		832			-			832
Net loss		-		-		-			(547,504	)		(547,504	)
Balance, March 31, 2019		87,175,522		872		32,188,412			(17,409,267	)		14,780,017	)
Net loss		-		-		-			(519,266	)		(519,266	)
Balance, June 30, 2019		87,175,522		872		32,188,412			(17,928,533	)		14,260,751
Exercise of warrants		176,842		2		(2	)		-			-
Net loss		-		-		-			(1,116,050	)		(1,116,050	)
Balance, September 30, 2019		87,352,364	$	874	$	32,188,410		$	(19,044,583	)	$	13,144,701

(The accompanying notes are an integral part of these condensed consolidated financial statements)

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RENOVACARE, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019

(Unaudited)

	Nine Months Ended
	September 30,
	2020			2019
Cash flows from operating activities
Net loss	$	(7,004,310	)	$	(2,182,820	)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation		309			237
Stock based compensation expense		3,172,100			832
Amortization of right-of-use asset		6,978
Changes in operating assets and liabilities:
(Increase) decrease in other current assets		(69,608	)		68,707
Increase in accounts payable and accrued expenses		416,045			190,925
(Decrease) increase in accounts payable - related parties		20,675			66,474
Decrease in interest payable – related parties		-			(167,497	)
Lease liability		(6,874	)
Net cash flows used in operating activities		(3,464,685	)		(2,023,142	)
Cash flows from investing activities
Payment for security deposit		(7,995	)		-
Purchase of fixed assets		(41,273	)		-
Net cash flows used in investing activities		(49,268	)		-
Decrease in cash and cash equivalents		(3,513,953	)		(2,023,142	)
Cash and cash equivalents at beginning of period		12,185,248			15,397,524
Cash and cash equivalents at end of period	$	8,671,295		$	13,374,382
Supplemental disclosure of cash flow information:
Interest paid in cash	$	-		$	167,497
Income taxes paid in cash	$	-		$	-
Supplemental disclosure of noncash financing activities:
Stock based compensation issued for prepaid services	$	260,997		$	-

(The accompanying notes are an integral part of these condensed consolidated financial statements)

4

RENOVACARE, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1. Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Loss) Per Share

Basis of Presentation

The accompanying interim unaudited condensed consolidated financial statements and related disclosures of RenovaCare, Inc. and Subsidiary (the “Company”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed on May 14, 2020. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted.

In the opinion of management, the interim condensed consolidated financial statements reflect all adjustments considered necessary for a fair statement of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the year ended December 31, 2020.

Organization

RenovaCare, Inc. was incorporated on July 14, 1983 in the State of Utah under the name Far West Gold, Inc., and changed its domicile to Nevada in 1997. On January 7, 2014, the Company changed its name at the time from “Janus Resources, Inc.” to “RenovaCare, Inc.” so as to more fully reflect its current operations and business, and changed its trading symbol from “JANI” to “RCAR” effective as of January 9, 2014.

RenovaCare has an authorized capital of 500,000,000 shares of $0.00001 par value common stock, of which 87,352,364 shares are outstanding as of September 30, 2020, and 10,000,000 shares of $0.0001 par value preferred stock, of which none are outstanding.

Overview of Operations

The Company focuses on the research, development and commercialization of autologous (using a patient's own cells) cellular therapies that can be used for medical and aesthetic applications.

On July 12, 2013, the Company, through its wholly owned subsidiary, RenovaCare Sciences Corp., completed the acquisition of its flagship technologies (collectively, the “CellMist^TM System”) along with associated United States patent applications and two foreign patent applications, all of which have been granted. In August 2019, the Company was awarded a continuation of a patent allowing the Company’s novel solution sprayer device (the “SkinGun^TM”) to be used to spray all varieties of tissues and cells, thus allowing for its potential application in the regeneration of tissues and organs, beyond skin.

The CellMist^TM System is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “CellMist^TM Solution”) and (b) the SkinGun^TM for delivering the cells to the treatment area. In August 2020, the Company announced that the US Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous skin and pluripotent stem cells rendered by its manual CellMist™ System from donor skin and applied topically with the electronic SkinGun™ spray device for treatment of acute burn wounds. The clinical trial protocol is an open-label single-arm clinical study that will enroll 14 adult human burn subjects with partial-thickness, second-degree thermal burn wounds covering between 10 and 30% total body surface area. The Company expects to conduct the clinical study at four (4) U.S. burn centers commencing in 2021.

Improvements in the design and efficiency of the CellMist™ System including a closed, self-contained, semi-automated sterile cell isolation device and the SkinGun™ spray device are in development with StemCell Systems (Berlin, Germany), the Company’s R&D innovation partner. The Company is adapting its core technologies for possible use in other clinical indications. The Company is also developing the cell isolation and spray gun devices as stand-alone 510 (k)-cleared products for isolation of cells from other tissues and spraying other solutions of medical importance.

5

The Company does not have any commercialized products. The Company's activities have consisted principally of performing research and development activities and raising capital to support such activities. The Company has enlisted the assistance of several Contract Manufacturing Organizations (CMO) to manufacture clinical supplies including components of the CellMist System™ and the electronic SkinGun™ spray devices in compliance with FDA’s guidance for current Good Manufacturing Practices (cGMP) and Contract Research Organizations (CRO) to conduct clinical trials to evaluate the safety and feasibility of an autologous skin cell therapy using the Company’s products to facilitate burn wound healing. These development activities are subject to significant risks and uncertainties, including possible failure of preclinical and clinical testing. The Company has not generated any revenue and has sustained recurring losses and negative cash flows from operations since inception. The Company expects to incur losses as it continues development of its products and technologies and expects that it will need to raise additional capital through partnerships or the sale of its securities to accomplish its business plan. Failing to secure such additional funding before achieving sustainable revenue and profit from operations poses a significant risk. The Company's ability to fund the development of its cellular therapies depends on the amount and timing of cash receipts from future financing activities. There can be no assurance as to the availability or terms upon which such financing and capital might be available. Additionally, there is significant uncertainty relating to the full impact of the COVID-19 pandemic on the Company’s operations and capital requirements. Should financing when needed be unavailable or prohibitively expensive or the COVID-19 pandemic continue, it may adversely affect the Company’s ability to (i) retain employees and consultants; (ii) obtain additional financing on terms acceptable to the Company, if at all; (iii) delay regulatory submissions and approvals; (iv) delay, limit or preclude the Company from securing clinical study sites; (v) delay, limit or preclude the Company from achieving technology or product development goals, milestones, or objectives; and (vi) preclude or delay entry into joint venture or partnership arrangements. The occurrence of any one or more of such events may affect the Company’s ability to continue on its pathway to commercialization of its technology or products.

Liquidity

As of September 30, 2020, the Company had $8,671,295 of cash on hand and cash equivalents, and working capital of $8,182,984. As a result, the Company believes it currently has sufficient cash to meet its funding requirements over the next twelve months following the issuance of this Quarterly Report on Form 10-Q. However, the Company has experienced and continues to experience negative cash flows from operations, as well as an ongoing requirement for substantial additional capital investment. The Company expects that it may need to raise additional capital to accomplish its business plan over the next several years. There can be no assurance as to the availability or terms upon which such financing and capital might be available. See “Overview of Operations” above.

New Accounting Standards

Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative non-governmental U.S. GAAP as found in the Financial Accounting Standards Board's Accounting Standards Codification.

In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. ASU 2019-12 is effective for the Company beginning in fiscal 2021. The Company is currently assessing the impact that this pronouncement will have on its consolidated financial statements.

The Company reviews new accounting standards as issued. Although some of these accounting standards issued or effective after the end of the Company’s previous fiscal year may be applicable, the Company has not identified any standards that the Company believes merit further discussion other than as discussed above. The Company believes that none of the new standards will have a significant impact on the financial statements.

6

Earnings (Loss) Per Share

The Company presents both basic and diluted earnings per share ("EPS") amounts. Basic EPS is calculated by dividing net income (loss) by the weighted average number of common shares outstanding during the period presented. Diluted EPS amounts are based upon the weighted average number of common and common equivalent shares outstanding during the period presented. The Company has not included the effects of warrants or stock on net loss per share because to do so would be antidilutive.

Following is the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
Basic and Diluted EPS Computation
Numerator:
Loss available to common stockholders'	$	(2,817,964	)	$	(1,116,050	)	$	(7,004,310	)	$	(2,182,820	)
Denominator:
Weighted average number of common shares outstanding		87,352,364			87,243,352			87,352,364			87,198,132
Basic and diluted EPS	$	(0.03	)	$	(0.01	)		(0.08	)	$	(0.03	)

The shares listed below were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods presented:

Stock options	5,883,070	317,500	5,883,070	317,500
Warrants	12,296,912	13,106,912	12,296,912	13,106,912
Total shares not included in the computation of diluted losses per share	18,179,982	13,242,412	18,179,982	13,424,412

Note 2. Other Current Assets

Other current assets consist of the following:

	September 30,		December 31,
	2020		2019
Prepaid insurance	$	108,360	$	-
Prepaid stock options for services		86,999		-
Prepaid professional fees		65,000		102,500
Other prepaid costs		13,247		-
Total prepaid expenses	$	273,606	$	102,500

Note 3. Assets – Intellectual Property

On July 12, 2013, the Company, together with its wholly owned subsidiary, RenovaCare Sciences, entered into an asset purchase agreement (“APA”) with Dr. Jörg Gerlach, MD, PhD, pursuant to which RenovaCare Sciences purchased all of Dr. Gerlach’s rights, title and interest in the CellMist^TM System. Acquisition-related costs amounted to $52,852 and were capitalized together with the cash payment upon the closing of the transaction in July 2013 of $100,002. Intangible assets amounted to $152,854 at September 30, 2020 and December 31, 2019.

7

Note 4. Common Stock and Warrants

Common Stock

At September 30, 2020, the Company had 500,000,000 authorized shares of common stock with a par value of $0.00001 per share, 87,352,364 shares of common stock outstanding and 20,000,000 shares reserved for issuance under the Company’s 2013 Long-Term Incentive Plan (the “2013 Plan”) as adopted and approved by the Company’s Board of Directors (the “Board”) on June 20, 2013 that provides for the grant of stock options to employees, directors, officers and consultants. During the nine months ended September 30, 2020, the Company granted options to purchase an aggregate 3,565,570 shares of the Company’s common stock to employees and consultants. See “Note 5. Stock Options” for further discussion.

Warrants

The following table summarizes information about warrants outstanding at September 30, 2020 and December 31, 2019:

		Shares of Common Stock Issuable from Warrants Outstanding as of				Weighted
		September 30,		December 31,		Average
Description		2020		2019		Exercise Price		Expiration
	Series D		-		810,000	$	1.10	June 5, 2020
	Series E		584,416		584,416	$	1.54	September 8, 2021
	Series F		7,246		7,246	$	3.45	February 23, 2022 & March 9, 2022
	Series G		460,250		460,250	$	2.68	July 21, 2022
	Series H		910,000		910,000	$	2.75	October 16, 2022
	Series I		10,335,000		10,335,000	$	2.00	November 26, 2025
	Total		12,296,912		13,106,912

Note 5. Stock Options

The following table summarizes stock option activity for the period ended September 30, 2020:

	Number of Options			Weighted Average Exercise Price ($)		Weighted Average Remaining Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding at December 31, 2019		2,317,500			2.68		5.68	$	1,460,507
Grants		3,565,570			2.30		-		-
Forfeited		(37,500	)		4.20		-		-
Outstanding at September 30, 2020		5,845,570			2.46		5.38	$	7,200,064
Vested and Exercisable at September 30, 2020		1,402,499			2.07		5.39		2,322,524
Available for grant at September 30, 2020		13,912,695

On January 2, 2020, the Company granted Alan L. Rubino, the Company’s President and Chief Executive Officer, an option to purchase up to 620,571 shares of the Company’s common stock at an exercise price of $3.23. The option was granted in fulfillment of the Company’s obligation under the terms of Mr. Rubino’s employment agreement dated November 15, 2019. On May 22, 2020, the Board of Directors approved the modification of these 620,571 options to accelerate the vesting from November 14, 2023 to November 14, 2022. The Company calculated the fair value of the options immediately before and after the modification using the Black-Scholes model. There was no incremental consideration due to the modification.

8

On May 22, 2020, the Company granted options to two consultants and a board member to purchase an aggregate 1,550,000 shares of the Company’s common stock at an exercise price of $1.40. On June 1, 2020, pursuant to his employment agreement, the Company granted Dr. Robin Robinson, the Company’s Chief Scientific Officer, an option to purchase up to 200,000 shares of the Company’s common stock at an exercise price of $1.65. On June 22, 2020, pursuant to his employment agreement, the Company granted Robert Cook, the Company’s Chief Financial Officer, an option to purchase up to 100,000 shares of the Company’s common stock at an exercise price of $1.96.

On August 1, 2020, in connection with her appointment to the Board of Directors, the Company granted Lydia M. Evans, M.D. an option to purchase up to 20,000 shares of the Company’s common stock at an exercise price of $3.17 per share. 10,000 of the options vested immediately with the balance vesting on August 3, 2021.

In consideration of entering into a Right of First Refusal and Corporate Opportunities Agreement (the “ROFR Agreement”) dated July 1, 2020, the Company granted StemCell Systems GmbH (“SCS”), an option to purchase 999,999 shares of the Company’s common stock. The option grant vests as follows: (i) 99,999 on July 29, 2020, (ii) 900,000 in 36 equal monthly installments beginning on August 31, 2020. Concurrent with the option grant, SCS assigned and transferred its rights in the options to Jörg Gerlach, MD, PhD.

The fair value of the options was estimated at the date of grant using the Black-Scholes option pricing model. Assumptions regarding volatility, expected term, dividend yield and risk-free interest rate are required under the Black-Scholes model. The volatility assumption is based on the Company’s historical experience. The risk-free interest rate is based on a U.S. Treasury note with maturity similar to the option award’s expected life. The expected life represents the average period of time that options granted are expected to be outstanding.

The assumptions for volatility, expected life, dividend yield and risk-free interest rate for the options granted are as follows:

	Nine Months Ended
	September 30, 2020
Risk-free interest rate	0.21%	-	1.67%
Expected life in years	3.25	-	6.00
Expected Volatility	103.56%	-	110.71%
Expected dividend yield		0%

The share-based compensation cost resulting from stock option grants, including those previously granted and vesting over time, is expensed ratably over the respective vesting periods. During the three and nine months ended September 30, 2020, the Company recognized $1,463,969 and $3,172,000, respectively, in stock-based compensation expense. Compensation costs for consultant option grants are recognized in the same period and in the same manner as if the Company had paid cash for the services. The Company recognized a prepaid expense in the amount of $260,997 for the 99,999 vested options granted to SCS for entering into the ROFR Agreement. During the three and nine months ended September 30, 2019, the Company recognized $832 and $191,275 respectively, in stock-based compensation. As of September 30, 2020, the Company’s unrecognized compensation cost related to unvested stock options was $5,416,522 to be amortized through 2023. Stock-based compensation has been included in the consolidated statement of operations as follows:

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019
Research and development	$	631,876	$	832	$	1,087,047	$	191,275
General and administrative		832,093		-		2,084,953		-
Total	$	1,463,969	$	832	$	3,172,000	$	191,275

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The following table summarizes information about stock options outstanding and exercisable as of September 30, 2020:

	Stock Options Outstanding						Stock Options Exercisable
Range of Exercise Prices	Number of Shares Subject to Outstanding Options		Weighted Average Contractual Life (years)		Weighted Average Exercise Price		Number of Shares Subject to Options Exercise		Weighted Average Remaining Contractual Life (Years)		Weighted Average Exercise Price
1.05		55,000		3.50		1.05		55,000		3.50		1.05
1.25		7,500		4.71		1.25		7,500		4.71		1.25
1.34		7,500		4.75		1.34		7,500		4.75		1.34
1.40		1,550,000		5.64		1.40		775,000		5.64		1.40
1.65		200,000		5.67		1.65		100,000		5.67		1.65
1.70		7,500		5.04		1.70		7,500		5.04		1.70
1.96		100,000		5.73		1.96		50,000		5.73		1.96
2.28		7,500		5.80		2.28		7,500		5.80		2.28
4.20		195,000		4.26		4.20		195,000		4.26		4.20
1.98		667,800		5.13		1.98		-		-		-
2.48		667,800		5.13		2.48		-		-		-
3.23		664,400		5.13		3.23		-		-		-
3.23		620,571		5.13		3.23		-		-		-
3.19		1,074,999		5.84		3.19		187,499		5.84		3.19
3.17		20,000		5.84		3.17		10,000		5.84		3.17
Total		5,845,570		5.38	$	2.44		1,402,499		5.39	$	2.07

Note 6. Leases

The Company determines if an arrangement is a lease, or contains a lease, at the inception of an arrangement. If the Company determines that the arrangement is a lease, or contains a lease, at lease inception, it then determines whether the lease is an operating lease or finance lease. Operating and finance leases result in recording a right-of-use (“ROU”) asset and lease liability on the consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. For purposes of calculating operating lease ROU assets and operating lease liabilities, the Company uses the non-cancellable lease term plus options to extend that it is reasonably certain to exercise. Lease expense for operating lease payments is recognized on a straight-line basis over the lease term. The Company’s leases generally do not provide an implicit rate. As such, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company has elected not to recognize ROU assets and lease liabilities that arise from short-term (12 months or less) leases for any class of underlying asset. The Company has elected not to separate lease and non-lease components for any class of underlying asset.

In February 2020, the Company entered into a two-year lease for office premises located at 4 Becker Farm Road, Suite 105, Roseland, New Jersey. Monthly base rent in year one of the lease is $4,356; and $4,459 in year 2 of the lease. The term (and payment of the monthly rent) commences upon substantial completion of the landlord’s work, which was expected to occur on or before May 31, 2020. Due to the COVID-19 pandemic the lease term commenced on August 1, 2020.

Supplemental lease information at September 30, 2020:

Right-of-use asset	$	86,587
Short-term operating lease liability	$	44,458
Long-term operating lease liability	$	42,233
Remaining term (years)		1.9
Discount rate		7	%

The Company does not have any finance leases.

Supplemental cash flow information for the nine months ended September 30, 2020:

Cash paid for amount included in the measurement of lease liabilities for operating lease	$	13,068
Right-of-use asset obtained in exchange for lease obligation	$	98,402

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The Company leases office space under a non-cancellable operating lease expiring in 2022. Future lease payments included in the measurement of lease liabilities on the balance sheet at September 30, 2020 for future periods are as follows:

Years ending December 31, 2020,
2020 (remaining)	$	8,712
2021	$	52,787
2022	$	31,213
Total future minimum lease payments	$	92,712
Less imputed interest	$	6,125
Total	$	86,587

Note 7. Commitments and Contingencies

The Company has engaged StemCell Systems GmbH (“StemCell Systems”) to provide it with prototypes and related documents related to the CellMist™ system and the SkinGun™ under various agreements. Pursuant to these engagements the Company incurred expenses of $125,655 and $400,612 during the three and nine months ended September 30, 2020 and, $100,000 and $223,175 during the three and nine months ended September 30, 2019, respectively. Dr. Gerlach, from whom the Company purchased the CellMist^TM System and SkinGun^TM technologies, is a principal of StemCell Systems.

On June 3, 2019, the Company entered into a Charitable Gift Agreement with the University of Pittsburgh (“University”), pursuant to which the Company committed to provide a charitable donation to the University in the amount of $250,000 (the “Grant”). The Company paid the Grant in four installments with the first payment made in July 2019. During each of the three and nine months ended September 30, 2020 the Company made payments totaling $62,500 and $62,500, respectively. During the three and nine months ended September 30, 2019 the Company made payments totaling $0 and $62,500, respectively. As of September 30, 2020, the Company’s obligation under the Grant has been satisfied.

Note 8. Related Party Transactions

During the nine months ended September 30, 2020, Talia Jevan Properties, Inc. made payments totaling $10,811 to Stephen Yan-Klassen, former CFO, for his salary on behalf of the Company. Talia Jevan Properties, Inc. is a related party of Harmel Rayat, former Chairman of the Board. The total compensation Talia Jevan Properties, Inc. made to Stephen Yan-Klassen during the three and nine months ended September 30, 2020 was $0 and $10,811, respectively. Subsequent to the period ended September 30, 2020 the $10,811 owed was paid to Talia Jevan Properties, Inc.

On August 1, 2013, the Company entered into a consulting agreement, as amended on May 1, 2016, with Jatinder Bhogal, an individual owning in excess of 5% of the Company’s issued and outstanding shares of common stock, to provide consulting services to the Company through his wholly owned company, Vector Asset Management, Inc. (“VAM”). Pursuant to the consulting agreement VAM assisted the Company with identifying subject matter experts in the medical device and biotechnology industries and assisted the Company with its ongoing research, development and eventual commercialization of its Regeneration Technology. Pursuant to an amendment dated May 1, 2016, the VAM monthly consulting fee was increased from $5,000 to $6,800. On June 22, 2018, the Company and VAM entered into an Executive Consulting Agreement (“ECA”) pursuant to which Mr. Bhogal served as the Company’s Chief Operating Officer. The ECA supersedes the prior consulting agreement. Pursuant to the ECA, VAM will receive compensation of $120,000 per year. On July 1, 2020 the company amended the agreement and will pay VAM $4,000 monthly through December 31, 2020 and $2,000 per month thereafter until May 31, 2021 at which time the agreement will expire. During the three months ended September 30, 2020 and 2019, the Company recognized expenses of $12,000 and $30,000 and during the nine months ended September 30, 2020 and 2019 the Company recognized $72,000 and $90,000 respectively, in expenses and for consulting services provided by VAM. Jatinder Bhogal resigned as the Company’s COO effective June 30, 2020.

Kalen Capital Corp (“KCC”) is wholly owned by Mr. Harmel Rayat, the former Chairman of the Board. On April 1, 2020 KCC provided a short-term advance of $50,000 to the Company. The short-term advance was repaid by the Company to KCC in July 2020. The Company paid KCC $65,156 for reimbursable expenses in October 2020.

Note 9. Subsequent Events

Management has reviewed for material events subsequent of the period ended September 30, 2020, and prior to the filing of financial statements in accordance with FASB ASC 855 “Subsequent Events”.

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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Cautionary Note Regarding Forward-Looking Statements

This discussion and analysis of financial condition and results of operations is based upon and should be read in conjunction with the unaudited interim consolidated financial statements of RenovaCare, Inc. (“RenovaCare”) and its wholly-owned subsidiary (collectively with RenovaCare, “we,” “our,” “us,” or the “Company”), appearing elsewhere in this Quarterly Report on Form 10-Q, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of any contingent liabilities at the financial statement date and reported amounts of revenue and expenses during the reporting period. On an on-going basis the Company reviews its estimates and assumptions. The estimates were based on historical experience and other assumptions that the Company believes to be reasonable under the circumstances. Actual results are likely to differ from those estimates under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results of operations. Critical accounting policies, the policies the Company believes are most important to the presentation of its financial statements and require the most difficult, subjective and complex judgments, are outlined below in “Critical Accounting Policies,” and have not changed significantly since 2019.

This Quarterly Report on Form 10-Q also contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as well as information relating to the Company that is based on management's exercise of business judgment and assumptions made by and information currently available to management. Although forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. When used in this document and other documents, releases and reports released by us, the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “the facts suggest” and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect our current view of future events and are subject to certain risks and uncertainties as noted below. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, our actual results could differ materially from those anticipated in these forward-looking statements. Actual events, transactions and results may materially differ from the anticipated events, transactions or results described in such statements. Although we believe that our expectations are based on reasonable assumptions, we can give no assurance that our expectations will materialize. Many factors could cause actual results to differ materially from our forward-looking statements and unknown, unidentified or unpredictable factors could materially and adversely impact our future results. We undertake no obligation and do not intend to update, revise or otherwise publicly release any revisions to our forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events. Several of these factors include, without limitation:

· our ability to meet requisite regulations or receive regulatory approvals in the United States, and our ability to retain any regulatory approvals that we may obtain; and the absence of adverse regulatory developments in the United States and abroad;

· new entrance of competitive products or further penetration of existing products in our markets;

· results of our clinical trials;

· failure of our products to gain market acceptance;

· the cost and success of our development programs;

· our failure to obtain financing as, if and when needed, on commercially acceptable terms;

· our failure to attract and retain qualified personnel;

· our failure to adequately manage our growth and expansion;

· the effect on us from adverse publicity related to our products or the Company itself; and

· our failure to defend against any adverse claims relating to our intellectual property.

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The safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, apply to forward-looking statements made by us. The reader is cautioned that no statements contained in this Form 10-Q should be construed as a guarantee or assurance of future performance or results. Actual events or results may differ materially from those discussed in forward-looking statements as a result of various factors, including, without limitation, the risks described in this report and matters described in this report generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur.

Background

RenovaCare, Inc. was incorporated on July 14, 1983 in the State of Utah under the name Far West Gold, Inc., and changed its domicile to Nevada in 1997. On January 7, 2014, the Company changed its name at the time from “Janus Resources, Inc.” to “RenovaCare, Inc.” so as to more fully reflect its current operations and business; and changed its trading symbol from “JANI” to “RCAR” effective as of January 9, 2014.”

RenovaCare  has an authorized capital of 500,000,000 shares of $0.00001 par value common stock, of which 87,352,364 shares are outstanding as of September 30, 2020, and 10,000,000 shares of $0.0001 par value preferred stock, of which none are outstanding.

Description of Business

We are a development-stage company focusing on the development and commercialization of autologous (using a patient’s own cells) cellular therapies for medical and aesthetic applications. The Company, through its wholly owned subsidiary, RenovaCare Sciences Corp., owns the CellMist™ System which is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “CellMist™ Solution”) and (b) a solution sprayer device (the (SkinGun™”) for delivering cells to the treatment area.

We have filed additional patent applications related to the CellMist™ System and other technologies.

Our proprietary CellMist™ System, and its component technologies were the subject of six trademarks and applications and over 37 U.S. and international granted or in-process patents in eight patent families. Our patent filings include three granted patents in the United States, two granted international patents, and two allowed international patents, while all in-process patent filings include the U.S. and multiple foreign jurisdictions. Our issued patents are scheduled to expire between 2026 and 2036 and may or may not be the basis for filing continuations. We continually assess opportunities to seek patent protection for those aspects of our technology, designs, and methodologies and processes that we believe may provide us with significant competitive advantages or additional commercial opportunities.

The development of our new closed, semi-automated cell isolation device for the CellMist^TM System is in the early stage  and we anticipate that we will be required to expend significant time and resources to further develop our technology and determine whether a commercially viable product can be developed. Research and development of new technologies involves a high degree of risk and there is no assurance that our development activities will result in a commercially viable product. The long-term profitability of our operations will be, in part, directly related to the cost and success of our development programs, which may be affected by a number of factors.

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We are currently evaluating the potential of our CellMist^TM System in the treatment of tissue that has been subject to severe trauma such as second-degree burns. The CellMist^TM System utilizes the patient’s own skin stem cells and can reduce the size of the donor site and significantly decrease scarring. Furthermore, we believe the CellMist^TM System could enable treatment of other skin disorders with minimal scarring.

In August 2020, the Company announced that the US Food and Drug Administration (“FDA”) conditionally approved the Company’s Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous stem cells rendered by its CellMist™ System from donor skin and applied topically with the SkinGun™ spray device for treatment of burn wounds. The clinical trial protocol is for an open-label single-arm clinical study that will enroll 14 human burn subjects with partial-thickness second- or- third degree thermal burn wounds. The Company expects to conduct the clinical study at four (4) U.S. burn centers.

Our Mission and Strategy

Our ultimate goal is to leverage the potential of our CellMist^TM System with the SkinGun^TM spray device, as next generation cell therapy for burns and other acute and chronic wounds and skin disorders. Before we can do so, however, there are a number of steps we must first take, including:

· initiating a series of clinical trials to determine the safety and efficacy of the CellMist^TM System with the SkinGun^TM spray device for treating partial-thickness second-degree thermal burns;

· formalizing collaborations with academic, scientific, and/or commercial partners;

· creating a network of clinical research partners;

· achieving FDA and/or other regulatory approval and clearance; and

· expanding the range of possible clinical applications for unmet health needs.

We believe that we now have an experienced leadership team which has come together to achieve our mission of improving the lives of burn patients by creating potentially more effective, safer, efficient, and cost-saving treatments. To achieve our goal, we have established the following strategic priorities:

· Obtain marketing approval and prepare to commercialize our CellMist^TM System with the SkinGun^TM spray device.

We have received conditional approval and we continue to pursue our efforts to secure regulatory (FDA) approval of our IDE in 2020, and if ultimately approved, commence our feasibility study in the United States.

· Selectively pursue strategic partnerships, joint ventures, and licensing opportunities to complement and expand our existing operations.

We intend to continue to pursue strategic licensing, partnership, and joint venture opportunities. We will continue to target opportunities that will complement our existing technology and operations to create value for stockholders and support our business strategy and mission.

· Secure additional financing as and when required.

Additionally, we will need to pursue financing opportunities, traditional and non-dilutive, and if available on acceptable terms, if at all, in order to raise sufficient capital to fund our ongoing research and development operations in order to expand the range of possible clinical applications of our CellMist^TM System.

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Our Market Opportunity

Burns

Burns are one of the most common and devastating forms of trauma. Most burn injuries involve layers of the upper skin, the epidermis. Severe major trauma involves a complete loss of the entire thickness of the skin and often requires major surgery involving split-skin mesh-grafting. Skin grafting is a procedure where healthy skin is removed from one area of the body and transplanted to a wound site.

Patients with serious thermal injury require immediate specialized definitive care in order to minimize morbidity and mortality. Data from the National Center for Injury Prevention and Control in the U.S. show that approximately 2 million fires are reported each year which result in 1.2 million people with burn injuries (see American Burn Association Burn Incidence and Treatment in the US: 2000 Fact Sheet, available at: http://www.ameriburn.org). Moderate to severe burn injuries requiring hospitalization account for approximately 100,000 of these cases, and about 5,000 patients die each year from burn-related complications (see Church D, Elsayed S, Reid O, Winston B, Lindsay R “Burn wound infections” Clinical Microbiology Reviews 2006;19(2):403–34, available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1471990).

The prevalence of patients with severe burns is even higher in emerging economies. For example, according to the World Health Organization over 1,000,000 people in India are moderately to severely burnt every year and approximately 180,000 people worldwide die from burn related injuries (see World Health Organization “Burns: Fact Sheet No. 365,” reviewed March 6, 2018, available at: http://www.who.int/mediacentre/factsheets/fs365/en/). According to Critical Care, an international clinical medical journal, burns are also among the most expensive traumatic injuries because of long and costly hospitalization, rehabilitation and wound and scar treatment (see Brusselaers, N., Monstrey, et al, “Severe Burn Injury in Europe: A systematic Review of the Incidence, Etiology, Morbidity, and Mortality” available at: http://ccforum.com/content/14/5/R188).

Burn injuries account for a significant cost to the health care system in North America and worldwide. In the U.S. there are currently 132 centers specializing in burn care. Recent estimates in the U.S. show that 40,000 patients are admitted annually for treatment with burn injuries, and over 60% of the estimated U.S. acute hospitalizations related to burn injury were admitted to burn centers. Such centers now average over 200 annual admissions each for burn injury and skin disorders requiring similar treatment. The other 4,500 U.S. acute care hospitals average less than 3 burn admissions each per year (see American Burn Association Burn Incidence and Treatment in the US: 2013 Fact Sheet, available at: http://www.ameriburn.org).

According to the Agency for Healthcare Research and Quality, the annual costs for the treatment of burns is $1.5 billion, with another $5 billion in costs associated with lost work (see https://www.hcup-us.ahrq.gov/reports/statbriefs/sb217-Burn-Hospital-Stays-ED-Visits-2013.pdf). Initial hospitalization costs and physicians' fees for specialized care of a patient with a major burn injury are currently estimated to be $200,000. Overall, costs escalate for major burn cases because of repeated admissions for reconstruction and rehabilitation therapy. In the U.S., current annual estimates show that more than $18 billion is spent on specialized care of patients with major burn injuries (see Church D, Elsayed S, Reid O, Winston B, Lindsay R “Burn wound infections” Clinical Microbiology Reviews 2006;19(2):403–34, available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1471990).

Wounds

According to The Wall Street Journal, 6.5 million people are affected by chronic wounds, and $25 billion is spent annually on treating chronic wounds on patients in the U.S. alone (see Järbrink, Krister et al. “Prevalence and incidence of chronic wounds and related complications: a protocol for a systematic review.” Systematic reviews vol. 5,1 152. 8 Sep. 2016 doi:10.1186/s13643-016-0329-y).

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The Wound Care Market Global Forecast to 2024 report issued by Markets & Markets states that in 2019, advanced wound care products accounted for the largest market share and is expected to have the highest growth projected at a compound annual growth rate of 4.6% to 2024. Major factors driving the growth of this market of hard-to-heal wounds are an increase in an aging population and greater prevalence of chronic disease, including diabetes and obesity. The development of regenerative medicine and healing capabilities allow for more effective treatment, quicker healing and improved health economic outcomes.

The healthcare facilities (hospitals and clinics) segment accounted for the largest market share in 2019 as these systems are used for critical cases, improve quality of care for patients, and have the infrastructure and resources to support treatment.

Our Technology

Our CellMist System is comprised of the CellMist^TM cell suspension derived by enzymatic digestion of a patient’s own skin tissue applied topically with our proprietary electronic SkinGun^TM spray device to deliver a fine single-cell mist onto the patient’s burn wound.

The duration of the cell isolation and cell spraying procedure is approximately 1.5–2 hours. Published studies show that within days following the wound treatment procedure, complete wound closure occurs, and the skin cells generate a protective skin layer (re-epithelialization), and within weeks to months the skin regains its function, color and texture.

Our cell isolation and cell spraying procedure occur on the same day, in an on-site hospital setting. Because the skin cells sprayed using the SkinGun^TM spray device are actually the patient's own cells, the skin that is regenerated looks more natural than other skin replacement technologies. During recovery, the skin cells grow into fully functional skin layers, and the regenerated skin leaves minimal scarring in observational case studies. Additionally, our methods require substantially smaller donor areas than skin grafting, reducing donor area burden such as pain and the risk of complications.

In August 2019, the Company was awarded a patent continuation, allowing the SkinGun^TM spray device to be used to spray all varieties of tissues and cells, thus opening the door for its potential application in the regeneration of tissues and organs, beyond skin.

The CellMist^TM System remains an experimental, unproven methodology and we continue to evaluate its safety and efficacy. There is no guarantee that we will able to develop a commercially viable product based upon the CellMist^TM System and its underlying technology.

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Competition

The biotechnology, medical device, and wound care industries are characterized by intense competition, rapid product development and technological change. Our CellMist^TM System competes with a variety of companies in the wound care markets, many of which offer substantially different treatments for similar problems.

Most of our competitors are larger, well-established companies with considerably greater financial, marketing, sales and technical resources than those available to us. Additionally, many of our present and potential competitors have research and development capabilities that may allow them to develop new or improved products that may compete with our product lines. Our potential products could be rendered obsolete or made uneconomical by the development of new products to treat the conditions addressed by our products, technological advances affecting the cost of production, or marketing or pricing actions by one or more of our competitors. Our closest direct competitor with their own skin cell therapy for burn wounds received FDA approval in September 2018 and launched its product in 2019; however our next generation skin cell therapy for burn wounds has multiple notable advantages including more cell types from both epidermal and dermal layers of the skin; greater cell yield and viability; smaller ratio of donor tissue to burn wound area; greater burn wound coverage; and single cells applied with the SkinGun™ spray device that rapidly adhere to the burn wound.

Intellectual Property

General

In the course of conducting our business, we from time to time create inventions. Obtaining, maintaining and protecting our inventions, including seeking patent protection, might be important depending on the nature of the invention. To that end, we seek to implement patent and other intellectual property strategies to appropriately protect our intellectual property. While we file and prosecute patent applications to protect our inventions, our pending patent applications might not result in the issuance of patents or issued patents might not provide competitive advantages. Also, our patent protection might not prevent others from developing competitive products using related or other technology.

The scope, enforceability and effective term of issued patents can be highly uncertain and often involve complex legal and factual questions. Moreover, the issuance of a patent in one country does not assure the issuance of a patent with similar claim scope in another country, and claim interpretation and infringement laws vary among countries, so we are unable to predict the extent of patent protection in any country. The patents we obtain and the unpatented proprietary technology we hold might not afford us significant commercial protection or advantage.

Our proprietary CellMist™ System and its component technologies were the subject of six trademarks and applications and over 37 U.S. and international granted or in-process patents in eight patent families. Our patent filings include three granted patents in the United States, two granted international patents, and two allowed international patents, while all in-process patent filings include the U.S. and multiple foreign jurisdictions. Our issued patents are scheduled to expire between 2026 and 2036, and may or may not be the basis for filing continuations. We continually assess opportunities to seek patent protection for those aspects of our technology, designs, and methodologies and processes that we believe may provide us with significant competitive advantages or additional commercial opportunities.

In addition to issued patents describe above, we plan to file additional patent applications that, if issued, would provide further protection for The CellMist^TM System. Although we believe the bases for these patents and patent applications are sound, they are untested; and there is no assurance that they will not be successfully challenged. There can be no assurance that any patent previously issued will be of commercial value, that any patent applications will result in issued patents of commercial value, or that our technology will not be held to infringe patents held by others.

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Operations

We expect to be engaged in research and development activities for the foreseeable future.

Results of Operations

Three Months Ended September 30, 2020 Compared with the Three Months Ended September 30, 2019

Operating Expenses

A summary of our operating expenses for the three months ended September 30, 2020 and 2019 follows:

	Three Months Ended September 30,				Increase /		Percentage
	2020		2019		(Decrease)		Change
Operating expenses
Research and development	$	1,551,989	$	130,467	$	1,421,522		1090	%
General and administrative		1,290,890		1,070,314		220,576		20	%
Total operating expenses	$	2,842,879	$	1,200,781	$	1,642,098		136	%

Research and Development

Research and development costs relate to the development of our CellMist^TM System. Our business model is dependent upon our company continuing to conduct a significant amount of research and development. Our research and development costs consist primarily of expenses incurred under agreements for preclinical and clinical support to our regulatory submissions, manufacturing of our clinical trial supplies, consultants that assist in research and development activities and employee-related expenses, which include salaries and benefits, and non-cash share-based compensation.

We make payments to consultants based on agreed upon terms that may include payments in advance of preclinical and clinical support. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Advance payments to be expensed in future research and development activities are capitalized and amounted to $246,497 at September 30, 2020 and $0 at December 31, 2019. Research and development expenditures will continue to be significant as we continue development of our CellMist^TM System.

Research and development costs for the three months ended September 30, 2020 increased $1,421,522, or 1,090%, to $1,551,989, compared with $130,467 for the three months ended September 30, 2019. Research and development costs increased as a result of a scale up of our clinical supply manufacturing, regulatory submissions, and product development activities for clinical trial support, and employee-related expenses. Costs related to the scale up of our manufacturing activities and product development for clinical trial support increased approximately $937,000 during the three months ended September 30, 2020 compared to the three months ended September 30, 2019. Employee-related expenses increased approximately $484,000 during the three months ended September 30, 2020 compared to the three months ended September 30, 2019 primarily due to the additions of the Company’s new Chief Scientific Officer and Chief Medical Officer. Included in the $484,000 increase is share-based compensation of approximately $455,000.

General and Administrative

General and administrative costs for the three months ended September 30, 2020 increased $211,144 or 20%, to $1,290,890, compared with $1,070,314 for the three months ended September 30, 2019. General and administrative costs include employee-related expenses, which include salaries and benefits, and non-cash share-based compensation, professional fees for legal, accounting and consulting and other general operating expenses. Employee-related expenses increased approximately $1,235,000, including share-based compensation in the amount of approximately $1,120,000 during the three months ended September 30, 2020 compared to the three months ended September 30, 2019. The increase is primarily attributable to the addition of our new Chief Executive Officer in November 2019 and stock option grants to employees and consultants. Professional fees decreased approximately $595,000 during the three months ended September 30, 2020 compared to the three months ended September 30, 2019 due to decreased costs related to corporate compliance and governance matters. Other general operating expenses increased approximately $26,000 during the three months ended September 30, 2020 compared to the three months ended September 30, 2019 due primarily to increased insurance costs.

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Other Income

Other income relates to interest earned on bank account deposits. Other income decreased approximately $59,800 to approximately $24,900 for the three months ended September 30, 2020 compared with the three months ended September 30, 2019 due to a lower average cash balance during the three months ended September 30, 2020 compared with September 30, 2019 and lower rates being earned on deposits.

Nine Months Ended September 30, 2020 Compared with the Nine Months Ended September 30, 2019

	Nine Months Ended September 30,						Percentage
	2020		2019		Increase		Change
Operating expenses
Research and development	$	3,091,383	$	504,169	$	2,587,214		513	%
General and administrative		4,024,317		1,944,111		2,080,206		107	%
Total operating expenses	$	7,115,700	$	2,448,280	$	4,667,420		190	%

Research and Development

Research and development costs relate to the development of our CellMist^TM System and SkinGun^TM spray device. Our business model is dependent upon our company continuing to conduct a significant amount of research and development activities. Current expenditures are primarily dedicated to (i) the development and validation of the SkinGun^TM spray devices at StemCell System (SCS); (ii) the development of a prototype cell isolation device at SCS; and (iii) the cGMP manufacturing of clinical supplies at CMOs for clinical trials to evaluate the safety, feasibility, and efficacy of our autologous skin cell therapy for burn wounds. Additionally, R&D expenses include consultants that assist in research and development activities and employee-related expenses, which include salaries and benefits, and non-cash share-based compensation.

We make payments to consultants based on agreed upon terms that may include payments in advance of preclinical support. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Advance payments to be expensed in future research and development activities are capitalized and amounted to $246,497 at September 30, 2020 and $0 at December 31, 2019. Research and development expenditures will continue to be significant as we continue development of the cell isolation device and SkinGun^TM spray device for our CellMist^TM System and the preparation and execution of clinical trials.

Research and development costs for the nine months ended September 30, 2020 increased $2,587,241, or 513%, to $3,091,383 compared with $504,169 for the nine months ended September 30, 2019. Research of development costs increased as a result of a scale up of our manufacturing activities for clinical trial support and employee-related expenses. Costs related to the scale up of our manufacturing activities for clinical trial support increased approximately $1,342,121 during the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. Employee-related expenses increased approximately $1,204,279 during the nine months ended September 30, 2020 compared with the nine months ended September 30, 2019 primarily due to the additions of the Company’s new Chief Scientific Officer and Chief Medical Officer. Included in the $1,204,279 increase is share-based compensation of approximately $1,087,000 to the Company’s new Chief Scientific Officer pursuant to his employment agreement and other research consultants.

General and Administrative

General and administrative costs for the nine months September 30, 2020 increased $2,070,773 or 107%, to $4,024,317, compared with $1,944,111 for the nine months ended September 30, 2019. General and administrative costs include employee-related expenses, which include salaries and benefits, and non-cash share-based compensation, professional fees for legal, accounting and consulting and other general operating expenses. Employee-related expenses increased approximately $2,439,000, including share-based compensation in the amount of approximately $2,084,000, during the nine months ended September 30, 2020 compared with the nine months ended September 30, 2019. The increase is primarily attributable to the addition of our new Chief Executive Officer in November 2019 and stock option grants to employees and consultants. Professional fees decreased approximately $518,000 during the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019 due to a large decrease in legal fees in the prior period. Other general operating expenses increased approximately $188,000 during the nine months ended September 30, 2020 compared with the nine months ended September 30, 2020 due primarily to increased insurance costs and the charitable gift agreement with the University of Pittsburgh entered into in June 2019.

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Other Income

Other income relates to interest earned on bank account deposits. Other income decreased approximately $154,000 to approximately $111,000 for the nine months ended September 30, 2020 compared with the nine months ended September 30, 2019 due to a lower average cash balance during the nine months ended September 30, 2020 compared with September 30, 2019 and lower rates being earned on deposits.

Liquidity and Capital Resources

We do not have any commercialized products, have not generated any revenue since acquiring the technology underlying the CellMist™ System and have sustained recurring losses and negative cash flows from operations since inception. We have incurred operating losses of $7,115,700 and $2,448,280 for the nine months ended September 30, 2020 and 2019, respectively. For the three months ended September 30, 2020 and 2019 we have incurred operating losses of $2,842,879 and $1,200,781, respectively. We expect to incur losses as we continue development of our products and technologies and prepare to commence the clinical trial to evaluate the safety and feasibility of autologous stem cells rendered by our CellMist™ System from donor skin and applied topically with the SkinGun™ spray device for treatment of burn wounds.

We have been funded through the sale of equity securities. As of September 30, 2020, the Company had $8,671,295 of cash and cash equivalents. We believe that we currently have sufficient cash to meet our funding requirements through the next fiscal year.

Cash used in investing activities was $49,268 for the nine months ended September 30, 2020 compared with $0 for the nine months ended September 30, 2019. The increase is due to the payment of a security deposit and office furniture for our new corporate headquarters located in Roseland, New Jersey.

Fair Value of Financial Instruments and Risks

The carrying value of cash and cash equivalents, prepaid expenses and accounts payable, approximate their fair value because of the short-term nature of these instruments and their liquidity. Management is of the opinion that we are not exposed to significant interest or credit risks arising from these financial instruments.

Off-balance Sheet Arrangements and Contractual Obligations

We do not have any off-balance sheet arrangements or contractual obligations at September 30, 2020, and the subsequent period to through the date of this report, that are likely to have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that have not been disclosed in our consolidated financial statements.

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Recently Issued Accounting Standards

See Note 1 to our Consolidated Financial Statements for more information regarding recent accounting standards and their impact to our consolidated results of operations and financial position.

Related Party Transactions

During the nine months ended September 30, 2020, Talia Jevan Properties, Inc. made a payment of $10,811 to Stephen Yan-Klassen, former CFO, for his salary on our behalf. Talia Jevan Properties, Inc. is a related party of Harmel Rayat, Chairman of the Board. The total compensation Talia Jevan Properties, Inc. made to Stephen Yan-Klassen during the three and nine months ended September 30, 2020 was $0 and $10,811, respectively. Subsequent to the period ended September 30, 2020 the $10,811 owed was paid to Talia Jevan Properties, Inc.

On August 1, 2013, we entered into a consulting agreement, as amended on May 1, 2016, with Jatinder Bhogal, an individual owning in excess of 5% of our issued and outstanding shares of common stock, to provide consulting services to the Company through his wholly owned company, Vector Asset Management, Inc. (“VAM”). Pursuant to the consulting agreement VAM assisted us with the identification of subject matter experts in the medical device and biotechnology industries and assisted the Company with its ongoing research, development and eventual commercialization of our Regeneration Technology. Pursuant to an amendment dated May 1, 2016, the VAM monthly consulting fee was increased from $5,000 to $6,800. On June 22, 2018, we entered into an Executive Consulting Agreement (“ECA”) pursuant to which Mr. Bhogal served as the Company’s Chief Operating Officer. The ECA supersedes the prior consulting agreement. Pursuant to the ECA, VAM will receive compensation of $120,000 per year. On July 1, 2020 we amended the agreement and will pay VAM $4,000 monthly through December 31, 2020 and $2,000 per month thereafter until May 31, 2021 at which time the agreement will expire. During the three months ended September 30, 2020 and 2019, we recognized expenses of $12,000 and $30,000 and during the nine months ended September 30, 2020 and 2019 we recognized $72,000 and $90,000 respectively, in expenses for consulting services provided by VAM. Jatinder Bhogal resigned as the Company’s COO effective June 30, 2020.

Kalen Capital Corp (“KCC”) is wholly owned by Mr. Harmel Rayat, the Chairman of the Board. On April 1, 2020 KCC provided us short-term advance of $50,000 to the Company. The short-term advance was repaid to KCC in July 2020. We also paid KCC $65,156 for reimbursable expenses in October 2020.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined as a process designed by, or under the supervision of, our principal executive and principal financial officers, or persons performing similar functions, and effected by our Board of Directors, management and other personnel, 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.

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The Company maintains “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) and 15d-15(e) of the Exchange Act, that are designed to provide reasonable assurance that information required to be disclosed in the Company’s Exchange Act reports 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 Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Our management conducted an evaluation of the effectiveness of the Company’s internal control over financial reporting based on the framework in “Internal Control — Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this evaluation, management concluded that our internal control over financial reporting was not effective at September 30, 2020 because of the material weaknesses described below.

There is inadequate segregation of duties consistent with control objectives. Our Company’s management is comprised of a very small number of individuals resulting in a situation where limitations of segregation of duties exist. In order to remedy this situation, we would need to hire additional staff to provide greater segregation of duties. In addition, management has concluded that there are ineffective monitoring controls related to the financial close and reporting process, including management’s risk assessment process and its identification, evaluation, and timely remediation of control deficiencies.

Changes in Internal Control over Financial Reporting

During the period ended September 30, 2020 the Company hired additional personnel including a new Chief Financial Officer to work to remediate material weaknesses of our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act), or in factors that could materially affect internal controls, during the period ended September 30, 2020.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

None.

Item 1A. Risk Factors

Smaller reporting companies are not required to provide the information required by this item.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

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Item 6. Exhibits

No.	Exhibit No.
4.1	Stock Option Agreement dated as of July 30, 2020 **
10.1	Director’s Offer Letter dated as of July 13, 2020 between the Company and Lydia Evans.**
10.2	Director’s Retention Letter dated as of October 8, 2020 between the Company and Kenneth Kirkland**
10.3	Strategic Research and Development Agreement dated as of July 1, 2020 by and between Renovacare, Inc. and StemCell Systems GmbH (incorporated by reference to Form 8-K filed on July 7, 2020).
10.4	Right of First Refusal and Corporate Opportunities Agreement dated as of July 29, 2020 by and among RenovaCare. Inc., StemCell Systems GmbH, Jörg Gerlach, and Reinhard Bornemann.**
31.1	Certification of the Principal Executive Officer pursuant to Rule 13a-14(a).*
31.2	Certification of the Principal Financial Officer pursuant to Rule 13a-14(a).*
32.1	Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
101. INS	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**

_______________

*	Filed herewith.
**	Furnished herewith. XBRL (eXtensible Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections.

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SIGNATURES

Pursuant to the requirements of Sections 13 or 15 (d) of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

RenovaCare, Inc.

(Registrant)

Date: November 13, 2020	By:	/s/ Alan L. Rubino
	Name:	Alan L. Rubino
	Title:	Chief Executive Officer
		(Principal Executive Officer)

Date: November 13, 2020	By:	/s/ Robert W. Cook
	Name:	Robert W. Cook
	Title:	Chief Financial Officer
		(Principal Financial Officer and Principal Accounting Officer)

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EX-4.1

Exhibit 4.1

Stock Option Agreement

Pursuant to RenovaCare, Inc.’s 2013 Long Term Incentive Plan

THIS STOCK OPTION AGREEMENT dated as of the 30th day of July, 2020 between RenovaCare, Inc., a Nevada Corporation having an office at 4 Becker Farm Road, Suite 105, Roseland, NJ 07068 (the “Company”), and Lydia M. Evans, MD, an individual residing in the State of New York (the “Participant”).

The Participant is a director of the Company (the “Company Relationship”) as of August 1, 2020.

In connection with the Participant’s Company Relationship, the Company desires to grant to Participant certain stock options, on the terms and conditions hereinafter set forth.

Accordingly, in consideration of the mutual promises and covenants made herein and the mutual benefits to be derived here from, the parties hereto agree as follows:

1.   Option Information.

(a)  Grant Date of Option:	July 30, 2020 (the “Grant Date”)
(b) Effective Date:	August 1, 2020
(c)  Participant:	Lydia M. Evans, MD
(d)  Number of Shares:	20,000 shares of the Company’s Stock (as defined below)
(e)  Exercise Price Per Share:	$3.19 (closing price on July 30, 2020)
(f) Term of Option:	six (6) years

2.   Acknowledgements.

(a)  Participant is a member of the Company’s Board of Directors (the “Board” which term may include an authorized committee of the Board of Directors). Participant was appointed to the Board pursuant to an Offer Letter dated July 13, 2020 (the “Offer Letter).

(b) Pursuant to the terms of the Offer Letter, the Company agreed to issue Participant a stock option to purchase, in the aggregate, up to 20,000 shares of Stock (as defined below) subject to, among other things, certain terms and conditions set forth in the Offer Letter, which terms and conditions Participant acknowledges and agrees have been included in this Agreement.

(c)  Accordingly, the Board has authorized and granted to Participant a non-statutory stock option (“Option”), pursuant to the Company’s 2013 Long Term Incentive Plan (the “Plan”), to purchase shares of common stock of the Company (“Stock”) upon the terms and conditions hereinafter stated and pursuant to exemptions from registration under the Securities Act of 1933, as amended (the “Securities Act”).

3.   Shares; Price.  The Company hereby grants to Participant the right to purchase, upon and subject to the terms and conditions herein stated, the number of shares of Stock set forth in Section 1(d) above (the “Shares”) for cash or other consideration set forth below at the price per Share set forth in Section 1(e) above (the “Per Share Exercise Price”), such price being the fair market value per share of the Shares covered by this Option as of the date hereof.

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4.   Term of Option.  The term of the Option (the “Term”) shall commence on the Effective Date, and shall expire, and all rights hereunder to purchase the Shares shall terminate, on August 1, 2026 (the “Option Expiration Date”). Nothing contained herein shall be construed to interfere in any way with the right of the Company to terminate Participant as a consultant to the Company or remove him as a member of the Board, or to increase or decrease the compensation paid to Participant from the rate in effect as of the date hereof.

5.   Vesting and Acceleration.

5.1 Vesting. Subject to remaining a director of the Company through the following dates, the Option shall become vested and exercisable as follows:

Vesting Date	Number of Shares Vesting and as to Which This Option is Exercisable
August 1, 2020	10,000
August 1, 2021	10,000

Except as otherwise specifically provided herein, upon the termination of the Company Relationship that portion of the Option that is not vested as of such date, subject to and in accordance with the provisions of this Section 5, shall cease vesting and terminate immediately.

5.2 Acceleration upon Change in Control. Anything in this Agreement to the contrary notwithstanding, in the event that, following a Change of Control (as defined below), the Company Relationship is terminated prior to the 1^st anniversary of Grant Date, then all unvested stock option hereunder, regardless of date or condition of vesting, shall vest as of the date of such termination. If, upon the Change of Control, (i) the Company shall cease to be a stand-alone publicly traded entity, or (ii) the acquiring entity is unwilling to assume the equity in an economically equivalent manner, then in either event, all equity shall be deemed to have vested two (2) days prior to the Change of Control, but only if such Change of Control shall actually be consummated.

For the purposes this Agreement, “Change of Control” shall mean:

(i) the acquisition by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), other than any individual, entity or group which, as of the date of this Agreement, beneficially owns more than ten percent (10%) of the then outstanding shares of common stock of the Company (the “Stock ”), of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of fifty percent (50%) or more of the then outstanding Stock ; provided, however, that any acquisition by the Company or its subsidiaries, or any employee benefit plan (or related trust) of the Company or its subsidiaries of fifty percent (50%) or more of outstanding Stock shall not constitute a Change of Control, and provided, further, that any acquisition by an entity with respect to which, following such acquisition, more than fifty percent (50%) of the then outstanding equity interests of such entity, is then beneficially owned, directly or indirectly, by all or substantially all of the individuals and entities who were the beneficial owners of the outstanding Stock immediately prior to such acquisition of the outstanding Stock , shall not constitute a Change in Control; or

(ii) the consummation of a reorganization, merger or consolidation (any of the foregoing, a “Merger”), in each case, with respect to which all or substantially all of the individuals and entities who were the beneficial owners of the outstanding Stock immediately prior to such Merger do not, following such Merger, beneficially own, directly or indirectly, more than fifty percent (50%) of the then outstanding shares of common stock of the corporation resulting from Merger; or

(iii) the sale or other disposition of all or substantially all of the assets of the Company, excluding (1) a sale or other disposition of assets to a subsidiary of the Company; and (2) a sale or other disposition of assets to any individual, entity or group which, as of the date of this Agreement, beneficially owns more than ten percent (10%) of the then outstanding Stock .

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6.        Exercise of the Option; Payment.

6.1 Exercise. The portion of the Option as to which the Participant is vested shall be exercisable by delivery to the Company of a written or electronic notice, substantially in the form of Exhibit A hereto(the “Exercise Notice”), stating the number of whole shares to be purchased pursuant to this Agreement and accompanied by payment of the full purchase price for all of the Shares to be purchased (the “Aggregate Purchase Price”). Fractional share interests, if any, shall be disregarded.

6.2 Payment of Purchase Price.

6.2.1 The Aggregate Purchase Price of the Shares being purchased shall be paid:

(i) in cash or by certified check or bank draft payable to the order of the Company; or

(ii) to the extent permitted by applicable law, through a broker-assisted cashless exercise by delivering, along with a properly executed exercise notice to the Company, a copy of irrevocable instructions to a broker to deliver promptly to the Company the aggregate exercise price and, if requested by the Participant, the amount of any applicable federal, state, local or foreign withholding taxes required to be withheld by the Company, provided, however, that such exercise may be implemented solely under a program or arrangement established and approved by the Company with a brokerage firm selected by the Company;

(iii) at any time prior to the Company’s listing of any of its securities for trading on a “national stock exchange,” pursuant to “a net issue” or “cashless” exercise pursuant to Section 6.2.2 below; or,

(iv) by any other method approved by the Board or its Compensation Committee, if any, or

(v) by a combination of the foregoing.

6.2.2 Subject to the provisions of Section 6.2.1 above, in lieu of exercising the Option pursuant to Section 6.2.1 (i) and (ii) above the Participant may elect to receive Option Shares equal to the value of the Option (or portion thereof being exercised) by delivery of the Exercise Notice together with this Agreement to the Company, in which event the Company shall issue to the Participant a number of Option Shares computed using the following formula:

Y (A-B)

X = ———————

A

Where:

X =        the number of the Option Shares to be issued to the Participant;

Y = the number of the vested Option Shares purchasable under this Option or if only a portion of this Option is being exercise, the portion being exercised;

A = the fair market value of one share of the Company’s common stock on the date prior to the date of exercise; and

B =        the per share Exercise Price (as adjusted to the date of such calculation). 

For purposes of this Section 6.2.2, the “per share fair market value” of the Option Shares shall mean:

(i) If the Company’s Stock is publicly traded, the per share fair market value of the Warrant Shares shall be the closing price of the Stock as quoted on the OTC Market Group’s Pink Sheets, or on such other exchange or trading platform on which the Company’s Stock may then be listed or quoted for trading, on the trading day immediately preceding the date of exercise;

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(ii) If the Company’s Stock is not so publicly traded, the per share fair market value of the Option Shares shall be such fair market value as is determined in good faith by the Board of Directors of the Company after taking into consideration factors it deems appropriate, including, without limitation, recent sale and offer prices of the capital stock of the Company in private transactions negotiated at arm’s length.

7. Termination of the Company Relationship.

7.1 Termination Due to Death or Disability. If prior to the Option Expiration Date the Company Relationship is terminated as a result of Participant’s death or Disability (as defined below) this Option, to the extent vested, shall be exercisable, within the period of one year following the date of death or Disability of Participant, by Participant (or in the case of death by an authorized transferee); provided, however,  this Option shall be exercisable only to the extent that this Option was exercisable by Participant on the date of his death or Disability, and further provided that this Option shall not be exercisable after the Option Expiration Date. There shall be no further vesting of the Option following the date of Participant’s death or Disability. For purposes of this Agreement, “Permanent Disability” shall mean the inability of the Employee to perform the essential functions of one or more of his primary duties as a result of his incapacity, despite any reasonable accommodation required by law, due to bodily injury or disease or any other mental or physical illness, which inability continues for a period of sixty (60) Business Days, which need not be consecutive, within any three hundred sixty five (365) day period. A “Business Day” shall mean any day other than weekends and US federal holidays.

7.2 Termination for Cause. If the Company Relationship is terminated by the Company for Cause (as defined below), the right to exercise this Option to the extent vested, shall terminate immediately upon the effective date of such termination by the Company; and, there shall be no further vesting of the Option following the effective date of the termination of the Company Relationship.

7.3 Termination for Good Reason. If the Company Relationship is terminated by Participant for Good Reason (as defined below), the unvested portion of the Option shall vest and, to the extent vested, shall be exercisable, within the period of one year following the effective date of the termination of the Company Relationship by Participant; provided, however,  in no event shall this option be exercisable after the Option Expiration Date. For purposes of this Agreement, Good Reason shall mean the material breach of the Offer Letter by the Company which breach is not cured by the Company within 30 Business Days following its receipt of written notice from Participant of such breach.

7.4 Termination Without Good Reason or for No Reason. If, the Company Relationship is terminated by Participant without Good Reason or for no reason, to the extent vested, the Option shall be exercisable, within the period of one year following the effective date of the termination of the Company Relationship by Participant; The Option shall not be exercisable after the Option Expiration Date; and, there shall be no further vesting of the Option following the effective date of the termination of the Company Relationship.

7.5 Cause. For purposes of this Agreement, “Cause” shall mean:

“Cause” shall mean:

(i) Participant’s breach of her fiduciary duties to the Company under applicable law;

(ii) the commission of any act of fraud, misappropriation, embezzlement or similar dishonest or wrongful act by Participant including, without limitation, any violation of the Sarbanes-Oxley Act, the United States securities laws or similar laws or legal standards applicable to Participant’s performance of her duties to the Company;

(iii) Participant’s abuse of alcohol, prescription drugs or any substance which materially interferes with Consultant’s ability to fulfill her responsibilities on behalf of the Company;

(iv) Participant’s violation of any laws, agreements or Company policies or codes prohibiting engagement discrimination, harassment, conflicts of interest, retaliation;

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(v) Participant’s material breach of this Agreement; or

(vi) Participant’s commission of, conviction for, or plea of guilty or nolo contendere to, a felony.

8.        Non-transferability of the Option. The Option is non-transferable by the Participant other than by will or the laws of descent and distribution or pursuant to a qualified domestic relations order, and the Option may be exercised, during the lifetime of the Participant, only by the Participant or by the Participant’s guardian or legal representative or any transferee described above.

9.        Tax Matters.

9.1 The Option is intended to be a Non-statutory Option and shall not be treated as an incentive stock option within the meaning of Section 422(b) of the Code. 

9.2 At the time the Option is exercised, in whole or in part, or at any time thereafter as requested by the Company, the Participant hereby authorizes withholding from payroll and any other amounts payable to the Participant, and otherwise agrees to make adequate provision for (including by means of a Cashless Exercise to the extent permitted by the Company), any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company, if any, which arise in connection with the Option, including, without limitation, obligations arising upon (i) the exercise, in whole or in part, of the Option, (ii) the transfer, in whole or in part, of any shares acquired upon exercise of the Option, (iii) the operation of any law or regulation providing for the imputation of interest, or (iv) the lapsing of any restriction with respect to any shares acquired upon exercise of the Option. The Participant is cautioned that the Option is not exercisable unless the tax withholding obligations of the Company are satisfied. Accordingly, the Participant may not be able to exercise the Option when desired even though the Option is vested, and the Company shall have no obligation to issue a certificate for such shares or release such shares from any escrow provided for herein.

9.3 The Participant should consult with a tax advisor before exercising the Option or disposing of the Shares to obtain advice as to the consequences of such exercise or disposition. 

10.        Rights as a Stockholder. A Participant or a transferee of the Option shall have no rights as a stockholder with respect to any Shares covered by such Option until the date when his or her purchase is entered upon the records of the duly authorized transfer agent of the Company. No adjustment shall be made for dividends (ordinary or extraordinary, whether in cash, securities or other property) or distribution of other rights for which the record date is prior to the date a stock certificate is issued, except as provided in the Plan.

11.       Adjustment in the Event of Change in Stock. In accordance with Article 12 of the Plan, in the event of any change in Corporate capitalization (including, but not limited to, a change in the number of shares of Stock outstanding), and the number and kind of shares subject to the Option and/or the exercise price per share will be adjusted. The determination of the Board or a duly appointed Compensation Committee thereof regarding any adjustment will be final and conclusive.

12.        No Guarantee of Continued Service. Nothing in the Plan or this Agreement shall confer on Participant any right to continue as a director of, or other relationship with, the Company or any Parent or Subsidiary of the Company, or limit in any way the right of the Company or any Parent or Subsidiary of the Company to terminate Participant’s employment or other relationship at any time, with or without Cause.

13.        Other Restrictions.

13.1       Board Discretionary Action. The exercise of the Option shall be subject to the requirement that, if at any time the Board or its Compensation Committee, if any, shall determine that (i) the listing, registration or qualification of the shares of Stock subject or related thereto upon any securities exchange or under any state or federal law, or (ii) the consent or approval of any government regulatory body or (iii) an agreement by the Participant with respect to the disposition of shares of Stock is necessary or desirable as a condition of, or in connection with, such exercise or the delivery or purchase of shares pursuant thereto, then in any such event, such exercise shall not be effective unless such listing, registration, qualification, consent, or approval or agreement shall have been effected or obtained free of any conditions not acceptable to the Board or its Compensation Committee, if any.

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13.2       Restrictions on Grant of the Option and Issuance of Shares. The grant of the Option and the issuance of shares of Stock upon exercise of the Option shall be subject to compliance with all applicable requirements of federal, state or foreign law with respect to such securities. The Option may not be exercised if the issuance of shares of Stock upon exercise would constitute a violation of any applicable federal, state or foreign securities laws or other law or regulations or the requirements of any stock exchange or market system upon which the Stock may then be listed. THE OPTIONEE IS CAUTIONED THAT THE STOCK OPTION MAY NOT BE EXERCISED UNLESS THE FOREGOING CONDITIONS ARE SATISFIED. ACCORDINGLY, THE OPTIONEE MAY NOT BE ABLE TO EXERCISE THE OPTION WHEN DESIRED EVEN THOUGH THE STOCK OPTION IS VESTED. Questions concerning this restriction should be directed to the Company’s General Corporate Counsel or the Chief Financial Officer of the Company. The inability of the Company to obtain from any regulatory body having jurisdiction the authority, if any, deemed by the Company’s legal counsel to be necessary to the lawful issuance and sale of any shares subject to the Option shall relieve the Company of any liability in respect of the failure to issue or sell such shares as to which such requisite authority shall not have been obtained. As a condition to the exercise of the Option, the Company may require the Participant to satisfy any qualifications that may be necessary or appropriate, to evidence compliance with any applicable law or regulation and to make any representation or warranty with respect thereto as may be requested by the Company.

13.3       Legends. The Company may at any time place legends referencing any applicable federal, state or foreign securities law restrictions on all certificates representing shares of stock subject to the provisions of this Agreement. The Participant shall, at the request of the Company, promptly present to the Company any and all certificates representing shares acquired pursuant to the Option in the possession of the Participant in order to carry out the provisions of this Section. The Company may, but will in no event be obligated to, register any securities issuable upon the exercise of all or any portion of the Option pursuant to the Securities Act of 1933 (as now in effect or as hereafter amended) or to take any other affirmative action in order to cause the exercise of the Option or the issuance of shares pursuant thereto to comply with any law or regulation of any governmental authority. The certificates representing shares issued to Participant hereunder shall bear such legends as Company determines appropriate referring to restrictions on the transfer of such shares imposed by this Agreement and such other legends as are required or appropriate under applicable law.

13.4 Trading Restrictions. The Company may establish periods from time to time during which the Participant’s ability to engage in transactions involving the Company’s stock is subject to specific restrictions (“Restricted Periods”). Notwithstanding any other provisions herein, the Participant may not exercise Option s during an applicable Restricted Period unless such exercise is specifically permitted by the Company (in its sole discretion). The Participant may be subject to a Restricted Period for any reason that the Company determines appropriate, including, Restricted Periods generally applicable to employees or groups of employees or Restricted Periods applicable to the Participant during an investigation of allegations of misconduct or conduct detrimental to the Company by the Participant.

14.        Notices.

14.1       Any notice or other communication required or permitted pursuant to this Agreement shall be in writing and addressed as follows:

If to the Company:

RenovaCare, Inc.

4 Becker Farm Road

Suite 105

Roseland, NJ 07068

Attention: Alan L. Rubino, President and Chief Executive Officer

Email Address: arubino@renovacareinc.com

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If to the Participant, to the address set forth on the signature page to this Agreement;

or, to such other address or facsimile number as any Party shall have furnished to the other in writing in accordance with this Section 14.

14.2       Notices sent in accordance with this Section shall be deemed effectively given: (a) when received, if delivered by hand (with written confirmation of receipt); (b) when received, if sent by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile or e-mail (in each case, with confirmation of transmission), if sent during normal business hours of the recipient, and on the next Business Day if sent after normal business hours of the recipient; or (d) on the third (3rd) Business Day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid.

15.        Effect of Agreement. Except as otherwise provided hereunder, this Agreement shall be binding upon and shall inure to the benefit of any successor or successors of the Company, and to any transferee or successor of the Participant pursuant to Section 8.

16.        Severability. The invalidity or enforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement. If the final judgment of a court of competent jurisdiction declares that any provision of this Agreement is invalid or unenforceable, the parties hereto agree that the court making the determination of invalidity or unenforceability shall have the power, and is hereby directed, to reduce the scope, duration or area of the provision, to delete specific words or phrases and to replace any invalid or unenforceable provision with a provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable provision and this Agreement shall be enforceable as so modified.

17.        Conflicts and Interpretation. This Agreement is subject to all the terms, conditions and provisions of the Plan. In the event of any conflict between this Agreement and the Plan, the Plan shall control. In the event of any ambiguity in this Agreement, any term which is not defined in this Agreement, or any matters as to which this Agreement is silent, the Plan shall govern including, without limitation, the provisions thereof pursuant to which the Board or its Compensation Committee, if any has the power, among others, to (i) interpret the Plan, (ii) prescribe, amend and rescind rules and regulations relating to the Plan and (iii) make all other determinations deemed necessary or advisable for the administration of the Plan.

18.        Amendment. This Agreement may not be modified, amended or waived except by an instrument in writing signed by both parties hereto. The waiver by either party of compliance with any provision of this Agreement shall not operate or be construed as a waiver of any other provision of this Agreement, or of any subsequent breach by such party of a provision of this Agreement.

19.        Counterparts. This Agreement may be executed in any number of counterparts, each of which when so executed and delivered shall be deemed an original, and all of which together shall constitute one and the same agreement. Execution of a facsimile or scanned copy will have the same force and effect as execution of an original, and a facsimile or scanned signature will be deemed an original and valid signature.

20.       Data Privacy Consent. As a condition of the grant of the Shares, Participant consents to the collection, use and transfer of personal data as described in this Section 20. Participant understands that the Company and its Subsidiaries hold certain personal information about Participant including Participant’s name, home address and telephone number, date of birth, social security number, salary, nationality, job title, ownership interests or directorships held in the Company or its Subsidiaries, and details of all stock options or other equity awards or other entitlements to shares of common stock awarded, cancelled, exercised, vested or unvested (“Data”). Participant further understand that the Company and its Subsidiaries will transfer Data amongst themselves as necessary for the purposes of implementation, administration and management of Participant’s participation in the Plan, and that the Company and any of its Subsidiaries may each further transfer Data to any third parties assisting the Company in the implementation, administration and management of the Plan. Participant understands that these recipients may be located in the United States or elsewhere. You authorize them to receive, possess, use, retain and transfer such Data as may be required for the administration of the Plan or the subsequent holding of shares of common stock on Participant’s behalf, in electronic or other form, for the purposes of implementing, administering and managing Participant’s participation in the Plan, including any requisite transfer to a broker or other third party with whom Participant may elect to deposit any shares of common stock acquired under the Plan. Participant understands that Participant may, at any time, view such Data or require any necessary amendments to it.

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21.        Other Agreements. Nothing in this Agreement alters, amends, supersedes, or modifies any other agreements, or contractual provisions of other agreements, between the Participant and the Company (including but not limited to consulting agreements, nondisclosure agreements or restrictive covenants), all such other agreements being wholly separate and apart from this Agreement.

22.  Interpretation. For purposes of this Agreement, (a) the words “include,” “includes,” and “including” shall be deemed to be followed by the words “without limitation”; (b) the word “or” is not exclusive; and (c) the words “herein,” “hereof,” “hereby,” “hereto,” and “hereunder” refer to this Agreement as a whole. Unless the context otherwise requires, references herein: (x) to Sections, Exhibits and Schedules refer to the Sections of, and Exhibits and Schedules attached to, this Agreement; (y) to an agreement, instrument, or other document means such agreement, instrument, or other document as amended, supplemented, and modified from time to time to the extent permitted by the provisions thereof; and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. Any Exhibits or Schedules referred to herein shall be construed with, and as an integral part of, this Agreement to the same extent as if they were set forth verbatim herein. The headings of Sections herein are included solely for convenience of reference and shall not affect the meaning or interpretation of any of the provisions of this Agreement.

23.        Laws Applicable to Construction. The interpretation, performance and enforcement of this Agreement shall be governed by the laws of the State of Nevada without reference to principles of conflict of laws, as applied to contracts executed in and performed wholly within the State of Nevada.

[SIGNATURE PAGE FOLLOWS]

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IN WITNESS WHEREOF, the Company and the Participant have executed and delivered this Agreement effective as of the date first above written.

RENOVACARE, INC.

BY: /s/Alan L. Rubino

Name: Alan L. Rubino

Title: President and Chief Executive Officer

Participant

BY: /s/Lydia M. Evans, MD

Name: Lydia M. Evans, MD

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Exhibit A

To the Option Agreement Dated as of ▲

Between

RenovaCare, Inc. and Lydia Evans

Form of Notice of Exercise of Option

__________

 RenovaCare, Inc.

4 Becker Farm Road

Suite 105

Roseland, NJ 07068

Attention: Alan L. Rubino, President and Chief Executive Officer

Re: Notice of Exercise of Stock Option

This letter constitutes an unconditional and irrevocable notice that I hereby exercise [all] [a portion] of the Option (s) granted to me by RenovaCare, Inc., a Nevada corporation (the “Company”) on _____________ (“date of grant” at a fair market value of US$ _______ per Share (equal to the closing price of the Shares of Stock of the Company on the date of grant). Pursuant to the terms of such Option (s), I wish to purchase _______________ Shares of the Stock covered by such Option (s) at the Exercise Price(s) of US$ ______ per Share or $________________in the aggregate. Payment being made as follows pursuant to (check as appropriate):

{ }Section 3(b)(i);

{ }Section 3(b)(ii);

{ }Section 3(b)(iii) and (c); or

{ }Section 3(b)(iv)

of the Stock Option Agreement dated as of __________________ between me and the Company and calculated as follows (and subject to the Company’s confirmation):

These Shares should be delivered as follows:

Name:

Address:

Social Security Number:

I represent that I will not dispose of such Shares in any manner that would involve a violation of applicable securities laws.

Dated:	By:
	Name:
	Email:
	Phone:

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EX-10.1

Exhibit 10.1

July 13, 2020

By Email

Dr. Lydia Evans

RE: Offer to Join the Board of Directors

Dear Lydia:

On behalf of RenovaCare, Inc. (the "Company"), in recognition of our belief that your skills, expertise and knowledge will prove helpful to the Company's progress, I am pleased to extend to you an offer to join the Company's Board of Directors (the "Board''), and if asked to serve or chair any committee established by the Board, commencing on August I, 2020 (the "Commencement Date"), and to serve in such capacity until the next annual meeting of stockholders (or, stockholder consent in lieu of such annual meeting), or your earlier resignation or removal.

As compensation for your service on the Board, you will receive an annual retainer of $ 20,000, (the "Retainer") payable in four equal quarterly payments, in arrears, on the last business day of each calendar quarter (each a "Payment Date") of $5,000, plus reimbursement of certain out-of-pocket costs incurred in connection with your activities as a Board member. The Retainer shall be prorated for any portion of your tenure as a member of the Board which is less than a calendar quarter.

In addition, upon acceptance of your appointment to the Board, you will be granted on the Commencement Date stock options (collectively, the "Stock Option") to purchase up 20,000 shares of the Company's common stock at an exercise price equal to the closing price of the Company's common stock on its Principal Market (as defined below) on the Commencement Date. The options shall vest and exercisable as to 10,000 shares on the Commencement Date and as to the remaining 10,000 shares on the first anniversary of the Commencement Date. You may be eligible for future equity awards in the discretion of the Board.

The Company will reimburse you for any reasonable expenses incurred by you in connection with your travel on behalf of the Company, provided that you furnish the Company with invoices, with receipts and other appropriate supporting documentation evidencing such expenses within 30 days of incurrence, and otherwise comply with the Company's travel and expense reimbursement policies as may be in effect from time to time. Any expenditures of more than $250, individually, or collectively in any calendar quarter, shall require the Company's prior written approval.

In addition, the Company will provide you coverage under its D&O insurance policy as in effect from time to time.

In accepting this offer, you are representing to the Company (i) that you will devote adequate time and effort to perform your duties in a manner consistent with prevailing professional standards, (ii) that you do not know of any conflict which would restrict your ability to consult with the Company or serve on the Board, and (iii) that you will not provide the Company with any documents, records, or other confidential information belonging to other parties. You further represent that during the term of your service on the Board, you will not engage in any activity that competes with or creates an actual conflict of interest with the Company, and that you will notify the Board before engaging in any activity that creates a potential conflict of interest with the Company.

As a condition of your service on the Board and in accordance with your fiduciary duty to the Company, you agree to hold in strict confidence and trust, and not to use or disclose, any confidential information you receive or learn in connection with your service on the Board. In the event your service on the Board is terminated for any reason, you agree to return to the Company any materials received by you in the course of your service relating to the Company or the Board or to retain the confidentiality of the confidential information you may have received until such time as such information is no longer confidential.

Your service on the Board is entirely "at wilf' for both you and the Company. As a result, you are free to terminate your role as a Board member at any time, for any reason. Similarly, you may be removed by the Company as a Board member at any time, with or without cause, subject only to compliance with applicable law and the Company's governing documents. Nothing in this letter creates any offer of employment or employment relationship between you and the Company.

If the foregoing terms are agreeable, please indicate your acceptance by signing this letter in the space provided below and returning this letter to the Company. We look forward to your serving as a member of the Board.

Sincerely,

RenovaCare, Inc.

Name: Alan L. Rubino

Title: President and Chief Executive Officer, and Member of the Board

The foregoing terms are agreed to and accepted on this 13th day of July 2020:

By: /s/ Lydia Evans

Name: Lydia Evans

EX-10.2

Exhibit 10.2 

October 8, 2020

By Email

Kenneth Kirkland

RE:          Retention Compensation

Dear Ken:

On behalf of RenovaCare, Inc. (the “Company”), in recognition of our belief that your skills, expertise and knowledge will prove helpful to the Company’s progress, I am pleased to provide the terms and conditions regarding your ongoing compensation for your services as a member of the Company’s Board of Directors. In consideration therefor, you agree to serve in such capacity until the next annual meeting of stockholders (or, stockholder consent in lieu of such annual meeting), or your earlier resignation or removal.

As compensation for your service on the Board, effective for the calendar quarter ended September 30, 200 you will receive an annual retainer of $ 20,000, (the “Retainer”) payable in four equal quarterly payments, in arrears, on the last business day of each calendar quarter (each a “Payment Date”) of $5,000, plus reimbursement of certain out-of-pocket costs incurred in connection with your activities as a Board member. The Retainer shall be prorated for any portion of your tenure as a member of the Board which is less than a calendar quarter.  

In addition, you may be eligible for future equity awards in the discretion of the Board.

The Company will reimburse you for any reasonable expenses incurred by you in connection with your travel on behalf of the Company, provided that you furnish the Company with invoices, with receipts and other appropriate supporting documentation evidencing such expenses within 30 days of incurrence, and otherwise comply with the Company’s travel and expense reimbursement policies as may be in effect from time to time. Any expenditures of more than $250, individually, or collectively in any calendar quarter, shall require the Company’s prior written approval.

In addition, the Company will provide you coverage under its D&O insurance policy as in effect from time to time.

In accepting this offer, you are representing to the Company (i) that you will devote adequate time and effort to perform your duties in a manner consistent with prevailing professional standards, (ii) that you do not know of any conflict which would restrict your ability to consult with the Company or serve on the Board, and (iii) that you will not provide the Company with any documents, records, or other confidential information belonging to other parties.  You further represent that during the term of your service on the Board, you will not engage in any activity that competes with or creates an actual conflict of interest with the Company, and that you will notify the Board before engaging in any activity that creates a potential conflict of interest with the Company. 

As a condition of your service on the Board and in accordance with your fiduciary duty to the Company, you agree to hold in strict confidence and trust, and not to use or disclose, any confidential information you receive or learn in connection with your service on the Board.  In the event your service on the Board is terminated for any reason, you agree to return to the Company any materials received by you in the course of your service relating to the Company or the Board or to retain the confidentiality of the confidential information you may have received until such time as such information is no longer confidential.

Your service on the Board is entirely “at will” for both you and the Company.  As a result, you are free to terminate your role as a Board member at any time, for any reason.  Similarly, you may be removed by the Company as a Board member at any time, with or without cause, subject only to compliance with applicable law and the Company’s governing documents.  Nothing in this letter creates any offer of employment or employment relationship between you and the Company.

If the foregoing terms are agreeable, please indicate your acceptance by signing this letter in the space provided below and returning this letter to the Company.  We look forward to your continuing service as a member of the Board.

Sincerely,

RenovaCare, Inc.

By: /s/ Alan L. Rubino

Name: Alan L. Rubino

Title: President and Chief Executive Officer, and Member of the Board

The foregoing terms are agreed to and accepted on this 14th day of October, 2020:

By:	/s/ Kenneth Kirkland
Name:	Kenneth Kirkland

EX-10.4

Exhibit 10.4

This Right of First Refusal and Corporate Opportunities Agreement (this “Agreement”) is made as of July 29, 2020 (the “Effective Date”) by and among RenovaCare. Inc. (“RCAR” or the “Company”)), StemCell Systems GmbH (“SCS), an entity formed and existing under the laws of Germany, Jörg Gerlach, an individual (“Gerlach”) and Reinhard Bornemann, an individual (“Bornemann”). Gerlach and Bornemann are collectively herein sometimes referred to as the “SCS Stockholders;” the SCS Stockholders and SCS are collectively referred to as the “SCS Group”); and RCAR, SCS, and the SCS Stockholders are sometimes individually referred to in this Agreement as a “Party” and collectively, as the “Parties.”

RECITALS:

Whereas, RCAR is a developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues (the “Company’s Technologies”);

Whereas, SCS is experienced in, among other things, applied human cell, stem cell, and progenitor cell sciences and associated bioengineering for regenerative medicine therapies;

Whereas, the Parties have had a strategic collaboration relationship since 2013;

Whereas, RCAR and SCS have entered into the Strategic R&D Agreement dated July 1, 2020 (the “Strategic R&D Agreement”) the for the purpose of further enhancing the collaborative research relations that exists between RCAR’s and the SCS Group;

Whereas, the SCS Stockholders own all of the issued and outstanding ownership interests of SCS (the “SCS Ownership Interests”) as more fully set forth on Exhibit A attached to this Agreement;

Whereas, in light of the Parties long established and ongoing collaboration regarding RCAR’s Technologies and in order to ensure that (i) such continue collaboration as contemplated by the Strategic R&D Agreement, is not disrupted or mitigated, and (ii) that the Service Goals are achieved, the Parties believe it to be in their respective best interests to enter into this Agreement pursuant to which the SCS Group grants a right of first refusal and first offer to RCAR with respect to certain the SCS Group Inventions and related SCS Intellectual Property Rights (as those terms are defined below), all on the terms and conditions set forth in this Agreement.

Now, Therefore, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1.        Definitions.

For purposes of this Agreement the following terms shall have the meanings ascribed thereto below:

“Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by or under common control with such Person; for the purpose of this definition, the term “control” (including, with correlative meanings, the terms “controlling”, “controlled by” and “under common control with”), as used with respect to any Person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by contract or otherwise.

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“Business Day” means any day except a Saturday, Sunday or other day on which commercial banks in New York City are authorized by law to close.

“Intellectual Property Rights” means all rights in and to U.S. and foreign (i) patents, patent disclosures, inventions (ii) trademarks, trademark applications and registrations, service marks, trade dress, trade names, logos, corporate names and domain names, and other similar designations of source or origin, together with the goodwill symbolized by any of the foregoing, (iii) copyrights and copyrightable works (including computer programs), and rights in data and databases, (iv) other confidential information, and (v) all other intellectual property rights, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights, and all similar or equivalent rights or forms of protection in any part of the world.

“Permitted Transferee” means;

(i) with respect to any SCS Stockholder who is an individual, any spouse, lineal descendant, sibling, parent, heir, executor, administrator, testamentary trustee, legatee or beneficiary of such SCS Stockholder or a trust, the beneficiaries of which, or a corporation or partnership, the shareholders or partners of which, include only such Stockholder and any spouse, lineal descendant, sibling, parent or heir of such SCS Stockholder;

(ii) with respect to any Stockholder that is an entity, any general or limited partner, member, shareholder or Affiliate of such SCS Stockholder, or to a trust the beneficiaries of which include only such general or limited partner, member, shareholder or Affiliate; and

(iii) with respect to any SCS Stockholder that is a trust whose beneficiaries consist of one or more of the spouse, lineal descendant, sibling, parent, heir, executor, administrator, testamentary trustee, legatee or testamentary beneficiary of the settlor of such trust, any beneficiary of that trust or any other trust for the benefit of one or more of such beneficiaries.

“Person” means an individual, corporation, limited liability company, partnership, association, trust or other entity or organization, including a government or political subdivision or an agency or instrumentality thereof.

“SCS Inventions” means, with respect to skin, burns and wounds, any discoveries, developments, concepts, designs, ideas, know how, modifications, improvements, derivative works, inventions, trade secrets and/or original works of authorship, whether or not patentable, copyrightable or otherwise legally protectable made, developed or created by any member of the SCS Group solely or jointly with SCS employees, consultants or affiliates otherwise than in connection with, or as a result of, the services performed for RCAR, or based upon Confidential Information, or otherwise in connection with the Consulting Relationship as defined in the Strategic R&D Agreement.

“SCS Intellectual Property Rights” means all Intellectual Property Rights related to SCS Inventions.

2.       Right of First Refusal with Respect to the Sale of SCS Ownership Interests.

2.1       Transfer of SCS Ownership Interests.

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2.1       No Transfer Without Compliance. During the Term, no SCS Stockholder shall sell, assign, transfer, pledge, hypothecate or otherwise dispose of, by operation of law or otherwise (collectively, “Transfer”) any of the SCS Ownership Interests, or any interest therein during the term of this Agreement without complying with the terms of this Section 2 other than pursuant to a Permitted Transferee (as defined in Section 1). During the term of this Agreement SCS shall not offer or sell any shares of stock or other securities representing ownership interests in SCS without the prior written consent of RCAR and the purchaser of such securities agreeing in writing be bound by the terms and conditions of this Agreement.

2.2       Offeror and Offer Notice. In the event that a SCS Stockholder (“Selling SCS Stockholder”) receives a bona fide written offer (a “Third-Party Offer”) from a third party (a “Third-Party Offeror”) to acquire the Selling SCS Stockholder’s SCS Ownership Interests which Third-Party Offer the Selling SCS Stockholder desires to accept, the Selling SCS Stockholder, upon receipt of the Third-Party Offer, shall provide RCAR with written notice thereof, specifying the number of SCS Ownership Interests to be transferred, the price per share, payment and other terms (along with a copy of the Third-Party Offer (the “Selling SCS Stockholder Notice”) to RCAR , which shall constitute an irrevocable offer (the “Selling SCS Stockholder Offer”) to sell such SCS Ownership Interests to RCAR on substantially the terms and conditions set forth in the Third-Party Offer.

2.3       Acceptance by RCAR. RCAR shall be entitled to accept the Selling SCS Stockholder Offer to purchase all of such offered SCS Ownership Interests set forth in the Selling SCS Stockholder Notice by delivering a written notice (the “RCAR Acceptance”) to the Selling SCS Stockholder within ten (10) Business Day period following delivery of the Selling SCS Stockholder Notice; provided that the total number of SCS Ownership Interests to be purchased by RCAR must equal in the aggregate the number of SCS Ownership Interests specified in the Selling SCS Stockholder Notice.

2.4       Non-Acceptance by RCAR.

2.4.1       If the offer set forth in the Selling SCS Stockholder Notice is not accepted by RCAR within such 10 Business Day period, such offer shall be deemed to be rejected and terminated, and the Selling SCS Stockholder shall be free to sell all of the SCS Ownership Interests to the Third-Party Offeror who delivered the Third-Party Offer, but only upon the same or no more favorable terms and conditions than shall have been contained in the Selling SCS Stockholder Notice; provided, however, that if the transaction contemplated by the Third-Party Offer shall not have been consummated within fifteen (15) Business Days after the termination of the aforementioned 10 Business Day period the Selling SCS Stockholder's right to Transfer such SCS Ownership Interests to the Third-Party Offeror shall terminate, and such SCS Ownership Interests shall again be subject to this Agreement to the same extent as if never originally offered to RCAR.

2.4.2       Upon any such sale to a third party, notice of such sale shall be given by the Selling SCS Stockholder to RCAR. Notwithstanding the foregoing, no Transfer to a Third-Party Offeror shall be effective unless, prior to acquiring any such SCS Ownership Interests in such a Transfer, such Offeror executes and delivers to RCAR a copy of this Agreement, and thereby agrees to be bound by each and every provision imposed hereunder upon SCS Stockholders.

2.5       Closing. The purchase price payable under the terms of the Selling SCS Stockholder Offer by RCAR to the Selling SCS Stockholder shall be due and payable on the terms and conditions specified in the Selling SCS Stockholder Notice, against delivery of certificates evidencing all of the securities so purchased, duly endorsed for transfer free and clear of any and all liens, charges and encumbrances, and with any and all required transfer tax stamps affixed. If no time for such closing is specified in the Offer Notice, then the closing of such sale shall occur on a date mutually agreeable to the Selling SCS Stockholder and RCAR.

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2.6       A Transfer to a Permitted Transferee. Subject to the foregoing, any SCS Stockholder may at any time Transfer any or all of his SCS Ownership Interests to a Permitted Transferee without the consent of any Person, so long as (a) such Permitted Transferee shall have agreed in writing to be bound by the terms of this Agreement by executing a joinder agreement in the form of Exhibit A attached hereto; (b) the Transfer is in compliance with applicable laws and any other restrictions on Transfer contained in this Agreement. Such SCS Stockholder must give written prior notice to RCAR of any proposed Transfer to a Permitted Transferee, including the identity of such proposed Permitted Transferee and such other information reasonably requested by RCAR to ensure compliance with the terms of this Agreement.

3       Right of First Offer with Respect to the SCS Ownership Interests.

3.1       First Offer Notice.

3.1.1       Each of the SCS Stockholders (the “Offering SCS Stockholder”) hereby agrees that during the Term, should he desire to sell any SCS Ownership Interest owned by him (the “ROFO SCS Ownership Interests”), he shall not enter into any discussions, negotiations or agreement with any third party for the purchase and/or sale of any ROFO SCS Ownership Interests without first offering RCAR the right to purchase such ROFO SCS Ownership Interests, by delivering to RCAR written notice thereof (the “ROFO SCS Ownership Interests Notice”), which ROFO SCS Ownership Interests Notice shall set forth the material business terms of such proposal including, without limitation, such Offering SCS Stockholder’s proposed sales price, payment method, number of ROFO SCS Ownership Interests and other principal terms. RCAR shall have the option to purchase the ROFO SCS Ownership Interests, which RCAR shall exercise by delivering irrevocable notice to the Offering SCS Stockholder, (the “ROFO Acceptance Notice”) or a counter proposal (the “ROFO Counter Proposal”), within ten (10) Business Days of the giving of the ROFO SCS Ownership Interests Notice, which ROFO Counter Proposal shall set forth RCAR’s counter proposals to the operative terms and conditions set forth in the ROFO SCS Ownership Interests Notice on which RCAR would be willing to purchase he ROFO SCS Ownership Interests.

3.1.2       If the Offering SCS Stockholder does not accept the ROFO Counter Proposal as evidenced by his written notice of non-acceptance (the “CP Non-acceptance Notice”) which CP Non-acceptance Notice shall state that the ROFO Counter Proposal is rejected and, at the option of the Offering SCS Stockholder, may also set forth the Offering SCS Stockholders final proposal if any (the “Offering SCS Stockholder Final Proposal”); if an Offering SCS Stockholder Final Proposal is set forth in the CP Non-acceptance Notice, RCAR shall then have three (3) Business Days from the date of the CP Non-acceptance Notice to agree to accept or reject the SCS Stockholder Final Proposal, by providing the Offering SCS Stockholder written notice thereof.

Failure by RCAR to provide the notice contemplated by this Section 3.1.2 as to its acceptance or rejection of the SCS Stockholder Final Proposal shall be deemed to constitute a rejection of such SCS Stockholder Final Proposal. If RCAR does not accept the SCS Stockholder’s Final Notice, then the Parties shall have such rights as are set forth in Section 3.2.

3.2       Non-Acceptance of the ROFO SCS Ownership Interests Notice or the ROFO Counter Proposal. Subject to the further provisions of Section 3.3, upon rejection of the SCS Stockholder Final Proposal or the ROFO SCS Ownership Interests Notice, as the case may be, the Offering SCS Stockholder shall thereafter be free to offer for sale (and sell) the ROFO SCS Ownership Interests.

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3.3       Re-offer. Anything in Sections 3.1 and 3.2 to the contrary notwithstanding:

3.3.1       If the Offering SCS Stockholder is subsequently willing to sell the ROFO SCS Ownership Interests on terms which are “substantially more favorable” to a third party purchaser than the terms set forth in the SCS Stockholder Final Proposal or the ROFO SCS Ownership Interests Notice, as applicable, then such Offering SCS Stockholder shall provide RCAR with a revised ROFO SCS Ownership Interests Notice (the “Revised ROFO SCS Ownership Interests Notice”) in accordance with the terms of this Section 3.3 setting forth such revised terms of offer, and RCAR shall have all of the same rights with respect to the Revised ROFO Notice, as are set forth in this Section 3, except that RCAR must deliver an Acceptance Notice within five (5) Business Days of the giving of such Revised ROFO SCS Ownership Interests Notice. Time shall be of the essence as to RCAR’s giving of any Acceptance Notice. Failure to do so shall be deemed a rejection of the Revised ROFO SCS Ownership Interests Notice and the Offering SCS Stockholder may again proceed to offer and sell the ROFO SCS Ownership Interests pursuant to Section 3.2.

3.3.2       If the Offering SCS Stockholder has not sold the ROFO SCS Ownership Interests within six (6) months of the expiration of the time frame set forth in Section 3.1 above, then the Selling SCS Stockholder's right to Transfer such SCS Ownership Interests to a third party purchaser shall terminate, and such SCS Ownership Interests shall again be subject to this Agreement to the same extent as if never originally offered to RCAR.

3.4       Closing. If accepted. a closing of the transactions contemplated by this Section 3 shall occur within ten (10) Business Days of the Acceptance Notice.

4. Disclosure of SCS Inventions. Within thirty-days of the development, creation or making of a SCS Invention the “Disclosable SCS Invention”), and prior to the disclosure thereof to any third party, the SCS Group member (the “Disclosing SCS Member”) who developed, created or made such SCS Invention shall provide RCAR with notice thereof (the “SCS Invention Disclosure Notice”), which notice shall set forth pertinent information regarding such SCS Invention so as to permit RCAR to assess the SCS Invention for possible acquisition or license in accordance with Section 5.

5.       First Option to Purchase SCS Inventions.

5.1 Option to Purchase

5.1.1       Each member of the SCS Group hereby agrees that during the Term, RCAR shall have twenty (20) Business Days from the date of the disclosure by such member of the SCS Group claiming ownership rights in and to the Disclosable SCS Invention (the “Disclosing SCS Member”) of the Disclosable SCS Invention to RCAR, to review and assess each Disclosable SCS Invention for its potential acquisition or licensing by RCAR (the “Review Period”).

5.1.2       During the Review Period, RCAR may ask the Disclosing SCS Member for such additional information as RCAR may reasonably require in order to complete its assessment of the Disclosable SCS Invention; the SCS Group shall provide such additional information in as expeditious a manner as possible or advise RCAR in writing that the requested information is not available or cannot be provided without undue expense. The Review Period shall toll pending delivery of the requested information or notice of unavailability.

5.1.3       Following an assessment of the Disclosable SCS Invention but prior to the expiration of the Review Period, RCAR shall provide the Disclosing SCS Group Member with written notice (the “RCAR SCS Invention Notice”) which shall state that either RCAR has (i) no interest in acquiring or licensing the Disclosable SCS Invention or (ii) an interest in acquiring or licensing the Disclosable SCS Invention.

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5.1.4       If RCAR has an interest in acquiring or licensing the SCS Invention RCAR and the Disclosing SCS Member shall have ten (10) Business Days following the date of the RCAR SCS Invention Notice to negotiate mutually agreeable terms for RCAR’s acquisition or licensing of the Disclosable SCS Invention (the “Negotiation Period”). To facilitate this process RCAR first shall provide the Disclosing SCS Member with a written purchase proposal setting forth the principal terms on which RCAR is willing to purchase the Disclosable SCS Invention (the “RCAR Purchase Proposal”).

5.1.5       If the RCAR Purchase Proposal is accepted, the Disclosing SCS Member and RCAR shall proceed to consummation of the RCAR Purchase Proposal pursuant to Section 5.3.

5.1.6       If the RCAR Purchase Proposal is not accepted the Disclosing SCS Member and RCAR shall continue discussions and negotiations for the balance of the Negotiation Period. At any time during the Negotiation Period, the Disclosing SCS Member may, but is not obligated to, provide in writing a final proposal setting forth the terms it or he is, will or is willing to sell or license the Disclosable SCS Invention (the “Disclosing SCS Member’s Final Proposal”) following which RCAR shall have three (3) Business Days to provide written notice to the Disclosing SCS Member either accepting or rejecting the Disclosing SCS Member’s Final Proposal. Failure to provide such written notice of acceptance or rejection within the aforesaid 3-Business Day period shall be deemed a rejection by RCAR.

5.1.7       If the Disclosing SCS Member’s Final Proposal is accepted the Disclosing SCS Member and RCAR shall proceed to consummation of the RCAR Purchase Proposal pursuant to Section 5.3.

5.1.8       If the Disclosing SCS Member’s Final Proposal is not accepted, then, subject to the further provisions of Section 5.2, the Disclosing SCS Member may proceed to sell or license the Disclosable SCS Invention to a third party.

5.2       Re-Offer.

Anything in Sections 5.1 to the contrary notwithstanding:

5.2.1       If the Disclosing SCS Member is subsequently willing to sell or license the Disclosable SCS Invention on terms which are “substantially more favorable” to a third party purchaser than the terms set forth in the Disclosing SCS Member’s Final Proposal, or the RCAR Purchase Proposal (if a Disclosing SCS Member’s Final Proposal was not provided), as applicable in which case the Disclosing SCS Member shall provide RCAR with notice of the terms and conditions of the proposed sale or license to such third party(the “Invention Offer Notice”), and RCAR shall have all of the same rights with respect to the Revised ROFO Notice, as set forth in this Section 3 except that RCAR must deliver a written notice (the “Invention Acceptance Notice”) within five (5) Business Days of the giving of such Invention Offer Notice. Time shall be of the essence as to RCAR’s giving of any Invention Acceptance Notice. Failure to provide the Invention Acceptance Notice shall be deemed a rejection of the Invention Offer Notice and the Offering SCS Stockholder may again proceed to offer, sell or license the Disclosable SCS Invention in accordance with Section 5.1.8 above.

5.2.2       If the Disclosing SCS Member has not sold or licensed the Disclosable SCS Invention within six (6) months of the expiration of the time frame set forth in Section 5.1 above, RCAR shall again have the rights set forth in Section 5.1 as to the Disclosing SCS Member’s Disclosable SCS Invention.

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5.3       Closing. Subject to the preparation, execution, delivery of definitive documents relating to any proposed transaction, a closing of the transactions contemplated by this Section 5 shall occur within ten (10) Business Days of the Acceptance of the RCAR Final Proposal or the RCAR Acceptance Notice.

6.        Option to Purchase RCAR Stock.

6.1       Grant; Number of Shares.

6.1.1 Grant Date and Number of Shares. On the Effective Date of this Agreement, and as a further inducement to the SCS Group to enter into this Agreement, RCAR shall grant to SCS an option (the “SCS Stock Purchase Right”) to purchase up to nine hundred ninety-nine thousand nine hundred ninety-nine (999,999) shares of RCAR’s common stock at a price per share equal to the Per Share Fair Market Value (as defined below) on the date of grant (the “Exercise Price”). For purposes of this Agreement the “Per Share Fair Market Value” of shall mean, if the RCAR ’s Common Stock is:

(i) publicly traded, the closing price of the RCAR’s Common Stock as quoted on the OTC Market Group’s Pink Sheets, or on such other exchange or trading platform on which the RCAR’s Common Stock may then be listed or quoted for trading, on the date of grant; or

(ii) not so publicly traded, the fair market value as is determined in good faith by the Board of Directors of RCAR after taking into consideration factors it deems appropriate, including, without limitation, recent sale and offer prices of RCAR’s Common Stock in private transactions negotiated at arm’s length.

6.1.2       Payment Methods.

6.1.2.1 The portion of the SCS Stock Purchase Right that has vested, as set forth in Section 6.2 below, shall be exercisable by delivery to RCAR of a written or electronic notice, substantially in the form of annexed to the Derivative Security Agreement, stating the number of whole shares to be purchased and accompanied by payment of the full purchase price of the shares of to be purchased Fractional share interests, if any, shall be disregarded except that they may be accumulated.

6.1.2.2 The Exercise Price of the SCS Stock Purchase Right shall be paid: (i) in cash or by certified check or bank draft payable to the order of RCAR; (ii) by delivering, along with a properly executed exercise notice to RCAR, a copy of irrevocable instructions to a broker to deliver promptly to RCAR the aggregate purchase price, provided, however, that such exercise may be implemented solely under a program or arrangement established and approved by RCAR with a brokerage firm selected by RCAR; (iii) at any time prior to the RCAR’s listing of any of its securities for trading on a national stock exchange, pursuant to “a net issue” or “cashless” exercise basis or, (iv) by any other procedure approved by the Board or its Compensation Committee, if any, or by a combination of the foregoing.

6.1.3       Derivative Security Agreement. The SCS Stock Purchase Right shall be subject to the terms and conditions of a derivative security agreement to be executed as of the Effective Date containing the terms, conditions, and provisions set forth in Section 6.2 below as well as such other terms, conditions and provisions as are generally included in such agreements (the “Derivative Security Agreement”).

6.2       Additional Terms of the SCS Stock Purchase Right.

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6.2.1       Term of the SCS Stock Purchase Right. The term of the SCS Stock Purchase Right shall be six (6) years from the Effective Date.

6.2.2.       Vesting.

6.2.2.1       Vesting. The SCS Stock Purchase Right shall vest as follows:

(a) as to 99,999 shares on the date of grant; and

(b) as to the remaining 900,000 shares in 36 equal monthly installments, in arrears during the Initial Term, in arrears, commencing on August 31, 2020 and continuing monthly thereafter. Upon earlier termination of this Agreement as provided in Section 7, except as otherwise provided in Sections 6.2.2.2 and 6.2.2.3 below, the SCS Stock Purchase Right shall terminate and no further vesting of the SCS Stock Purchase Right shall occur.

6.2.2.2 Acceleration upon Change in Control. In the event that, following a Change of Control (as defined below), the Strategic R&D Agreement is terminated without Cause during the Initial Term then all unvested stock option hereunder, regardless of date or condition of vesting, shall vest as of the date of such termination. If, upon the Change of Control, (i) RCAR shall cease to be a stand-alone publicly traded entity, or (ii) the acquiring entity is unwilling to assume the equity in an economically equivalent manner, then in either event, all equity shall be deemed to have vested two (2) days prior to the Change of Control, but only if such Change of Control shall actually be consummated.

For the purposes this Agreement, “Change of Control” shall mean:

(i) the acquisition by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), other than any individual, entity or group which, as of the date of this Agreement, beneficially owns more than ten percent (10%) of the then outstanding shares of common stock of RCAR (the “Common Stock”), of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of fifty percent (50%) or more of the then outstanding Common Stock; provided, however, that any acquisition by RCAR or its subsidiaries, or any employee benefit plan (or related trust) of RCAR or its subsidiaries of fifty percent (50%) or more of outstanding Common Stock shall not constitute a Change of Control, and provided, further, that any acquisition by an entity with respect to which, following such acquisition, more than fifty percent (50%) of the then-outstanding equity interests of such entity, is then beneficially owned, directly or indirectly, by all or substantially all of the individuals and entities who were the beneficial owners of the outstanding Common Stock immediately prior to such acquisition of the outstanding Common Stock, shall not constitute a Change in Control; or

(ii) the consummation of a reorganization, merger or consolidation (any of the foregoing, a “Merger”), in each case, with respect to which all or substantially all of the individuals and entities who were the beneficial owners of the outstanding Common Stock immediately prior to such Merger do not, following such Merger, beneficially own, directly or indirectly, more than fifty percent (50%) of the then outstanding shares of common stock of the corporation resulting from Merger; or

(iii) the sale or other disposition of all or substantially all of the assets of RCAR, excluding (a) a sale or other disposition of assets to a subsidiary of RCAR; and (b) a sale or other disposition of assets to any individual, entity or group which, as of the date of this Agreement, beneficially owns more than ten percent (10%) of the then outstanding Common Stock.

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6.2.2.3 Earlier Termination. Upon earlier termination of this Agreement as provided in Section 7:

(i)       if the basis for termination by RCAR is Section 7.2.1, there shall be no further vesting of the SCS Stock Purchase Right and the vested and unvested portion of the SCS Stock Purchase Right shall be forfeited and cancelled;

(ii)       if the basis for termination by RCAR was without Cause, then the unvested portion of the SCS Stock Purchase Right shall vest immediately as of the date of such termination and to the extent vested, the SCS Stock Purchase Right may thereafter be exercised for a period of up to one year following the date of termination;

(iii)       if the basis for the termination by any member of the SCS Group is Section 7.2.2 then the unvested portion of the SCS Stock Purchase Right shall vest immediately as of the date of such termination and to the extent vested, the SCS Stock Purchase Right may thereafter be exercised for a period of up to one year following the date of termination;

(iv)       if the basis for termination by any member of the SCS Group is without Cause, there shall be no further vesting of the SCS Stock Purchase Right and the vested and unvested portion of the SCS Stock Purchase Right shall be forfeited and cancelled;

(v)       if the basis for termination is Section 7.2.3, then there shall be no further vesting of the SCS Stock Purchase Right and thereafter to the extent vested the SCS Stock Purchase Right may be exercised for a period of up to one year following the date of termination; and

(vi)       if the basis for the termination is Section 7.2.4, then then there shall be no further vesting of the SCS Stock Purchase Right and thereafter to the extent vested the SCS Stock Purchase Right may be exercised for a period of up to one year following the date of termination.

6.3       Assignment and Transfer to Gerlach. Each of SCS and Bornemann hereby assign and transfer any and all rights each may have in and to the SCS Stock Purchase Right and to the Extension Stock Option to Gerlach; and each of SCS and Bornemann hereby further directs that the SCS Stock Purchase Right and the Extension Option (as, if and when issued, and as defined in Section 7.1 below) be issued by RCAR directly to and in the name of Gerlach, as to which assignment, transfer and issuance RCAR agrees.

7.       Term; Extensions; Termination.

7.1 Initial Term and Extended Terms. This Agreement shall become effective on Effective Date and shall remain in effect for a period to expire upon the earlier of (i) July 28, 2023 or (ii) the termination of the Strategic R&D Agreement (the “Initial Term”). Anything in this Agreement to the contrary notwithstanding if the term of Strategic R&D Agreement is extended as provided for therein, RCAR shall have the option of extending the Term of this Agreement for the same period of time, upon written notice to SCS Group within fifteen (15) days of the date on which the term of the Strategic R&D Agreement was extended (any such extension of the Term, an “Extended Term”). The Initial Term and any Extended Term are collectively referred to in this Agreement as the “Term.” Upon the extension of the Initial Term or any Extended Term, as consideration therefor, RCAR shall grant SCS an option (the “Extension Stock Option”) on the date that the Parties agree to the Extended Term (the “ESO Grant Date”), to acquire up to three hundred thirty-three thousand three hundred thirty-three (333,333) shares of RCAR common stock (the “Extension Option”) at an exercise price equal to the Per Share Fair Market Value of RCAR’s common stock on the date of grant, which date shall be the first day of the Extended Term.

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7.2       Termination

7.2.1       For Cause by RCAR. This Agreement may be terminated by RCAR for Cause (i) if any member of the SCS Group has breached the terms or conditions of this Agreement and such breach is incapable of cure, or with respect to a breach capable of cure, the SCS Group does not cure such breach within fifteen (15) calendar days after receipt of written notice of such breach from RCAR; or, (ii) if the Strategic R&D Agreement has been terminated by RCAR for Cause (as provided therein).

7.2.2       For Cause by SCS Group. This Agreement may be terminated by the SCS Group for Cause if RCAR has breached the terms and conditions of this Agreement and such breach is incapable of cure, or with respect to a breach capable of cure, RCAR does not cure such breach within fifteen (15) calendar days after receipt of written notice of such breach from the SCS Group; or if the Strategic R&D Agreement has been terminated by SCS for Cause (as provided therein).

7.2.3       By Mutual Consent. This Agreement may be terminated by mutual written consent of the Parties;

7.2.4       Automatic Termination. This Agreement shall be automatically terminated upon the expiration of the Term or Extended Term, if not further extended. This Agreement also shall be automatically terminated upon termination of the Strategic R&D Agreement is terminated with or without Cause (as provided therein).

7.3       Effect of Termination.

7.3.1       Termination of this Agreement shall not affect any accrued rights, if any, of the Parties through the date of termination.

7.3.2       Generally, any obligation undertaken hereunder by either Party that, by its nature or its terms, is intended to extend beyond the Term shall survive the termination hereof. Without limiting the generality of the foregoing, the terms and conditions of Sections 3, 4 and 5 (to the extent applicable to matters arising prior to the termination date), Sections 6, 7 and 8 shall survive termination of this Agreement.

8. Miscellaneous.

8.1       Assignment. SCS Group, individually or collectively, may not assign or transfer this Agreement, in whole or in part (except as provided in Section 5), without RCAR’s express prior written consent. Any attempt to assign this Agreement, without such consent, will be void. Subject to the foregoing, this Agreement will bind and benefit the Parties and their respective successors and assigns, including any party into which RCAR is merged or to which RCAR sell substantially all of its assets.

8.2       No Election of Remedies. Except as expressly set forth in this Agreement, the exercise by RCAR of any of its remedies under this Agreement will not be deemed an election of remedies and will be without prejudice to its other remedies under this Agreement or available at law or in equity or otherwise.

8.3       No-trade. Each of the members of the SCS Group acknowledges that it may be in possession of material nonpublic information which is considered to be any information concerning RCAR that is both (i) material (meaning the average investor would want to know such information before deciding whether to buy, sell or hold securities of RCAR, or, in other words, information that could affect the market price of RCAR securities); and (ii) nonpublic (meaning the information has not been disclosed in RCAR's filings with the United States Securities and Exchange Commission (the “SEC”) or in a press release issued by RCAR that has been broadly disseminated to the investing public). Information is not considered public until the second business day after such disclosure in a SEC filing or press release. If such material nonpublic information is disclosed to the public, any member of the SCS Group having knowledge of such information may not trade in RCAR securities until the second business day after such disclosure (i.e., the second day after the applicable SEC filing or press release). The prohibition on trading while in possession of material nonpublic information continues for as long as any information each of the members of the SCS Group has is both material and nonpublic and can continue even after SCS’s engagement as a consultant to RCAR has terminated.

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8.4       Severability. If any provision of this Strategic R&D Agreement is held invalid or unenforceable by a court of competent jurisdiction, the remaining provisions of this Strategic R&D Agreement will remain in full force and effect, and the provision affected will be construed so as to be enforceable to the maximum extent permissible by law.

8.5       Waiver. The failure by either party to enforce any provision of this Strategic R&D Agreement will not constitute a waiver of future enforcement of that or any other provision.

8.6       Notices. Any notice, demand or request required or permitted to be given under this Agreement shall be in writing and addressed as follows:

If to RCAR:

RenovaCare, Inc.

4 Becker Farm Road

Suite 105

Roseland, NJ 07068

Attention: Alan L. Rubino, Chief Executive Officer

Email Address: arubino@renovacareinc.com

If to any SGS Group member:

StemCell Systems GmbH

Tempelhofer Damm 45

Flughafengebäude Hangar 6.c

12101 Berlin

Germany

Attention: Frank Schubert

Email Address: frank.schubert@stemcell-systems.com

or, to such other address or facsimile number as any Party shall have furnished to the other in writing in accordance with this Section 10.5. Notices sent in accordance with this Section shall be deemed effectively given: (i) when received, if delivered by hand (with written confirmation of receipt); (ii) when received, if sent by a nationally recognized overnight courier (receipt signature requested); (iii) on the date sent by facsimile or e-mail (in each case, with confirmation of transmission), if sent during normal business hours of the recipient, and on the next Business Day if sent outside normal business hours of the recipient; or (iv) on the third (3rd) Business Day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid.

8.7       Further Assurances.

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8.7.1         Assignments; Applications. At RCAR’s expense, whenever requested by RCAR, both during the Term and thereafter, the SCS Group will promptly sign and deliver to RCAR any and all applications, assignments and other documents that RCAR considers necessary or desirable in order to:

(a) assign, apply for, obtain, and maintain any Intellectual Property Rights in the United States and for other countries relating to any Disclosable SCS Invention acquired or licensed by RCAR pursuant to this Agreement (the “Acquired SCS Invention”); and

(b) assign and convey to RCAR or its designee the sole and exclusive right, title, and interest in and to all Intellectual Property related to the Acquired SCS Invention;

(c) provide evidence regarding the Intellectual Property that RCAR considers necessary or desirable;

(d) confirm RCAR’s ownership of the Intellectual Property related to the Acquired SCS Invention, all without royalty or any other further consideration to SCS; and

(e) at the request of RCAR, execute and deliver the Power of Attorney referenced in Section 8.7.3 in such form as may be reasonably required by RCAR’s counsel so as to give full effect to the intent of Section 8.7.3.

8.7.2       Enforcement. Whenever requested by RCAR, both during the Term and thereafter, SCS will assist RCAR in assigning, obtaining, maintaining, defending, registering and from time to time enforcing, in any and all countries, RCAR’s right to the Work Product. This assistance may include, without limitation, testifying in a suit or other proceeding. If RCAR requires assistance from SCS after termination this Strategic R&D Agreement, SCS will be compensated for time actually spent in providing assistance at an hourly rate equivalent to the compensation rates in effect on the date of termination together with its reasonable, actual out-of-pocket expenses incurred in providing such assistance.

8.7.3       Power of Attorney. Each SCS Group member agrees that if RCAR is unable, because of SCS’s documented unavailability for 10 or more calendar days, as a result of SCS’s dissolution, mental or physical incapacity of its duly authorized officers or principals, or for any other reason, to secure SCS’s signature to apply for or to pursue any application for any United States or foreign jurisdiction’s patents or copyright registrations covering SCS Inventions sold, assigned or licensed to RCAR pursuant to this Agreement. For all SCS Inventions acquired by RCAR pursuant to this Agreement, SCS hereby irrevocably designates and appoints RCAR and its duly authorized officers and agents as SCS’s agent and Attorney-In-Fact, to act for and such SCS Group member behalf and stead to execute and file any such instruments and papers and to do all other lawfully permitted acts to further the application for, prosecution, issuance, maintenance or transfer of letters patent, copyright, mask work and other related registrations. This Power of Attorney is coupled with an interest and shall not be affected by SCS’s subsequent incapacity or unavailability.

8.8       Effectiveness; Counterparts. This Agreement may be executed in counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. A signature transmitted by facsimile or in a PDF file shall have the same effect as an original signature. Each Party represents and warrants that the representatives signing this Agreement on its behalf has all right and authority to bind and commit that Party to the terms and conditions of this Agreement. This Agreement shall be effective only when signed by both parties.

8.9       SCS Group Incurred Costs and Expenses. It is acknowledged and agreed by RCAR that post-closing of RCAR’s purchase of any Ownership Interests or Acquired SCS Invention, the reasonable costs and expenses, including the billable time provided by SCS personnel, in assisting the RCAR in effecting, securing or maintaining any of the assignments or rights assigned, or assistance provided, to it pursuant to this Agreement shall be paid for by the RCAR.

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8.10        Entire Agreement. This Agreement, together with the Strategic R&D Agreement, constitutes the complete and exclusive understanding and agreement of the parties with respect to its subject matter and supersedes all prior understandings and agreements, whether written or oral, with respect to its subject matter. Any waiver, modification or amendment of any provision of this Strategic R&D Agreement will be effective only if in writing and signed by the parties hereto.

8.11       Governing Law. This Agreement will be governed by and construed in accordance with the laws of the United States of America and the State of Nevada, excluding its body of law controlling conflict of laws. Any legal action or proceeding arising under this Agreement will be brought exclusively in the federal courts located in the State of New Jersey and the parties irrevocably consent to the personal jurisdiction and venue therein.

8.12.        Mutual Waiver of Jury Trial. BECAUSE DISPUTES ARISING IN CONNECTION WITH COMPLEX FINANCIAL TRANSACTIONS ARE MOST QUICKLY AND ECONOMICALLY RESOLVED BY AN EXPERIENCED AND EXPERT PERSON AND THE PARTIES WISH APPLICABLE LAWS TO APPLY (RATHER THAN ARBITRATION RULES), THE PARTIES DESIRE THAT THEIR DISPUTES BE RESOLVED BY A JUDGE APPLYING SUCH APPLICABLE LAWS. THEREFORE, TO ACHIEVE THE BEST BENEFITS OF THE JUDICIAL SYSTEM, THE PARTIES HERETO WAIVE ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, SUIT, OR PROCEEDING BROUGHT TO ENFORCE OR DEFEND ANY RIGHTS OR REMEDIES UNDER THIS AGREEMENT OR ANY DOCUMENTS RELATED HERETO.

[Signatures Follow on Next Page]

[Balance of this page is intentionally blank.]

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IN WITNESS WHEREOF, the parties hereto have executed this Right of First Refusal and Corporate Opportunities Agreement as of the date first specified above.

RenovaCare, Inc.

By: /s/ Alan L. Rubino

Name: Alan L. Rubino

Title: President and Chief Executive Officer

SCS GROUP”

Stemcell Systems GmbH

By:  /s/ Jörg Gerlach

Name: Jörg Gerlach

Title: Authorized Signatory and Principal

_______________________________________

Name:Reinhard Bornemann

Title: CEO and Principal

_______________________________________

Jörg Gerlach, individually

_______________________________________

Reinhard Bornemann, individually

14

Exhibit A

To the

Right of First Refusal and Corporate Opportunities Agreement made as of July 1, 2020 by and among RenovaCare. Inc. (“RCAR”), StemCell Systems GmbH (“SCS), Jörg Gerlach, an individual (“Gerlach”) and Reinhard Bornemann, an individual (“Bornemann”).

SCS Ownership Interests

Name	Amount	Type	Percentage
Gerlach	50%	full registered shares	50%
Bornemann	50%	full registered shares	50%

15

EX-31.1

EXHIBIT 31.1

CERTIFICATION PURSUANT TO RULE 13A-14(A) OR RULE 15D-14(A)

UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Alan L. Rubino, certify that:

1. I have reviewed this quarterly report on Form 10-Q of RenovaCare, 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. I am 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.

5. I have disclosed, based on my 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: November 13, 2020	By:	/s/ Alan L. Rubino
	Name:	Alan L. Rubino
	Title:	Chief Executive Officer
		(Principal Executive Officer)

EX-31.2

EXHIBIT 31.2

CERTIFICATION PURSUANT TO RULE 13A-14(A) OR RULE 15D-14(A)

UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Robert W. Cook, certify that:

1. I have reviewed this quarterly report on Form 10-Q of RenovaCare, 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. I am 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.

5. I have disclosed, based on my 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: November 13, 2020	By:	/s/ Robert W. Cook
	Name:	Robert W. Cook
	Title:	Chief Financial Officer
		(Principal Executive Officer)

EX-32.1

EXHIBIT 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

The undersigned, as the Chief Executive Officer and the Chief Financial Officer of RenovaCare, Inc., respectively, certifies that, to the best of their knowledge and belief, the Quarterly Report on Form 10-Q for the period ended September 30, 2020 that accompanies this certification fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and the information contained in the quarterly report fairly presents, in all material respects, the financial condition and results of operations of RenovaCare, Inc. at the dates and for the periods indicated. The foregoing certification is made pursuant to 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and shall not be relied upon for any other purpose.

Date: November 13, 2020

By: /s/ Alan L. Rubino

Name: Alan L. Rubino

Title: Chief Executive Officer and Director

(Principal Executive Officer)

Date: November 13, 2020

By:/s/ Robert W. Cook

Name: Robert W. Cook

Title: Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

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Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2020	Nov. 12, 2020
Document And Entity Information
Entity Registrant Name	RenovaCare, Inc.
Entity Central Index Key	0001016708
Document Type	10-Q
Document Period End Date	Sep. 30, 2020
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity File Number	000-30156
Is Entity's Reporting Status Current?	Yes
Is Entity Emerging Growth Company?	false
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Incorporation, State or Country Code	NV
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		87,352,364
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2020

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Condensed Consolidated Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Current assets
Cash and cash equivalents	$ 8,671,295	$ 12,185,248
Other current assets	273,606	102,500
Total current assets	8,944,901	12,287,748
Fixed Assets, net	40,965	0
Right of use asset	86,587	0
Security deposit	7,995	0
Prepaid R&D - noncurrent	159,498	0
Intangible assets	152,854	152,854
Total assets	9,392,800	12,440,602
Current liabilities
Accounts payable and accrued expenses	585,089	169,044
Accounts payable - related parties	132,371	111,696
Operating lease liability	44,458	0
Total current liabilities	761,918	280,740
Operating lease liability	42,233	0
Total liabilities	804,151	280,740
Commitments and contingencies	0	0
Stockholders' equity (deficit)
Preferred stock: $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding	0	0
Common stock: $0.00001 par value; 500,000,000 shares authorized, 87,352,364 shares issued and outstanding at September 30, 2020 and December 31, 2019	874	874
Additional paid-in capital	35,811,930	32,378,833
Retained deficit	(27,224,155)	(20,219,845)
Total stockholders' equity	8,588,649	12,159,862
Total liabilities and stockholders' equity	$ 9,392,800	$ 12,440,602

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Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, Authorized	10,000,000	10,000,000
Preferred stock, shares Issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.00001	$ 0.00001
Common stock, Authorized	500,000,000	500,000,000
Common stock, shares Issued	87,352,364	87,352,364
Common stock, shares outstanding	87,352,364	87,352,364

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Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Income Statement [Abstract]
Revenue
Operating expenses
Research and development	1,551,989	130,467	3,091,383	504,169
General and administrative	1,290,890	1,070,314	4,024,317	1,944,111
Total operating expenses	2,842,879	1,200,781	7,115,700	2,448,280
Loss from operations	(2,842,879)	(1,200,781)	(7,115,700)	(2,448,280)
Other income (expense)
Interest income	24,915	84,731	111,390	265,460
Total other income (expense)	24,915	84,731	111,390	265,460
Net loss	$ (2,817,964)	$ (1,116,050)	$ (7,004,310)	$ (2,182,820)
Basic and Diluted Loss per Common Share	$ (0.03)	$ (0.01)	$ (0.08)	$ (0.03)
Weighted average number of common shares outstanding - basic and diluted	87,352,364	87,243,352	87,352,364	87,198,132

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Condensed Consolidated Statments Of Stockholders' (EQUITY) (Unaudited) - USD ($)	Common Stock	Additional Paid-In Capital	Retained Deficit	Total
Beginning Balance, Shares at Dec. 31, 2018	87,175,522
Beginning Balance, Amount at Dec. 31, 2018	$ 872	$ 32,187,580	$ (16,861,763)	$ 15,326,689
Stock based compensation		832		832
Net loss			(547,504)	(547,504)
Ending Balance, Shares at Mar. 31, 2019	87,175,522
Ending Balance, Amount at Mar. 31, 2019	$ 872	32,188,412	(17,409,267)	14,780,017
Beginning Balance, Shares at Dec. 31, 2018	87,175,522
Beginning Balance, Amount at Dec. 31, 2018	$ 872	32,187,580	(16,861,763)	15,326,689
Stock based compensation issued for prepaid services				0
Net loss				(2,182,820)
Ending Balance, Shares at Sep. 30, 2019	87,352,364
Ending Balance, Amount at Sep. 30, 2019	$ 874	32,188,410	(19,044,583)	13,144,701
Beginning Balance, Shares at Mar. 31, 2019	87,175,522
Beginning Balance, Amount at Mar. 31, 2019	$ 872	32,188,412	(17,409,267)	14,780,017
Net loss			(519,266)	(519,266)
Ending Balance, Shares at Jun. 30, 2019	87,175,522
Ending Balance, Amount at Jun. 30, 2019	$ 872	32,188,412	(17,928,533)	14,260,751
Exercise of warrants, Shares	176,842
Exercise of warrants, Amount	$ 2	(2)
Net loss			(1,116,050)	(1,116,050)
Ending Balance, Shares at Sep. 30, 2019	87,352,364
Ending Balance, Amount at Sep. 30, 2019	$ 874	32,188,410	(19,044,583)	13,144,701
Beginning Balance, Shares at Dec. 31, 2019	87,352,264
Beginning Balance, Amount at Dec. 31, 2019	$ 874	32,378,833	(20,219,845)	12,159,862
Stock based compensation		465,763		465,763
Net loss			(1,174,753)	(1,174,753)
Ending Balance, Shares at Mar. 31, 2020	87,352,264
Ending Balance, Amount at Mar. 31, 2020	$ 874	32,844,596	(21,394,598)	11,450,872
Beginning Balance, Shares at Dec. 31, 2019	87,352,264
Beginning Balance, Amount at Dec. 31, 2019	$ 874	32,378,833	(20,219,845)	12,159,862
Stock based compensation issued for prepaid services				260,997
Net loss				(7,004,310)
Ending Balance, Shares at Sep. 30, 2020	87,352,264
Ending Balance, Amount at Sep. 30, 2020	$ 874	35,811,930	(27,224,155)	8,588,649
Beginning Balance, Shares at Mar. 31, 2020	87,352,264
Beginning Balance, Amount at Mar. 31, 2020	$ 874	32,844,596	(21,394,598)	11,450,872
Stock based compensation		1,586,522		1,586,522
Net loss			(3,011,593)	(3,011,593)
Ending Balance, Shares at Jun. 30, 2020	87,352,264
Ending Balance, Amount at Jun. 30, 2020	$ 874	34,431,118	(24,406,191)	10,025,801
Stock based compensation		1,119,815		1,119,815
Stock based compensation issued for prepaid services		260,997		260,997
Net loss			(2,817,964)	(2,817,964)
Ending Balance, Shares at Sep. 30, 2020	87,352,264
Ending Balance, Amount at Sep. 30, 2020	$ 874	$ 35,811,930	$ (27,224,155)	$ 8,588,649

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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Cash flows used in operating activities
Net loss	$ (7,004,310)	$ (2,182,820)
Adjustments to reconcile net loss to net cash flows used in operating activities
Depreciation	309	237
Stock based compensation expense	3,172,100	832
Amortization of right-of-use asset	6,978
Changes in operating assets and liabilities:
(Increase) decrease in other current assets	(69,608)	68,707
Increase in accounts payable and accrued expenses	416,045	190,925
(Decrease) increase in accounts payable - related parties	20,675	66,474
Decrease in interest payable - related parties	0	(167,497)
Lease liability	(6,874)	0
Net cash flows used in operating activities	(3,464,685)	(2,023,142)
Cash flows from investing activities
Payment for security deposit	(7,995)	0
Purchase of fixed assets	(41,273)	0
Net cash flows used in investing activities	(49,268)	0
Decrease in cash and cash equivalents	(3,513,953)	(2,023,142)
Cash and cash equivalents at beginning of period	12,185,248	15,397,524
Cash and cash equivalents at end of period	8,671,295	13,374,382
Supplemental disclosure of cash flow information:
Interest paid in cash	0	167,497
Income taxes paid in cash	0	0
Supplemental disclosure of noncash financing activities:
Stock based compensation issued for prepaid services	$ 260,997	$ 0

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Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings Per Share

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Loss) Per Share

Note 1. Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Loss) Per Share

Basis of Presentation

The accompanying interim unaudited condensed consolidated financial statements and related disclosures of RenovaCare, Inc. and Subsidiary (the “Company”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed on May 14, 2020. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted.

In the opinion of management, the interim condensed consolidated financial statements reflect all adjustments considered necessary for a fair statement of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the year ended December 31, 2020.

Organization

RenovaCare, Inc. was incorporated on July 14, 1983 in the State of Utah under the name Far West Gold, Inc., and changed its domicile to Nevada in 1997. On January 7, 2014, the Company changed its name at the time from “Janus Resources, Inc.” to “RenovaCare, Inc.” so as to more fully reflect its current operations and business, and changed its trading symbol from “JANI” to “RCAR” effective as of January 9, 2014.

RenovaCare has an authorized capital of 500,000,000 shares of $0.00001 par value common stock, of which 87,352,364 shares are outstanding as of September 30, 2020, and 10,000,000 shares of $0.0001 par value preferred stock, of which none are outstanding.

Overview of Operations

The Company focuses on the research, development and commercialization of autologous (using a patient's own cells) cellular therapies that can be used for medical and aesthetic applications.

On July 12, 2013, the Company, through its wholly owned subsidiary, RenovaCare Sciences Corp., completed the acquisition of its flagship technologies (collectively, the “CellMist^TM System”) along with associated United States patent applications and two foreign patent applications, all of which have been granted. In August 2019, the Company was awarded a continuation of a patent allowing the Company’s novel solution sprayer device (the “SkinGun^TM”) to be used to spray all varieties of tissues and cells, thus allowing for its potential application in the regeneration of tissues and organs, beyond skin.

The CellMist^TM System is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “CellMist^TM Solution”) and (b) the SkinGun^TM for delivering the cells to the treatment area. In August 2020, the Company announced that the US Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous skin and pluripotent stem cells rendered by its manual CellMist™ System from donor skin and applied topically with the electronic SkinGun™ spray device for treatment of acute burn wounds. The clinical trial protocol is an open-label single-arm clinical study that will enroll 14 adult human burn subjects with partial-thickness, second-degree thermal burn wounds covering between 10 and 30% total body surface area. The Company expects to conduct the clinical study at four (4) U.S. burn centers commencing in 2021.

Improvements in the design and efficiency of the CellMist™ System including a closed, self-contained, semi-automated sterile cell isolation device and the SkinGun™ spray device are in development with StemCell Systems (Berlin, Germany), the Company’s R&D innovation partner. The Company is adapting its core technologies for possible use in other clinical indications. The Company is also developing the cell isolation and spray gun devices as stand-alone 510 (k)-cleared products for isolation of cells from other tissues and spraying other solutions of medical importance.

The Company does not have any commercialized products. The Company's activities have consisted principally of performing research and development activities and raising capital to support such activities. The Company has enlisted the assistance of several Contract Manufacturing Organizations (CMO) to manufacture clinical supplies including components of the CellMist System™ and the electronic SkinGun™ spray devices in compliance with FDA’s guidance for current Good Manufacturing Practices (cGMP) and Contract Research Organizations (CRO) to conduct clinical trials to evaluate the safety and feasibility of an autologous skin cell therapy using the Company’s products to facilitate burn wound healing. These development activities are subject to significant risks and uncertainties, including possible failure of preclinical and clinical testing. The Company has not generated any revenue and has sustained recurring losses and negative cash flows from operations since inception. The Company expects to incur losses as it continues development of its products and technologies and expects that it will need to raise additional capital through partnerships or the sale of its securities to accomplish its business plan. Failing to secure such additional funding before achieving sustainable revenue and profit from operations poses a significant risk. The Company's ability to fund the development of its cellular therapies depends on the amount and timing of cash receipts from future financing activities. There can be no assurance as to the availability or terms upon which such financing and capital might be available. Additionally, there is significant uncertainty relating to the full impact of the COVID-19 pandemic on the Company’s operations and capital requirements. Should financing when needed be unavailable or prohibitively expensive or the COVID-19 pandemic continue, it may adversely affect the Company’s ability to (i) retain employees and consultants; (ii) obtain additional financing on terms acceptable to the Company, if at all; (iii) delay regulatory submissions and approvals; (iv) delay, limit or preclude the Company from securing clinical study sites; (v) delay, limit or preclude the Company from achieving technology or product development goals, milestones, or objectives; and (vi) preclude or delay entry into joint venture or partnership arrangements. The occurrence of any one or more of such events may affect the Company’s ability to continue on its pathway to commercialization of its technology or products.

Liquidity

As of September 30, 2020, the Company had $8,671,295 of cash on hand and cash equivalents, and working capital of $8,182,984. As a result, the Company believes it currently has sufficient cash to meet its funding requirements over the next twelve months following the issuance of this Quarterly Report on Form 10-Q. However, the Company has experienced and continues to experience negative cash flows from operations, as well as an ongoing requirement for substantial additional capital investment. The Company expects that it may need to raise additional capital to accomplish its business plan over the next several years. There can be no assurance as to the availability or terms upon which such financing and capital might be available. See “Overview of Operations” above.

New Accounting Standards

Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative non-governmental U.S. GAAP as found in the Financial Accounting Standards Board's Accounting Standards Codification.

In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. ASU 2019-12 is effective for the Company beginning in fiscal 2021. The Company is currently assessing the impact that this pronouncement will have on its consolidated financial statements.

The Company reviews new accounting standards as issued. Although some of these accounting standards issued or effective after the end of the Company’s previous fiscal year may be applicable, the Company has not identified any standards that the Company believes merit further discussion other than as discussed above. The Company believes that none of the new standards will have a significant impact on the financial statements.

Earnings (Loss) Per Share

The Company presents both basic and diluted earnings per share ("EPS") amounts. Basic EPS is calculated by dividing net income (loss) by the weighted average number of common shares outstanding during the period presented. Diluted EPS amounts are based upon the weighted average number of common and common equivalent shares outstanding during the period presented. The Company has not included the effects of warrants or stock on net loss per share because to do so would be antidilutive.

Following is the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
Basic and Diluted EPS Computation
Numerator:
Loss available to common stockholders'	$	(2,817,964	)	$	(1,116,050	)	$	(7,004,310	)	$	(2,182,820	)
Denominator:
Weighted average number of common shares outstanding		87,352,364			87,243,352			87,352,364			87,198,132
Basic and diluted EPS	$	(0.03	)	$	(0.01	)		(0.08	)	$	(0.03	)

The shares listed below were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods presented:

Stock options	5,883,070	317,500	5,883,070	317,500
Warrants	12,296,912	13,106,912	12,296,912	13,106,912
Total shares not included in the computation of diluted losses per share	18,179,982	13,242,412	18,179,982	13,424,412

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Other Current Assets

9 Months Ended

Sep. 30, 2020

Notes to Financial Statements

Other Current Assets

Note 2. Other Current Assets

Other current assets consist of the following:

	September 30,		December 31,
	2020		2019
Prepaid insurance	$	108,360	$	-
Prepaid stock options for services		86,999		-
Prepaid professional fees		65,000		102,500
Other prepaid costs		13,247		-
Total prepaid expenses	$	273,606	$	102,500

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Assets - Intellectual Property

9 Months Ended

Sep. 30, 2020

Notes to Financial Statements

Assets - Intellectual Property

Note 3. Assets – Intellectual Property

On July 12, 2013, the Company, together with its wholly owned subsidiary, RenovaCare Sciences, entered into an asset purchase agreement (“APA”) with Dr. Jörg Gerlach, MD, PhD, pursuant to which RenovaCare Sciences purchased all of Dr. Gerlach’s rights, title and interest in the CellMist^TM System. Acquisition-related costs amounted to $52,852 and were capitalized together with the cash payment upon the closing of the transaction in July 2013 of $100,002. Intangible assets amounted to $152,854 at September 30, 2020 and December 31, 2019.

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Common Stock and Warrants

9 Months Ended

Sep. 30, 2020

Equity [Abstract]

Common Stock and Warrants

Note 4. Common Stock and Warrants

Common Stock

At September 30, 2020, the Company had 500,000,000 authorized shares of common stock with a par value of $0.00001 per share, 87,352,364 shares of common stock outstanding and 20,000,000 shares reserved for issuance under the Company’s 2013 Long-Term Incentive Plan (the “2013 Plan”) as adopted and approved by the Company’s Board of Directors (the “Board”) on June 20, 2013 that provides for the grant of stock options to employees, directors, officers and consultants. During the nine months ended September 30, 2020, the Company granted options to purchase an aggregate 3,565,570 shares of the Company’s common stock to employees and consultants. See “Note 5. Stock Options” for further discussion.

Warrants

The following table summarizes information about warrants outstanding at September 30, 2020 and December 31, 2019:

		Shares of Common Stock Issuable from Warrants Outstanding as of				Weighted
		September 30,		December 31,		Average
Description		2020		2019		Exercise Price		Expiration
	Series D		-		810,000	$	1.10	June 5, 2020
	Series E		584,416		584,416	$	1.54	September 8, 2021
	Series F		7,246		7,246	$	3.45	February 23, 2022 & March 9, 2022
	Series G		460,250		460,250	$	2.68	July 21, 2022
	Series H		910,000		910,000	$	2.75	October 16, 2022
	Series I		10,335,000		10,335,000	$	2.00	November 26, 2025
	Total		12,296,912		13,106,912

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Stock Options

9 Months Ended

Sep. 30, 2020

Share-based Payment Arrangement [Abstract]

Stock Options

Note 5. Stock Options

The following table summarizes stock option activity for the period ended September 30, 2020:

	Number of Options			Weighted Average Exercise Price ($)		Weighted Average Remaining Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding at December 31, 2019		2,317,500			2.68		5.68	$	1,460,507
Grants		3,565,570			2.30		-		-
Forfeited		(37,500	)		4.20		-		-
Outstanding at September 30, 2020		5,845,570			2.46		5.38	$	7,200,064
Vested and Exercisable at September 30, 2020		1,402,499			2.07		5.39		2,322,524
Available for grant at September 30, 2020		13,912,695

On January 2, 2020, the Company granted Alan L. Rubino, the Company’s President and Chief Executive Officer, an option to purchase up to 620,571 shares of the Company’s common stock at an exercise price of $3.23. The option was granted in fulfillment of the Company’s obligation under the terms of Mr. Rubino’s employment agreement dated November 15, 2019. On May 22, 2020, the Board of Directors approved the modification of these 620,571 options to accelerate the vesting from November 14, 2023 to November 14, 2022. The Company calculated the fair value of the options immediately before and after the modification using the Black-Scholes model. There was no incremental consideration due to the modification.

On May 22, 2020, the Company granted options to two consultants and a board member to purchase an aggregate 1,550,000 shares of the Company’s common stock at an exercise price of $1.40. On June 1, 2020, pursuant to his employment agreement, the Company granted Dr. Robin Robinson, the Company’s Chief Scientific Officer, an option to purchase up to 200,000 shares of the Company’s common stock at an exercise price of $1.65. On June 22, 2020, pursuant to his employment agreement, the Company granted Robert Cook, the Company’s Chief Financial Officer, an option to purchase up to 100,000 shares of the Company’s common stock at an exercise price of $1.96.

On August 1, 2020, in connection with her appointment to the Board of Directors, the Company granted Lydia M. Evans, M.D. an option to purchase up to 20,000 shares of the Company’s common stock at an exercise price of $3.17 per share. 10,000 of the options vested immediately with the balance vesting on August 3, 2021.

In consideration of entering into a Right of First Refusal and Corporate Opportunities Agreement (the “ROFR Agreement”) dated July 1, 2020, the Company granted StemCell Systems GmbH (“SCS”), an option to purchase 999,999 shares of the Company’s common stock. The option grant vests as follows: (i) 99,999 on July 29, 2020, (ii) 900,000 in 36 equal monthly installments beginning on August 31, 2020. Concurrent with the option grant, SCS assigned and transferred its rights in the options to Jörg Gerlach, MD, PhD.

The fair value of the options was estimated at the date of grant using the Black-Scholes option pricing model. Assumptions regarding volatility, expected term, dividend yield and risk-free interest rate are required under the Black-Scholes model. The volatility assumption is based on the Company’s historical experience. The risk-free interest rate is based on a U.S. Treasury note with maturity similar to the option award’s expected life. The expected life represents the average period of time that options granted are expected to be outstanding.

The assumptions for volatility, expected life, dividend yield and risk-free interest rate for the options granted are as follows:

	Nine Months Ended
	September 30, 2020
Risk-free interest rate	0.21%	-	1.67%
Expected life in years	3.25	-	6.00
Expected Volatility	103.56%	-	110.71%
Expected dividend yield		0%

The share-based compensation cost resulting from stock option grants, including those previously granted and vesting over time, is expensed ratably over the respective vesting periods. During the three and nine months ended September 30, 2020, the Company recognized $1,463,969 and $3,172,000, respectively, in stock-based compensation expense. Compensation costs for consultant option grants are recognized in the same period and in the same manner as if the Company had paid cash for the services. The Company recognized a prepaid expense in the amount of $260,997 for the 99,999 vested options granted to SCS for entering into the ROFR Agreement. During the three and nine months ended September 30, 2019, the Company recognized $832 and $191,275 respectively, in stock-based compensation. As of September 30, 2020, the Company’s unrecognized compensation cost related to unvested stock options was $5,416,522 to be amortized through 2023. Stock-based compensation has been included in the consolidated statement of operations as follows:

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019
Research and development	$	631,876	$	832	$	1,087,047	$	191,275
General and administrative		832,093		-		2,084,953		-
Total	$	1,463,969	$	832	$	3,172,000	$	191,275

The following table summarizes information about stock options outstanding and exercisable as of September 30, 2020:

	Stock Options Outstanding						Stock Options Exercisable
Range of Exercise Prices	Number of Shares Subject to Outstanding Options		Weighted Average Contractual Life (years)		Weighted Average Exercise Price		Number of Shares Subject to Options Exercise		Weighted Average Remaining Contractual Life (Years)		Weighted Average Exercise Price
1.05		55,000		3.50		1.05		55,000		3.50		1.05
1.25		7,500		4.71		1.25		7,500		4.71		1.25
1.34		7,500		4.75		1.34		7,500		4.75		1.34
1.40		1,550,000		5.64		1.40		775,000		5.64		1.40
1.65		200,000		5.67		1.65		100,000		5.67		1.65
1.70		7,500		5.04		1.70		7,500		5.04		1.70
1.96		100,000		5.73		1.96		50,000		5.73		1.96
2.28		7,500		5.80		2.28		7,500		5.80		2.28
4.20		195,000		4.26		4.20		195,000		4.26		4.20
1.98		667,800		5.13		1.98		-		-		-
2.48		667,800		5.13		2.48		-		-		-
3.23		664,400		5.13		3.23		-		-		-
3.23		620,571		5.13		3.23		-		-		-
3.19		1,074,999		5.84		3.19		187,499		5.84		3.19
3.17		20,000		5.84		3.17		10,000		5.84		3.17
Total		5,845,570		5.38	$	2.44		1,402,499		5.39	$	2.07

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Leases

9 Months Ended

Sep. 30, 2020

Leases [Abstract]

Leases

Note 6. Leases

The Company determines if an arrangement is a lease, or contains a lease, at the inception of an arrangement. If the Company determines that the arrangement is a lease, or contains a lease, at lease inception, it then determines whether the lease is an operating lease or finance lease. Operating and finance leases result in recording a right-of-use (“ROU”) asset and lease liability on the consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. For purposes of calculating operating lease ROU assets and operating lease liabilities, the Company uses the non-cancellable lease term plus options to extend that it is reasonably certain to exercise. Lease expense for operating lease payments is recognized on a straight-line basis over the lease term. The Company’s leases generally do not provide an implicit rate. As such, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company has elected not to recognize ROU assets and lease liabilities that arise from short-term (12 months or less) leases for any class of underlying asset. The Company has elected not to separate lease and non-lease components for any class of underlying asset.

In February 2020, the Company entered into a two-year lease for office premises located at 4 Becker Farm Road, Suite 105, Roseland, New Jersey. Monthly base rent in year one of the lease is $4,356; and $4,459 in year 2 of the lease. The term (and payment of the monthly rent) commences upon substantial completion of the landlord’s work, which was expected to occur on or before May 31, 2020. Due to the COVID-19 pandemic the lease term commenced on August 1, 2020.

Supplemental lease information at September 30, 2020:

Right-of-use asset	$	86,587
Short-term operating lease liability	$	44,458
Long-term operating lease liability	$	42,233
Remaining term (years)		1.9
Discount rate		7	%

The Company does not have any finance leases.

Supplemental cash flow information for the nine months ended September 30, 2020:

Cash paid for amount included in the measurement of lease liabilities for operating lease	$	13,068
Right-of-use asset obtained in exchange for lease obligation	$	98,402

The Company leases office space under a non-cancellable operating lease expiring in 2022. Future lease payments included in the measurement of lease liabilities on the balance sheet at September 30, 2020 for future periods are as follows:

Years ending December 31, 2020,
2020 (remaining)	$	8,712
2021	$	52,787
2022	$	31,213
Total future minimum lease payments	$	92,712
Less imputed interest	$	6,125
Total	$	86,587

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Commitments and Contingencies

9 Months Ended

Sep. 30, 2020

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Note 7. Commitments and Contingencies

The Company has engaged StemCell Systems GmbH (“StemCell Systems”) to provide it with prototypes and related documents related to the CellMist™ system and the SkinGun™ under various agreements. Pursuant to these engagements the Company incurred expenses of $125,655 and $400,612 during the three and nine months ended September 30, 2020 and, $100,000 and $223,175 during the three and nine months ended September 30, 2019, respectively. Dr. Gerlach, from whom the Company purchased the CellMist^TM System and SkinGun^TM technologies, is a principal of StemCell Systems.

On June 3, 2019, the Company entered into a Charitable Gift Agreement with the University of Pittsburgh (“University”), pursuant to which the Company committed to provide a charitable donation to the University in the amount of $250,000 (the “Grant”). The Company paid the Grant in four installments with the first payment made in July 2019. During each of the three and nine months ended September 30, 2020 the Company made payments totaling $62,500 and $62,500, respectively. During the three and nine months ended September 30, 2019 the Company made payments totaling $0 and $62,500, respectively. As of September 30, 2020, the Company’s obligation under the Grant has been satisfied.

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Related Party Transactions

9 Months Ended

Sep. 30, 2020

Related Party Transactions [Abstract]

Related Party Transactions

Note 8. Related Party Transactions

During the nine months ended September 30, 2020, Talia Jevan Properties, Inc. made payments totaling $10,811 to Stephen Yan-Klassen, former CFO, for his salary on behalf of the Company. Talia Jevan Properties, Inc. is a related party of Harmel Rayat, former Chairman of the Board. The total compensation Talia Jevan Properties, Inc. made to Stephen Yan-Klassen during the three and nine months ended September 30, 2020 was $0 and $10,811, respectively. Subsequent to the period ended September 30, 2020 the $10,811 owed was paid to Talia Jevan Properties, Inc.

On August 1, 2013, the Company entered into a consulting agreement, as amended on May 1, 2016, with Jatinder Bhogal, an individual owning in excess of 5% of the Company’s issued and outstanding shares of common stock, to provide consulting services to the Company through his wholly owned company, Vector Asset Management, Inc. (“VAM”). Pursuant to the consulting agreement VAM assisted the Company with identifying subject matter experts in the medical device and biotechnology industries and assisted the Company with its ongoing research, development and eventual commercialization of its Regeneration Technology. Pursuant to an amendment dated May 1, 2016, the VAM monthly consulting fee was increased from $5,000 to $6,800. On June 22, 2018, the Company and VAM entered into an Executive Consulting Agreement (“ECA”) pursuant to which Mr. Bhogal served as the Company’s Chief Operating Officer. The ECA supersedes the prior consulting agreement. Pursuant to the ECA, VAM will receive compensation of $120,000 per year. On July 1, 2020 the company amended the agreement and will pay VAM $4,000 monthly through December 31, 2020 and $2,000 per month thereafter until May 31, 2021 at which time the agreement will expire. During the three months ended September 30, 2020 and 2019, the Company recognized expenses of $12,000 and $30,000 and during the nine months ended September 30, 2020 and 2019 the Company recognized $72,000 and $90,000 respectively, in expenses and for consulting services provided by VAM. Jatinder Bhogal resigned as the Company’s COO effective June 30, 2020.

Kalen Capital Corp (“KCC”) is wholly owned by Mr. Harmel Rayat, the former Chairman of the Board. On April 1, 2020 KCC provided a short-term advance of $50,000 to the Company. The short-term advance was repaid by the Company to KCC in July 2020. The Company paid KCC $65,156 for reimbursable expenses in October 2020.

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Subsequent Events

9 Months Ended

Sep. 30, 2020

Subsequent Events [Abstract]

Subsequent Events

Note 9. Subsequent Events

Management has reviewed for material events subsequent of the period ended September 30, 2020, and prior to the filing of financial statements in accordance with FASB ASC 855 “Subsequent Events”.

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Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Policies)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation

The accompanying interim unaudited condensed consolidated financial statements and related disclosures of RenovaCare, Inc. and Subsidiary (the “Company”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed on May 14, 2020. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted.

In the opinion of management, the interim condensed consolidated financial statements reflect all adjustments considered necessary for a fair statement of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the year ended December 31, 2020.

Organization

Organization

RenovaCare, Inc. was incorporated on July 14, 1983 in the State of Utah under the name Far West Gold, Inc., and changed its domicile to Nevada in 1997. On January 7, 2014, the Company changed its name at the time from “Janus Resources, Inc.” to “RenovaCare, Inc.” so as to more fully reflect its current operations and business, and changed its trading symbol from “JANI” to “RCAR” effective as of January 9, 2014.

RenovaCare has an authorized capital of 500,000,000 shares of $0.00001 par value common stock, of which 87,352,364 shares are outstanding as of September 30, 2020, and 10,000,000 shares of $0.0001 par value preferred stock, of which none are outstanding.

Overview of Operations

Overview of Operations

The Company focuses on the research, development and commercialization of autologous (using a patient's own cells) cellular therapies that can be used for medical and aesthetic applications.

On July 12, 2013, the Company, through its wholly owned subsidiary, RenovaCare Sciences Corp., completed the acquisition of its flagship technologies (collectively, the “CellMist^TM System”) along with associated United States patent applications and two foreign patent applications, all of which have been granted. In August 2019, the Company was awarded a continuation of a patent allowing the Company’s novel solution sprayer device (the “SkinGun^TM”) to be used to spray all varieties of tissues and cells, thus allowing for its potential application in the regeneration of tissues and organs, beyond skin.

The CellMist^TM System is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “CellMist^TM Solution”) and (b) the SkinGun^TM for delivering the cells to the treatment area. In August 2020, the Company announced that the US Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous skin and pluripotent stem cells rendered by its manual CellMist™ System from donor skin and applied topically with the electronic SkinGun™ spray device for treatment of acute burn wounds. The clinical trial protocol is an open-label single-arm clinical study that will enroll 14 adult human burn subjects with partial-thickness, second-degree thermal burn wounds covering between 10 and 30% total body surface area. The Company expects to conduct the clinical study at four (4) U.S. burn centers commencing in 2021.

Improvements in the design and efficiency of the CellMist™ System including a closed, self-contained, semi-automated sterile cell isolation device and the SkinGun™ spray device are in development with StemCell Systems (Berlin, Germany), the Company’s R&D innovation partner. The Company is adapting its core technologies for possible use in other clinical indications. The Company is also developing the cell isolation and spray gun devices as stand-alone 510 (k)-cleared products for isolation of cells from other tissues and spraying other solutions of medical importance.

The Company does not have any commercialized products. The Company's activities have consisted principally of performing research and development activities and raising capital to support such activities. The Company has enlisted the assistance of several Contract Manufacturing Organizations (CMO) to manufacture clinical supplies including components of the CellMist System™ and the electronic SkinGun™ spray devices in compliance with FDA’s guidance for current Good Manufacturing Practices (cGMP) and Contract Research Organizations (CRO) to conduct clinical trials to evaluate the safety and feasibility of an autologous skin cell therapy using the Company’s products to facilitate burn wound healing. These development activities are subject to significant risks and uncertainties, including possible failure of preclinical and clinical testing. The Company has not generated any revenue and has sustained recurring losses and negative cash flows from operations since inception. The Company expects to incur losses as it continues development of its products and technologies and expects that it will need to raise additional capital through partnerships or the sale of its securities to accomplish its business plan. Failing to secure such additional funding before achieving sustainable revenue and profit from operations poses a significant risk. The Company's ability to fund the development of its cellular therapies depends on the amount and timing of cash receipts from future financing activities. There can be no assurance as to the availability or terms upon which such financing and capital might be available. Additionally, there is significant uncertainty relating to the full impact of the COVID-19 pandemic on the Company’s operations and capital requirements. Should financing when needed be unavailable or prohibitively expensive or the COVID-19 pandemic continue, it may adversely affect the Company’s ability to (i) retain employees and consultants; (ii) obtain additional financing on terms acceptable to the Company, if at all; (iii) delay regulatory submissions and approvals; (iv) delay, limit or preclude the Company from securing clinical study sites; (v) delay, limit or preclude the Company from achieving technology or product development goals, milestones, or objectives; and (vi) preclude or delay entry into joint venture or partnership arrangements. The occurrence of any one or more of such events may affect the Company’s ability to continue on its pathway to commercialization of its technology or products.

Liquidity

Liquidity

As of September 30, 2020, the Company had $8,671,295 of cash on hand and cash equivalents, and working capital of $8,182,984. As a result, the Company believes it currently has sufficient cash to meet its funding requirements over the next twelve months following the issuance of this Quarterly Report on Form 10-Q. However, the Company has experienced and continues to experience negative cash flows from operations, as well as an ongoing requirement for substantial additional capital investment. The Company expects that it may need to raise additional capital to accomplish its business plan over the next several years. There can be no assurance as to the availability or terms upon which such financing and capital might be available. See “Overview of Operations” above.

New Accounting Standards

New Accounting Standards

Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative non-governmental U.S. GAAP as found in the Financial Accounting Standards Board's Accounting Standards Codification.

In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. ASU 2019-12 is effective for the Company beginning in fiscal 2021. The Company is currently assessing the impact that this pronouncement will have on its consolidated financial statements.

The Company reviews new accounting standards as issued. Although some of these accounting standards issued or effective after the end of the Company’s previous fiscal year may be applicable, the Company has not identified any standards that the Company believes merit further discussion other than as discussed above. The Company believes that none of the new standards will have a significant impact on the financial statements.

Earnings (Loss) Per Share

Earnings (Loss) Per Share

The Company presents both basic and diluted earnings per share ("EPS") amounts. Basic EPS is calculated by dividing net income (loss) by the weighted average number of common shares outstanding during the period presented. Diluted EPS amounts are based upon the weighted average number of common and common equivalent shares outstanding during the period presented. The Company has not included the effects of warrants or stock on net loss per share because to do so would be antidilutive.

Following is the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
Basic and Diluted EPS Computation
Numerator:
Loss available to common stockholders'	$	(2,817,964	)	$	(1,116,050	)	$	(7,004,310	)	$	(2,182,820	)
Denominator:
Weighted average number of common shares outstanding		87,352,364			87,243,352			87,352,364			87,198,132
Basic and diluted EPS	$	(0.03	)	$	(0.01	)		(0.08	)	$	(0.03	)

The shares listed below were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods presented:

Stock options	5,883,070	317,500	5,883,070	317,500
Warrants	12,296,912	13,106,912	12,296,912	13,106,912
Total shares not included in the computation of diluted losses per share	18,179,982	13,242,412	18,179,982	13,424,412

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Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Tables)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Summary of computation of basic and diluted net loss per share

Following is the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
Basic and Diluted EPS Computation
Numerator:
Loss available to common stockholders'	$	(2,817,964	)	$	(1,116,050	)	$	(7,004,310	)	$	(2,182,820	)
Denominator:
Weighted average number of common shares outstanding		87,352,364			87,243,352			87,352,364			87,198,132
Basic and diluted EPS	$	(0.03	)	$	(0.01	)		(0.08	)	$	(0.03	)

The shares listed below were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods presented:

Stock options	5,883,070	317,500	5,883,070	317,500
Warrants	12,296,912	13,106,912	12,296,912	13,106,912
Total shares not included in the computation of diluted losses per share	18,179,982	13,242,412	18,179,982	13,424,412

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Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2020

Notes to Financial Statements

Other Current Assets

Other current assets consist of the following:

	September 30,		December 31,
	2020		2019
Prepaid insurance	$	108,360	$	-
Prepaid stock options for services		86,999		-
Prepaid professional fees		65,000		102,500
Other prepaid costs		13,247		-
Total prepaid expenses	$	273,606	$	102,500

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Common Stock and Warrants (Tables)

9 Months Ended

Sep. 30, 2020

Equity [Abstract]

Summary of warrants outstanding

The following table summarizes information about warrants outstanding at September 30, 2020 and December 31, 2019:

		Shares of Common Stock Issuable from Warrants Outstanding as of				Weighted
		September 30,		December 31,		Average
Description		2020		2019		Exercise Price		Expiration
	Series D		-		810,000	$	1.10	June 5, 2020
	Series E		584,416		584,416	$	1.54	September 8, 2021
	Series F		7,246		7,246	$	3.45	February 23, 2022 & March 9, 2022
	Series G		460,250		460,250	$	2.68	July 21, 2022
	Series H		910,000		910,000	$	2.75	October 16, 2022
	Series I		10,335,000		10,335,000	$	2.00	November 26, 2025
	Total		12,296,912		13,106,912

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Stock Options (Tables)

9 Months Ended

Sep. 30, 2020

Share-based Payment Arrangement [Abstract]

Summary of stock option activity

The following table summarizes stock option activity for the period ended September 30, 2020:

	Number of Options			Weighted Average Exercise Price ($)		Weighted Average Remaining Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding at December 31, 2019		2,317,500			2.68		5.68	$	1,460,507
Grants		3,565,570			2.30		-		-
Forfeited		(37,500	)		4.20		-		-
Outstanding at September 30, 2020		5,845,570			2.46		5.38	$	7,200,064
Vested and Exercisable at September 30, 2020		1,402,499			2.07		5.39		2,322,524
Available for grant at September 30, 2020		13,912,695

Summary of assumption of stock option activity

The assumptions for volatility, expected life, dividend yield and risk-free interest rate for the options granted are as follows:

	Nine Months Ended
	September 30, 2020
Risk-free interest rate	0.21%	-	1.67%
Expected life in years	3.25	-	6.00
Expected Volatility	103.56%	-	110.71%
Expected dividend yield		0%

Summary of consolidated statement of operations

As of September 30, 2020, the Company’s unrecognized compensation cost related to unvested stock options was $5,416,522 to be amortized through 2023. Stock-based compensation has been included in the consolidated statement of operations as follows:

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019
Research and development	$	631,876	$	832	$	1,087,047	$	191,275
General and administrative		832,093		-		2,084,953		-
Total	$	1,463,969	$	832	$	3,172,000	$	191,275

Summary of stock options outstanding and exercisable

The following table summarizes information about stock options outstanding and exercisable as of September 30, 2020:

	Stock Options Outstanding						Stock Options Exercisable
Range of Exercise Prices	Number of Shares Subject to Outstanding Options		Weighted Average Contractual Life (years)		Weighted Average Exercise Price		Number of Shares Subject to Options Exercise		Weighted Average Remaining Contractual Life (Years)		Weighted Average Exercise Price
1.05		55,000		3.50		1.05		55,000		3.50		1.05
1.25		7,500		4.71		1.25		7,500		4.71		1.25
1.34		7,500		4.75		1.34		7,500		4.75		1.34
1.40		1,550,000		5.64		1.40		775,000		5.64		1.40
1.65		200,000		5.67		1.65		100,000		5.67		1.65
1.70		7,500		5.04		1.70		7,500		5.04		1.70
1.96		100,000		5.73		1.96		50,000		5.73		1.96
2.28		7,500		5.80		2.28		7,500		5.80		2.28
4.20		195,000		4.26		4.20		195,000		4.26		4.20
1.98		667,800		5.13		1.98		-		-		-
2.48		667,800		5.13		2.48		-		-		-
3.23		664,400		5.13		3.23		-		-		-
3.23		620,571		5.13		3.23		-		-		-
3.19		1,074,999		5.84		3.19		187,499		5.84		3.19
3.17		20,000		5.84		3.17		10,000		5.84		3.17
Total		5,845,570		5.38	$	2.44		1,402,499		5.39	$	2.07

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Leases (Tables)

9 Months Ended

Sep. 30, 2020

Leases [Abstract]

Schedule of supplemental lease information

Supplemental lease information at September 30, 2020:

Right-of-use asset	$	86,587
Short-term operating lease liability	$	44,458
Long-term operating lease liability	$	42,233
Remaining term (years)		1.9
Discount rate		7	%

Supplemental cash flow information for the nine months ended September 30, 2020:

Cash paid for amount included in the measurement of lease liabilities for operating lease	$	13,068
Right-of-use asset obtained in exchange for lease obligation	$	98,402

Schedule of future lease payments

Future lease payments included in the measurement of lease liabilities on the balance sheet at September 30, 2020 for future periods are as follows:

Years ending December 31, 2020,
2020 (remaining)	$	8,712
2021	$	52,787
2022	$	31,213
Total future minimum lease payments	$	92,712
Less imputed interest	$	6,125
Total	$	86,587

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Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Details) - USD ($)	3 Months Ended						9 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
Numerator:
Loss available to common stockholders'	$ (2,817,964)	$ (3,011,593)	$ (1,174,753)	$ (1,116,050)	$ (519,266)	$ (547,504)	$ (7,004,310)	$ (2,182,820)
Denominator:
Weighted average number of common shares outstanding	87,352,364			87,243,352			87,352,364	87,198,132
Basic and diluted EPS	$ (0.03)			$ (0.01)			$ (0.08)	$ (0.03)
The shares listed below were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods presented:
Total shares not included in the computation of diluted losses per share	18,179,982			13,242,412			18,179,982	13,424,412
Stock options [Member]
The shares listed below were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods presented:
Total shares not included in the computation of diluted losses per share	5,883,070			317,500			5,883,070	317,500
Warrants [Member]
The shares listed below were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods presented:
Total shares not included in the computation of diluted losses per share	12,296,912			13,106,912			12,296,912	13,106,912

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Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards (Details Narrative) - USD ($)	Sep. 30, 2020	Dec. 31, 2019	Sep. 30, 2019	Dec. 31, 2018
Accounting Policies [Abstract]
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, Authorized	10,000,000	10,000,000
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.00001	$ 0.00001
Common stock, Authorized	500,000,000	500,000,000
Common stock, shares Issued	87,352,364	87,352,364
Common stock, shares outstanding	87,352,364	87,352,364
Cash	$ 8,671,295	$ 12,185,248	$ 13,374,382	$ 15,397,524
Working capital	$ 8,182,984

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Other Current Assets (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Notes to Financial Statements
Prepaid insurance	$ 108,360	$ 0
Prepaid stock options for services	86,999	0
Prepaid professional fees	65,000	102,500
Other prepaid costs	13,247	0
Total prepaid expenses	$ 273,606	$ 102,500

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Assets - Intellectual Property (Details Narrative) - USD ($)	1 Months Ended
	Jul. 31, 2013	Sep. 30, 2020	Dec. 31, 2019
Intangible Assets		$ 152,854	$ 152,854
Asset purchase agreement [Member] | Dr. Gerlach [Member]
Acquisition related costs	$ 52,852
Closing cash payment	$ 100,002

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Common Stock and Warrants (Details) - $ / shares	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Series D [Member]
Shares of Common Stock Issuable from Warrants Outstanding	0	810,000
Weighted Average Exercise Price	$ 1.1	$ 1.1
Expiration	Jun. 05, 2020
Series E [Member]
Shares of Common Stock Issuable from Warrants Outstanding	584,416	584,416
Weighted Average Exercise Price	$ 1.54	$ 1.54
Expiration	Sep. 08, 2021
Series F [Member]
Shares of Common Stock Issuable from Warrants Outstanding	7,246	7,246
Weighted Average Exercise Price	$ 3.45	$ 3.45
Series F [Member] | Minimum [Member]
Expiration	Feb. 23, 2022
Series F [Member] | Maximum [Member]
Expiration	Mar. 09, 2022
Series G [Member]
Shares of Common Stock Issuable from Warrants Outstanding	460,250	460,250
Weighted Average Exercise Price	$ 2.68	$ 2.68
Expiration	Jul. 21, 2022
Series H [Member]
Shares of Common Stock Issuable from Warrants Outstanding	910,000	910,000
Weighted Average Exercise Price	$ 2.75	$ 2.75
Expiration	Oct. 16, 2022
Series I [Member]
Shares of Common Stock Issuable from Warrants Outstanding	10,335,000	10,335,000
Weighted Average Exercise Price	$ 2	$ 2
Expiration	Nov. 26, 2025
Warrants [Member]
Shares of Common Stock Issuable from Warrants Outstanding	12,296,912	13,106,912

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Common Stock and Warrants (Details Narrative) - $ / shares	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Common stock, Authorized	500,000,000	500,000,000
Common stock, par value	$ 0.00001	$ 0.00001
Common stock, shares outstanding	87,352,364	87,352,364
Number of shares available for grant under incentive plan	20,000,000
Number of options granted	13,912,695
Employees and Consultants [Member]
Number of options granted	3,565,570

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Stock Options (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Number of Options
Options outstanding - beginning balance	2,317,500
Options granted	3,565,570
Options forfeited	(37,500)
Options oustanding - ending balance	5,845,570	2,317,500
Vested and Exercisable	1,402,499
Options available for grant	13,912,695
Weighted average exercise price
Options outstanding - beginning balance	$ 2.68
Options granted	2.3
Options forfeited	4.2
Options outstanding - ending balance	2.46	$ 2.68
Vested and Exercisable	$ 2.07
Weighted average remaining contracted term
Options outstanding	5 years 4 months 17 days	5 years 8 months 5 days
Vested and Exercisable	5 years 4 months 20 days
Aggregate intrinsic value
Options outstanding - beginning balance	$ 1,460,507
Options oustanding - ending balance	7,200,064	$ 1,460,507
Vested and Exercisable	$ 2,322,524

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Stock Options (Details 1)	9 Months Ended
	Sep. 30, 2020
Expected dividend yield	0.00%
Minimum [Member]
Risk-free interest rate	0.21%
Expected life in years	3 years 2 months 30 days
Expected Volatility	103.56%
Maximum [Member]
Risk-free interest rate	1.67%
Expected life in years	6 years
Expected Volatility	110.71%

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Stock Options (Details 2) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Total	$ 1,463,969	$ 832	$ 3,172,000	$ 191,275
Stock Option [Member] | Research and development[Member]
Total	631,876	832	1,087,047	191,275
Stock Option [Member] | General and administrative [Member]
Total	$ 832,093		$ 2,084,953

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Stock Options (Details 3)	9 Months Ended
	Sep. 30, 2020 $ / shares shares
Number of Shares Subject to Outstanding Options | shares	5,845,570
Weighted Average Contractual Life (years)	5 years 4 months 17 days
Weighted Average Exercise Price	$ 2.44
Number of Shares Subject To Options Exercise | shares	1,402,499
Weighted Average Remaining Contractual Life (Years)	5 years 4 months 20 days
Weighted Average Exercise Price	$ 2.07
Exercise Price Range One [Member]
Range of Exercise Prices	$ 1.05
Number of Shares Subject to Outstanding Options | shares	55,000
Weighted Average Contractual Life (years)	3 years 6 months
Weighted Average Exercise Price	$ 1.05
Number of Shares Subject To Options Exercise | shares	55,000
Weighted Average Remaining Contractual Life (Years)	3 years 6 months
Weighted Average Exercise Price	$ 1.05
Exercise Price Range Two [Member]
Range of Exercise Prices	$ 1.25
Number of Shares Subject to Outstanding Options | shares	7,500
Weighted Average Contractual Life (years)	4 years 8 months 16 days
Weighted Average Exercise Price	$ 1.25
Number of Shares Subject To Options Exercise | shares	7,500
Weighted Average Remaining Contractual Life (Years)	4 years 8 months 16 days
Weighted Average Exercise Price	$ 1.25
Exercise Price Range Three [Member]
Range of Exercise Prices	$ 1.34
Number of Shares Subject to Outstanding Options | shares	7,500
Weighted Average Contractual Life (years)	4 years 9 months
Weighted Average Exercise Price	$ 1.34
Number of Shares Subject To Options Exercise | shares	7,500
Weighted Average Remaining Contractual Life (Years)	4 years 9 months
Weighted Average Exercise Price	$ 1.34
Exercise Price Range Four [Member]
Range of Exercise Prices	$ 1.4
Number of Shares Subject to Outstanding Options | shares	1,550,000
Weighted Average Contractual Life (years)	5 years 7 months 21 days
Weighted Average Exercise Price	$ 1.4
Number of Shares Subject To Options Exercise | shares	775,000
Weighted Average Remaining Contractual Life (Years)	5 years 7 months 21 days
Weighted Average Exercise Price	$ 1.4
Exercise Price Range Five [Member]
Range of Exercise Prices	$ 1.65
Number of Shares Subject to Outstanding Options | shares	200,000
Weighted Average Contractual Life (years)	5 years 8 months 2 days
Weighted Average Exercise Price	$ 1.65
Number of Shares Subject To Options Exercise | shares	100,000
Weighted Average Remaining Contractual Life (Years)	5 years 8 months 2 days
Weighted Average Exercise Price	$ 1.65
Exercise Price Range Six [Member]
Range of Exercise Prices	$ 1.7
Number of Shares Subject to Outstanding Options | shares	7,500
Weighted Average Contractual Life (years)	5 years 15 days
Weighted Average Exercise Price	$ 1.7
Number of Shares Subject To Options Exercise | shares	7,500
Weighted Average Remaining Contractual Life (Years)	5 years 15 days
Weighted Average Exercise Price	$ 1.7
Exercise Price Range Seven [Member]
Range of Exercise Prices	$ 1.96
Number of Shares Subject to Outstanding Options | shares	100,000
Weighted Average Contractual Life (years)	5 years 8 months 23 days
Weighted Average Exercise Price	$ 1.96
Number of Shares Subject To Options Exercise | shares	50,000
Weighted Average Remaining Contractual Life (Years)	5 years 8 months 23 days
Weighted Average Exercise Price	$ 1.96
Exercise Price Range Eight [Member]
Range of Exercise Prices	$ 2.28
Number of Shares Subject to Outstanding Options | shares	7,500
Weighted Average Contractual Life (years)	5 years 9 months 18 days
Weighted Average Exercise Price	$ 2.28
Number of Shares Subject To Options Exercise | shares	7,500
Weighted Average Remaining Contractual Life (Years)	5 years 9 months 18 days
Weighted Average Exercise Price	$ 2.28
Exercise Price Range Nine [Member]
Range of Exercise Prices	$ 4.2
Number of Shares Subject to Outstanding Options | shares	195,000
Weighted Average Contractual Life (years)	4 years 3 months 4 days
Weighted Average Exercise Price	$ 4.2
Number of Shares Subject To Options Exercise | shares	195,000
Weighted Average Remaining Contractual Life (Years)	4 years 3 months 4 days
Weighted Average Exercise Price	$ 4.2
Exercise Price Range Ten [Member]
Range of Exercise Prices	$ 1.98
Number of Shares Subject to Outstanding Options | shares	667,800
Weighted Average Contractual Life (years)	5 years 1 month 16 days
Weighted Average Exercise Price	$ 1.98
Number of Shares Subject To Options Exercise | shares
Weighted Average Exercise Price
Exercise Price Range Eleven [Member]
Range of Exercise Prices	$ 2.48
Number of Shares Subject to Outstanding Options | shares	667,800
Weighted Average Contractual Life (years)	5 years 1 month 16 days
Weighted Average Exercise Price	$ 2.48
Number of Shares Subject To Options Exercise | shares
Weighted Average Exercise Price
Exercise Price Range Twelve [Member]
Range of Exercise Prices	$ 3.23
Number of Shares Subject to Outstanding Options | shares	664,400
Weighted Average Contractual Life (years)	5 years 1 month 16 days
Weighted Average Exercise Price	$ 3.23
Number of Shares Subject To Options Exercise | shares
Weighted Average Exercise Price
Exercise Price Range Thirteen [Member]
Range of Exercise Prices	$ 3.23
Number of Shares Subject to Outstanding Options | shares	620,571
Weighted Average Contractual Life (years)	5 years 1 month 16 days
Weighted Average Exercise Price	$ 3.23
Number of Shares Subject To Options Exercise | shares
Weighted Average Exercise Price
Exercise Price Range Fourteen [Member]
Range of Exercise Prices	$ 3.19
Number of Shares Subject to Outstanding Options | shares	1,074,999
Weighted Average Contractual Life (years)	5 years 10 months 3 days
Weighted Average Exercise Price	$ 3.19
Number of Shares Subject To Options Exercise | shares	187,499
Weighted Average Remaining Contractual Life (Years)	5 years 10 months 3 days
Weighted Average Exercise Price	$ 3.19
Exercise Price Range Fifteen [Member]
Range of Exercise Prices	$ 3.17
Number of Shares Subject to Outstanding Options | shares	20,000
Weighted Average Contractual Life (years)	5 years 10 months 3 days
Weighted Average Exercise Price	$ 3.17
Number of Shares Subject To Options Exercise | shares	10,000
Weighted Average Remaining Contractual Life (Years)	5 years 10 months 3 days
Weighted Average Exercise Price	$ 3.17

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Stock Options (Details Narrative) - USD ($)	1 Months Ended				3 Months Ended		9 Months Ended
	Aug. 02, 2020	Jul. 02, 2020	Jun. 22, 2020	May 22, 2020	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Stock based compensation expense					$ 1,463,969	$ 832	$ 3,172,100	$ 191,275
Prepaid expenses					273,606		273,606		$ 102,500
Unrecognized compensation cost					5,416,522		$ 5,416,522
Number of options granted							13,912,695
Exercise price							$ 2.3
Alan L. Rubino [Member]
Number of options granted							620,571
Exercise price							$ 3.23
Two Consultants and Board Member [Member]
Number of options granted				1,550,000
Exercise price				$ 1.40
Robin Robinson [Member]
Number of options granted							200,000
Exercise price							$ 1.65
Robert Cook [Member]
Number of options granted			100,000
Exercise price			$ 1.96
Lydia M. Evans [Member]
Number of options granted	20,000
Exercise price	$ 3.17
Options vested	10,000
StemCell Systems GmbH [Member]
Number of options granted		999,999
Options vested, description		The option grant vests as follows: (i) 99,999 on July 29, 2020, (ii) 900,000 in equal 36 monthly installments beginning on August 31, 2020
StemCell Systems GmbH [Member]
Prepaid expenses					$ 260,997		$ 260,997

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Leases (Details) - USD ($)	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Leases [Abstract]
Right-of-use asset	$ 86,587	$ 0
Short-term operating lease liability	44,458	0
Long-term operating lease liability	$ 42,233	$ 0
Remaining term (years)	1 year 10 months 25 days
Discount rate	7.00%
Cash paid for amount included in the measurement of lease liabilities for operating lease	$ 13,068
Right-of-use asset obtained in exchange for lease obligation	$ 98,402

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Leases (Details 1) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Leases [Abstract]
2020 (remaining)	$ 8,712
2021	52,787
2022	31,213
Total future minimum lease payments	92,712
Less imputed interest	(6,125)
Total	$ 86,587	$ 0

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Leases (Details Narrative)	9 Months Ended
	Sep. 30, 2020 USD ($)
Leases [Abstract]
Lease term	2 years
Base rent for First year	$ 4,356
Base rent for Second year	$ 4,459

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Commitments (Details Narrative) - USD ($)		3 Months Ended		9 Months Ended
	Jun. 03, 2019	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Company agreement expense		$ 125,655	$ 100,000	$ 400,612	$ 223,175
Charitable Gift Agreement [Member] | University of Pittsburgh
Donation	$ 250,000
Payment of donations		$ 62,500	$ 0	$ 62,500	$ 62,500

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Related Party Transactions (Details Narrative) - USD ($)	1 Months Ended		3 Months Ended		9 Months Ended
	Oct. 31, 2020	Jun. 22, 2018	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Apr. 02, 2020
Vector Asset Management, Inc [Member]
Compensation expense		$ 120,000
Payment of compensation, description		On July 1, 2020 the company amended the agreement and will pay VAM $4,000 monthly through December 31, 2020 and $2,000 per month thereafter until May 31, 2021 at which time the agreement will expire
Consulting services, expense			$ 12,000	$ 30,000	$ 72,000	$ 90,000
Stephen Yan-Klesson
Related Party expenses					10,811
Compensation expense			$ 0		$ 10,811
Kalen Capital Corp [Member]
Short-term advance							$ 50,000
Kalen Capital Corp [Member] | Subsequent Event [Member]
Payment to related party	$ 65,156