0001171843-19-003364.txt : 20190515 0001171843-19-003364.hdr.sgml : 20190515 20190514175255 ACCESSION NUMBER: 0001171843-19-003364 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 44 CONFORMED PERIOD OF REPORT: 20190331 FILED AS OF DATE: 20190515 DATE AS OF CHANGE: 20190514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RenovaCare, Inc. CENTRAL INDEX KEY: 0001016708 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 980170247 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-30156 FILM NUMBER: 19824198 BUSINESS ADDRESS: STREET 1: 9375 E. SHEA BLVD. STREET 2: SUITE 107-A CITY: SCOTTSDALE STATE: AZ ZIP: 85260 BUSINESS PHONE: 888-398-0202 MAIL ADDRESS: STREET 1: 9375 E. SHEA BLVD. STREET 2: SUITE 107-A CITY: SCOTTSDALE STATE: AZ ZIP: 85260 FORMER COMPANY: FORMER CONFORMED NAME: Janus Resources, Inc. DATE OF NAME CHANGE: 20110110 FORMER COMPANY: FORMER CONFORMED NAME: ENTHEOS TECHNOLOGIES INC DATE OF NAME CHANGE: 20001002 FORMER COMPANY: FORMER CONFORMED NAME: WHATSONLINE COM INC DATE OF NAME CHANGE: 19990722 10-Q 1 f10q_051319.htm FORM 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 March 31, 2019

 

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

 

Commission file number 000-30156

 

  RENOVACARE, INC.  
  (Exact name of registrant as specified in its charter)  

 

Nevada   98-0384030
(State or other jurisdiction of incorporation)   (I.R.S. Employer Identification No.)
     

9375 E. Shea Blvd., Suite 107-A,

Scottsdale, AZ 85260

  888-398-0202
(Address of principal executive offices)   (Registrant's telephone number, including area code)

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 ☒ (Do not check if a smaller reporting company)  
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 ☒

 

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

 

As of May 8, 2019, the registrant had 87,175,522 shares of its common stock, par value $0.00001 per share, issued and outstanding.

 

 

 

 

 

RENOVACARE, INC.

FORM 10-Q

For The Quarter Ended March 31, 2019

 

TABLE OF CONTENTS

 

    Page #  
PART I - FINANCIAL INFORMATION      
         
Item 1. Financial Statements      
  Consolidated Balance Sheets   1  
  Consolidated Statements of Operations   2  
  Consolidated Statements of Stockholders’ Equity   3  
  Consolidated Statements of Cash Flows   4  
  Notes to Consolidated Financial Statements   5  
         
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations   11  
         
Item 3. Quantitative and Qualitative Disclosures About Market Risk   20  
         
Item 4. Controls and Procedures   20  
         
PART II - OTHER INFORMATION
       
Item 1. Legal Proceedings   21  
         
Item 1A. Risk Factors   21  
         
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   21  
         
Item 6. Exhibits   22  
         
Signatures   23  

 

 

 

 

 

 

PART I

Item 1. Financial Statements

 

RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
AS OF MARCH 31, 2019 AND DECEMBER 31, 2018

 

   March 31,
2019
  December 31,
2018
ASSETS  (Unaudited)   
Current assets          
Cash and cash equivalents  $14,943,550   $15,397,524 
Prepaid expenses and deposits   138,655    168,707 
Total current assets   15,082,205    15,566,231 
           
Equipment, net of accumulated depreciation of $766 and $687, respectively   185    264 
Intangible assets   152,854    152,854 
Total assets  $15,235,244   $15,719,349 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
           
Current liabilities          
Accounts payable and accrued liabilities  $249,492   $222,163 
Accounts payable - related parties   10,000    3,000 
Interest payable to related parties   167,497    167,497 
Total current liabilities   426,989    392,660 
           
Total liabilities   426,989    392,660 
           
Commitments and contingencies          
           
Stockholders' equity (deficit)          
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, 87,175,522 shares issued and outstanding at March 31, 2019 and December 31, 2018   872    872 
Additional paid-in capital   32,188,412    32,187,580 
Retained deficit   (17,381,029)   (16,861,763)
Total stockholders' equity   14,808,255    15,326,689 
Total liabilities and stockholders' equity  $15,235,244   $15,719,349 

 

(See accompanying notes to unaudited consolidated financial statements)

 

1

 

 

RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
FOR THE THREE MONTHS ENDED MARCH 31, 2019 AND 2018

 

   Three Months Ended
March 31,
   2019  2018
       
Revenue  $-     $-   
           
Operating expense          
Research and development   194,510    125,111 
General and administrative   409,461    449,558 
Total operating expense   603,971    574,669 
           
Loss from operations   (603,971)   (574,669)
           
Other income (expense)          
Interest income   84,705    4,425 
Interest expense   -      (20,465)
Accretion of debt discount   -      (58,438)
Total other income (expense)   84,705    (74,478)
           
Net loss  $(519,266)  $(649,147)
           
Basic and Diluted Loss per Common Share  $(0.01)  $(0.01)
           
Weighted average number of common shares outstanding - basic and diluted   87,175,522    76,498,552 

 

(See accompanying notes to unaudited consolidated financial statements)

 

2

 

 

RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

 

 

 

FOR THE THREEMONTHS ENDED MARCH 31, 2019     
           Additional         Total  
   Common Stock    Paid-in      Retained      Stockholders'  
     Shares      Amount      Capital      Deficit      Equity  
Balance, January 1, 2019   87,175,522   $872   $32,187,580   $(16,861,763)  $15,326,689 
                          
Stock based compensation due to common stock purchase options   -    -    832    -    832 
Net loss for the three months ended March 31, 2019   -    -    -    (519,266)   (519,266)
Balance, March 31, 2019   87,175,522   $872   $32,188,412   $(17,381,029)  $14,808,255 
                          
FOR THE THREEMONTHS ENDED MARCH 31, 2018                         
                          
Balance, January 1, 2018   76,145,418   $762   $16,404,673   $(14,740,922)  $1,664,513 
                          
Issuance of common stock from the exercise of warrants   569,797    6    109,994    -    110,000 
Issuance of common stock from the exercise of stock options   125,307    1    (1)   -    - 
Stock based compensation due to common stock purchase options   -    -    122,497    -    122,497 
Net loss for the three months ended March 31, 2018   -    -    -    (649,147)   (649,147)
Balance, March 31, 2018   76,840,522   $769   $16,637,163   $(15,390,069)  $1,247,863 

 

 

(See accompanying notes to unaudited consolidated financial statements)

 

 

3

 

 

RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
FOR THE THREE MONTHS ENDED MARCH 31, 2019 AND 2018

 

 
 
 
 
Three Months Ended
March 31,
   2019  2018
Cash flows from operating activities          
Net loss  $(519,266)  $(649,147)
Adjustments to reconcile net loss to net cash flows used in from operating activities          
Depreciation   79    79 
Stock based compensation expense   832    122,497 
Accretion of debt discount   -      58,438 
Changes in operating assets and liabilities:          
Decrease (increase) in prepaid expenses   30,052    (351)
Increase (decrease) in accounts payable   27,329    (86,174)
Increase (decrease) in accounts payable - related parties   7,000    2,814 
Increase (decrease) in interest payable - related parties   -      20,466 
Increase (decrease) in contract payable   -      (100,000)
Net cash flows used in from operating activities   (453,974)   (631,378)
           
           
Cash flows from financing activities          
Proceeds from exercise of warrants and issuance of common stock   -      110,000 
Net cash flows from financing activities   -      110,000 
           
Increase (decrease) in cash and cash equivalents   (453,974)   (521,378)
           
Cash and cash equivalents at beginning of period   15,397,524    2,906,237 
           
Cash and cash equivalents at end of period  $14,943,550   $2,384,859 
           
Supplemental disclosure of cash flow information:          
Interest paid in cash  $-     $-   
Income taxes paid in cash  $-     $-   

 

(See accompanying notes to unaudited consolidated financial statements)

 

4

 

 

RENOVACARE, INC. AND SUBSIDIARY

NOTES TO UNAUDITED 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 unaudited consolidated financial statements of RenovaCare, Inc. and Subsidiary(the “Company”) as of March 31, 2019, and for the three months ended March 31, 2019 and 2018, have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States for interim financial reporting and include the Company’s wholly-owned subsidiary, RenovaCare Sciences. Accordingly, they do not include all of the disclosures required by accounting principles generally accepted in the United States for complete financial statements and should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2018, as filed with the Securities and Exchange Commission as part of the Company’s Form 10-K. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the interim financial information have been included. The Company did not record an income tax provision during the periods presented due to net taxable losses. The results of operations for any interim period are not necessarily indicative of the results of operations for the entire year.

 

Organization

 

RenovaCare, Inc., together with its wholly owned subsidiary, focuses on the acquisition, research, development and, if warranted, 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 “CellMistTM System”) along with associated United States patent applications and two foreign patent applications, the first of which was filed on August 23, 2007 (DE 10 2007 040 252.1) and the second of which was filed on April 27, 2011 (DE 10 2011 100 450.9), both of which have been granted. One of the US patent applications was granted on November 29, 2016 (Patent No. US 9,505,000) and the other patent application was granted on April 4, 2017 (Patent No. US 9,610,430).

 

The CellMistTM System is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “CellMistTM Solution”) and (b) a solution sprayer device (the “SkinGunTM”) for delivering the cells to the treatment area. The Company has filed additional patent applications related to the CellMistTM Solution and SkinGunTM technologies.

 

Nature and Continuance of Operations

 

The Company does not have any commercialized products. The Company's activities have consisted principally of performing research and development activities and raising capital. These development activities are subject to significant risks and uncertainties, including possible failure of preclinical testing. The Company has not generated any revenue since inception 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 the sale of its securities to accomplish its business plan and 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 will depend 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.

 

As of March 31, 2019, the Company had $14,943,550 of cash on hand. As a result of the cash on hand, 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. If additional funding is required, the Company expects to seek to obtain that funding through private equity or convertible debt. There can be no assurance as to the availability or terms upon which such financing and capital might be available.

 

5

 

 

The accompanying unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“US GAAP”), which contemplates continuation of the Company as a going concern, which is dependent upon the Company’s ability to establish itself as a profitable business.

 

Applicable Accounting Guidance

 

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

 

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, which supersedes ASC Topic 840, Leases, and creates a new topic, ASC Topic 842, Leases. ASU 2016-02 requires lessees to recognize a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months on its balance sheet. ASU 2016-02 also expands the required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for the Company beginning January 1, 2019. Early adoption is permitted. The Company has determined that the adoption of ASU 2016-02 did not have an impact 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, stock options and convertible debt on net loss per share because to do so would be antidilutive.

 

6

 

 

Following is the computation of basic and diluted net loss per share for the three months ended March 31, 2019 and 2018:

 

   Three Months Ended
March 31,
   2019  2018
Basic and Diluted EPS Computation          
Numerator:          
Loss available to common stockholders'  $(519,266)  $(649,147)
Denominator:          
Weighted average number of common shares outstanding   87,175,522    76,498,552 
Basic and diluted EPS  $(0.01)  $(0.01)
           
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   317,500    357,500 
Warrants   13,346,912    3,011,912 
Convertible debt   -      629,954 
Total shares not included in the computation of diluted losses per share   13,664,412    3,999,366 

 

Note 2. 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 CellMistTM 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 March 31, 2019 and December 31, 2018.

 

Note 3. Common Stock and Warrants

 

Common Stock

 

At March 31, 2019, the Company had 500,000,000 authorized shares of common stock with a par value of $0.00001 per share, 87,175,522 shares of common stock outstanding and 19,440,765 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. No stock awards were made during the three months ended March 31, 2019. See “Note 7. Stock Options” for further discussion.

 

Warrants

 

The following table summarizes information about warrants outstanding at March 31, 2019 and December 31, 2018:

 

   Shares of Common Stock Issuable from Warrants Outstanding as of  Weighted   
Description  March 31,
2019
  December 31,
2018
 

Average

Exercise Price

  Expiration
Series A    240,000    240,000   $0.35   July 12, 2019
Series D    810,000    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    13,346,912    13,346,912         

 

7

 

 

Note 4. Stock Options

 

The following table summarizes stock option activity for the period ended March 31, 2019:

 

   Number of Options  Weighted Average Exercise Price ($)  Weighted Average Remaining Contractual Term  Aggregate Intrinsic Value ($)
Outstanding at December 31, 2018   317,500    3.41           
Outstanding at March 31, 2019   317,500    3.41    7.44 years    29,225 
Exercisable at March 31, 2019   307,500    3.49    7.52 years    24,525 
Available for grant at March 31, 2019   19,440,765                

 

There were no options granted during the three months ended March 31, 2019.

 

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 months ended March 31, 2019 and 2018, the Company recognized $832 and $122,497, respectively, in stock-based compensation. As of March 31, 2019, the Company had no unrecognized compensation cost related to unvested stock options. Stock-based compensation has been included in the unaudited consolidated statement of operations as follows:

 

   Three Months Ended March 31,
   2019  2018
Research and development  $-     $20,875 
General and administrative   832    101,622 
Total  $832   $122,497 

 

The following table summarizes information about stock options outstanding and exercisable at March 31, 2019:

 

   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    5.01    1.05    45,000    5.01    1.05 
1.25   7,500    6.22    1.25    7,500    6.22    1.25 
1.34   7,500    6.26    1.34    7,500    6.26    1.34 
1.70   7,500    6.55    1.70    7,500    6.55    1.70 
2.28   7,500    7.31    2.28    7,500    7.31    2.28 
4.20   232,500    8.12    4.20    232,500    8.12    4.20 
Total   317,500    7.44   $3.41    307,500    7.52   $3.49 

 

8

 

 

Note 5. Commitments

 

In connection with the Company’s anticipated regulatory filings, the Company has engaged StemCell Systems GmbH (“StemCell Systems”) to provide it with prototypes and related documents under various agreements. Pursuant to these engagements the Company incurred expenses of $76,600 and $12,015 in during the three months ended March 31, 2019 and 2018, respectively. Dr. Gerlach, from whom the Company purchased the CellMistTM System technologies, is a principal of StemCell Systems.

 

See also “Note 6. Related Party Transactions.”

 

Note 6. Related Party Transactions

 

As compensation for their service on the Board, Dr. Kirkland receives an annual retainer of $6,000, payable in equal quarterly installments in arrears. Additionally, on March 15, 2016, the Company granted to Dr. Kirkland an incentive stock option to purchase up to 50,000 shares of the Company’s common stock at an exercise price of $1.91 per share; and on May 11, 2017, the Company granted to Dr. Kirkland an incentive stock option to purchase up to 75,000 shares of the Company’s common stock at an exercise price of $4.20 per share. The 50,000 options granted on March 15, 2016 became fully vested upon grant and the 75,000 options granted on May 11, 2017 vested 50% on the date of grant and 50% one year hence. The options may be exercised on a “cashless basis”. On February 22, 2018, Dr. Kirkland exercised all 50,000 of the March 15, 2016 options on a cashless basis and received 41,033 shares of common stock. He has not exercised his May 11, 2017 options. Compensation expense of $0 and $29,654 with respect to these options was recorded during the three months ended March 31, 2019 and 2018 respectively.

 

In connection with the Company’s anticipated FDA and other regulatory filings, the Company engaged StemCell Systems to provide it with prototypes and related documents. Pursuant to these engagements the Company incurred expenses of $76,600 and $12,015 in during the three months ended March 31, 2019 and 2018, respectively. Dr. Gerlach, from whom the Company purchased the CellMistTM System technologies, is a principal of StemCell Systems. Thomas Bold is a business consultant and economic advisor to StemCell Systems.

 

Dr. Gerlach is entitled to payments for consulting services. During the three months ended March 31, 2019 and 2018, the Company recognized expenses related to Dr. Gerlach services of $0 and $4,660, respectively. Accounts payable to Dr. Gerlach amounted to $0 at March 31, 2019 and December 31, 2018.

 

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 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 Vector 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”) whereby Mr. Bhogal will serve 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. During the three months ended March 31, 2019 and 2018, the Company recognized expenses of $30,000 and $20,400, respectively for consulting services provided by VAM.

 

During the year ended December 31, 2018, the Company was offered executive office space located at 9375 E. Shea Blvd., Suite 107-A, Scottsdale, AZ 85260 for consideration of $1 per year. The executive office space is owned indirectly by Harmel S. Rayat, the Company’s majority shareholder and Chairman and CEO.

 

On November 26, 2018, the Company entered into Subscription Agreements with KCC for the purchase and sale of 10,335,000 Units of the Company's equity securities at a price of $1.50 per Unit, pursuant to a private placement offering conducted by the Company for (i) aggregate cash proceeds of $14,407,500 and (ii) conversion of $1,095,000 principal amount of outstanding loan indebtedness. The unpaid interest related to the loan indebtedness totaled $167,497 and is reflected on our balance sheet as a non-interest bearing liability. Each Unit consisted of: (i) one (1) share of common stock; and (ii) one (1) Series I Stock Purchase Warrant to purchase one (1) share of common stock at a price of $2.00 per share for a period of seven (7) years commencing on the date the Warrants were first issued. The Series I Warrants do not have a cashless exercise provision. KCC does not have any registration rights with respect to the shares comprising a part of the Units or issuable upon exercise of the Series I Warrants.

 

9

 

 

Note 7. Subsequent Events

 

Management has reviewed material events subsequent of the period ended March 31, 2019 and prior to the filing of financial statements in accordance with FASB ASC 855 “Subsequent Events”.

 

On May 9, 2019, the Company and StemCell Systems entered into a Research & Development Agreement whereby StemCell Systems will work to advance the Company’s technologies. The Research & Development Agreement is on a work-made-for-hire basis with an 18 month duration and estimated monthly fee of $25,000.

 

 

 

 

 

 

 

10

 

 

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

 

Forward-Looking Statements

 

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this Quarterly Report filed on Form 10-Q. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors.

 

This discussion and analysis should be read in conjunction with the accompanying unaudited interim consolidated financial statements and related notes. The discussion and analysis of the financial condition and results of operations are based upon the unaudited interim consolidated financial statements, 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 of America requires us 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 we review our estimates and assumptions. The estimates were based on historical experience and other assumptions that we believe 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 us 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.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q 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 RenovaCare, Inc. and its subsidiaries 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;
  · the effect on us from adverse publicity related to our products or the company itself; and
  · 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.

 

Overview

 

RenovaCare, Inc. (formerly Janus Resources, Inc.) (together with its wholly owned subsidiary, “RenovaCare” the “Company” “we” “us” and “our”) was incorporated under the laws of the State of Nevada and has an authorized capital of 500,000,000 shares of $0.00001 par value common stock, of which 87,175,522 shares are outstanding as of March 31, 2019, and 10,000,000 shares of $0.0001 par value preferred stock, of which none are outstanding.

 

On January 7, 2014, we filed a Certificate of Amendment to Articles of Incorporation changing our name from “Janus Resources, Inc.” to “RenovaCare, Inc.” so as to more fully reflect our operations. The Financial Industry Regulatory Authority (“FINRA”) declared the name change effective as of January 9, 2014. In conjunction with the name change, we changed our stock symbol on the OTCQB from “JANI” to “RCAR”.

 

Our principal executive offices are located at 9375 East Shea Blvd., Suite 107-A, , Scottsdale, AZ 85260. Our telephone number is (888) 398-0202.

 

Description of Business

 

We are a development-stage company focusing on the acquisition, development and commercialization of autologous (using a patient’s own cells) cellular therapies for medical and aesthetic applications. On July 12, 2013, we, through our wholly owned subsidiary, RenovaCare Sciences Corp., completed the acquisition of our flagship CellMistTM System along with associated United States patent applications and two foreign patent applications, the first of which was filed on August 23, 2007 (DE 10 2007 040 252.1) and the second of which was filed on April 27, 2011 (DE 10 2011 100 450.9), both of which have been granted. One of the US patent applications was granted to us on November 29, 2016 (Patent No. US 9,505,000) and the other patent application was granted to us on April 4, 2017 (Patent No. US 9,610,430). Two additional patent applications are pending.

 

On or about April 11, 2017, we received from Avita Medical a Petition for Inter Partes Review purporting to challenge the validity of the claims in U.S. Patent No. 9,610,430 before the PTAB of the U.S. Patent & Trademark Office. Upon consideration of the arguments and evidence set forth by us and Avita, on December 18, 2017, the PTAB rendered a Final Written Decision dismissing the Petition in its entirety and, accordingly, confirming all such claims. Avita Medical’s right to file an appeal expired on February 21, 2018.

 

In the case of U.S. patents, a typical utility patent term is 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications, from the date on which the earliest such application was filed. Patents filed outside of the U.S. have a patent term typically running 20 years from the date of first filing, but which are determined by the law of the country in which they issue. Patent term may be affected by events such as maintenance (or annuity) fee payment, terminal or statutory disclaimer, post-grant proceedings, patent term adjustment, and/or patent term extension.

 

The development of our CellMistTM 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.

 

The average adult human has a skin surface area of between 16 - 21 square feet, which protects all other organs against the external environment. When a person’s skin is assailed by trauma or exposed to extreme heat, the skin’s various layers may be destroyed and depending on the severity of the injury, might cause life-threatening conditions. Currently, severe trauma to the skin, such as second or third degree burns, requires surgical mesh-grafting of skin, whereby healthy skin is removed from one area of the patient’s body (a “donor site”) and implanted on the damaged area.

 

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While mesh grafting is often the method of choice, there are significant deficiencies with this method. The surgical procedure to remove healthy skin from the donor site can be painful and leaves the patient with a new wound that must also be attended to. In many instances the aesthetic results are not satisfying, as the color of the skin from the donor site may not match the skin color of the damaged skin. Additionally, the size of the donor skin removed must be substantially equal in size to the damaged skin area. These donor and injury sites can take weeks to heal, requiring expensive hospital stays, ongoing wound dressing management, and in some cases, complex anti-infection strategies.

 

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

 

Our Market Opportunity

 

According to medical market research firm, Kalorama Information, the global market for wound care products is projected to grow to approximately $18.3 billion by 2019.

 

Burn Wounds

 

Burns are one of the most common and devastating forms of trauma. Patients with serious thermal injury require immediate specialized 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 265,000 people worldwide die from burn related injuries (see World Health Organization “Burns: Fact Sheet No. 365,” reviewed September 2016, 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 127 centers specializing in burn care. Recent estimates in the U.S. show that 40,000 patients are admitted annually for treatment with burn injuries, 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 for burn injury and skin disorders requiring similar treatment. The other 4,500 U.S. acute care hospitals average less than 3 burn admissions per year (see American Burn Association Burn Incidence and Treatment in the US: 2013 Fact Sheet, available at: http://www.ameriburn.org).

 

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).

 

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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.

 

Our Technology

 

Our cell isolation methodology is referred to as the CellMistTM process, and our cell deposition device is referred to as the SkinGunTM. We isolate a patient's stem cells from a small biopsy of the patient's skin. The stem cells are placed into a liquid solution, which is then filled into a sterile syringe. The syringe is inserted into the SkinGunTM, which then sprays the stem cell-loaded liquid solution into the wound.

 

The first phase of gathering the patient's stem cells, creating a liquid solution, and applying the stem cells takes approximately 1.5–2 hours. Within two weeks following the wound treatment procedure, the skin cells fully generate a normal upper skin layer (re-epithelialization), and within months the skin regains its color and texture.

 

Our cell isolation procedure and the cell spraying are performed on the same day, in an on-site setting. Because the skin cells sprayed using the SkinGunTM are actually the patient's own cells, the skin that is regenerated looks more natural than artificial skin replacements. During recovery, the skin cells grow into fully functional layers of the skin and the regenerated skin leaves minimal scarring. Additionally, our methods require substantially smaller donor areas than skin grafting, reducing donor area burden such as pain and the risk of complications.

 

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

 

Domestic Regulation

 

Governmental authorities in the U.S., at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of products or devices such as those we are attempting to develop. Our device candidates, to the extent they are developed, will be subject to pre-market approval by the FDA prior to their marketing for commercial use in the U.S., and to any approvals required by foreign governmental entities prior to their marketing outside the U.S. In addition, any changes or modifications to a device that has received regulatory clearance or approval that could significantly affect its safety or effectiveness, or would constitute a major change in its intended use, may require the submission of a new application in the U.S. for pre-market approval, or for foreign regulatory approvals outside the U.S.. The process of obtaining foreign approvals, can be expensive, time consuming and uncertain.

 

Premarket Approval

 

We will be required to file for premarket approval (“PMA”) for the SkinGunTM or any other device that we commercialize if it is deemed a Class III medical device. PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, the FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a PMA application under section 515 of the Federal Food, Drug and Cosmetic Act in order to obtain marketing clearance.

 

PMA is the most stringent type of device marketing application required by the FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device.

 

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Investigational Device Exemption (“IDE”)

 

Among the data required in a PMA application is human clinical test data. The FDA’s regulation that governs the human testing is the IDE and other patient protection regulations. For devices that are considered Significant Risk, an IDE application is required. It consists of the proposed clinical protocol and all supporting study documentation and must be submitted and approved by FDA and an Institutional Review Board (IRB) prior to initiation of the human testing. Since the CellMistTM System employs the use of stem cells taken from the patient, it is considered Significant Risk by the FDA; therefore, we will be required to file an IDE application prior to conducting a clinical study for any application, such as for treatment of severe burns. The FDA has a specified review timeline and process for IDE reviews - each review phase takes 30 days and if the FDA has questions or concerns about the study design, there may be multiple review rounds until FDA either: (a) conditionally approves, (b) approves or (c) denies approval of the clinical study conduct under the submitted IDE. There is no guarantee that any IDE application we submit will be approved by the FDA.

 

HIPAA Requirements

 

Other federal legislation may affect our ability to obtain certain health information in conjunction with any research activities we conduct. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), mandates, among other things, the adoption of standards designed to safeguard the privacy and security of individually identifiable health information. In relevant part, the U.S. Department of Health and Human Services (“HHS”), has released two rules to date mandating the use of new standards with respect to such health information. The first rule imposes new standards relating to the privacy of individually identifiable health information. These standards restrict the manner and circumstances under which covered entities may use and disclose protected health information so as to protect the privacy of that information. The second rule released by HHS establishes minimum standards for the security of electronic health information. While we do not believe we are directly regulated as a covered entity under HIPAA, the HIPAA standards impose requirements on covered entities conducting research activities regarding the use and disclosure of individually identifiable health information collected in the course of conducting the research.

 

Other U.S. Regulatory Requirements

 

In the U.S., the research, manufacturing, distribution, sale, and promotion of drug and biological products are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration), other divisions of the U.S. Department of Health and Human Services (e.g., the Office of Inspector General), the U.S. Department of Justice and individual U.S. Attorney offices within the Department of Justice, and state and local governments. For example, sales, marketing and scientific/educational grant programs must comply with the anti-fraud and abuse provisions of the Social Security Act, the False Claims Act, and similar state laws, each as amended. Pricing and rebate programs must comply with the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990 and the Veterans Health Care Act of 1992, each as amended. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal and state consumer protection, unfair competition, and other laws.

 

International Regulation

 

The regulation of any potential product candidates we may produce outside of the U.S. varies by country. Certain countries regulate human tissue products as a biological product, which would require us to make extensive filings and obtain regulatory approvals before selling our product candidates. Certain other countries may classify our product candidates as human tissue for transplantation but may restrict its import or sale. Other countries have no application regulations regarding the import or sale of products similar to potential product candidates, creating uncertainty as to what standards we may be required to meet.

 

Competition

 

The biotechnology, medical device, and wound care industries are characterized by intense competition, rapid product development and technological change. Our CellMistTM System competes with a variety of companies in the wound care markets, many of which offer substantially different treatments for similar problems. Currently Avita Medical Limited is evaluating the efficacy of ReCell, a cell spray device and a cell isolation procedure for autologous cells. Integra Lifesciences Holding Corp. sells Integra Dermal Regeneration Template, which does not use autologous cells, but instead uses an animal-derived intercellular matrix with an artificial waterproof barrier. Other competitors include: MiMedx Group, Inc.; Kinetic Concepts Inc.; Fibrocell Science, Inc.; Shire Plc and Organogenesis, Inc.

 

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Many of our competitors are large, 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.

 

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.

 

In addition to issued patents describe above, we plan to file additional patent applications that, if issued, would provide further protection for The CellMistTM 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.

 

Strategy

 

Our ultimate goal is to leverage the potential of our CellMistTM System, together with our cell isolation method, as cutting edge treatments in skin therapy. 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 CellMistTM System’s safety and efficacy for treating wounds and burns;
   
·formalizing collaborations with universities and scientific partners;
   
·creating a network of clinical and research partners;
   
·achieving FDA and other regulatory clearance; and
   
·expanding the range of possible applications.

 

Additionally, we will likely continue to raise significant capital in order to fund our ongoing research and development operations, and there is no guarantee that we will be able to continue to raise capital on acceptable terms, if at all.

 

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Results of Operations

 

Three Months Ended March 31, 2019 Compared with the Three Months Ended March 31, 2018

 

Operating Expenses

 

A summary of our operating expenses for the three months ended March 31, 2019 and 2018 follows:

 

   Three Months Ended March 31,  Increase /  Percentage
   2019  2018  (Decrease)  Change
Operating expenses                    
Research and development  $194,510   $104,236   $90,274    87%
General and administrative   408,629    347,936    60,693    17%
Stock compensation   832    122,497    (121,665)   -99%
Total operating expenses  $603,971   $574,669   $29,302    5%

 

Research and Development

 

Research and development (“R&D”) costs represent costs incurred to develop our CellMistTM System and are incurred pursuant to agreements with third party providers and certain internal R&D cost allocations. Payments under these agreements include salaries and benefits for R&D personnel, allocated overhead, contract services and other costs. R&D costs are expensed when incurred. R&D costs, excluding stock based compensation, increased during the three months ended March 31, 2019 compared to 2018, as a result of the timing of our R&D expenses.

 

General and Administrative

 

General and administrative costs include all expenditures incurred other than research and development related costs, including costs related to personnel, professional fees, travel and entertainment, public company costs, insurance and other office related costs. Costs increased during the three months ended March 31, 2019 compared to 2018 and included an increase of $186,000 related to professional fees offset by a $123,000 decrease in investor communications costs.

 

Stock Compensation

 

Expense associated with equity based transactions is calculated and expensed in our financial statements as required pursuant to various accounting rules and is non-cash in nature. Stock compensation represents the expense associated with the amortization of our stock options. Stock compensation expense decreased during the quarter ended March 31, 2019 compared to 2018 primarily due to the May 11, 2017 grant of 310,000 stock options with a weighted average grant date fair value of $3.38 per share whereby one-half vested immediately and the second half vested through May 11, 2018; combined with no option grants since, resulted in virtually no expense in 2019 compared to 2018.

 

Other Income (Expense)

 

Other income relates to interest earned on bank account deposits. Other expense relates to our convertible promissory notes. Interest expense relates to the stated interest of the convertible promissory notes. Accretion of debt discount represents the accretion of the discount applied to the notes as a result of the issuance of detachable warrants and the beneficial conversion feature contained in the notes.

 

Liquidity and Capital Resources

 

The Company does not have any commercialized products, has not generated any revenue since inception and has sustained recurring losses and negative cash flows since inception. The Company has incurred recurring operating losses of $603,971 and $574,669 for the three months ended March 31, 2019 and 2018, respectively. The Company expects to incur losses as it continues development of its products and technologies. The Company has been funded through the sale of equity securities. As of March 31, 2019, the Company had $14,943,550 of cash. The Company believes that it currently has sufficient cash to meet its funding requirements over the next year.

 

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Net cash used in operating activities was $453,974 during the three months ended March 31, 2019, compared to net cash used in operating activities of $631,378 during the three months ended March 31, 2018. The decrease in cash used in operating activities is primarily due to the timing of payments of accounts payable and realization of prepaid expenses compared to the prior period.

 

There was no net cash used in investing activities during the three months ended March 31, 2019 and 2018.

 

Net cash provided by financing activities was $0 during three months ended March 31, 2019, compared to $110,000 during the three months ended March 31, 2018. During the three months ended March 31, 2018, the Company received $110,000 from the exercise of 100,000 Series D Warrants at an exercise price of $1.10

 

On November 26, 2018, the Company issued 9,605,000 units of the Company’s equity securities at a price of $1.50 per unit, pursuant to a private placement offering conducted by the Company resulting in $14,407,500 of proceeds to the Company.

 

On November 26, 2018, the Company issued 730,000 units of the Company’s equity securities at a price of $1.50 per unit, pursuant to a private placement offering conducted by the Company resulting in conversion of $1,095,000 principal amount of loan indebtedness.

 

On February 13, 2018, the Company issued 100,000 shares of common stock upon the exercise of a Series D Warrant at an exercise price of $1.10 per share resulting in $110,000 of proceeds to the Company.

 

Fair Value of Financial Instruments and Risks

 

The carrying value of cash and cash equivalents, accounts payable, and contract and contribution payable, approximate their fair value because of the short-term nature of these instruments and their liquidity. It is not practical to determine the fair value of the Company’s notes payable and accrued interest due to the complex terms. Management is of the opinion that the Company is not exposed to significant interest or credit risks arising from these financial instruments.

 

Recently Issued Accounting Standards

 

See Note 1 to our Unaudited 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

 

Our proposed business raises potential conflicts of interests between certain of our officers and directors and us. Certain of our directors are employees or consultants to other companies in the healthcare industry and, to the extent that such other companies may participate in ventures in which we may participate, our directors may have a conflict of interest in negotiating and concluding terms regarding the extent of such participation. In the event that such a conflict of interest arises at a meeting of our directors, a director who has such a conflict will abstain from voting for or against the approval of such participation or such terms. Other than as indicated, we have no other procedures or mechanisms to deal with conflicts of interest. We are not aware of the existence of any conflict of interest as described herein.

 

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The Board is responsible for review, approval, or ratification of “related-person transactions” involving RenovaCare, Inc. or its subsidiaries and related persons. Under SEC rules (Section 404 (d) of Regulation S-K), a related person is a director, officer, nominee for director, or 5% stockholder of the company since the beginning of the previous fiscal year, and their immediate family members. RenovaCare, Inc. is required to report any transaction or series of transactions in which the company or a subsidiary is a participant, and a related person has a direct or indirect material interest where the amount involved exceeds the lesser of $120,000 or one percent of the average of the smaller reporting company’s total assets at year end for the last two completed fiscal years.

 

Other than as disclosed below, during the three months ended March 31, 2019, none of our current directors, officers or principal shareholders, nor any family member of the foregoing, nor, to the best of our information and belief, any of our former directors, senior officers or principal shareholders, nor any family member of such former directors, officers or principal shareholders, has or had any material interest, direct or indirect, in any transaction, or in any proposed transaction which has materially affected or will materially affect us.

 

As compensation for their service on the Board, Dr. Kirkland receives an annual retainer of $6,000, payable in equal quarterly installments in arrears. Additionally, on March 15, 2016, the Company granted to Dr. Kirkland an incentive stock option to purchase up to 50,000 shares of the Company’s common stock at an exercise price of $1.91 per share; and on May 11, 2017, the Company granted to Dr. Kirkland an incentive stock option to purchase up to 75,000 shares of the Company’s common stock at an exercise price of $4.20 per share. The 50,000 options granted on March 15, 2016 became fully vested upon grant and the 75,000 options granted on May 11, 2017 vested 50% on the date of grant and 50% one year hence. The options may be exercised on a “cashless basis” using the formula contained therein. On February 22, 2018, Dr. Kirkland exercised all 50,000 of the March 15, 2016 options on a cashless basis and received 41,033 shares of common stock. He has not exercised his May 11, 2017 options. Compensation expense of $0 and $29,654 with respect to these options was recorded during the three months ended March 31, 2019 and 2018 respectively.

 

In connection with the Company’s anticipated FDA and other regulatory filings, the Company engaged StemCell Systems to provide it with prototypes and related documents. Pursuant to these engagements the Company incurred expenses of $76,600 and $12,015 in during the three months ended March 31, 2019 and 2018, respectively. Dr. Gerlach, from whom the Company purchased the CellMistTM System technologies, is a principal of StemCell Systems. Thomas Bold is a business consultant and economic advisor to StemCell Systems.

 

Dr. Gerlach is entitled to payments for consulting services. During the three months ended March 31, 2019 and 2018, the Company recognized expenses related to Dr. Gerlach services of $0 and $4,660, respectively. Accounts payable to Dr. Gerlach amounted to $0 at March 31, 2019 and December 31, 2018.

 

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 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 Vector 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”) whereby Mr. Bhogal will serve 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. During the three months ended March 31, 2019 and 2018, the Company recognized expenses of $30,000 and $20,400, respectively for consulting services provided by VAM.

 

During the year ended December 31, 2018, the Company was offered executive office space located at 9375 E. Shea Blvd., Suite 107-A, Scottsdale, AZ 85260 for consideration of $1 per year. The executive office space is owned indirectly by Harmel S. Rayat, the Company’s majority shareholder and Chairman and CEO.

 

On November 26, 2018, the Company entered into Subscription Agreements with KCC for the purchase and sale of 10,335,000 Units of the Company's equity securities at a price of $1.50 per Unit, pursuant to a private placement offering conducted by the Company for (i) aggregate cash proceeds of $14,407,500 and (ii) conversion of $1,095,000 principal amount of outstanding loan indebtedness. The unpaid interest related to the loan indebtedness totaled $167,497 and is reflected on our balance sheet as a non-interest bearing liability. Each Unit consisted of: (i) one (1) share of common stock; and (ii) one (1) Series I Stock Purchase Warrant to purchase one (1) share of common stock at a price of $2.00 per share for a period of seven (7) years commencing on the date the Warrants were first issued. The Series I Warrants do not have a cashless exercise provision. KCC does not have any registration rights with respect to the shares comprising a part of the Units or issuable upon exercise of the Series I Warrants.

 

19

 

 

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.

The Company maintains “disclosure controls and procedures,” as such term is defined under Rule 13a-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 March 31, 2019 because of the material weaknesses described below.

 

Based on the COSO criteria, management identified control deficiencies that constitute material weaknesses. A “material weakness”, as defined by COSO, is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is more than a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management has identified the following material weaknesses in our internal control over financial reporting:

 

  · Ineffective control environment due to an insufficient number of independent board members, insufficient oversight of work performed, and the lack of compensating controls over financial reporting due to limited personnel;
     
  · Ineffective design, implementation, and documentation of internal controls impacting financial statement accounts and general controls over technology pertaining to user access and segregation of duties, banking and disbursements, and financial accounting system applications; and
     
  · 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

 

20

 

 

Changes in Internal Control over Financial Reporting

 

The Company continues to take actions to remediate the material weaknesses in our internal controls over financial reporting, including implementing additional processes and controls designed to address the underlying causes associated with the above mentioned material weaknesses. The Company’s internal control implementation and remediation efforts include the following:

 

·On October 22, 2018, we appointed Steve Yan-Klassen, CPA, CMA as our CFO in a effort to provide Sr. financial oversight and increased segregation of duties.
·In April 2019, we hired a CPA to oversee the day-to-day accounting and financial reporting activities in support of our CFO and to further the segregation of duties.
·Performing more extensive reviews of critical estimates, journal entries, complex calculations and the financial close and reporting process.
·Realigning certain roles to provide better segregation of duties and implementing stronger user access controls.
·Implementing IT storage and backup services to ensure the integrity of financial data.

 

We have and will continue to take the necessary steps to implement additional review and approval procedures as applicable to strengthen our controls over the financial reporting and disclosure process. In addition, we continue to create and implement new information technology policies and procedures related to controls over information technology operations and security. To the extent necessary, we may hire additional staff or reassign duties of existing staff in connection with our remediation efforts.

 

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.

 

21

 


Item 6. Exhibits

 

Exhibit No.  Description of Exhibit
4.1  Form of Subscription Agreement for Units Dated November 26, 2018 (Incorporated by reference to Form 8-K filed on November 30, 2018)
4.2  Form of Series I Stock Purchase Warrant dated November 26, 2018 (Incorporated by reference to Form 8-K filed on November 30, 2018)
10.1  Amendment to the February 2017 Loan Agreement dated November 26, 2018 (Incorporated by reference to Form 8-K filed on November 30, 2018)
10.2  Amendment to the September 2016 Loan Agreement as amended dated November 26, 2018 (Incorporated by reference to Form 8-K filed on November 30, 2018)
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.

 

22

 

 

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: May 14, 2019 By: /s/ Harmel S. Rayat  
  Name: Harmel Rayat  
  Title: Chief Executive Officer  
    (Principal Executive Officer)
       
Date: May 14, 2019 By: /s/ Stephen Yan-Klassen  
  Name: Stephen Yan-Klassen  
  Title: Chief Financial Officer  
    (Principal Financial Officer and Principal Accounting Officer)

 

 

 

23

 

EX-31.1 2 exh_311.htm EXHIBIT 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, Harmel S. Rayat, 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: May 14, 2019 By: /s/ Harmel S. Rayat  
  Name: Harmel S. Rayat  
  Title: Chief Executive Officer  
    (Principal Executive Officer)

 

 

 

EX-31.2 3 exh_312.htm EXHIBIT 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, Stephen Yan-Klassen, 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: May 14, 2019 By: /s/ Stephen Yan-Klassen  
  Name: Stephen Yan-Klassen  
  Title: Chief Financial Officer  
    (Principal Financial Officer and Principal Accounting Officer)

 

 

 

EX-32.1 4 exh_321.htm EXHIBIT 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 three months ended March 31, 2019 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: May 14, 2019 By: /s/ Harmel S. Rayat  
  Name: Harmel S. Rayat  
  Title: Chief Executive Officer  
    (Principal Executive Officer)
       
Date: May 14, 2019 By: /s/ Stephen Yan-Klassen  
  Name: Stephen Yan-Klassen  
  Title: Chief Financial Officer  
    (Principal Financial Officer and Principal Accounting Officer)

 

 

 

 

 

 

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Common stock, shares Issued 87,175,522 87,175,522
Common stock, shares outstanding 87,175,522 87,175,522
XML 14 R4.htm IDEA: XBRL DOCUMENT v3.19.1
Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Income Statement [Abstract]    
Revenue
Operating expense    
Research and development 194,510 125,111
General and administrative 409,461 449,558
Total operating expense 603,971 574,669
Loss from operations (603,971) (574,669)
Other income (expense)    
Interest income 84,705 4,425
Interest expense (20,465)
Accretion of debt discount (58,438)
Total other income (expense) 84,705 (74,478)
Net loss $ (519,266) $ (649,147)
Basic and Diluted Loss per Common Share $ (0.01) $ (0.01)
Weighted average number of common shares outstanding - basic and diluted 87,175,522 76,498,552
XML 15 R5.htm IDEA: XBRL DOCUMENT v3.19.1
Consolidated Statements of Stockholders’ Equity - USD ($)
Common Stock
Additional Paid-in Capital
Retained Deficit
Total
Beginning Balance at Dec. 31, 2017 $ 762 $ 16,404,673 $ (14,740,922) $ 1,664,513
Beginning Balance, Shares at Dec. 31, 2017 76,145,418      
Issuance of common stock from the exercise of warrants $ 6 109,994 110,000
Issuance of common stock from the exercise of warrants, shares 569,797      
Issuance of common stock from the exercise of stock options $ 1 (1)
Issuance of common stock from the exercise of stock options, shares 125,307      
Stock based compensation due to common stock purchase options   122,497   122,497
Net loss     (649,147) (649,147)
Ending Balance at Mar. 31, 2018 $ 769 16,637,163 (15,390,069) 1,247,863
Ending Balance, Shares at Mar. 31, 2018 76,840,522      
Beginning Balance at Dec. 31, 2018 $ 872 32,187,580 (16,861,763) 15,326,689
Beginning Balance, Shares at Dec. 31, 2018 87,175,522      
Stock based compensation due to common stock purchase options   832   832
Net loss     (519,266) (519,266)
Ending Balance at Mar. 31, 2019 $ 872 $ 32,188,412 $ (17,381,029) $ 14,808,255
Ending Balance, Shares at Mar. 31, 2019 87,175,522      
XML 16 R6.htm IDEA: XBRL DOCUMENT v3.19.1
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Cash flows from operating activities    
Net loss $ (519,266) $ (649,147)
Adjustments to reconcile net loss to net cash flows used in from operating activities    
Depreciation 79 79
Stock based compensation expense 832 122,497
Accretion of debt discount 58,438
Changes in operating assets and liabilities:    
Decrease (increase) in prepaid expenses 30,052 (351)
Increase (decrease) in accounts payable 27,329 (86,174)
Increase (decrease) in accounts payable - related parties 7,000 2,814
Increase (decrease) in interest payable - related parties 20,466
Increase (decrease) in contract payable (100,000)
Net cash flows used in from operating activities (453,974) (631,378)
Cash flows from financing activities    
Proceeds from exercise of warrants and issuance of common stock 110,000
Net cash flows from financing activities 110,000
Increase (decrease) in cash and cash equivalents (453,974) (521,378)
Cash and cash equivalents at beginning of period 15,397,524 2,906,237
Cash and cash equivalents at end of period 14,943,550 2,384,859
Supplemental disclosure of cash flow information:    
Interest paid in cash
Income taxes paid in cash
XML 17 R7.htm IDEA: XBRL DOCUMENT v3.19.1
Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings Per Share
3 Months Ended
Mar. 31, 2019
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 unaudited consolidated financial statements of RenovaCare, Inc. and Subsidiary(the “Company”) as of March 31, 2019, and for the three months ended March 31, 2019 and 2018, have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States for interim financial reporting and include the Company’s wholly-owned subsidiary, RenovaCare Sciences. Accordingly, they do not include all of the disclosures required by accounting principles generally accepted in the United States for complete financial statements and should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2018, as filed with the Securities and Exchange Commission as part of the Company’s Form 10-K. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the interim financial information have been included. The Company did not record an income tax provision during the periods presented due to net taxable losses. The results of operations for any interim period are not necessarily indicative of the results of operations for the entire year.

 

Organization

 

RenovaCare, Inc., together with its wholly owned subsidiary, focuses on the acquisition, research, development and, if warranted, 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 “CellMistTM System”) along with associated United States patent applications and two foreign patent applications, the first of which was filed on August 23, 2007 (DE 10 2007 040 252.1) and the second of which was filed on April 27, 2011 (DE 10 2011 100 450.9), both of which have been granted. One of the US patent applications was granted on November 29, 2016 (Patent No. US 9,505,000) and the other patent application was granted on April 4, 2017 (Patent No. US 9,610,430).

 

The CellMistTM System is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “CellMistTM Solution”) and (b) a solution sprayer device (the “SkinGunTM”) for delivering the cells to the treatment area. The Company has filed additional patent applications related to the CellMistTM Solution and SkinGunTM technologies.

 

Nature and Continuance of Operations

 

The Company does not have any commercialized products. The Company's activities have consisted principally of performing research and development activities and raising capital. These development activities are subject to significant risks and uncertainties, including possible failure of preclinical testing. The Company has not generated any revenue since inception 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 the sale of its securities to accomplish its business plan and 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 will depend 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.

 

As of March 31, 2019, the Company had $14,943,550 of cash on hand. As a result of the cash on hand, 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. If additional funding is required, the Company expects to seek to obtain that funding through private equity or convertible debt. There can be no assurance as to the availability or terms upon which such financing and capital might be available.

 

The accompanying unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“US GAAP”), which contemplates continuation of the Company as a going concern, which is dependent upon the Company’s ability to establish itself as a profitable business.

 

Applicable Accounting Guidance

 

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

 

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, which supersedes ASC Topic 840, Leases, and creates a new topic, ASC Topic 842, Leases. ASU 2016-02 requires lessees to recognize a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months on its balance sheet. ASU 2016-02 also expands the required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for the Company beginning January 1, 2019. Early adoption is permitted. The Company has determined that the adoption of ASU 2016-02 did not have an impact 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, stock options and convertible debt 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 months ended March 31, 2019 and 2018:

 

    Three Months Ended
March 31,
    2019   2018
Basic and Diluted EPS Computation                
Numerator:                
Loss available to common stockholders'   $ (519,266 )   $ (649,147 )
Denominator:                
Weighted average number of common shares outstanding     87,175,522       76,498,552  
Basic and diluted EPS   $ (0.01 )   $ (0.01 )
                 
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     317,500       357,500  
Warrants     13,346,912       3,011,912  
Convertible debt     -         629,954  
Total shares not included in the computation of diluted losses per share     13,664,412       3,999,366  

XML 18 R8.htm IDEA: XBRL DOCUMENT v3.19.1
Assets - Intellectual Property
3 Months Ended
Mar. 31, 2019
Goodwill and Intangible Assets Disclosure [Abstract]  
Assets - Intellectual Property

Note 2. 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 CellMistTM 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 March 31, 2019 and December 31, 2018.

XML 19 R9.htm IDEA: XBRL DOCUMENT v3.19.1
Common Stock and Warrants
3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
Common Stock and Warrants

Note 3. Common Stock and Warrants

 

Common Stock

 

At March 31, 2019, the Company had 500,000,000 authorized shares of common stock with a par value of $0.00001 per share, 87,175,522 shares of common stock outstanding and 19,440,765 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. No stock awards were made during the three months ended March 31, 2019. See “Note 7. Stock Options” for further discussion.

 

Warrants

 

The following table summarizes information about warrants outstanding at March 31, 2019 and December 31, 2018:

 

    Shares of Common Stock Issuable from Warrants Outstanding as of   Weighted    
Description   March 31,
2019
  December 31,
2018
 

Average

Exercise Price

  Expiration
Series A       240,000       240,000     $ 0.35     July 12, 2019
Series D       810,000       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       13,346,912       13,346,912              

 

XML 20 R10.htm IDEA: XBRL DOCUMENT v3.19.1
Stock Options
3 Months Ended
Mar. 31, 2019
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Stock Options

Note 4. Stock Options

 

The following table summarizes stock option activity for the period ended March 31, 2019:

 

    Number of Options   Weighted Average Exercise Price ($)   Weighted Average Remaining Contractual Term   Aggregate Intrinsic Value ($)
Outstanding at December 31, 2018     317,500       3.41                  
Outstanding at March 31, 2019     317,500       3.41       7.44 years       29,225  
Exercisable at March 31, 2019     307,500       3.49       7.52 years       24,525  
Available for grant at March 31, 2019     19,440,765                          

 

There were no options granted during the three months ended March 31, 2019.

 

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 months ended March 31, 2019 and 2018, the Company recognized $832 and $122,497, respectively, in stock-based compensation. As of March 31, 2019, the Company had no unrecognized compensation cost related to unvested stock options. Stock-based compensation has been included in the unaudited consolidated statement of operations as follows:

 

    Three Months Ended March 31,
    2019   2018
Research and development   $ -       $ 20,875  
General and administrative     832       101,622  
Total   $ 832     $ 122,497  

 

The following table summarizes information about stock options outstanding and exercisable at March 31, 2019:

 

    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       5.01       1.05       45,000       5.01       1.05  
1.25     7,500       6.22       1.25       7,500       6.22       1.25  
1.34     7,500       6.26       1.34       7,500       6.26       1.34  
1.70     7,500       6.55       1.70       7,500       6.55       1.70  
2.28     7,500       7.31       2.28       7,500       7.31       2.28  
4.20     232,500       8.12       4.20       232,500       8.12       4.20  
Total     317,500       7.44       $3.41       307,500       7.52       $3.49  

 

XML 21 R11.htm IDEA: XBRL DOCUMENT v3.19.1
Commitments
3 Months Ended
Mar. 31, 2019
Commitments and Contingencies Disclosure [Abstract]  
Commitments

Note 5. Commitments

 

In connection with the Company’s anticipated regulatory filings, the Company has engaged StemCell Systems GmbH (“StemCell Systems”) to provide it with prototypes and related documents under various agreements. Pursuant to these engagements the Company incurred expenses of $76,600 and $12,015 in during the three months ended March 31, 2019 and 2018, respectively. Dr. Gerlach, from whom the Company purchased the CellMistTM System technologies, is a principal of StemCell Systems.

 

See also “Note 6. Related Party Transactions.”

XML 22 R12.htm IDEA: XBRL DOCUMENT v3.19.1
Related Party Transactions
3 Months Ended
Mar. 31, 2019
Related Party Transactions [Abstract]  
Related Party Transactions

Note 6. Related Party Transactions

 

As compensation for their service on the Board, Dr. Kirkland receives an annual retainer of $6,000, payable in equal quarterly installments in arrears. Additionally, on March 15, 2016, the Company granted to Dr. Kirkland an incentive stock option to purchase up to 50,000 shares of the Company’s common stock at an exercise price of $1.91 per share; and on May 11, 2017, the Company granted to Dr. Kirkland an incentive stock option to purchase up to 75,000 shares of the Company’s common stock at an exercise price of $4.20 per share. The 50,000 options granted on March 15, 2016 became fully vested upon grant and the 75,000 options granted on May 11, 2017 vested 50% on the date of grant and 50% one year hence. The options may be exercised on a “cashless basis”. On February 22, 2018, Dr. Kirkland exercised all 50,000 of the March 15, 2016 options on a cashless basis and received 41,033 shares of common stock. He has not exercised his May 11, 2017 options. Compensation expense of $0 and $29,654 with respect to these options was recorded during the three months ended March 31, 2019 and 2018 respectively.

 

In connection with the Company’s anticipated FDA and other regulatory filings, the Company engaged StemCell Systems to provide it with prototypes and related documents. Pursuant to these engagements the Company incurred expenses of $76,600 and $12,015 in during the three months ended March 31, 2019 and 2018, respectively. Dr. Gerlach, from whom the Company purchased the CellMistTM System technologies, is a principal of StemCell Systems. Thomas Bold is a business consultant and economic advisor to StemCell Systems.

 

Dr. Gerlach is entitled to payments for consulting services. During the three months ended March 31, 2019 and 2018, the Company recognized expenses related to Dr. Gerlach services of $0 and $4,660, respectively. Accounts payable to Dr. Gerlach amounted to $0 at March 31, 2019 and December 31, 2018.

 

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 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 Vector 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”) whereby Mr. Bhogal will serve 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. During the three months ended March 31, 2019 and 2018, the Company recognized expenses of $30,000 and $20,400, respectively for consulting services provided by VAM.

 

During the year ended December 31, 2018, the Company was offered executive office space located at 9375 E. Shea Blvd., Suite 107-A, Scottsdale, AZ 85260 for consideration of $1 per year. The executive office space is owned indirectly by Harmel S. Rayat, the Company’s majority shareholder and Chairman and CEO.

 

On November 26, 2018, the Company entered into Subscription Agreements with KCC for the purchase and sale of 10,335,000 Units of the Company's equity securities at a price of $1.50 per Unit, pursuant to a private placement offering conducted by the Company for (i) aggregate cash proceeds of $14,407,500 and (ii) conversion of $1,095,000 principal amount of outstanding loan indebtedness. The unpaid interest related to the loan indebtedness totaled $167,497 and is reflected on our balance sheet as a non-interest bearing liability. Each Unit consisted of: (i) one (1) share of common stock; and (ii) one (1) Series I Stock Purchase Warrant to purchase one (1) share of common stock at a price of $2.00 per share for a period of seven (7) years commencing on the date the Warrants were first issued. The Series I Warrants do not have a cashless exercise provision. KCC does not have any registration rights with respect to the shares comprising a part of the Units or issuable upon exercise of the Series I Warrants.

XML 23 R13.htm IDEA: XBRL DOCUMENT v3.19.1
Subsequent Events
3 Months Ended
Mar. 31, 2019
Subsequent Events [Abstract]  
Subsequent Events

Note 7. Subsequent Events

 

Management has reviewed material events subsequent of the period ended March 31, 2019 and prior to the filing of financial statements in accordance with FASB ASC 855 “Subsequent Events”.

 

On May 9, 2019, the Company and StemCell Systems entered into a Research & Development Agreement whereby StemCell Systems will work to advance the Company’s technologies. The Research & Development Agreement is on a work-made-for-hire basis with an 18 month duration and estimated monthly fee of $25,000.

 

XML 24 R14.htm IDEA: XBRL DOCUMENT v3.19.1
Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Policies)
3 Months Ended
Mar. 31, 2019
Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation

 

The unaudited consolidated financial statements of RenovaCare, Inc. and Subsidiary(the “Company”) as of March 31, 2019, and for the three months ended March 31, 2019 and 2018, have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States for interim financial reporting and include the Company’s wholly-owned subsidiary, RenovaCare Sciences. Accordingly, they do not include all of the disclosures required by accounting principles generally accepted in the United States for complete financial statements and should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2018, as filed with the Securities and Exchange Commission as part of the Company’s Form 10-K. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the interim financial information have been included. The Company did not record an income tax provision during the periods presented due to net taxable losses. The results of operations for any interim period are not necessarily indicative of the results of operations for the entire year.

Organization

Organization

 

RenovaCare, Inc., together with its wholly owned subsidiary, focuses on the acquisition, research, development and, if warranted, 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 “CellMistTM System”) along with associated United States patent applications and two foreign patent applications, the first of which was filed on August 23, 2007 (DE 10 2007 040 252.1) and the second of which was filed on April 27, 2011 (DE 10 2011 100 450.9), both of which have been granted. One of the US patent applications was granted on November 29, 2016 (Patent No. US 9,505,000) and the other patent application was granted on April 4, 2017 (Patent No. US 9,610,430).

 

The CellMistTM System is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “CellMistTM Solution”) and (b) a solution sprayer device (the “SkinGunTM”) for delivering the cells to the treatment area. The Company has filed additional patent applications related to the CellMistTM Solution and SkinGunTM technologies.

 

Nature and Continuance of Operations

Nature and Continuance of Operations

 

The Company does not have any commercialized products. The Company's activities have consisted principally of performing research and development activities and raising capital. These development activities are subject to significant risks and uncertainties, including possible failure of preclinical testing. The Company has not generated any revenue since inception 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 the sale of its securities to accomplish its business plan and 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 will depend 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.

 

As of March 31, 2019, the Company had $14,943,550 of cash on hand. As a result of the cash on hand, 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. If additional funding is required, the Company expects to seek to obtain that funding through private equity or convertible debt. There can be no assurance as to the availability or terms upon which such financing and capital might be available.

  

The accompanying unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“US GAAP”), which contemplates continuation of the Company as a going concern, which is dependent upon the Company’s ability to establish itself as a profitable business.

 

Applicable Accounting Guidance

Applicable Accounting Guidance

 

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

 

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, which supersedes ASC Topic 840, Leases, and creates a new topic, ASC Topic 842, Leases. ASU 2016-02 requires lessees to recognize a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months on its balance sheet. ASU 2016-02 also expands the required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for the Company beginning January 1, 2019. Early adoption is permitted. The Company has determined that the adoption of ASU 2016-02 did not have an impact 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, stock options and convertible debt on net loss per share because to do so would be antidilutive.

 

6

 

 

Following is the computation of basic and diluted net loss per share for the three months ended March 31, 2019 and 2018:

 

    Three Months Ended
March 31,
    2019   2018
Basic and Diluted EPS Computation                
Numerator:                
Loss available to common stockholders'   $ (519,266 )   $ (649,147 )
Denominator:                
Weighted average number of common shares outstanding     87,175,522       76,498,552  
Basic and diluted EPS   $ (0.01 )   $ (0.01 )
                 
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     317,500       357,500  
Warrants     13,346,912       3,011,912  
Convertible debt     -         629,954  
Total shares not included in the computation of diluted losses per share     13,664,412       3,999,366  
XML 25 R15.htm IDEA: XBRL DOCUMENT v3.19.1
Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Tables)
3 Months Ended
Mar. 31, 2019
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 months ended March 31, 2019 and 2018:

 

    Three Months Ended
March 31,
    2019   2018
Basic and Diluted EPS Computation                
Numerator:                
Loss available to common stockholders'   $ (519,266 )   $ (649,147 )
Denominator:                
Weighted average number of common shares outstanding     87,175,522       76,498,552  
Basic and diluted EPS   $ (0.01 )   $ (0.01 )
                 
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     317,500       357,500  
Warrants     13,346,912       3,011,912  
Convertible debt     -         629,954  
Total shares not included in the computation of diluted losses per share     13,664,412       3,999,366  
XML 26 R16.htm IDEA: XBRL DOCUMENT v3.19.1
Common Stock and Warrants (Tables)
3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
Summary of warrants outstanding

The following table summarizes information about warrants outstanding at March 31, 2019 and December 31, 2018:

 

    Shares of Common Stock Issuable from Warrants Outstanding as of   Weighted    
Description   March 31,
2019
  December 31,
2018
 

Average

Exercise Price

  Expiration
Series A       240,000       240,000     $ 0.35     July 12, 2019
Series D       810,000       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       13,346,912       13,346,912              
XML 27 R17.htm IDEA: XBRL DOCUMENT v3.19.1
Stock Options (Tables)
3 Months Ended
Mar. 31, 2019
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Summary of stock option activity

The following table summarizes stock option activity for the period ended March 31, 2019:

        

    Number of Options   Weighted Average Exercise Price ($)   Weighted Average Remaining Contractual Term   Aggregate Intrinsic Value ($)
Outstanding at December 31, 2018     317,500       3.41                  
Outstanding at March 31, 2019     317,500       3.41       7.44 years       29,225  
Exercisable at March 31, 2019     307,500       3.49       7.52 years       24,525  
Available for grant at March 31, 2019     19,440,765                          
Summary of consolidated statement of operations
    Three Months Ended March 31,
    2019   2018
Research and development   $ -       $ 20,875  
General and administrative     832       101,622  
Total   $ 832     $ 122,497  
Summary of stock options outstanding and exercisable

The following table summarizes information about stock options outstanding and exercisable at March 31, 2019:

 

    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       5.01       1.05       45,000       5.01       1.05  
1.25     7,500       6.22       1.25       7,500       6.22       1.25  
1.34     7,500       6.26       1.34       7,500       6.26       1.34  
1.70     7,500       6.55       1.70       7,500       6.55       1.70  
2.28     7,500       7.31       2.28       7,500       7.31       2.28  
4.20     232,500       8.12       4.20       232,500       8.12       4.20  
Total     317,500       7.44       $3.41       307,500       7.52       $3.49  

        

XML 28 R18.htm IDEA: XBRL DOCUMENT v3.19.1
Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards and Earnings (Details) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Numerator:    
Loss available to common stockholders' $ (519,266) $ (649,147)
Denominator:    
Weighted average number of common shares outstanding 87,175,522 76,498,552
Basic and diluted EPS $ (0.01) $ (0.01)
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 13,664,412 3,999,366
Convertible debt [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 629,954
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 317,500 357,500
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 13,346,912 3,011,912
XML 29 R19.htm IDEA: XBRL DOCUMENT v3.19.1
Basis of Presentation, Organization, Nature and Continuance of Operations, Recent Accounting Standards (Details Narrative) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Mar. 31, 2018
Dec. 31, 2017
Accounting Policies [Abstract]        
Cash and cash equivalents $ 14,943,550 $ 15,397,524 $ 2,384,859 $ 2,906,237
XML 30 R20.htm IDEA: XBRL DOCUMENT v3.19.1
Assets - Intellectual Property (Details Narrative) - USD ($)
1 Months Ended
Jul. 31, 2013
Mar. 31, 2019
Dec. 31, 2018
Intangible Assets   $ 152,854 $ 152,854
Asset purchase agreement [Member] | Dr. Gerlach [Member]      
Acquisition related costs $ 52,852    
Closing cash payment $ 100,002    
XML 31 R21.htm IDEA: XBRL DOCUMENT v3.19.1
Common Stock and Warrants (Details) - $ / shares
3 Months Ended
Mar. 31, 2019
Dec. 31, 2018
Series D [Member]    
Shares of Common Stock Issuable from Warrants Outstanding 810,000 810,000
Weighted Average Exercise Price $ 1.10  
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  
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  
Series G [Member]    
Shares of Common Stock Issuable from Warrants Outstanding 460,250 460,250
Weighted Average Exercise Price $ 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  
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 $ 2.00  
Expiration Nov. 26, 2025  
Series A [Member]    
Shares of Common Stock Issuable from Warrants Outstanding 240,000 240,000
Weighted Average Exercise Price $ 0.35  
Expiration Jul. 12, 2019  
Warrants [Member]    
Shares of Common Stock Issuable from Warrants Outstanding 13,346,912 13,346,912
Minimum [Member] | Series F [Member]    
Expiration Feb. 23, 2022  
Maximum [Member] | Series F [Member]    
Expiration Mar. 09, 2022  
XML 32 R22.htm IDEA: XBRL DOCUMENT v3.19.1
Common Stock and Warrants (Details Narrative) - $ / shares
Mar. 31, 2019
Dec. 31, 2018
Equity [Abstract]    
Common stock, Authorized 500,000,000 500,000,000
Common stock, par value $ 0.00001 $ 0.00001
Common stock, shares outstanding 87,175,522 87,175,522
Number of shares available for grant under incentive plan 19,440,765  
XML 33 R23.htm IDEA: XBRL DOCUMENT v3.19.1
Stock Options (Details )
3 Months Ended
Mar. 31, 2019
USD ($)
$ / shares
shares
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Number of Options outstanding - beginning balance 317,500
Number of Options oustanding - ending balance 317,500
Number of Options Exercisable 307,500
Number of Options Available for grant 19,440,765
Weighted average exercise price, Outstanding - beginning balance | $ / shares $ 3.41
Weighted average exercise price, Outstanding - ending balance | $ / shares 3.41
Weighted average exercise price, Exercisable | $ / shares $ 3.49
Weighted Average Remaining Contractual Term, Oustanding 7 years 5 months 8 days
Weighted Average Remaining Contractual Term, Exercisable 7 years 6 months 7 days
Aggregate intrinsic value, Oustanding | $ $ 29,225
Aggregate intrinsic value, Exercisable | $ $ 24,525
XML 34 R24.htm IDEA: XBRL DOCUMENT v3.19.1
Stock Options (Details 1) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Total $ 832 $ 122,497
Research and development[Member] | Stock Option [Member]    
Total 20,875
General and administrative [Member] | Stock Option [Member]    
Total $ 832 $ 101,622
XML 35 R25.htm IDEA: XBRL DOCUMENT v3.19.1
Stock Options (Details 2)
3 Months Ended
Mar. 31, 2019
$ / shares
shares
Number of Shares Subject to Outstanding Options | shares 317,500
Weighted Average Contractual Life (years) 7 years 5 months 8 days
Weighted Average Exercise Price $ 3.41
Number of Shares Subject To Options Exercise | shares 307,500
Weighted Average Remaining Contractual Life (Years) 7 years 6 months 7 days
Weighted Average Exercise Price $ 3.49
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) 5 years 3 days
Weighted Average Exercise Price $ 1.05
Number of Shares Subject To Options Exercise | shares 45,000
Weighted Average Remaining Contractual Life (Years) 5 years 3 days
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) 6 years 2 months 19 days
Weighted Average Exercise Price $ 1.25
Number of Shares Subject To Options Exercise | shares 7,500
Weighted Average Remaining Contractual Life (Years) 6 years 2 months 19 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) 6 years 3 months 3 days
Weighted Average Exercise Price $ 1.34
Number of Shares Subject To Options Exercise | shares 7,500
Weighted Average Remaining Contractual Life (Years) 6 years 3 months 3 days
Weighted Average Exercise Price $ 1.34
Exercise Price Range Four [Member]  
Range of Exercise Prices $ 1.70
Number of Shares Subject to Outstanding Options | shares 7,500
Weighted Average Contractual Life (years) 6 years 6 months 18 days
Weighted Average Exercise Price $ 1.70
Number of Shares Subject To Options Exercise | shares 7,500
Weighted Average Remaining Contractual Life (Years) 6 years 6 months 18 days
Weighted Average Exercise Price $ 1.70
Exercise Price Range Five [Member]  
Range of Exercise Prices $ 2.28
Number of Shares Subject to Outstanding Options | shares 7,500
Weighted Average Contractual Life (years) 7 years 3 months 21 days
Weighted Average Exercise Price $ 2.28
Number of Shares Subject To Options Exercise | shares 7,500
Weighted Average Remaining Contractual Life (Years) 7 years 3 months 21 days
Weighted Average Exercise Price $ 2.28
Exercise Price Range Six [Member]  
Range of Exercise Prices $ 4.20
Number of Shares Subject to Outstanding Options | shares 232,500
Weighted Average Contractual Life (years) 8 years 1 month 13 days
Weighted Average Exercise Price $ 4.20
Number of Shares Subject To Options Exercise | shares 232,500
Weighted Average Remaining Contractual Life (Years) 8 years 1 month 13 days
Weighted Average Exercise Price $ 4.20
XML 36 R26.htm IDEA: XBRL DOCUMENT v3.19.1
Stock Options (Details Narrative) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]    
Stock based compensation expense $ 832 $ 122,497
XML 37 R27.htm IDEA: XBRL DOCUMENT v3.19.1
Commitments (Details Narrative) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Commitments and Contingencies Disclosure [Abstract]    
Company agreement expense $ 76,600 $ 12,015
XML 38 R28.htm IDEA: XBRL DOCUMENT v3.19.1
Related Party Transactions (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 12 Months Ended
Nov. 26, 2018
Feb. 22, 2018
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
May 11, 2017
Mar. 15, 2016
Number of option exercised     307,500        
Company agreement expense     $ 76,600 $ 12,015      
Dr. Kirkland [Member]              
Annual retainer payable             $ 6,000
Common stock shares reserved under stock option plan           75,000 50,000
Exercise price           $ 4.20 $ 1.91
Number of stock option granted           75,000 50,000
Number of option exercised   50,000          
Number of common stock issued   41,033          
Compensation expense     0 29,654      
Dr. Gerlach [Member]              
Consulting services, expense     0 4,660      
Accounts payable to related parties     0 0      
Vector Asset Management, Inc [Member]              
Compensation expense         $ 120,000    
Consulting services, expense     $ 30,000 $ 20,400      
Kalen Capital Corporation [Member]              
Number of equity security for sale 10,335,000            
Proceeds from sale of stock $ 14,407,500            
Sale price per share $ 1.50            
Shares issued for convertible debt, amount $ 1,095,000            
Loan interest unpaid $ 167,497            
XML 39 R29.htm IDEA: XBRL DOCUMENT v3.19.1
Subsequent Events (Details Narrative)
May 09, 2019
USD ($)
Subsequent Event [Member]  
Research and development monthly fee $ 25,000
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