Item 1. Financial Statements
RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
AS OF JUNE 30, 2019 AND DECEMBER 31, 2018
|
|
June 30,
|
|
December 31,
|
|
|
2019
|
|
2018
|
ASSETS
|
|
(Unaudited)
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
14,272,582
|
|
|
$
|
15,397,524
|
|
Prepaid expenses and deposits
|
|
|
193,121
|
|
|
|
168,707
|
|
Total current assets
|
|
|
14,465,703
|
|
|
|
15,566,231
|
|
|
|
|
|
|
|
|
|
|
Equipment, net of accumulated depreciation of $845 and $687, respectively
|
|
|
106
|
|
|
|
264
|
|
Intangible assets
|
|
|
152,854
|
|
|
|
152,854
|
|
Total assets
|
|
$
|
14,618,663
|
|
|
$
|
15,719,349
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
178,341
|
|
|
$
|
222,163
|
|
Accounts payable - related parties
|
|
|
12,074
|
|
|
|
3,000
|
|
Interest payable to related parties
|
|
|
167,497
|
|
|
|
167,497
|
|
Total current liabilities
|
|
|
357,912
|
|
|
|
392,660
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
357,912
|
|
|
|
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 June 30, 2019 and December 31, 2018
|
|
|
872
|
|
|
|
872
|
|
Additional paid-in capital
|
|
|
32,188,412
|
|
|
|
32,187,580
|
|
Retained deficit
|
|
|
(17,928,533
|
)
|
|
|
(16,861,763
|
)
|
Total stockholders' equity
|
|
|
14,260,751
|
|
|
|
15,326,689
|
|
Total liabilities and stockholders' equity
|
|
$
|
14,618,663
|
|
|
$
|
15,719,349
|
|
(See accompanying notes to unaudited consolidated financial statements)
RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2019 AND 2018
|
|
Three Months Ended
|
|
Six Months Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
179,193
|
|
|
|
108,207
|
|
|
|
373,702
|
|
|
|
233,318
|
|
General and administrative
|
|
|
464,335
|
|
|
|
341,223
|
|
|
|
873,797
|
|
|
|
790,781
|
|
Total operating expense
|
|
|
643,528
|
|
|
|
449,430
|
|
|
|
1,247,499
|
|
|
|
1,024,099
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(643,528
|
)
|
|
|
(449,430
|
)
|
|
|
(1,247,499
|
)
|
|
|
(1,024,099
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
96,024
|
|
|
|
5,001
|
|
|
|
180,729
|
|
|
|
9,426
|
|
Interest expense
|
|
|
–
|
|
|
|
(21,050
|
)
|
|
|
–
|
|
|
|
(41,515
|
)
|
Accretion of debt discount
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(58,438
|
)
|
Total other income (expense)
|
|
|
96,024
|
|
|
|
(16,049
|
)
|
|
|
180,729
|
|
|
|
(90,527
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(547,504
|
)
|
|
$
|
(465,479
|
)
|
|
$
|
(1,066,770
|
)
|
|
$
|
(1,114,626
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Loss per Common Share
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding - basic and diluted
|
|
|
87,175,522
|
|
|
|
76,840,522
|
|
|
|
87,175,522
|
|
|
|
76,668,585
|
|
(See accompanying notes to unaudited consolidated financial statements)
RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY
FOR THE SIX MONTHS ENDED JUNE 30, 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the three months ended June 30, 2019
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(547,504
|
)
|
|
|
(547,504
|
)
|
Balance, June 30, 2019
|
|
|
87,175,522
|
|
|
$
|
872
|
|
|
$
|
32,188,412
|
|
|
$
|
(17,928,533
|
)
|
|
$
|
14,260,751
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FOR THE SIX MONTHS ENDED JUNE 30, 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation due to common stock purchase options
|
|
|
–
|
|
|
|
–
|
|
|
|
47,649
|
|
|
|
–
|
|
|
|
47,649
|
|
Net loss for the three months ended June 30, 2018
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(465,479
|
)
|
|
|
(465,479
|
)
|
Balance, June 30, 2018
|
|
|
76,840,522
|
|
|
$
|
769
|
|
|
$
|
16,684,812
|
|
|
$
|
(15,855,548
|
)
|
|
$
|
830,033
|
|
(See accompanying notes to unaudited consolidated financial statements)
RENOVACARE, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
FOR THE SIX MONTHS ENDED JUNE 30, 2019 AND 2018
|
|
Six Months Ended
|
|
|
June 30,
|
|
|
2019
|
|
2018
|
Cash flows used in operating activities
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,066,770
|
)
|
|
$
|
(1,114,626
|
)
|
Adjustments to reconcile net loss to net cash flows used in operating activities
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
158
|
|
|
|
159
|
|
Stock based compensation expense
|
|
|
832
|
|
|
|
170,146
|
|
Accretion of debt discount
|
|
|
–
|
|
|
|
58,438
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses
|
|
|
(24,414
|
)
|
|
|
(31,818
|
)
|
Increase (decrease) in accounts payable
|
|
|
(43,822
|
)
|
|
|
(95,895
|
)
|
Increase (decrease) in accounts payable - related parties
|
|
|
9,074
|
|
|
|
9,334
|
|
Increase (decrease) in interest payable - related parties
|
|
|
–
|
|
|
|
41,515
|
|
Increase (decrease) in contract payable
|
|
|
–
|
|
|
|
(100,000
|
)
|
Net cash flows used in operating activities
|
|
|
(1,124,942
|
)
|
|
|
(1,062,747
|
)
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
Decrease in cash and cash equivalents
|
|
|
(1,124,942
|
)
|
|
|
(952,747
|
)
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
15,397,524
|
|
|
|
2,906,237
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
14,272,582
|
|
|
$
|
1,953,490
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Interest paid in cash
|
|
$
|
–
|
|
|
$
|
–
|
|
Income taxes paid in cash
|
|
$
|
–
|
|
|
$
|
–
|
|
(See accompanying notes to unaudited consolidated financial statements)
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 accompanying unaudited interim consolidated
financial statements of RenovaCare, Inc. and Subsidiary (the “
Company
”) as of June 30, 2019, and for the three
and six months ended June 30, 2019 and 2018, include the accounts of the Company and its wholly-owned and controlled subsidiary,
RenovaCare Sciences Corp., and have been prepared in accordance with generally accepted accounting principles in the United States
of America (“US GAAP”), for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation
S-X. Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have
been condensed or omitted.
The preparation of consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements,
and the reported amounts of expenses during the reporting periods. Actual results may differ from those estimates. The interim
financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2018. In the opinion of management, the accompanying unaudited
interim consolidated financial statements have been prepared on the same basis as the audited financial statements and include
all adjustments (including normal recurring adjustments) necessary for the fair presentation of the Company’s financial position
as of June 30, 2019, results of operations for the three and six months ended June 30, 2019 and 2018, and stockholders equity and
cash flows for the six months ended June 30, 2019 and 2018. 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
“
CellMist
TM
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 CellMist
TM
System is comprised
of (a) a treatment methodology for cell isolation for the regeneration of human skin cells (the “
CellMist
TM
Solution
”) and (b) a solution sprayer device (the “
SkinGun
TM
”) for delivering the cells
to the treatment area. The Company has filed additional patent applications related to the CellMist
TM
Solution and SkinGun
TM
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 June 30, 2019, the Company had $14,272,582
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 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.
Recent Accounting Standards
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 and six months ended June 30, 2019 and 2018:
|
|
Three Months Ended
|
|
Six Months Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Basic and Diluted EPS Computation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss available to common stockholders'
|
|
$
|
(547,504
|
)
|
|
$
|
(465,479
|
)
|
|
$
|
(1,066,770
|
)
|
|
$
|
(1,114,626
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
|
|
|
87,175,522
|
|
|
|
76,840,522
|
|
|
|
87,175,522
|
|
|
|
76,668,585
|
|
Basic and diluted EPS
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(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
|
|
|
|
317,500
|
|
|
|
357,500
|
|
Warrants
|
|
|
13,346,912
|
|
|
|
3,011,912
|
|
|
|
13,346,912
|
|
|
|
3,011,912
|
|
Convertible debt
|
|
|
–
|
|
|
|
670,757
|
|
|
|
–
|
|
|
|
670,757
|
|
Total shares not included in the computation of diluted losses per share
|
|
|
13,664,412
|
|
|
|
4,040,169
|
|
|
|
13,664,412
|
|
|
|
4,040,169
|
|
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
CellMist
TM
System. Acquisition related costs amounted to $52,852 and were capitalized together with the cash payment
upon the closing of the transaction in July 2013 of $100,002. Intangible assets amounted to $152,854 at June 30, 2019 and December
31, 2018.
Note 3. Common Stock and Warrants
Common Stock
At June 30, 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 six months ended June 30, 2019.
See “Note 4. Stock Options” for further discussion.
Warrants
The following table summarizes information
about warrants outstanding at June 30, 2019 and December 31, 2018:
|
|
Shares of Common Stock Issuable
from Warrants Outstanding as of
|
|
Weighted
|
|
|
|
|
June 30,
|
|
December 31,
|
|
Average
|
|
|
Description
|
|
2019
|
|
2018
|
|
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
|
|
|
|
|
|
|
|
|
|
Note 4. Stock Options
The following table summarizes stock option
activity for the period ended June 30, 2019:
|
|
Number of
Options
|
|
Weighted
Average
Exercise
Price ($)
|
|
Weighted
Average
Remaining
Contractual
Term (years)
|
|
Aggregate
Intrinsic
Value ($)
|
Outstanding at December 31, 2018
|
|
|
317,500
|
|
|
|
3.41
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2019
|
|
|
317,500
|
|
|
|
3.41
|
|
|
|
7.18
|
|
|
|
16,625
|
|
Exercisable at June 30, 2019
|
|
|
317,500
|
|
|
|
3.41
|
|
|
|
7.18
|
|
|
|
16,625
|
|
There were no options granted during the
six months ended June 30, 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 June 30, 2019 and 2018, the Company recognized $0 and $47,649, respectively, in share-based
compensation related to stock options. During the six months ended June 30, 2018 and 2017, the Company recognized $832 and $170,146,
respectively, in share-based compensation related to stock options. As of June 30, 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 June 30,
|
|
Six Months Ended June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Research and development
|
|
$
|
–
|
|
|
$
|
7,091
|
|
|
$
|
–
|
|
|
$
|
27,966
|
|
General and administrative
|
|
|
–
|
|
|
|
40,558
|
|
|
|
832
|
|
|
|
142,180
|
|
Total
|
|
$
|
–
|
|
|
$
|
47,649
|
|
|
$
|
832
|
|
|
$
|
170,146
|
|
The following table summarizes information
about stock options outstanding and exercisable at June 30, 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
|
|
|
|
4.76
|
|
|
|
1.05
|
|
|
|
55,000
|
|
|
|
4.76
|
|
|
|
1.05
|
|
1.25
|
|
|
7,500
|
|
|
|
5.96
|
|
|
|
1.25
|
|
|
|
7,500
|
|
|
|
5.96
|
|
|
|
1.25
|
|
1.34
|
|
|
7,500
|
|
|
|
6.01
|
|
|
|
1.34
|
|
|
|
7,500
|
|
|
|
6.01
|
|
|
|
1.34
|
|
1.70
|
|
|
7,500
|
|
|
|
6.30
|
|
|
|
1.70
|
|
|
|
7,500
|
|
|
|
6.30
|
|
|
|
1.70
|
|
2.28
|
|
|
7,500
|
|
|
|
7.06
|
|
|
|
2.28
|
|
|
|
7,500
|
|
|
|
7.06
|
|
|
|
2.28
|
|
4.20
|
|
|
232,500
|
|
|
|
7.87
|
|
|
|
4.20
|
|
|
|
232,500
|
|
|
|
7.87
|
|
|
|
4.20
|
|
Total
|
|
|
317,500
|
|
|
|
7.18
|
|
|
$
|
3.41
|
|
|
|
317,500
|
|
|
|
7.18
|
|
|
$
|
3.41
|
|
Note 5. Commitments
In connection with the Company’s
anticipated regulatory filings and ongoing investigations of new product development and expanded clinical indications, the Company
has engaged StemCell Systems GmbH (“StemCell Systems”) to provide design and engineering services, prototypes, testing,
and documentation under various agreements. Pursuant to these engagements the Company incurred expenses of $85,175 and $13,169
in during the three months ended June 30, 2019 and 2018, respectively, and $161,775 and $25,184 during the six months ended June
30, 2019 and 2018, respectively. Dr. Gerlach, from whom the Company purchased the CellMist
TM
System technologies, is
a principal of StemCell Systems.
On June 3,
2019, the Company entered into a Charitable Gift Agreement with the University of Pittsburgh (the "
University
"),
pursuant to which the Company committed to provide a charitable donation to the University in the aggregate amount of $250,000
(the "
Grant
"). The Company will pay the Grant in four quarterly installments with the first payment made on or
before July 1, 2019. During the three months ended June 30, 2019, the Company made the first of four payments totaling $62,500.
At June 30, 2019, the balance remaining under this gift was $187,500. Due to the terms of the Grant, the Company will recognize
the related expense upon payment. Dr. Gerlach, from whom the Company purchased the SkinGun
TM
technology,
is a professor at the University.
See also “Note 6. Related Party Transactions.”
Note 6. Related Party Transactions
As compensation for his 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 option grant on a cashless basis and received 41,033 shares of common stock.
He has not exercised his May 11, 2017 options. Compensation expense of $13,509 and $43,163 was recorded with respect to the May
11, 2017 grant during the three and six months ended June 30, 2018, respectively. No compensation costs were recorded in 2019 due
to completion of vesting on May 11, 2018.
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 $85,175 and $13,169 in during the three months ended June 30, 2019
and 2018, respectively, and $161,775 and $25,184 during the six months ended June 30, 2019 and 2018, respectively. Dr. Gerlach,
from whom the Company purchased the CellMist
TM
System technologies, is a principal of StemCell Systems.
Dr. Gerlach is entitled to payments
for consulting services. During the three months ended June 30, 2019 and 2018, the Company recognized expenses related to Dr. Gerlach
services of $0 and $8,000, respectively, and $0 and $15,020 during the six months ended June 30, 2019 and 2018, respectively. Accounts
payable to Dr. Gerlach amounted to $0 at June 30, 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 the ongoing research, development,
patents, and strategic positioning of its technologies. 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 June 30, 2019 and 2018,
the Company recognized expenses of $30,000 and $23,067, respectively, and $60,000 and $43,467 during the six months ended June
30, 2019 and 2018, 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.
On June 3,
2019, the Company entered into a Charitable Gift Agreement with the University of Pittsburgh (the "
University
"),
pursuant to which the Company committed to provide a charitable donation to the University in the aggregate amount of $250,000
(the "
Grant
"). The Company will pay the Grant in four quarterly installments with the first payment made on or
before July 1, 2019. During the three months ended June 30, 2019, the Company made the first of four payments totaling $62,500.
At June 30, 2019, the balance remaining under this gift was $187,500. Due to the terms of the Grant, the Company will recognize
the related expense upon payment. Dr. Gerlach, from whom the Company purchased the SkinGun
TM
technology,
is a professor at the University.
Note 7. Subsequent Events
Management has reviewed material events
subsequent of the period ended June 30, 2019 and prior to the filing of financial statements in accordance with FASB ASC 855 “Subsequent
Events”.
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.
|
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. (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 June 30, 2019, and 10,000,000 shares
of $0.0001 par value preferred stock, of which none are outstanding.
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 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 CellMist
TM
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.
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 CellMist
TM
System
is in the early stage and we anticipate that we will be required to expend significant time and resources to further develop our
technology and determine whether a commercially viable product can be developed. Research and development of new technologies involves
a high degree of risk and there is no assurance that our development activities will result in a commercially viable product. The
long-term profitability of our operations will be, in part, directly related to the cost and success of our development programs,
which may be affected by a number of factors.
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.
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 CellMist
TM
System in the treatment of tissue that has been subject to severe trauma such as second degree
burns. The CellMist
TM
System utilizes the patient’s own skin stem cells, reduces the size of the donor site,
and decreases scarring. Furthermore, we believe the CellMist
TM
System could enable treatment of other skin disorders.
Our Market Opportunity
According to medical market research firm,
Transparency Market Research, the global market for wound healing products is projected to grow to approximately $35.0 Billion
by 2025.
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).
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 CellMist
TM
process, and our cell deposition device is referred to as the SkinGun
TM
. 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 SkinGun
TM
, 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. Published studies show
that within days following the wound treatment procedure, the skin cells generate a protective 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 SkinGun
TM
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 CellMist
TM
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 CellMist
TM
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 SkinGun
TM
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.
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 CellMist
TM
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 CellMist
TM
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 has received regulatory approvals for 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.
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, we
plan to file additional patent applications that, if issued, would provide further protection for The CellMist
TM
System.
Although we believe the bases for these patents and patent applications are sound, they are untested; and there is no assurance
that they will not be successfully challenged. There can be no assurance that any patent previously issued will be of commercial
value, that any patent applications will result in issued patents of commercial value, or that our technology will not be held
to infringe patents held by others.
Strategy
Our ultimate goal is to leverage the potential
of our CellMist
TM
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 CellMist
TM
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.
Results of Operations
Three and Six Months Ended June 30,
2019 Compared with the Three and Six Months Ended June 30, 2018
Operating Expenses
A summary of our operating expenses for
the three and six months ended June 30, 2019 and 2018 follows:
|
|
Three Months Ended June 30,
|
|
Increase /
|
|
Percentage
|
|
|
2019
|
|
2018
|
|
(Decrease)
|
|
Change
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
179,193
|
|
|
$
|
101,116
|
|
|
$
|
78,077
|
|
|
|
77
|
%
|
General and administrative
|
|
|
464,335
|
|
|
|
300,665
|
|
|
|
163,670
|
|
|
|
54
|
%
|
Stock compensation
|
|
|
–
|
|
|
|
47,649
|
|
|
|
(47,649
|
)
|
|
|
-100
|
%
|
Total operating expenses
|
|
$
|
643,528
|
|
|
$
|
449,430
|
|
|
$
|
194,098
|
|
|
|
43
|
%
|
|
|
Six Months Ended June 30,
|
|
Increase /
|
|
Percentage
|
|
|
2019
|
|
2018
|
|
(Decrease)
|
|
Change
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
373,702
|
|
|
$
|
205,352
|
|
|
$
|
168,350
|
|
|
|
82
|
%
|
General and administrative
|
|
|
872,965
|
|
|
|
648,601
|
|
|
|
224,364
|
|
|
|
35
|
%
|
Stock compensation
|
|
|
832
|
|
|
|
170,146
|
|
|
|
(169,314
|
)
|
|
|
-100
|
%
|
Total operating expenses
|
|
$
|
1,247,499
|
|
|
$
|
1,024,099
|
|
|
$
|
223,400
|
|
|
|
22
|
%
|
Research and Development
Research and development (“
R&D
”)
costs represent costs incurred to develop our CellMist
TM
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 and six months ended June 30, 2019 compared to 2018, as a result of the company’s
regulatory, product development, and product expansion efforts.
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 June 30, 2019 compared to 2018 and included an increase of $62,500 related to the Charitable Grant Agreement with
the University of Pittsburgh and $100,000 increase in professional fees. Costs increased during the six months ended June 30, 2019
compared to 2018 and included an increase of $62,500 related to the Charitable Grant Agreement with the University of Pittsburgh
and $308,000 increase in professional fees offset by a $123,000 decrease in investor communications costs and $24,000 decrease
in various other general 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 three and six months ended June 30, 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 on the date of
grant and the second half vested on May 11, 2018; combined with no subsequent option grants, 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 $1,247,499 and $1,024,099 for the six months ended June 30, 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 June 30, 2019, the Company had $14,272,582 of cash. The Company believes
that it currently has sufficient cash to meet its funding requirements over the next year.
Net cash used in operating activities was
$1,124,942 during the six months ended June 30, 2019, compared to net cash used in operating activities of $1,062,747 during the
six months ended June 30, 2018. The increase 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 six months ended June 30, 2019 and 2018.
Net cash provided by financing activities
was $0 during six months ended June 30, 2019, compared to $110,000 during the six months ended June 30, 2018. During the six months
ended June 30, 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.
Recent 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.
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
six months ended June 30, 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 his 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 option grant on a cashless basis and received 41,033 shares of common stock.
He has not exercised his May 11, 2017 options. Compensation expense of $13,509 and $43,163 was recorded with respect to the May
11, 2017 grant during the three and six months ended June 30, 2018, respectively. No compensation costs were recorded in 2019 due
to completion of vesting on May 11, 2018.
In connection with the Company’s
anticipated regulatory filings and ongoing investigations of new product development and expanded clinical indications, the Company
has engaged StemCell Systems GmbH (“StemCell Systems”) to provide design and engineering services, prototypes, testing,
and documentation under various agreements. Pursuant to these engagements the Company incurred expenses of $85,175 and $13,169
in during the three months ended June 30, 2019 and 2018, respectively, and $161,775 and $25,184 during the six months ended June
30, 2019 and 2018, respectively. Dr. Gerlach, from whom the Company purchased the CellMist
TM
System technologies, is
a principal of StemCell Systems.
Dr. Gerlach is entitled to payments
for consulting services. During the three months ended June 30, 2019 and 2018, the Company recognized expenses related to Dr. Gerlach
services of $0 and $8,000, respectively, and $0 and $15,020 during the six months ended June 30, 2019 and 2018, respectively. Accounts
payable to Dr. Gerlach amounted to $0 at June 30, 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 June 30, 2019 and 2018,
the Company recognized expenses of $30,000 and $23,067, respectively, and $60,000 and $43,467 during the six months ended June
30, 2019 and 2018, 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.
On June 3,
2019, the Company entered into a Charitable Gift Agreement with the University of Pittsburgh (the "
University
"),
pursuant to which the Company committed to provide a charitable donation to the University in the aggregate amount of $250,000
(the "
Grant
"). The Company will pay the Grant in four quarterly installments with the first payment made on or
before July 1, 2019. During the three months ended June 30, 2019, the Company made the first of four payments totaling $62,500.
At June 30, 2019, the balance remaining under this gift was $187,500. Due to the terms of the Grant, the Company will recognize
the related expense upon payment. Dr. Gerlach, from whom the Company purchased the SkinGun
TM
technology,
is a professor at the University.