Cautionary Note Regarding Forward-Looking Statements
This discussion and analysis of financial condition and results of operations is based upon and should be read in conjunction with the unaudited interim consolidated financial statements ofRenovaCare, Inc. ("RenovaCare") and its wholly-owned subsidiary (collectively withRenovaCare , "we," "our," "us," or the "Company"), appearing elsewhere in this Quarterly Report on Form 10-Q, which have been prepared in accordance with accounting principles generally accepted inthe United States . The preparation of financial statements in conformity with accounting principles generally accepted inthe United States requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of any contingent liabilities at the financial statement date and reported amounts of revenue and expenses during the reporting period. On an on-going basis the Company reviews its estimates and assumptions. The estimates were based on historical experience and other assumptions that the Company believes to be reasonable under the circumstances. Actual results are likely to differ from those estimates under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results of operations. Critical accounting policies, the policies the Company believes are most important to the presentation of its financial statements and require the most difficult, subjective and complex judgments, are outlined below in "Critical Accounting Policies," and have not changed significantly since 2020. This Quarterly Report on Form 10-Q also contains certain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as well as information relating to the Company that is based on management's exercise of business judgment and assumptions made by and information currently available to management. Although forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. When used in this document and other documents, releases and reports released by us, the words "anticipate," "believe," "estimate," "expect," "intend," "the facts suggest" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect our current view of future events and are subject to certain risks and uncertainties as noted below. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, our actual results could differ materially from those anticipated in these forward-looking statements. Actual events, transactions and results may materially differ from the anticipated events, transactions or results described in such statements. Although we believe that our expectations are based on reasonable assumptions, we can give no assurance that our expectations will materialize. Many factors could cause actual results to differ materially from our forward-looking statements and unknown, unidentified or unpredictable factors could materially and adversely impact our future results. We undertake no obligation and do not intend to update, revise or otherwise publicly release any revisions to our forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events. Several of these factors include, without limitation:
· our ability to meet requisite regulations or receive regulatory approvals in
we may obtain; and the absence of adverse regulatory developments in the
· new entrance of competitive products or further penetration of existing
products in our markets; · results of our clinical trials; · failure of our products to gain market acceptance; · the cost and success of our development programs;
· our failure to obtain financing as, if and when needed, on commercially
acceptable terms; · our failure to attract and retain qualified personnel; · our failure to adequately manage our growth and expansion; · the effect on us from adverse publicity related to our products or the Company itself; and · our failure to defend against any adverse claims relating to our intellectual property. 14
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 We are a development-stage biotechnology and medical device company focusing on the research, development and commercialization of autologous (using a patient's own cells) cellular therapies that can be used for medical and aesthetic applications. The Company does not have any commercialized products. The Company's activities have consisted principally of performing research and development activities, business development efforts, and raising capital to support such activities. The Company, through its wholly owned subsidiary,RenovaCare Sciences Corp. , owns the CellMist™ System which is a cell isolation procedure that enzymatically renders stem cells from the patient's own skin or other tissues. The resulting stem cell suspension is administered topically with our SkinGun™ spray device as a cell therapy onto wounds including burns to facilitate healing. The CellMist™ System also includes our unique, closed, automated cell isolation device (the "CID") to harvest stem cells from tissues which is in prototype development. Currently, our proprietary technologies are the subject of forty-four (44)U.S. and foreign granted or pending patents or patent applications and seventeen (17)U.S. and foreign trademarks. Of the issued patents, five (5) areU.S. patents and seventeen (17) have issued or are allowed inAustralia ,Canada ,China ,Europe ,Germany ,France ,Italy ,Japan ,Korea ,Netherlands ,Spain ,Switzerland /Lichtenstein, and the United Kingdom.The Company has six (6) allowed trademarks inthe United States , two (2) European registered trademarks, two (2)United Kingdom trademarks, two (2)Japan trademarks, and two (2) pending inCanada . InMay 2021 , the Company announced that theUS Food and Drug Administration (FDA) fully approved the Company's Investigational Device Exemption (IDE) application to conduct a clinical trial, designated CELLMIST 1, designed to evaluate the safety and feasibility of autologous skin and pluripotent stem cells rendered by its manual CellMist™ System from donor skin and applied topically with the electronic SkinGun™ spray device for treatment of acute burn wounds. The clinical trial protocol is an open-label, single-arm clinical study designated to enroll 14 adult human burn subjects with partial-thickness, second-degree deep thermal burn wounds covering between 10% and 30% total body surface area. The Company may engage up to four (4)U.S. burn centers to conduct the clinical study.
During the end of Q1 2022, the Board decided to stop enrollment of patients into the clinical trial and take other measures to reduce the Company's overhead in an effort to conserve financial resources as it continues to defend against the Lawsuits; however, medical evaluation of the treated subjects will continue periodically as scheduled in the clinical protocol at the clinical study site untilOctober 2022 , when the study concludes. The Company hopes to restart the clinical trial at a future date upon the occurrence of a favorable outcome against the Lawsuits and with additional financing. Research, development and commercialization of new technologies generally requires significant financial resources, involves a high degree of risk, and there is no assurance that development activities will result in a commercially viable product. The Company has not generated any revenue and has sustained recurring losses and negative cash flows from operations since inception. The Company expects to incur losses as it continues development of its products and technologies and defends itself against the Lawsuits (as defined in "Part 2-Other Information, Item 1. Legal Proceedings"). The Company will need to raise additional capital through partnerships or the sale of securities to accomplish its business plan. Failing to secure such additional funding poses a significant risk. The Company's ability to meet its financial obligations, including to fund the development of its cellular therapies depends on the amount and timing of cash receipts from future financing activities. There can be no assurance as to the availability or terms upon which such financing and capital might be available. 15
Components of Our Results of Operations
Revenue
To date we have not generated any product revenues and do not expect to generate any revenue for the foreseeable future. Our ability to generate revenue and become profitable depends upon our ability to obtain marketing approval and successfully commercialization of our CellMistTM System.
Operating Expenses Research and Development
Research and development ("R&D") expenses consist primarily of costs incurred for the development of our CellMistTM System and include:
· design, pilot-scale manufacturing and pre-clinical testing of our cell isolation and SkinGunTM spray devices.
· employee-related expenses associated with our research and development
activities, including salaries, benefits, travel and non-cash stock-based compensation expenses. · costs associated with quality management systems including device verification and validation testing, and regulatory operations and regulatory compliance. · expenses incurred under agreements related to our clinical trial.
· other research and development costs including contract consulting fees
and non-cash stock-based compensation to contract research organizations (CROs) and other third parties. We do not believe that it is possible at this time to accurately project total expenses required for us to reach commercialization of our CellMistTM System. In the future, we expect that research and development expenses will increase due to our ongoing product development and approval efforts. We expense research and development costs as incurred. General and Administrative General and administrative expenses consist primarily of personnel costs, including non-cash stock-based compensation related to directors and employees, professional service costs including legal, accounting, and other consulting fees and other general and administrative expenses including investor relations, insurance, and facilities costs. We expect general and administrative expenses to increase in the future as we hire personnel and incur additional costs to support the expansion of our research and development activities, our operation as a public company and to defend against the Lawsuits. Stock-Based 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. Other Income (Expense)
Other expense consists of the interest payable under our convertible note. Other income consists of interest income earned on our cash and cash equivalents and the reimbursement of legal fees from our Directors & Officers insurance policy to the extent available up to the policy limit of$2,000,000 . Income Taxes We have yet to generate taxable income. We have historically incurred operating losses resulting in carry forward tax losses totaling approximately$21,945,000 as ofDecember 31, 2021 . We anticipate that we will continue to generate tax losses for the foreseeable future and that we will be able to carry forward these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes until we have taxable income after the full utilization of our carry forward tax losses. We have provided a full valuation allowance with respect to the deferred tax assets related to these carry forward losses. 16 Results of Operations
Comparison of Three and Six Months Ended
Research and Development Expenses
Three Months Ended Six Months Ended June 30, Increase / June 30, Increase / 2022 2021 (Decrease) 2022 2021 (Decrease) Manufacturing clinical supplies(1)$ 17,996 $ 31,887 $ (13,891 ) $ 31,715 $ 248,071 $ (216,356 ) Personnel related(2) 66,303 115,503 (49,200 ) 184,176 269,978 (85,802 )
Stock-based compensation(3) 217,500 228,625 (11,125 )
435,000 507,438 (72,438 ) Clinical trials(4) 41,655 219,601 (177,946 ) 195,370 525,957 (330,587 ) Regulatory 300 12,072 (11,772 ) 5,016 21,904 (16,888 ) All other(5) 35,650 96,881 (61,231 ) 124,380 185,514 (61,134 )$ 379,404 $ 704,569 $ (325,165 ) $ 975,657 $ 1,758,862 $ (783,205 )
(1) Manufacturing clinical supplies decreased due to completion of the
pilot-scale manufacturing and validation testing of the components of the
CellMist™ System and the electronic SkinGun™ spray device used in our
clinical trial which mostly tailed off during the quarter ended
2022.
(2) Personnel related expenses decreased primarily due to the suspension of the
clinical trial.
(3) Stock compensation expense relates to the stock purchase options granted to
R&D related personnel.
(4) In 2020 and early 2021, the Company's incurred certain costs in preparation
for its clinical trial during which time the set-up costs were mostly
completed with future clinical trial costs expected to fluctuate depending on
the number of enrollees into the clinical trial. During the three and six
months ended
trial expenses decreased primarily due to the completion of the set-up costs
and subsequent enrollment of only two patients. As a result of the decision
during Q1 2022 to stop enrollment, clinical trial expenses have and are
expected to continue to decrease.
(5) All other expenses relate primarily to the prototype development of the
electronic SkinGun™ and cell isolation device at StemCell Systems. The costs
have and are expected to decrease significantly due to the Company's cancellation of the Strategic Agreement datedApril 28, 2022 .
General and Administrative Expenses
Three Months Ended Six Months Ended June 30, Increase / June 30, Increase / 2022 2021 (Decrease) 2022 2021 (Decrease) Personnel related(1)$ 43,594 $ 238,911 $ (195,317 ) $ 172,904 $ 468,363 $ (295,459 ) Stock-based compensation(2) - (29,026 ) 26,026 5,500 (1,182,601 ) 1,188,101 Professional and consultant fees(3) 1,252,502 141,682 1,110,820 2,238,459 425,473 1,812,986 All other(4) 453,159 49,243 403,916 478,949 152,531 326,418 Total G&A Expense$ 1,749,255 $ 400,810 $ 1,348,445 $ 2,895,812 $ (136,234 ) $ 3,032,046
(1) Personnel related costs decreased due to lower headcount.
17
(2) All stock options issued to G&A related personnel fully vested in Q1 2022.
Stock compensation expense in 2021 decreased due to the forfeiture and
cancellation of 2,730,571 stock options as a result of the resignation of the
Company's former Chairman, President and Chief Executive Officer and two
members of the Company's Board of Directors. Compensation expense was
recorded on these options prior to their full vesting. As a result, the
Company recognized a
expense related to the cancelled options.
(3) Professional and consultant fees increased primarily due to an increase in
legal fees related to the Lawsuits. During the three months ended
2022, the Company incurred
preparation and audit of our financial statements and related filings with
the
related to the Lawsuits,
financial statements and related filings with the
legal related costs. The Company is obligated, pursuant to its bylaws, to
indemnify its directors and officers. As a result, all legal costs related to
the Lawsuits are recorded to the books of the Company. Insurance proceeds to
cover the cost of the Company's defense against the Lawsuits is recorded to
other income at the time of receipt.
(4) All other costs increased primarily due to the inclusion of
termination fee related to the Company's cancellation of the Strategic
Agreement with Stem Cell Systems in
lodging costs paid by
Q2.
Liquidity and Capital Resources
The Company does not have any commercialized products, has not generated any meaningful revenue since inception and has sustained recurring losses and negative cash flows since inception. During the six months endedJune 30, 2022 and 2021, the Company has incurred operating losses of$3,871,000 and$1,622,000 , respectively, and has used cash in operating activities of$3,405,000 and$3,070,000 , respectively. The Company expects to incur losses as it continues to fund its legal defense and scaled-back development of its products and technologies. AtJune 30, 2022 , the Company had current and total liabilities of$1,887,671 and$2,689,985 respectively, including$1,271,925 of current liabilities related to its defense against the Lawsuits compared to$1,395,107 of current assets. As ofJune 30, 2022 , the Company's working capital totaled negative$492,564 not including approximately$1,042,000 in proceeds expected to be realized under its D&O Policy with AIG during Q3 2022. In order to preserve its cash resources, the Company has taken measures to streamline operations, including ending enrollment of patients into its clinical trial, renegotiating and terminating certain agreements and service arrangements and entered into a loan agreement withKalen Capital Corporation , anAlberta Canada corporation ("Kalen Capital ") which is wholly-owned by the Mr. Harmel S. Rayat, the Company's President, Chief Executive Officer and Chairman, for$800,000 onMarch 18, 2022 . As a result of the actions taken, the Company has temporarily improved its ability to remain solvent. However, due to the nature and stage of the Lawsuits, the Company is unable to estimate the total costs to defend itself or the potential costs to the Company in the event that it is not successful in its defense. As a result, the Company estimates cash on hand will be insufficient for the twelve months following the date these financial statements are issued. Historically, the Company has been funded through the sale of equity securities and debt financings. The future of the Company will depend on its ability to successfully raise capital from external sources to fund operations. If the Company is unable to obtain adequate funds, or if such funds are not available to it on acceptable terms, the Company's ability to continue its business to develop its cellular therapies will be significantly impaired and it may cause the Company to curtail operations. Although the Company has instituted cost savings measures, it will continue to assess its ongoing expenses.
Fair Value of Financial Instruments and Risks
The carrying value of cash, accounts payable and interest 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 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. 18 Market Risk Disclosures
We have not entered into derivative contracts either to hedge existing risks or
for speculative purposes during the six months ended
Off-Balance Sheet Arrangements and Contractual Obligations
As part of our ongoing business, we do not participate in transactions that
generate relationships with unconsolidated entities or financial partnerships,
such as entities often referred to as structured finance or special purpose
entities (SPEs), which would have been established for the purpose of
facilitating off-balance sheet arrangements or other contractually limited
purposes. As of
Recently Accounting Standards
See Note 1 to our Consolidated Financial Statements for more information regarding recent accounting standards and their impact to our consolidated results of operations and financial position.
Transactions with Related Persons
During the three months ended
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