UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Section 7 - Regulation FD
On March 9, 2022, RenovaCare, Inc. issued a press release titled “RenovaCare Provides Clinical and Corporate Update”. A copy of the press release is attached as Exhibit 99.1 to this report.
Except for the historical information presented in this document, the matters discussed in this Report, or otherwise incorporated by reference into this document, contain “forward-looking statements” (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are identified by the use of forward-looking terminology such as “believes,” “plans,” “intend,” ”scheduled,” “potential,” “continue,” “estimates,” “hopes,” “goal,” “objective,” “expects,” “may,” “will,” “should” or “anticipates” or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. 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 the Registrant. The reader is cautioned that no statements contained in this Report should be construed as a guarantee or assurance of future performance or results. These forward-looking statements involve risks and uncertainties, including those identified within this Report. The actual results that the Registrant achieves may differ materially from any forward-looking statements due to such risks and uncertainties. These forward-looking statements are based on current expectations, and the Registrant assumes no obligation to update this information. Readers are urged to carefully review and consider the various disclosures made by the Registrant in this Report and in the Registrant’s other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks and factors that may affect the Registrant’s business.
Note: Information in this Report furnished pursuant to Item 7 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this Report shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933, as amended. The furnishing of the information in this Report is not intended to, and does not, constitute a representation that such furnishing is required by Regulation FD or that the information this Report contains is material investor information that is not otherwise publicly available.
The information presented in Item 7.01 of this Current Report including Exhibit 99.1 to this Current Report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.
Section 9 - Financial Statements and Exhibits
| Number | Description | |
| 99.1 | Press Release dated March 9, 2022 titled “RenovaCare Provides Clinical and Corporate Update”. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RenovaCare, Inc. | ||
| Date: March 15, 2022 | By: | /s/ Kaiyo Nedd, M.D. |
| Kaiyo Nedd, M.D. | ||
| President and Chief Executive Officer | ||
EXHIBIT 99.1
RenovaCare Provides Clinical and Corporate Update
SCOTTSDALE, Ariz., March 09, 2022 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), a clinical-stage developer of patented technologies for isolating and spraying cells for the regeneration of skin and other organs and tissues, today announced that following the review of its research and corporate activities, the Company is taking steps to streamline its clinical, research and development, and administrative operations in order to reduce costs.
These actions are due to a variety of factors, including (i) COVID-19 related low patient enrollment for the RenovaCare clinical trial (CELLMIST 1) which commenced in 2021 to evaluate the safety and feasibility of its Electronic SkinGun™ and CellMist™ System for the treatment of burn wounds, and (ii) the ongoing legal costs of the Company’s defense against a civil complaint filed by the U.S. Securities and Exchange Commission and several class action and derivative lawsuits.
Accordingly, the Company has suspended patient enrollment in its clinical study and plans to reduce its administrative overhead. Patients previously enrolled and treated with RenovaCare therapies and technologies will continue to receive ongoing care as per the FDA protocol. The clinical study and IDE remain open for possible resumption, and enrollment in the study may continue once the adverse impacts of the pandemic abate and capital funding becomes available.
The Company is also reviewing its patent portfolio (composed of eight patent families spanning the United States, Europe, Australia, and Asia) for potential reduction in annual filing costs and augmentation through in-licensing, while also focusing on those core patents having out-license or potential joint venture opportunities.
Meanwhile, the Company intends to maintain and continue its research and development efforts, including the development of a prototype automated cell isolation device with to isolate and harvest autologous cells for cell therapies being developed at the RenovaCare Research and Development Innovation Center located in Berlin, Germany.
About RenovaCare
RenovaCare, Inc. is a developer of new generation autologous stem cell therapies for the regeneration of human organs and tissues. The Company’s initial product under development targets the body’s largest organ, the skin. The Company’s flagship technology, the CellMist™ System, renders single-cell suspensions of tissue-specific pluripotent cells from donor tissues through sequential protease digestions. The RenovaCare CellMist™ System facilitates rapid healing of wounds or other afflicted tissues when applied topically as a gentle cell mist using the patented RenovaCare SkinGun™. The Company’s SkinGun™ is used to spray a liquid suspension of a patient’s stem cells – the CellMist™ cell suspension – onto wounds.
RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the Company’s planned or filed submissions to the U.S. Food and Drug Administration will be accepted or cleared by the FDA.
For additional information, please call Amit Singh at: 1-888-398-0202 or visit: https://renovacareinc.com
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https://renovacareinc.com/investors/register/
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Social Media Disclaimer
Investors and others should note that we announce material financial information to our investors using Securities and Exchange Commission (SEC) filings and press releases. We use our website and social media to communicate with our subscribers, shareholders and the public about the Company, RenovaCare, Inc., development and other corporate matters that are in the public domain. At this time, the Company will not post information on social media that could be deemed to be material information unless that information was provided to public distribution channels first.
We encourage investors, the media, and others interested in the Company to review the information we post on the Company’s website and the social media channels listed below:
LinkedIn
Facebook
Twitter
* This list may be updated from time to time
Legal Notice Regarding Forward-Looking Statements
No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although RenovaCare, Inc. (the “Company”) believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: the timing and success of clinical and preclinical studies of product candidates, the potential timing and success of the Company’s product programs through their individual product development and regulatory approval processes, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, obsolescence of the Company’s technologies, technical problems with the Company’s research, price increases for supplies and components, litigation and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Company’s operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Company’s ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, and other risks. There can be no assurance that further research and development will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that the Company will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Company’s most recent Form 10-Q and Form 10-K filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission at http://www.sec.gov. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1297695f-fc33-43a5-b978-f526b257f6c7
The photo is also available at Newscom, www.newscom.com, and via AP PhotoExpress.
Cover |
Mar. 09, 2022 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Mar. 09, 2022 |
| Entity File Number | 000-30156 |
| Entity Registrant Name | RenovaCare, Inc. |
| Entity Central Index Key | 0001016708 |
| Entity Tax Identification Number | 98-0384030 |
| Entity Incorporation, State or Country Code | NV |
| Entity Address, Address Line One | 9375 E. Shea Blvd., Suite 107-A |
| Entity Address, City or Town | Scottsdale |
| Entity Address, State or Province | AZ |
| Entity Address, Postal Zip Code | 85260 |
| City Area Code | 888 |
| Local Phone Number | 398-0202 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Entity Emerging Growth Company | false |