0001171843-20-002268.txt : 20200401 0001171843-20-002268.hdr.sgml : 20200401 20200401170353 ACCESSION NUMBER: 0001171843-20-002268 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20200325 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200401 DATE AS OF CHANGE: 20200401 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RenovaCare, Inc. CENTRAL INDEX KEY: 0001016708 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 980170247 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-30156 FILM NUMBER: 20766126 BUSINESS ADDRESS: STREET 1: 4 BECKER FARM ROAD STREET 2: SUITE 105 CITY: ROSELAND STATE: NJ ZIP: 07068 BUSINESS PHONE: 888-398-0202 MAIL ADDRESS: STREET 1: 4 BECKER FARM ROAD STREET 2: SUITE 105 CITY: ROSELAND STATE: NJ ZIP: 07068 FORMER COMPANY: FORMER CONFORMED NAME: Janus Resources, Inc. DATE OF NAME CHANGE: 20110110 FORMER COMPANY: FORMER CONFORMED NAME: ENTHEOS TECHNOLOGIES INC DATE OF NAME CHANGE: 20001002 FORMER COMPANY: FORMER CONFORMED NAME: WHATSONLINE COM INC DATE OF NAME CHANGE: 19990722 8-K 1 f8k_040120.htm FORM 8-K
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________

Form 8-K
_____________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): March 25, 2020  

RenovaCare, Inc.
(Exact Name of Registrant as Specified in Charter)

Nevada 000-30156 98-0384030
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number)

 

4 Becker Farm Road, Suite 105, Roseland, New Jersey 07068
(Address of Principal Executive Offices) (Zip Code)

(888) 398-0202
(Registrant's telephone number, including area code)


(Former name or former address, if changed since last report)

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))
  [   ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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. [   ]

 

 
 

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Item 8.01 (c) is incorporated by reference into this Item 5.02 as if set forth herein in full.

Item 8.01. Other Events.

                 (a)           On March 30, 2020, RenovaCare, Inc. (the “Company”) issued a press release announcing that the Company’s novel SkinGun™ is now being used to apply regenerative cells in a preclinical study of new gene therapies, underway at King’s College London.  Researchers are using the SkinGun™ to ultra-gently spray gene-supplemented cells for accelerated wound healing in Recessive Dystrophic Epidermolysis Bullosa (RDEB), a debilitating skin disease which afflicts young children and leads to premature death.

While RenovaCare continues pursuing the regulatory pathway for burns using its own cell isolation, the Company’s new patent protections, awarded in 2019, expanding the use of its SkinGun™ to spray all varieties of cells and tissues, enabled its use in the Kings College London gene therapy study.

A copy of the press release is attached to this Form 8-K as Exhibit 99.1.

                 (b)          With respect to the Company’s pursuit of the regulatory pathway for burns using its own cell isolation, it recently expanded the scope of its engagement of MCRA, LLC for it to, among other things (i) lead the Company’s interactions with the FDA and respond to any questions regarding any Company submissions and (ii) work with the Company to develop a timeline and overall regulatory strategy in preparation for a pivotal study and eventual PMA submission.

                (c)           Ms. Patsy Trisler, the Company’s former Vice-President for Regulatory and Clinical Affairs resigned her non-executive positon on March 25, 2020 in order to reduce her client work load of long-term commitments.  Ms. Trisler will continue providing consulting services regarding legacy matters, on an as needed basis, to the Company, pursuant to her at-will consulting agreement.  Ms. Trisler will be compensated at an hourly rate and is not expected to expend more than 5 hours per month in providing such services. Ms. Trisler’s resignation was not due to any fundamental disagreements with the Company.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

     
Exhibit
No.
      Description
   
99.1   Press Release dated March 30, 2020 Announcing Kings College London Study Using the SkinGun™


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 on April 1, 2020.

  RenovaCare, Inc.
     
   
  By:  /s/ Alan L. Rubino        
    Alan L. Rubino
    President and Chief Executive Officer
   

EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling

EXHIBIT 99.1

Spray-On Gene Therapy With RenovaCare SkinGun™ in New Study Underway at King’s College London

ROSELAND, N.J., March 30, 2020 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, today announced that the Company’s novel SkinGun™ is now being used to apply regenerative cells in a preclinical study of new gene therapies, underway at King’s College London. Researchers are using the SkinGun™ to ultra-gently spray gene-supplemented cells for accelerated wound healing in Recessive Dystrophic Epidermolysis Bullosa (RDEB), a debilitating skin disease which afflicts young children and leads to premature death.

“We are proud to support this much-needed gene therapy work on RDEB at King’s College London. It’s especially inspiring that this preclinical study marks the first-ever use of our SkinGun™ for a therapeutic application beyond the spray of our own RenovaCare cell therapy for burns and wounds,” stated Mr. Alan L. Rubino, President & CEO of RenovaCare, Inc.

Over 70 patients with various types of second-degree burns have been treated on an experimental basis utilizing the technology underlying the Company’s SkinGun™, which RenovaCare has developed as a potential alternative to skin grafting and other treatment options. Sprayed with a gentle mist of their own skin cells, many of these patients left the hospital within days, avoiding generally painful skin graft surgeries and potentially prolonged hospitalization.

While RenovaCare continues pursuing the regulatory pathway for burns using its own cell isolation, the Company was awarded new patent protections in 2019 expanding the use of its SkinGun™ to spray all varieties of cells and tissues and enabling the gene therapy study announced today.

“Patient-friendly effective therapies for RDEB are desperately needed. Our preclinical investigation of this new gene therapy with the SkinGun™ provides for a non-invasive gentle spray of regenerative cells to the wound site in order to improve the wound site and minimize pain,” explained Co-Principal Investigator, Dr. Su Lwin, Dermatology Registrar and Honorary Clinical Research Fellow at St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust, and King’s College London.

Dr. Su Lwin, Co-Principal Investigator

Dr. Su Lwin, Co-Principal Investigator, Spray-On Gene Therapy Uses RenovaCare SkinGun™, in King’s College Pre-Clinical Study

“Our goal from this early work is to realize longer-lasting therapeutic benefits including prevention of scarring, a condition which can severely restrict motion and lead to permanent disfigurement in RDEB such as fusing of the fingers, toes, and mouth, leaving young patients unable to eat and wheelchair-reliant by their teenage years in some cases. Sadly, many do not survive due to skin cancers and other complications,” concluded Dr. Lwin.

“This preclinical study will provide us with essential spray-on gene therapy data required for human applications,” stated Dr Michael Antoniou, Head of the Gene Expression and Therapy Group at the Department of Medical and Molecular Genetics of King’s College London, and Co-Principal Investigator of this study.

“We hope to translate this data into readily-available clinical therapies to benefit a wider population of RDEB sufferers,” stated Professor John McGrath, another Co-PI of this collaboration. Professor McGrath serves as the Mary Dunhill Chair in Cutaneous Medicine at King’s College London and Head of the St John’s Institute of Dermatology, the Guy’s and St Thomas’ NHS Foundation Trust in London. 

The preclinical gene therapy study announced today is the result of a Research Agreement entered into between RenovaCare and King’s College London. King’s College funding for this study is provided by DEBRA UK.

Dr. Su Lwin, Dr Michael Antoniou and Professor John McGrath are Co-Principal Investigators of this spray-on gene therapy study. 

The King’s College team is working directly with Dr. Roger Esteban-Vives, RenovaCare Vice President of Research & Product Development for use of the Company’s SkinGun™.

About RenovaCare
RenovaCare, Inc. is developing first-of-its-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Its initial product under development targets the body’s largest organ, the skin. The company’s flagship technology, the CellMist™ System, uses its patented SkinGun™ to spray a liquid suspension of a patient’s stem cells – the CellMist™ Solution – onto wounds.

RenovaCare is developing its CellMist™ System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars. In the US alone, this $45 billion market is greater than the spending on high-blood pressure management, cholesterol treatments, and back pain therapeutics.

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: 888-398-0202 or visit: https://renovacareinc.com

To receive future press releases via email, please visit: https://renovacareinc.com/investors/register/

Follow us on LinkedIn: https://www.linkedin.com/company/renovacare-inc-/

Follow us on Twitter: https://twitter.com/RenovaCareInc

Follow us on Facebook: https://www.facebook.com/renovacarercar

Social Media Disclaimer
Investors and others should note that we announce material financial information to our investors using 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 distributed 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
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  • 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.

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