Scottsdale, AZ – March 24, 2022 – 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 reductions in its management team to further streamline administrative expenses.
On March 24, Dr. Kaiyo Nedd resigned as Interim President, Chief Executive Officer and Director, and Mr. Justin Frere as Chief Financial Officer and Secretary. Their resignations were not due to any disagreements between the Company and them on any matter relating to the Company’s operations, policies, or practices. Dr. Nedd will continue to provide ongoing support to the Company as needed with respect to legacy matters, and Mr. Frere will continue to provide accounting services to the Company as needed. Chairman and majority stockholder, Mr. Harmel S. Rayat, will assume the roles of President, Chief Executive Officer, Chief Financial Officer and Secretary on an interim basis.
The Company has undertaken ongoing administrative and operating cost-cutting measures due to (i) COVID-19 related low patient enrollment in the RenovaCare clinical trial for safety and feasibility (CELLMIST 1), (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 piggyback class action and derivative lawsuits and (iii) the reputational damage suffered by the Company, which resulted in the loss of several clinical partners in June 2021 when the SEC complaint was announced and the clinical trial began and effectively precluded the Company from the capital markets for additional funding.
Accordingly, the Company will continue to be materially and adversely affected in all aspects of its operations and finances until these actions are resolved in court and may consider additional reductions in Company expenses. At this time, it is uncertain whether the Company will be able to bear the anticipated costs of its defense of the SEC civil complaint and the associated class action and derivative lawsuits.
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.
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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.