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HCYT

H-CYTE

$0.00 /

+ (+0.00%)

08:14
01/21/20
01/21
08:14
01/21/20
08:14

H-CYTE expects to achieve cashflow breakeven 'as early as this year'

H-CYTE issued the following letter to shareholders from its CEO Bill Horne. The letter read in part, "We have made significant progress toward our dramatic strategic goals due to the support of our gracious and accomplished investors. They share our vision for the future of the state of medicine. They understand that focusing on serving our patients is the best way possible to create significant shareholder value. The way forward to help more patients is to continue to work through our investigational new drug process with the FDA. Most recently, a $6M investment in H-CYTE was led by a group that includes Todd Wagner, a co-founder of Broadcast.com and Rex Farrior and Preston Farrior, prominent philanthropists and University of Florida benefactors. The new funding will be used to advance the company's development of our industry-leading investigational medical treatment for chronic lung diseases such as chronic obstructive pulmonary disease. Last year, Chris Sullivan and Bob Basham, co-founders of Outback Steakhouse, also made considerable investments into the company. On the heels of the recent financing, we have taken steps to reduce operating expenses so we can focus on pushing forward with FDA approval requirements. With these initiatives, we are currently seeing the previous gap in spending relative to revenues diminish. These newly implemented initiatives were specifically designed to result in the company achieving cashflow breakeven near term. I'm pleased with the recent progress and expect, although there can be no assurance, to realize the goal as early as this year...H-CYTE is focused on working toward our new treatment. We previously announced, as part of our strategic moves, that we have entered into a long-term agreement with Rion that will enable H-CYTE to develop proprietary biologics for the treatment of COPD. Rion will serve as the product supplier and co-developer of the new treatment with H-CYTE. As part of the agreement, H-CYTE will control commercial development and facilitate the clinical trial investigation. In addition, we intend to leverage Lung Health Institute, a provider team that has safely performed more than 8,000 minimally invasive procedures since 2013. These combined efforts are key to pursuing submission of an investigational new drug application for review by the U.S. Food and Drug Administration. The FDA has developed four distinct and successful approaches to making such drugs available as rapidly as possible. In light of these approaches, there are opportunities to apply for an expedited or accelerated pathway to application review. Lastly, I want to address something of critical importance to all of us, our stock price. I can tell you in no uncertain terms that neither the management team nor our board of directors is pleased with our current stock price. Our focus remains on bringing a needed medical solution to the marketplace, from which we expect to create significant shareholder value. Rest assured, we will continue to work diligently on positioning the company for long term success and value creation."

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