CEDAR KNOLLS, N.J., Dec. 14, 2018 /PRNewswire/ -- MYOS RENS Technology Inc. ("MYOS" or "the Company") (NASDAQ: MYOS), a biotherapeutics and bionutrition company and the owner of Fortetropin®, a proprietary bioactive composition derived from fertilized egg yolk that helps build lean muscle, issued the following letter to shareholders from MYOS CEO Joseph Mannello:
To our valued shareholders,
First, I want to thank everyone on our team for their hard work this year in executing our business plan.
This year has been all about leveraging Fortetropin® across our sports nutrition and veterinary nutrition verticals while solidifying our clinical research programs, and we have made great progress positioning the company to accelerate our revenue-generating efforts.
I'm going to start by mentioning the recent commercial launch of our Yolked® product line. This all-natural, nutritional product clinically proven to increase lean muscle mass is already being used in athletic departments across the country and is now available to the public through our website, Yolked.com. With the launch of Yolked, we announced that The Vitamin Shoppe® will carry Yolked at its 775 store locations across the U.S. and online at vitaminshoppe.com later this month. This is definitely a major accomplishment for us, one that will help build awareness in the Yolked brand, and with that, bring greater sales. It truly shows both the uniqueness of our Yolked brand as well as the power of Fortetropin.
Yolked® is all natural and contains only three ingredients– Fortetropin, dextrose and natural vanilla flavor. Research proves that Fortetropin has a unique molecular signature and in a clinical study, these molecules increase the rate of muscle building and decreases the rate of muscle loss. That's why Yolked is not just a protein supplement, but rather it enables the body to utilize protein more efficiently. Clinical trial subjects taking Yolked gained about 3 times more lean muscle relative to those who took a placebo over a 12-week period.
Yolked has been in athletic programs in various universities through our relationship with the sports marketing giant, IMG. We developed Yolked and sought NSF Certified for Sport® Certification, specifically to meet the needs of these athletes. NSF certification allows athletes, coaches and trainers to make more educated decisions when choosing sports supplements. The NSF certification program is recognized by the NFL, NFL Players Association, MLB, MLB Players Association, PGA, LPGA as well as the Canadian Centre for Ethics in Sports. Our goal is to have a major presence in locker rooms and training facilities of collegiate, and eventually, professional sports teams. Yolked is already helping athletes build muscle mass and reach peak performance at universities throughout the country, we expect to significantly increase our market penetration in 2019.
In other very recent news, the New Jersey Economic Development Authority agreed last week to transfer almost $1.2 million in available tax benefits to MYOS. This non-dilutive funding will be used for general working capital without reducing investor value or adding debt to our balance sheet; we expect $1.1 million from the sale.
One of our key pillars for future growth is in the veterinary segment with our MYOS Canine Muscle Formula™ product. We launched this product back in late June. Our initial marketing efforts generated substantial interest among dog owners and veterinarians who purchased the product through direct-to-consumer channels. We announced our first distribution agreement for MYOS Canine Muscle Formula with Miller Veterinary Supply East just about a month ago. This agreement with Miller will give the product exposure to more than 6,000 veterinary hospitals on the east coast.
We have received very important feedback and testimonials from our initial customers, many of whom have become repeat customers, enabling us to sharpen our marketing efforts. I urge you to visit our website, MyosPet.com and watch the video testimonials that we have received. When we talk to vets, they tell us that there are no products out there that address muscle health for middle-aged and older dogs. With our veterinary R&D efforts and targeted marketing, we are confident that the MYOS Canine brand will become recognized as a powerful supplement that can benefit dogs at any age.
I'm also happy to report that we have seen increased sales of MYOS Canine since the launch in late June and we expect revenues to increase in 2019 as more channels of distribution bear fruit.
In addition, our new MYOS Enteral Nutrition Formula™ was recently approved for Medicare and Medicaid reimbursement. The therapeutic potential of Fortetropin is becoming clearer, and we are committed to finding optimal future development pathways. Patients requiring enteral nutrition are typically very sick, and high-quality nutrition products like MYOS Enteral Nutrition Formula can make a big difference in their quality of life. We are currently working with physicians at leading academic medical centers to gain insight into how the enteral formulation of Fortetropin is tolerated among their patients.
Our researchers continue to explore the development and commercialization of medical nutrition products. While this is obviously a long-term initiative, we believe this research will enable us to further leverage the versatility of Fortetropin. That is why we are committed to continuing our focus on our clinical research studies. The results of these studies will underpin our commercial strategy for Fortetropin as well as enhance our intellectual property assets. We currently have one clinical study, two pre-clinical studies, and a discovery research program underway.
Until recently, this company had only scratched the surface with its R&D. But that has changed, as we realized that scientific research is essential to support our product claims, expand our commercial footprint, and with that, create shareholder value. We also believe that Fortetropin has "beyond-the-label" potential to enhance health benefits in both pets and humans. We intend to explore that potential through additional scientific studies. You never know where the science will lead you, but we believe Fortetropin has tremendous potential.
Our clinical study at the University of California, Berkeley's Department of Nutritional Science and Toxicology is investigating the effect of Fortetropin on increasing the fractional rate of skeletal muscle protein synthesis in men and women between the ages of 60 and 75. The sample and data analysis should be completed by the second quarter of 2019.
The pre-clinical study currently underway at the College of Veterinary Medicine at KSU is evaluating the impact of Fortetropin on reducing muscle atrophy in dogs after TPLO repair surgery, a common surgery that is similar to ACL surgery in humans. This study should be completed and reported by the end of the first quarter of 2019.
Our pre-clinical cachexia study with Weill Cornell Medical Center focuses on the impact of Fortetropin on preventing cachexia, a very serious form of muscle wasting, in a mouse model of lung cancer. This study is also expected to be completed and the results announced around the end of the second quarter of 2019.
Finally, our discovery research program with Rutgers focuses on discovering and isolating compounds from Fortetropin that will improve muscle health and performance. This is a long-term ongoing program with great potential to lead to valuable new therapeutic products.
We are in talks with leading principal investigators to explore clinical indications where Fortetropin may provide a significant benefit with respect to products that are currently on the market. The timing and the scope of these studies depend on the results of our current clinical studies. For example, based on feedback that we have received from leading veterinarian researchers who have used our MYOS Canine muscle formula extensively, we are actively discussing veterinary studies in a number of different areas with exciting potential.
2018 has been a significant year for MYOS. I'm proud of the progress we made throughout the year in building a portfolio of brands and products around Fortetropin. We have hired 5 new people who are helping transform the company. I want to thank them as well as the employees who have been at MYOS for years. I can assure you they are all committed to the success of MYOS.
There is a great deal of work left to do in executing our business plan to commercialize Fortetropin, but overall the business is heading in the right direction. We have become an R&D-based company. Our brands are unique and have resonated well with our targeted customer base, enabling us to secure key partnerships with leading distributors such as Vitamin Shoppe and Miller Veterinary Supply East. That said, we must strike the right balance between spending resources on traditional marketing efforts and reaching our internal sales goals.
In conclusion, there are many reasons for optimism in our ability to grow this business; the entire MYOS team and I remain focused on achieving this primary goal.
I agreed to forgo an annual salary last year, I purchased stock in the open market, as well as making direct investments in the company and extended a $1 million loan to the company because I truly believe there's massive upside potential in MYOS.
MYOS has a very strong balance sheet and consistently practices conservative cash management. Most importantly, we now have a constantly improving scientific profile, and we are developing brands that I believe will yield long-term success and significant profits to the company.
Thank you, Merry Christmas and Happy Holidays, wishing all of you a happy and healthy new year!
Chief Executive Officer
MYOS RENS Technology
About MYOS RENS Technology Inc.
MYOS RENS Technology Inc. (Nasdaq: MYOS), "The Muscle Company®", is a Cedar Knolls, NJ-based bionutrition company that develops and markets products that improve muscle health and performance. MYOS is the owner of Fortetropin®, a fertilized egg yolk-based product manufactured via a proprietary process to retain and optimize its biological activity. Fortetropin has been clinically shown to increase muscle size and lean body mass in conjunction with resistance training. MYOS believes Fortetropin has the potential to redefine existing standards of physical health and wellness. For more information, please visit www.MYOSRENS.com.
Any statements in this release that are not historical facts are forward-looking statements. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements involve risks and uncertainties, including but not limited to those relating to product and customer demand, market acceptance of our products, the ability to create new products through research and development, the successful results of strategic initiatives, the successful launch of our products, including Qurr®, Yolked®, MYOS Enteral Nutrition Formula™ and MYOS Canine Muscle Formula™ products, the success of our research and development, including the clinical studies described above, the results of the clinical evaluation of Fortetropin® and its effects, the ability to enter into new partnership opportunities and the success of our existing partnerships, the ability to generate the forecasted revenue stream and cash flow from sales of our products, the ability to continue increasing our revenue and gross profit margins, the ability to achieve a sustainable, profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, competition from other providers and products, the continued listing of our securities on the Nasdaq Stock Market, risks in product development, our ability to raise capital to fund continuing operations, and other factors discussed from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made except as required by law.
These statements have not been evaluated by the Food and Drug Administration. Our products are not intended to diagnose, treat, cure or prevent any disease.
Porter LeVay & Rose
Michael Porter, President
SOURCE MYOS RENS Technology Inc.