$MRZM: SPOTLIGHT GROWTH REPORT: MARIZYME, INC. (OT
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Posted On: 03/13/2019 10:21:06 AM
$MRZM: SPOTLIGHT GROWTH REPORT: MARIZYME, INC. (OTC PINK: MRZM)
For the Full MRZM Report: http://spotlightgrowth.com/index.php/2019/03/...pink-mrzm/
Summary:
This report offers analysis and insights into Marizyme, Inc. (OTC: MRZM)
Marizyme, Inc. operates as a development-stage biotechnology company that specializes in developing therapies and treatments across the acute care space.
One of Marizyme’s key products is Krillase, a combination of endo and exopeptidases, which are able to break down thrombogenic material and necrotic tissue in relation to wound healing.
Specifically, Marizyme’s goal is to commercialize treatments for thrombus-based diseases (stroke, acute myocardial infarctions, deep vein thrombosis, etc.), as well as other acute care conditions.
Krillase is classified as a Class III medical device in Europe for the treatment of chronic wounds. There have been over 500 patients tested in Europe
Killase’s active ingredient and secret behind the success of the treatment comes from Antarctic krill.
Antarctic krill provides Krillase with its “biochemical knife” characteristics due to its specialized enzyme system to help digest food in the extremely cold environment. A mix of proteinases and peptidases help provide a “cutting” capability to break down proteins.
As a result, Krillase has a wide range of potential medical applications, which provides Marizyme with strong expansion opportunities. For instance, the wound care market stands at $4.4 billion and thrombosis treatment market is valued at $22.58 billion globally.
Marizyme is also focusing on acquiring late-stage drugs, medical treatments, and devices to continue expanding its pipeline.
Marizyme, Inc. is based out of Fort Collins, Colorado
Marizyme, Inc. (OTC: MRZM):
Introduction to Marizyme, Inc.
Marizyme, Inc. operates as a development-stage biotechnology company that focuses on developing therapies and treatments across the acute care space. Specifically, the company is focused on developing novel treatments for thrombus-based diseases, as well as other applications that require additional funding. The company also is interested in continuing to acquire late-stage pharmaceuticals, medical treatments, and devices to help build out its pipeline.
Krillase is Marizyme’s main asset right now, which features a wide range of applications, such as the thrombolytic treatment, wound debridement and other potential applications. The active ingredient behind Krillase comes from a specialized enzyme that is found only in Antarctic krill. The mix of proteinases and peptidases helps the Antarctic krill digest and breaking down its food in the extremely cold environment. As a result, the specialized enzymes provide a “cutting” capability. Krillase has already been classified as a Class III medical device in Europe for the treatment of chronic wounds.
As of March 2019, Marizyme, Inc. is listed on the OTC Pink Sheets and is current with OTC Markets. Furthermore, the biotechnology company maintains a market cap of $45.48 million. Marizyme’s share structure consists of 75 million authorized shares, 19.74 million shares outstanding and a float of around 1 million shares, as of March 2019. Over the past 52 weeks, Marizyme, Inc. has seen a high of $5.51 and a low of $0.182. The low-float stock current trades at $2.10 at the time of this publication.
The Founder’s Patent for “cleaning wounds with enzymes from krill” was established back in 1987. From there, Pfizer, Inc.’s (NYSE: PFE) Pharmacia later divested the Founder’s Patent, as the market and demand for advanced wound care treatments was simply not robust 30+ years ago. Later, Biophausia acquired the medical technology and invested $14 million into Phase 1, 2, and 3 trials, proving advantages. All of the technology and research was eventually divested to its founders and Marizyme. This shows the Krillase platform has had strong development and testing prior to ownership by Marizyme.
Wound Care: $4.4 Billion Market
Although Krillase has wide application and usability across healthcare, Marizyme, Inc. sees wound care application as one the key markets for its treatment. Since Krillase is already established as a Class III medical device in Europe for wound treatment, this provides a great proof-of-concept for Marizyme. According to German Authorities at TUG, “…this product can be classified as a medical device … As this product is produced of material from animal origin and it comes in contact with injured skin, it has to be classified as a Class II product according to Rule 17 Medical Device Drug Law.”
According to ResearchAndMarkets.com, the global wound care market is estimated to grow to $42.07 billion by 2024, which represents a CAGR of 6.20% between 2018 and 2024. The market research firm notes that an increasingly aged population, growth in surgeries, and even increasing road accidents as major sources of growth for the wound care market. ResearchAndMarkets.com sees the United States as being one of the main drivers of growth, but the market researchers also see strength from other parts of the world.
Market analysis and estimates continue to support Marizyme and Krillase, as the company’s specialty is within one of the sub-segments with the highest growth outlook within the already strong-growth healthcare sector. Combine the fact that Krillase has a wide array of application capabilities, Marizyme has a strong “Swiss Army Knife” in its holdings.
Marizyme plans to continue raising funds, as well as seeking licensing, partnership and manufacturing opportunities to bring each unique Krillase application to market. However, unlike anything else on the market today, Krillase is able to efficiently debride pressure and diabetic necrotic ulcers without any damage to healthy tissue. Krillase has also been shown to be effective in cleaning and preparing wounds for skin grafting, which helps prevent debridement surgeries.
Krillase has been the subject of thirteen clinical studies, totaling 551 chronic wound and burn patients. The treatment has consistently demonstrated its ability to promote faster healing and help support existing skin grafting.
Overall, Krillase is shown to be an effective treatment in an industry where larger medical device companies are counting pennies while competing in the low-margin wound dressing market.
Thrombosis Treatment: $22.58 Billion Market
Strokes continue be a leading cause of death across the globe. According to the World Health Organization (WHO), there are roughly 17 million deaths each year due to stroke. The Centers for Disease Control and Prevention (CDC) further highlights that strokes are responsible for 1 out of 20 deaths here in the United States. The CDC also notes that stroke deaths in the U.S. cost $34 billion each year. “Higher rated of mortality associated with strokes highlight an impending need for innovative drugs and diagnostic devices,” details Hearldkeeper.
A stroke occurs when blood flow to the brain is disrupted, causing brain cells to begin dying. There are two major forms of stroke: ischemic and hemorrhagic. It is important to note that roughly 80% of all strokes are ischemic.
Ischemic strokes are can be either thrombotic or embolic. Thrombotic ischemic strokes are the result of blood clots forming in an artery that leads to the brain. An embolic ischemic stroke is a blood clot that forms somewhere else in the body (usually the neck or heart) that breaks loose and travels to the brain.
Hemorrhagic strokes are different from ischemic strokes in that they result in bursting blood vessels that bleed into the brain. There are two forms of hemorrhagic strokes: intracerebral and subarachnoid. An intracerebral hemorrhage, as the name suggests, occurs when a blood vessel ruptures within the brain. A subarachnoid hemorrhage is a blood vessel that bursts on the surface of the brain.
According to Allied Market Research, the global stroke management market was valued around $22.58 billion in 2016 and is forecast to reach $36.76 billion by 2023, which represents a CAGR of 7.10%.
The ischemic stroke market is eyed as one of key and primary goals for Marizyme, Inc. and Krillase. The company’s MB102 treatment is specifically designed for the treatment of acute ischemic stroke, which is currently nearing the end of its pre-clinical stage and needs funds to prepare for clinical stage.
Krillase: Diverse Application and Use
Now that we have established the fundamentals surrounding the active ingredient, let’s take a look at Krillase, how it works, its potential application in healthcare. We have established that Krillase combines endo and exopeptidases that are able to safely and efficiently break down thrombogenic material and necrotic tissue.
Pet/Human Dental Treatment: $1 Billion+ Market
Dental hygiene can have a major impact on life expectancy. Did you know your oral health can provide a window into your overall health? Improper oral hygiene can lead to gum disease, gingivitis, tooth decay, and more. Furthermore, some health conditions have been shown to have a potential negative affect on dental hygiene: diabetes, HIV/AIDS, osteoporosis, Alzheimer’s disease, and more.
It is not just humans that are suffering from poor dental hygiene, pets like dogs and cats have seen an explosion in dental issues over the past many decades. According to Banfield Pet Hospital’s “State of Pet Health Report” from 2016, “the prevalence of dental disease in dogs has risen since 2006, with steady growth each year. Dental disease in casts also increased over the last 10 years.”
One of the most common periodontal conditions that is affecting the globe right now is gingivitis. While gingivitis thrives in underdeveloped economies and in poor regions across the globe, market analysts see a very concern trend emerging showing gingivitis and other periodontal conditions could be on the rise. However, the rise is not due to living conditions, but rather diabetes. Studies show that “people with diabetes are at a higher risk of getting periodontitis than people without diabetes,” according to ResearchAndMarkets.com.
Furthermore, the World Health Organization (WHO) estimates 442 million adults across the world were living with diabetes in 2014. The WHO estimates that figure could double until 2025. Market research notes that emerging economies such as India and China could be hit particularly hard. This is why ResearchAndMarkets.com estimates the global periodontal market to jump from $259.50 million in 2016 to $580.5 million by 2025, which represents a CAGR of 9.20%.
The Krillase platform can also be used in dental plaque removal and treatment. Evaluations show Krillase’s ability to treat plaque removal versus placebos and other treatments on the market. The results show that Krillase can safely and effectively remove plaque without damaging teeth and gums. “This method has proven to be reliable and efficient has been used for the dental clinical studies analysis (plaque extension in a particular tooth),” according to Marizyme. As of the time of this writing, the dental plaque removal market is worth around $500 Million and provides another opportunity for Marizyme. Check out exhibit eight to see Krillase results compared to placebo and competing treatment:
As you can see, Krillase was far more effective in treating plaque removal compared to the placebo and Denivit competitor. In addition, Krillase was proven to be effective in reducing plaque formation over both short (5 days) and long term (10-14 days) periods, according to Computerized Dental Analysis (CDA). Patients also noted that their mouths felt “fresher” while using the Krillase treatment.
Krillase: Other Growth Application Opportunities
Over the next five years, Marizyme seek to pursue additional high-growth opportunities for Krillase application. To develop products that meet these high-growth opportunities, Marizyme will need to raise additional funds to engage in the necessary steps to progress and develop new products. This will include proper clinical research and testing.
HIV/AIDS Treatment: $20.45 Billion Market
According to Allied Market Research, the HIV/AIDS drug market was valued at $20.45 billion in 2015. The market research firm estimates that the drug treatment market will expand to a $26.46 billion market by 2022, which represents a CAGR of 3.7%. UGH – SAME COMMENT AS ABOVE, WHY THE TOTAL AIDS DRUG MARKET? This makes no sense.
The National Institute of Health’s (NIH) National Institute of Dental and Craniofacial Research notes that people with HIV/AIDS “are at special risk for oral health problems,” according to the agency. The agency notes that the most common oral problems with HIV/AIDS patients are: gingivitis, dry mouth, canker sores, oral warts, bone loss in teeth, fever blisters, thrush, hairy leukoplakia, and more.
Krillase may be a potential solution to help heal these oral health issues in patients that have HIV/AIDS. Krillase’s natural debridement properties and wide application within the dental field make it a natural fit as a potential option to assist patients. This helps provide to support the immune system, provides a chance for the mouth to heal and eliminate painful sores.
Oral Mucositis Treatment: $1 Billion Market
Oral mucositis is among the most common complication and side effect of chemotherapy and radiation cancer treatments. The painful open sores in the mucosa can be so excruciating that patients are unable to eat, face nutritional problems, and increased risk of infection due to the open sores. The condition is also common in HIV patients.
Marizyme’s Krillase is seemingly a good potential fit for the treatment of oral mucositis due to its efficient ulcer debridement and anti-herpetic properties. The company is looking at potentially utilizing Krillase in a mouthwash, gel or chewing gum form for oral mucositis treatment. This would be a major expansion for Krillase and Marizyme, as the oral mucositis treatment market is worth $1 billion.
Herpes Treatment Market: $1.8 Billion Market
Another key growth area for Krillase is for the treatment of the herpes virus. The treatment’s natural wound healing, ulcer debridement and viricidal properties make it a natural fit for potentially treating herpes flair ups and control outbreaks.
Marizyme is currently preparing to enter to proof-of-concept stage after in vitro studies showed Krillase to be a transdermal galenic that avoids herpes lesion appearances. The company’s studies will focus on acyclovir-resistant Herpes Simplex Virus (HSV) and Varicella Zoster Virus (VZV).
Canker Sore Treatment: $400 Million Market
Another dental application for Krillase, aside from plaque removal, is in the treatment of canker sores. Canker sores are painful oral soft tissue lesions that can naturally occur for numerous reasons. However, not all canker sores are created equal and some patients suffer from more severe and reoccurring sores.
“Krillase® could be used to treat specific lesions such as recurrent Aphtae Stomatitis, erosive Lichen Planus, Herpetic Gingivostomatitis, Herpes Zoster, and necrotic alveolus dry socket as well as post-operative wounds in general,” according to Marizyme. In 2017, about 20% of the population suffered from some type of canker sore (about 16% of adult population), with around 60% of those affected seeking treatment/medication.
Marizyme Product Pipeline
As of early 2019, Marizyme, Inc. has a product pipeline consisting of four initial treatments. Management details they are focusing on developing products that treat the most expensive conditions within the acute care market. Here is a breakdown of the current pipeline and where it stands in the clinical stages:
MB101 – Therapy for Complex Infected Wounds & Burns: Completed Phase 1 trials
MB102 – Therapy for Acute Ischemic Stroke: Nearing end of pre-clinical stage
MB103 – Therapy for Ischemic Myocardial Infarcs: Halfway through pre-clinical stage
MB104 – Therapy for Deep Vein Thrombosis: Early pre-clinical stage
MRZM: Business Plan for Next 24 Months
Development/Commercialization:
Over the next two years, Marizyme management has laid out a detailed business plan and set of goals for the company. Management sees the official launch of MB101 as a medical debridement device across Europe. Remember, Krillase is already classified as a Class III medical device for chronic wound treatment in Europe.
In the United States, Marizyme wants to begin clinical research and testing of its MB101 and MB102 product. MB103 and MB104 are estimated to begin IND programs.
Aside from its existing product pipeline, Marizyme sees itself acquiring more late-stage or approved products and assets within the acute care industry. In addition, as progress continues to pick up steam, it will be necessary for Marizyme to establish a medical advisory board specializing in wound, stroke and AMI. Marizyme also hopes to continue optimizing its manufacturing process for Krillase and its proteolytic enzymes. Lastly, the company wants to “license indications for Krillase platform for non-core applications,” such as dental, veterinary care, and more.
Monetization Plan:
Over the next twenty-four months, Marizyme sees several paths to revenue generation. Management sees an opportunity to sell its MB101 product as a wound debridement device across Europe alongside a “hybrid sales force and distribution partner.”
In its current state, Marizyme is already an enticing opportunity within the acute care space. One potential takeover scenario that could be viable would be as a roll-up acquisition to a hospital-focused pharmaceutical company that is looking to invest in a “deep pipeline of valuable assets for the acute care space.”
Part of Marizyme’s monetization plan includes raising additional funds in order to engage in further research & development. Over the next five years, Marizyme seek to pursue additional high-growth opportunities for Krillase application.
Analysis:
Overall, Marizyme’s technology and capabilities look even more impressive when comparing to some of its competitors. To be fair, Anika Therapeutics and Smith & Nephew are larger competitors, which could be a good barometer for Marizyme’s potential future.
However, when comparing Marizyme and Krillase to United Health Products, Arch Therapeutics, and MediWound (to name a few), these other competitors simply do not have the same breakthrough technology. While the competitor products may have a more general application, Marizyme’s Krillase has a wide range of potential applications and can be utilized in a variety of different scenarios.
In September 2018, the U.S. Biomedical Advanced Research and Development Authority (BARDA) awarded MediWound a $43 million contract to continue developing its NexoBrid. This is extremely interesting being that MediWound is an Israeli company and the fact that Krillase is a potentially more effective treatment than MediWound’s technology, which is still in development. Krillase is a Class III medical device in Europe and has more than enough available clinical research to at least show a proof-of-concept. Even with this generous contract from the BARDA, it could take MediWound years before they are able to fully develop, deploy, and demonstrate clear effectiveness of their wound care technologies.
Management Team
Executive Chairman: James Sapirstein
James Sapirstein, age 57, is a highly-regarded pharmaceutical industry executive with more than 35 years of success in building companies and leading the commercial launch of nearly two dozen prescription drugs in the fields of CNS, infectious disease, and cancer. He has worked at major pharmaceutical companies including Bristol-Myers Squibb, Hoffmann-LaRoche and Eli Lilly, and has led commercial teams for successful biotech companies such as Gilead Sciences and Serono Laboratories. In recent years, Mr. Sapirstein has been the founding CEO of the following early-stage biotech companies – Tobira Therapeutics (NASDAQ:TBRA) from 2006 to 2011, Alliqua Therapeutics (NASDAQ:ALQA) from 2012 to 2014, and most recently, Contravir Pharmaceuticals (NASDAQ:CTRV), from 2014 to 2018, where he defined and executed corporate strategy, raised significant capital, advanced drug development programs, and built shareholder value.
Director: Terry Brostowin
Terry Brostowin, age 59, is an accomplished attorney admitted to the Federal Court in both the Eastern and Southern districts of New York. He has extensive expertise in contracts, and commercial litigation. Mr. Brostowin has advised the New York City Mayor’s office on judicial appointments and was a compliance specialist ensuring agencies followed court ordered activities and ensured the financial integrity of the Financial Systems Division accounting and budgetary systems. Mr. Brostowin has been affiliated with the law firm Brostowin & Associates, PC, since 2009. From 2002 to 2009, Mr. Brostowin was affiliated with the law firm Conway & Brostowin, LLC.
Chief Executive Officer/Director: Michael K. Handley
Mike is successful life science business professional with over 23 years of cross-functional experience in drug/device commercialization, operations, mergers/acquisitions, regulatory/clinical affairs, venture formation/financing, market development and partnering/licensing. Mike has successfully assisted or led in the global commercialization of seventeen devices or drugs that account for over three billion dollars of sales annually. He has experience successfully leading management teams in a variety of capacities in high growth organizations and has secured millions of dollars in private equity and venture capital.
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For the Full MRZM Report: http://spotlightgrowth.com/index.php/2019/03/...pink-mrzm/
Summary:
This report offers analysis and insights into Marizyme, Inc. (OTC: MRZM)
Marizyme, Inc. operates as a development-stage biotechnology company that specializes in developing therapies and treatments across the acute care space.
One of Marizyme’s key products is Krillase, a combination of endo and exopeptidases, which are able to break down thrombogenic material and necrotic tissue in relation to wound healing.
Specifically, Marizyme’s goal is to commercialize treatments for thrombus-based diseases (stroke, acute myocardial infarctions, deep vein thrombosis, etc.), as well as other acute care conditions.
Krillase is classified as a Class III medical device in Europe for the treatment of chronic wounds. There have been over 500 patients tested in Europe
Killase’s active ingredient and secret behind the success of the treatment comes from Antarctic krill.
Antarctic krill provides Krillase with its “biochemical knife” characteristics due to its specialized enzyme system to help digest food in the extremely cold environment. A mix of proteinases and peptidases help provide a “cutting” capability to break down proteins.
As a result, Krillase has a wide range of potential medical applications, which provides Marizyme with strong expansion opportunities. For instance, the wound care market stands at $4.4 billion and thrombosis treatment market is valued at $22.58 billion globally.
Marizyme is also focusing on acquiring late-stage drugs, medical treatments, and devices to continue expanding its pipeline.
Marizyme, Inc. is based out of Fort Collins, Colorado
Marizyme, Inc. (OTC: MRZM):
Introduction to Marizyme, Inc.
Marizyme, Inc. operates as a development-stage biotechnology company that focuses on developing therapies and treatments across the acute care space. Specifically, the company is focused on developing novel treatments for thrombus-based diseases, as well as other applications that require additional funding. The company also is interested in continuing to acquire late-stage pharmaceuticals, medical treatments, and devices to help build out its pipeline.
Krillase is Marizyme’s main asset right now, which features a wide range of applications, such as the thrombolytic treatment, wound debridement and other potential applications. The active ingredient behind Krillase comes from a specialized enzyme that is found only in Antarctic krill. The mix of proteinases and peptidases helps the Antarctic krill digest and breaking down its food in the extremely cold environment. As a result, the specialized enzymes provide a “cutting” capability. Krillase has already been classified as a Class III medical device in Europe for the treatment of chronic wounds.
As of March 2019, Marizyme, Inc. is listed on the OTC Pink Sheets and is current with OTC Markets. Furthermore, the biotechnology company maintains a market cap of $45.48 million. Marizyme’s share structure consists of 75 million authorized shares, 19.74 million shares outstanding and a float of around 1 million shares, as of March 2019. Over the past 52 weeks, Marizyme, Inc. has seen a high of $5.51 and a low of $0.182. The low-float stock current trades at $2.10 at the time of this publication.
The Founder’s Patent for “cleaning wounds with enzymes from krill” was established back in 1987. From there, Pfizer, Inc.’s (NYSE: PFE) Pharmacia later divested the Founder’s Patent, as the market and demand for advanced wound care treatments was simply not robust 30+ years ago. Later, Biophausia acquired the medical technology and invested $14 million into Phase 1, 2, and 3 trials, proving advantages. All of the technology and research was eventually divested to its founders and Marizyme. This shows the Krillase platform has had strong development and testing prior to ownership by Marizyme.
Wound Care: $4.4 Billion Market
Although Krillase has wide application and usability across healthcare, Marizyme, Inc. sees wound care application as one the key markets for its treatment. Since Krillase is already established as a Class III medical device in Europe for wound treatment, this provides a great proof-of-concept for Marizyme. According to German Authorities at TUG, “…this product can be classified as a medical device … As this product is produced of material from animal origin and it comes in contact with injured skin, it has to be classified as a Class II product according to Rule 17 Medical Device Drug Law.”
According to ResearchAndMarkets.com, the global wound care market is estimated to grow to $42.07 billion by 2024, which represents a CAGR of 6.20% between 2018 and 2024. The market research firm notes that an increasingly aged population, growth in surgeries, and even increasing road accidents as major sources of growth for the wound care market. ResearchAndMarkets.com sees the United States as being one of the main drivers of growth, but the market researchers also see strength from other parts of the world.
Market analysis and estimates continue to support Marizyme and Krillase, as the company’s specialty is within one of the sub-segments with the highest growth outlook within the already strong-growth healthcare sector. Combine the fact that Krillase has a wide array of application capabilities, Marizyme has a strong “Swiss Army Knife” in its holdings.
Marizyme plans to continue raising funds, as well as seeking licensing, partnership and manufacturing opportunities to bring each unique Krillase application to market. However, unlike anything else on the market today, Krillase is able to efficiently debride pressure and diabetic necrotic ulcers without any damage to healthy tissue. Krillase has also been shown to be effective in cleaning and preparing wounds for skin grafting, which helps prevent debridement surgeries.
Krillase has been the subject of thirteen clinical studies, totaling 551 chronic wound and burn patients. The treatment has consistently demonstrated its ability to promote faster healing and help support existing skin grafting.
Overall, Krillase is shown to be an effective treatment in an industry where larger medical device companies are counting pennies while competing in the low-margin wound dressing market.
Thrombosis Treatment: $22.58 Billion Market
Strokes continue be a leading cause of death across the globe. According to the World Health Organization (WHO), there are roughly 17 million deaths each year due to stroke. The Centers for Disease Control and Prevention (CDC) further highlights that strokes are responsible for 1 out of 20 deaths here in the United States. The CDC also notes that stroke deaths in the U.S. cost $34 billion each year. “Higher rated of mortality associated with strokes highlight an impending need for innovative drugs and diagnostic devices,” details Hearldkeeper.
A stroke occurs when blood flow to the brain is disrupted, causing brain cells to begin dying. There are two major forms of stroke: ischemic and hemorrhagic. It is important to note that roughly 80% of all strokes are ischemic.
Ischemic strokes are can be either thrombotic or embolic. Thrombotic ischemic strokes are the result of blood clots forming in an artery that leads to the brain. An embolic ischemic stroke is a blood clot that forms somewhere else in the body (usually the neck or heart) that breaks loose and travels to the brain.
Hemorrhagic strokes are different from ischemic strokes in that they result in bursting blood vessels that bleed into the brain. There are two forms of hemorrhagic strokes: intracerebral and subarachnoid. An intracerebral hemorrhage, as the name suggests, occurs when a blood vessel ruptures within the brain. A subarachnoid hemorrhage is a blood vessel that bursts on the surface of the brain.
According to Allied Market Research, the global stroke management market was valued around $22.58 billion in 2016 and is forecast to reach $36.76 billion by 2023, which represents a CAGR of 7.10%.
The ischemic stroke market is eyed as one of key and primary goals for Marizyme, Inc. and Krillase. The company’s MB102 treatment is specifically designed for the treatment of acute ischemic stroke, which is currently nearing the end of its pre-clinical stage and needs funds to prepare for clinical stage.
Krillase: Diverse Application and Use
Now that we have established the fundamentals surrounding the active ingredient, let’s take a look at Krillase, how it works, its potential application in healthcare. We have established that Krillase combines endo and exopeptidases that are able to safely and efficiently break down thrombogenic material and necrotic tissue.
Pet/Human Dental Treatment: $1 Billion+ Market
Dental hygiene can have a major impact on life expectancy. Did you know your oral health can provide a window into your overall health? Improper oral hygiene can lead to gum disease, gingivitis, tooth decay, and more. Furthermore, some health conditions have been shown to have a potential negative affect on dental hygiene: diabetes, HIV/AIDS, osteoporosis, Alzheimer’s disease, and more.
It is not just humans that are suffering from poor dental hygiene, pets like dogs and cats have seen an explosion in dental issues over the past many decades. According to Banfield Pet Hospital’s “State of Pet Health Report” from 2016, “the prevalence of dental disease in dogs has risen since 2006, with steady growth each year. Dental disease in casts also increased over the last 10 years.”
One of the most common periodontal conditions that is affecting the globe right now is gingivitis. While gingivitis thrives in underdeveloped economies and in poor regions across the globe, market analysts see a very concern trend emerging showing gingivitis and other periodontal conditions could be on the rise. However, the rise is not due to living conditions, but rather diabetes. Studies show that “people with diabetes are at a higher risk of getting periodontitis than people without diabetes,” according to ResearchAndMarkets.com.
Furthermore, the World Health Organization (WHO) estimates 442 million adults across the world were living with diabetes in 2014. The WHO estimates that figure could double until 2025. Market research notes that emerging economies such as India and China could be hit particularly hard. This is why ResearchAndMarkets.com estimates the global periodontal market to jump from $259.50 million in 2016 to $580.5 million by 2025, which represents a CAGR of 9.20%.
The Krillase platform can also be used in dental plaque removal and treatment. Evaluations show Krillase’s ability to treat plaque removal versus placebos and other treatments on the market. The results show that Krillase can safely and effectively remove plaque without damaging teeth and gums. “This method has proven to be reliable and efficient has been used for the dental clinical studies analysis (plaque extension in a particular tooth),” according to Marizyme. As of the time of this writing, the dental plaque removal market is worth around $500 Million and provides another opportunity for Marizyme. Check out exhibit eight to see Krillase results compared to placebo and competing treatment:
As you can see, Krillase was far more effective in treating plaque removal compared to the placebo and Denivit competitor. In addition, Krillase was proven to be effective in reducing plaque formation over both short (5 days) and long term (10-14 days) periods, according to Computerized Dental Analysis (CDA). Patients also noted that their mouths felt “fresher” while using the Krillase treatment.
Krillase: Other Growth Application Opportunities
Over the next five years, Marizyme seek to pursue additional high-growth opportunities for Krillase application. To develop products that meet these high-growth opportunities, Marizyme will need to raise additional funds to engage in the necessary steps to progress and develop new products. This will include proper clinical research and testing.
HIV/AIDS Treatment: $20.45 Billion Market
According to Allied Market Research, the HIV/AIDS drug market was valued at $20.45 billion in 2015. The market research firm estimates that the drug treatment market will expand to a $26.46 billion market by 2022, which represents a CAGR of 3.7%. UGH – SAME COMMENT AS ABOVE, WHY THE TOTAL AIDS DRUG MARKET? This makes no sense.
The National Institute of Health’s (NIH) National Institute of Dental and Craniofacial Research notes that people with HIV/AIDS “are at special risk for oral health problems,” according to the agency. The agency notes that the most common oral problems with HIV/AIDS patients are: gingivitis, dry mouth, canker sores, oral warts, bone loss in teeth, fever blisters, thrush, hairy leukoplakia, and more.
Krillase may be a potential solution to help heal these oral health issues in patients that have HIV/AIDS. Krillase’s natural debridement properties and wide application within the dental field make it a natural fit as a potential option to assist patients. This helps provide to support the immune system, provides a chance for the mouth to heal and eliminate painful sores.
Oral Mucositis Treatment: $1 Billion Market
Oral mucositis is among the most common complication and side effect of chemotherapy and radiation cancer treatments. The painful open sores in the mucosa can be so excruciating that patients are unable to eat, face nutritional problems, and increased risk of infection due to the open sores. The condition is also common in HIV patients.
Marizyme’s Krillase is seemingly a good potential fit for the treatment of oral mucositis due to its efficient ulcer debridement and anti-herpetic properties. The company is looking at potentially utilizing Krillase in a mouthwash, gel or chewing gum form for oral mucositis treatment. This would be a major expansion for Krillase and Marizyme, as the oral mucositis treatment market is worth $1 billion.
Herpes Treatment Market: $1.8 Billion Market
Another key growth area for Krillase is for the treatment of the herpes virus. The treatment’s natural wound healing, ulcer debridement and viricidal properties make it a natural fit for potentially treating herpes flair ups and control outbreaks.
Marizyme is currently preparing to enter to proof-of-concept stage after in vitro studies showed Krillase to be a transdermal galenic that avoids herpes lesion appearances. The company’s studies will focus on acyclovir-resistant Herpes Simplex Virus (HSV) and Varicella Zoster Virus (VZV).
Canker Sore Treatment: $400 Million Market
Another dental application for Krillase, aside from plaque removal, is in the treatment of canker sores. Canker sores are painful oral soft tissue lesions that can naturally occur for numerous reasons. However, not all canker sores are created equal and some patients suffer from more severe and reoccurring sores.
“Krillase® could be used to treat specific lesions such as recurrent Aphtae Stomatitis, erosive Lichen Planus, Herpetic Gingivostomatitis, Herpes Zoster, and necrotic alveolus dry socket as well as post-operative wounds in general,” according to Marizyme. In 2017, about 20% of the population suffered from some type of canker sore (about 16% of adult population), with around 60% of those affected seeking treatment/medication.
Marizyme Product Pipeline
As of early 2019, Marizyme, Inc. has a product pipeline consisting of four initial treatments. Management details they are focusing on developing products that treat the most expensive conditions within the acute care market. Here is a breakdown of the current pipeline and where it stands in the clinical stages:
MB101 – Therapy for Complex Infected Wounds & Burns: Completed Phase 1 trials
MB102 – Therapy for Acute Ischemic Stroke: Nearing end of pre-clinical stage
MB103 – Therapy for Ischemic Myocardial Infarcs: Halfway through pre-clinical stage
MB104 – Therapy for Deep Vein Thrombosis: Early pre-clinical stage
MRZM: Business Plan for Next 24 Months
Development/Commercialization:
Over the next two years, Marizyme management has laid out a detailed business plan and set of goals for the company. Management sees the official launch of MB101 as a medical debridement device across Europe. Remember, Krillase is already classified as a Class III medical device for chronic wound treatment in Europe.
In the United States, Marizyme wants to begin clinical research and testing of its MB101 and MB102 product. MB103 and MB104 are estimated to begin IND programs.
Aside from its existing product pipeline, Marizyme sees itself acquiring more late-stage or approved products and assets within the acute care industry. In addition, as progress continues to pick up steam, it will be necessary for Marizyme to establish a medical advisory board specializing in wound, stroke and AMI. Marizyme also hopes to continue optimizing its manufacturing process for Krillase and its proteolytic enzymes. Lastly, the company wants to “license indications for Krillase platform for non-core applications,” such as dental, veterinary care, and more.
Monetization Plan:
Over the next twenty-four months, Marizyme sees several paths to revenue generation. Management sees an opportunity to sell its MB101 product as a wound debridement device across Europe alongside a “hybrid sales force and distribution partner.”
In its current state, Marizyme is already an enticing opportunity within the acute care space. One potential takeover scenario that could be viable would be as a roll-up acquisition to a hospital-focused pharmaceutical company that is looking to invest in a “deep pipeline of valuable assets for the acute care space.”
Part of Marizyme’s monetization plan includes raising additional funds in order to engage in further research & development. Over the next five years, Marizyme seek to pursue additional high-growth opportunities for Krillase application.
Analysis:
Overall, Marizyme’s technology and capabilities look even more impressive when comparing to some of its competitors. To be fair, Anika Therapeutics and Smith & Nephew are larger competitors, which could be a good barometer for Marizyme’s potential future.
However, when comparing Marizyme and Krillase to United Health Products, Arch Therapeutics, and MediWound (to name a few), these other competitors simply do not have the same breakthrough technology. While the competitor products may have a more general application, Marizyme’s Krillase has a wide range of potential applications and can be utilized in a variety of different scenarios.
In September 2018, the U.S. Biomedical Advanced Research and Development Authority (BARDA) awarded MediWound a $43 million contract to continue developing its NexoBrid. This is extremely interesting being that MediWound is an Israeli company and the fact that Krillase is a potentially more effective treatment than MediWound’s technology, which is still in development. Krillase is a Class III medical device in Europe and has more than enough available clinical research to at least show a proof-of-concept. Even with this generous contract from the BARDA, it could take MediWound years before they are able to fully develop, deploy, and demonstrate clear effectiveness of their wound care technologies.
Management Team
Executive Chairman: James Sapirstein
James Sapirstein, age 57, is a highly-regarded pharmaceutical industry executive with more than 35 years of success in building companies and leading the commercial launch of nearly two dozen prescription drugs in the fields of CNS, infectious disease, and cancer. He has worked at major pharmaceutical companies including Bristol-Myers Squibb, Hoffmann-LaRoche and Eli Lilly, and has led commercial teams for successful biotech companies such as Gilead Sciences and Serono Laboratories. In recent years, Mr. Sapirstein has been the founding CEO of the following early-stage biotech companies – Tobira Therapeutics (NASDAQ:TBRA) from 2006 to 2011, Alliqua Therapeutics (NASDAQ:ALQA) from 2012 to 2014, and most recently, Contravir Pharmaceuticals (NASDAQ:CTRV), from 2014 to 2018, where he defined and executed corporate strategy, raised significant capital, advanced drug development programs, and built shareholder value.
Director: Terry Brostowin
Terry Brostowin, age 59, is an accomplished attorney admitted to the Federal Court in both the Eastern and Southern districts of New York. He has extensive expertise in contracts, and commercial litigation. Mr. Brostowin has advised the New York City Mayor’s office on judicial appointments and was a compliance specialist ensuring agencies followed court ordered activities and ensured the financial integrity of the Financial Systems Division accounting and budgetary systems. Mr. Brostowin has been affiliated with the law firm Brostowin & Associates, PC, since 2009. From 2002 to 2009, Mr. Brostowin was affiliated with the law firm Conway & Brostowin, LLC.
Chief Executive Officer/Director: Michael K. Handley
Mike is successful life science business professional with over 23 years of cross-functional experience in drug/device commercialization, operations, mergers/acquisitions, regulatory/clinical affairs, venture formation/financing, market development and partnering/licensing. Mike has successfully assisted or led in the global commercialization of seventeen devices or drugs that account for over three billion dollars of sales annually. He has experience successfully leading management teams in a variety of capacities in high growth organizations and has secured millions of dollars in private equity and venture capital.
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