Cytonics: The Future of Regenerative Medicine

Upshot 

• The core of Cytonics’ technology rests upon an anti-inflammatory protein called Alpha-2-Macroglobulin (A2M), found naturally in the blood stream and involved in inhibiting the body’s inflammatory response to trauma or infection to many bodily tissues. 
• Cytonics primary indication is osteoarthritis (OA), a debilitating disease characterized by cartilage degradation caused by hyper-active, catabolic enzymes called "proteases".
• To date, there are no effective therapies for OA that treat the root molecular cause (protease activity), and merely mask the symptoms (pain and inflammation).
• The current market size for a true therapy that reverses the progression of OA is $240B, growing at a CAGR of ~13%.
• Cytonics has commercialized an FDA-approved, super-concentrated A2M formulation using a proprietary filtration method applied to a patient's own blood  - "Autologous Protease Inhibitor Concentrate" (APIC™) therapy.
• The APIC™ therapy has been used to treat cartilage breakdown in over 8,000 patients, preventing hundreds of joint replacements and restoring quality of life since 2015.
• Cytonics’ current focus is on the development of an engineered, synthetic variant of the naturally occurring A2M molecule, which has been genetically modified to increase its anti-inflammatory effects in treating OA of the joints. This lead drug candidate has been dubbed “CYT-108”.
• Cytonics recently concluded a preclinical study in a large animal model of post-traumatic osteoarthritis. The results were extremely promising – CYT-108 was well-tolerated when injected into the blood stream and showed no adverse effects on the major organs.
• Importantly, the CYT-108 showed clear signs of cartilage and joint tissue protection, reducing the destruction of cartilage and the joint membrane by almost 90%!
• When CYT-108 is approved for sale by the FDA and is successfully commercialized it will quickly penetrate the market and become a first-line therapy before total joint replacement surgery. 
• Cytonics will initiate preclinical trials to investigate the ability of CYT-108 to inhibit lung inflammation (caused by Acute Respiratory Distress Syndrome, COVID-19, COPD, and more).
• CYT-108 may be a potent inhibitor of both the proteases and cytokines that underly inflammatory lung diseases. Interestingly, both OA and COVID-19 are caused by the same signaling mechanisms, mediated by proteases and inflammatory molecules called “cytokines” that produce a hyper-inflammatory response called the “cytokine storm”. ‍‍
• The company is currently raising capital for the pursuance of preclinical and Phase 1 trials for both osteoarthritis and ARDS/COVID-19 through the issuance of preferred stock under Regulation CF (available to accredited and non-accredited investors).
• IND application will be submitted in 3Q23.
• Phase 1 clinical study will begin in 4Q23.

Cytonics’ Ingenuity

Harnessing nature’s design

The core of Cytonics’ technology rests lies in the anti-inflammatory activity of the Alpha-2-Macroglobulin (A2M) protein that is found naturally in the blood stream and plays a critical role in inhibiting the body’s inflammatory response to trauma or infection. A2M is a broad-spectrum protease inhibitor, capable of rendering the protease enzymes responsible for cartilage erosion impotent. Cytonics has commercialized an FDA-approved, super-concentrated A2M formulation using a proprietary filtration method applied to a patient's own blood - the "Autologous Protease Inhibitor Concentrate" (APIC™) therapy. When injected into arthritic joints, this super-concentrated A2M produced by the APIC system potently inhibits proteases, providing both immediate relief of symptoms and long-term reversal of the cartilage damage that plagues arthritic joints.

The APIC™ therapy has been used to treat cartilage breakdown in over 8,000 patients suffering from joint pain and inflammation. The clinical and commercial success of the APIC therapy is a testament to the power of A2M to heal cartilage damage and reduce joint inflammation, and proof that Cytonics has a clear regulatory path outlined to develop its core technologies. Since commercializing the APIC product in 2015, the company made a critical pivot away from medical devices towards the development of biologics (biopharmaceuticals). Cytonics’ current focus is on the development of an engineered, synthetic variant (recombinant) of the naturally occurring A2M molecule, which has been genetically modified to increase its anti-inflammatory effects in treating OA of the joints. This patented A2M variant, dubbed “CYT-108”, has been shown to be both safe and effective in preclinical trials, a critical milestone achievement on the path towards FDA drug approval. Importantly, the activity of CYT-108 is 2-4x greater than that of the natural A2M protein, and can be concentrated over 100-fold that of the naturally occurring levels. Once approved by the FDA, CYT-108 will be the first and only biologic capable of treating OA at its source, halting and eventually reversing the cartilage degradation process that plagues arthritic joints.

A platform technology

CYT-108 is not a single drug, but a byproduct of a platform technology that employs both high-throughput screening and intelligent genetic engineering. The core A2M protein can be tweaked many ways to increase its affinity (its likelihood of binding to molecules of interest) for many different proteases and inflammatory mediators (like "cytokines"). In fact, Cytonics has already developed a library of over 100 A2M variants that could be potent drugs in other inflammatory diseases. The obvious first candidate is COVID-19, an inflammatory disease mediated by pro-inflammatory molecules called "cytokines". As it turns out, the natural A2M is a potent cytokine inhibitor on its own, and Cytonics has a strategy to drastically increase its efficacy in reducing lung inflammation. The company anticipates initiating a preclinical trial in the first half of 2023.

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Osteoarthritis: a global health crisis

According to the CDC, over 30 million Americans are treated for back pain every year, and over 27 million of those cases are directly attributable to osteoarthritis (OA). Globally, over 600M people suffer from OA-related joint pain and inflammation. Back pain is the #1 cause of missed work and the #1 healthcare expense in our country, with over $180B spent each year in treating OA-related symptoms. Joint pain and inflammation account for millions of doctor office visits each year and the prevalence is rapidly rising as the average life expectancy increases in this modern era. In all, OA burdens our nation (and the world) with human suffering, lost productivity, missed work, and excessive medical expenses.

To date, there are no FDA approved therapies with long-term efficacy for OA. Clinicians have few options before resorting to total joint replacement surgery, an extremely costly and invasive procedure that renders the patient immobile for weeks after the procedure and costs tens of thousands of dollars. Lifestyle changes such as weight loss and exercise are often recommended and supplemented with periodic injections of corticosteroids or hyaluronic acid (HA). Unfortunately, corticosteroids and HA do not address the root cause of the disease and merely treat the symptoms (pain and inflammation), bringing temporary and mild relief to the damaged joints. These injection therapies represent a $20B yearly market in the US alone. To-date, the treatment of osteoarthritis is limited to temporary pain relief that delays an inevitable joint replacement surgery. 

The interest in non-surgical approaches to treating OA has grown over the years as our population ages and remains active. Many new technologies are offered in this segment with relatively little market penetration and no compelling randomized clinical trial data. These inferior treatment options fall into three main categories:

1. Platelet Rich Plasma or “PRP” (without concentrated A2M) (2) “stem-cell” offerings derived from autologous adipose (fat) tissue or bone marrow,
2. Viscosupplmentation, such as hyaluronic acid, a thick viscous substance that provides temporary cushioning when injected in the damaged joint. Eventually, the hyaluronic acid seeps out of the joint and is not a long-term solution.
3. Placental-derived allograft products. Notably, the large orthopedic players have declined to participate in these segments because they would prefer to wait until a new technology is clinically proven in human clinical studies, has specific FDA clearance for osteoarthritis, and has gained reimbursement before in-licensing the experimental drug for further development or purchasing the asset at a premium post-approval. To date, none of the companies with autologous or allograft treatments have shown any indication that they will pursue this route, so Cytonics is one of the few (if not only) regenerative medicine companies developing biopharmaceuticals for OA.

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CYT-108: A first-in-class biopharmaceutical

Since its inception in 2006, Cytonics has developed first-in-class diagnostics and therapeutics for osteoarthritis (OA). In 2010, the company launched its flagship product “FACT™” (Fibronectin-Aggrecan Complex Test), a first-in-kind biomarker assay that detects byproducts of cartilage degradation in joint fluid. The FACT™ diagnostic test is currently sold to physicians nationwide and is used to assess the extent of cartilage damage in patients and determine the appropriate course of treatment. The FACT™ diagnostic is often used in conjunction with the company’s innovative Autologous Platelet Integrated Concentrate (“APIC™”) therapy for OA. The APIC™ system is predicated on Platelet Rich Plasma (PRP) technology, which concentrates the plasma cells found in blood and is injected into damaged. The APIC™ system differs from PRP in that it selectively concentrates Alpha-2-Macroglobulin (A2M) while removing other harmful, pro-inflammatory blood proteins. A2M is a well-known blood serum enzyme inhibitor which prevents the enzymes (proteases) that degrade cartilage from destroying the joint. The core of Cytonics’ technology is based upon the therapeutic effect of this A2M protein, and the company has shown in the clinic that super-concentrated doses of autologous A2M (i.e., A2M derived from the patient’s own blood) can prevent cartilage decay and reverse the effects of osteoarthritis in the afflicted joint. The APIC™ system prepares a highly-concentrated, A2M-rich solution from the patient’s own blood that can be delivered into painful and inflamed joints, often providing immediate relief and allowing patients to get back to their active lifestyle.

Cytonics’ current focus is on the development of a genetically engineered A2M variant, “CYT-108”, based upon the protein structure of the naturally-occurring A2M molecule that has been shown to inhibit the protease enzymes that degrade cartilage in OA. This patented therapeutic protein has demonstrated superior efficacy by inhibiting the cartilage-degrading enzymes by up to 4-fold over the naturally-occurring A2M molecule. Cytonics recently concluded a preclinical study in a large animal model of post-traumatic osteoarthritis. The results were extremely promising – CYT-108 was well-tolerated when injected into the blood stream and showed no adverse effects on the major organs. Importantly, the drug showed clear signs of cartilage and joint tissue protection – Treatment with CYT-108 reduced the destruction of cartilage and the joint membrane by up to 90%! (see graphs below) from the degradative enzymes. If CYT-108 is approved for sale by the FDA and is successfully commercialized, the company anticipates that CYT-108 will quickly penetrate the market and become a first-line therapy before total joint replacement.

“The results of our study look very promising. The purpose of this pilot preclinical study was to examine whether CYT-108 is a feasible drug candidate for treating osteoarthritis and safe to administer to patients. Importantly, CYT-108 was well-tolerated when injected into the joint and no adverse effects were observed when administered at a 10-fold higher dose under the skin (subcutaneous injection). Moreover, we observed cartilage-protective effects of CYT-108 when administered into arthritic joints. CYT-108 is a recombinant variant of the naturally-occurring A2M protein, which is a well-characterized anti-inflammatory agent due to its ability to “scavenge” for pro-inflammatory molecules (cytokines) and inhibit the enzymes (proteases) that cause cartilage degeneration in osteoarthritis. 

~ Joey Bose, President and CEO

Drug development pipeline

Cytonics’ portfolio of diagnostics, medical devices, and biopharmaceuticals for inflammatory diseases such as osteoarthritis and COVID-19 is expansive, diverse, and in various stages of FDA approval. The company has successfully commercialized 2 technologies through the FDA approval process and has their first-in-class drug, CYT-108, in development for both osteoarthritis and COVID-19. It is important to note that the clinical success of their APIC therapy is a testament to the power of A2M as a therapeutic, which de-risks the development of their synthetic A2M variant, CYT-108, substantially (see Investment Considerations below). Cytonics is preparing for OA Phase 1 human trials in 2021 as the FDA reviews its preclinical dataset. Additionally, Cytonics has developed a preclinical study protocol to test the safety and efficacy of CYT-108 in a preclinical model of COVID-19, and intends to submit the preclinical and COVID Phase 1 trial protocols by the end of September 2022 in their IND filing.

Key Catalysts

Cytonics began discussions with the FDA in 2019, and has maintained consistent contact with the Agency. These "pre-IND" meetings with the FDA are a critical step along the path towards drug approval. The FDA’s review of the company’s pilot preclinical data and proposed Phase 1 human clinical trial was overall positive. The agency determined that the design of the pilot preclinical trial was sufficient to determine the toxicology of the drug, and Cytonics must simply repeat the toxicology study under more stringent, GLP conditions. Cytonics has already begun this final, "IND-enabling" toxicology study, which is significantly de-risked by the company's large body of preliminary animal safety and efficacy data and the FDA's positive response. Cytonics expects to submit the final preclinical results  to the FDA in early Q3 2023. This will allow the company to initiate their Phase 1 clinical trial for CYT-108 as a treatment for OA in Q4 2023.

Milestones:

• GMP-grade CYT-108 has been produced for IND-enabling preclinical study and Phase 1 human trial (completed Q1 2022)
• CYT-108 for Osteoarthritis IND-enabling preclinical study (completed Q2 2022) - safety and pharmacokinetics established
• Reg CF equity crowdfunding investment opportunity open until April 1, 2023  - Learn more here 
• IND application to be submitted in early Q3 2023
• Phase 1 study to be initiated by Q4 2023
• Exit opportunities - shop Phase 1 human clinical data to strategics (e.g. Johnson and Johnson) - potential NASDAQ listing in H2 2024
  

“The production of our genetically modified A2M protein, CYT-108, is a significant accomplishment for the company, as we now have a process to create high-yield, pure CYT-108 protein on an industrial scale. This milestone is a break-through for the company and a strong indication that we are capable of advancing our drug development program through the complicated FDA regulatory process”

~ Joey Bose, President and CEO

Not A One-Trick Pony

CYT-108 as a treatment for lung inflammation

The outbreak of SARS-CoV-2, the virus that leads to COVID-19 disease, has inspired mass hysteria on an unprecedented level (maybe on par with the Black Plague?). Never in the modern era has a pathogen captured the attention of the global populace, inspired so many armchair epidemiologists, and politicized human health and well-being. The COVID epidemic has cast a spotlight on the ill-preparedness of the WHO and national centers of disease control to deal with pandemic of this magnitude and has also illuminated the ineffectiveness of a bipartisan government and the fragility of the global economy. The life sciences industry is rapidly evolving as attention is turned towards developing novel anti-virals while regulation is being aggressively scrutinized as governments push for new COVID therapies and vaccines to enter the market ASAP

While the negative impacts of COVID-19 on our healthcare system and the global economy cannot be overstated, many biotech companies have seized upon the critical unmet need to develop robust and effective diagnostics, vaccines, and therapeutics for SARS-CoV-2 infection. With great calamity comes great disruption, followed by rapid consolidation as the wheat separates from the chaff. The ability to seize upon this once-in-a-lifetime opportunity and pivot within the dynamic landscape of drug development is a strong sign that a biotech company’s research and development program is innovative, has broad applications, and is not limited to a niche disease area. This agility also highlights the excellence of the management team’s grasp of corporate strategy, R&D, and project management.

Importantly, CYT-108 could be effective as a treatment for many inflammatory lung diseases that are caused by hyperactive immune responses (e.g., excess cytokines and protease activity), such as Acute Respiratory Distress Syndrome (ARDS) and Chronic Obstructive Pulmonary Disease (COPD). Cytonics intends to pursue these indications once they prove that CYT-108 will function as an effective therapy for SARS-CoV-2 -induced lung inflammation.

The Search for an effective treatment

Infection with SARS-CoV-2 follows the classic pathway of viral invasion, beginning with the internalization of the virus into the human host cells, a Trojan Horse approach that has been optimized over evolutionary timescales. The CoV-2 virus hijacks the human cell’s replicative machinery and turns it into a virus-producing factory, with the end goal of using the cell until exhaustion and pumping out carbon copies of the virus until the cell eventually dies. Cell death and recognition of the virus by the body’s immune system sets off a cascade of inflammation focused in the lungs and upper respiratory tract that very quickly leads to lung failure (at which point the patient is put on a ventilator) and death in the elderly and other compromised patients (i.e. patients with comorbid obesity, diabetes, asthma, COPD, pneumonia, tuberculosis, etc.). This hyperinflammation is mediated by small signaling molecules called “cytokines,” which play a role in directing other immune cells to sources of infection. Hyperactive cytokines produce a destructive inflammatory effect in the lungs termed the “cytokine storm”. The cytokine storm is also responsible for irritating the vascular system and decreases the transport of oxygen in the lungs, causing them to fail. Clinicians have also noted the formation of life-threatening blood clots throughout the body. An effective therapy for COVID-19 would inhibit the inflammatory and hypercoagulation symptoms in the lungs, allowing patients to live long enough to develop adaptive immunity against the virus. 

Carpe diem

The cure to COVID-19 will not be found in a single vaccine. Vaccine development is a costly process fraught with many pitfalls, such as patient attrition, ongoing virus mutation, and limitations on the duration and strength of conferred immunity. Cytonics believes that a dual approach that includes clinical treatment of symptoms and anti-viral support in COVID-19 patients is the most effective way to improve patient morbidity and mortality. With this in mind, Cytonics has seized the opportunity to develop a first-in-class therapeutic for COVID-19.

Ironically, the emergence of COVID-19 could not have come at a better time for the company. Cytonics’ preclinical study in OA clearly demonstrated the safety and anti-inflammatory effects of CYT-108, and is convincing evidence that the drug is a viable candidate for human clinical studies. It just so happens that the inflammatory cascade (cytokine storm) that leads to cartilage damage in arthritic joints is almost identical to the hyperinflammation of the lungs that leads to death in COVID-19 patients. Serendipity, blind luck, karma… all words that describe how Cytonics feels about the potential for CYT-108 to treat COVID-19. CYT-108 has been designed to inhibit the “cytokine storm” that leads to lung inflammation and eventual death. There are currently no effective therapies on the market (the FDA has approved remdesivir and convalescent plasma, but neither have demonstrated substantial improvement in patient survival and are dubious at best). If CYT-108 demonstrates efficacy in bringing down the levels of the SARS-CoV-2 virus and inhibiting the cytokine storm in a preclinical model of COVID-19, the drug may be eligible for Emergency Use Authorization from the FDA to expedite the drug approval pathway in humans.

“The cure to COVID-19 will not be found in a single vaccine. Vaccine development is a costly process fraught with many pitfalls, such as patient attrition, ongoing virus mutation, and limitations on the duration and strength of conferred immunity. We believe that a dual approach that includes clinical treatment of symptoms (via a therapeutic drug) and anti-viral support in COVID-19 patients is the most effective way to improve patient morbidity and mortality. With this in mind, we have seized the opportunity to develop a first-in-class therapeutic for COVID-19 that has the potential to reduce the inflammation of the lungs in COVID-19 patients, extending life and decreasing morbidity.”

~ Joey Bose, President and CEO of Cytonics

Cytonics has entered into an agreement with a Contract Research Organization that performs toxicology and anti-infective efficacy studies for COVID-19. Cytonics plans on allocating $1M of the funds raised during their Reg CF+ for pursuing FDA approval, and expedited review through the Emergency Use Authorization (EUA), of CYT-108 as a first-in-class treatment for COVID-19. The company expects to begin COVID preclinical trials in Q1 2021. 

The company expects to begin SARS-CoV-2 induced lung inflammation preclinical trials in Q1 2023. 

Investment Considerations

Track record of success

Cytonics’ management team is comprised of key opinion leaders in the field of regenerative medicine, a Chief Scientific Officer with over 30 years’ in genetic engineering of biologic therapies, former C-level executives of Big Pharma companies, and regulatory advisors with a  combined 75+ years’ experience in executing FDA clinical trials. Their expertise has allowed Cytonics to achieve tremendous success in translating drug discovery into commercialized therapies through the FDA approval process. The company has CLIA certification for its FACT™ diagnostic assay, a 510(k) approval for the APIC™ therapy, and the only IND filing for a plasma-based medical technology. Cytonics has proven that A2M-based therapies can inhibit cartilage damage through blocking the inflammatory response in damaged joints, and has successfully treated over 7,000 patients using their APIC™ therapy. This clinical success of their first-generation A2M-based treatment significantly “de-risks” the development of their first-in-class, genetically engineered variant of the A2M protein. With strong preclinical evidence suggesting that CYT-108 is safe and effective to be administered into damaged joints, Cytonics is well on their way to human clinical studies and FDA approval for CYT-108 as a treatment for osteoarthritis. The recent development of a preclinical safety and efficacy study for COVID-19 is a key addition to the company’s drug development pipeline, and the strong evidence for CYT-108 as an inhibitor of lung inflammation makes CYT-108 an excellent candidate for a COVID-19 therapy.

Cytonics has already engaged the FDA and received feedback on our proposed preclinical and Phase 1 clinical trial designs. This feedback was overall very positive. The Agency agreed that, based on our pilot preclinical toxicology data, that our protocols were well-designed to support an Investigational New Drug application ahead of the Phase 1 study. This significantly de-risks the development process. If approved by the FDA, CYT-108 will be a first-in-class biologic treatment for osteoarthritis, providing patients with the first safe and effective therapy to slow down the progression of the disease by preventing the cartilage breakdown.”  

~ Joey Bose, President and CEO

Tried and true approach

Cytonics’ lead drug candidate, CYT-108, is in a class of its own. As a genetically engineered variant of the naturally occurring A2M protein found in the bloodstream, its mechanism of action is identical yet its efficacy as an anti-inflammatory and protease inhibitor is substantially enhanced. Interestingly, the approach employed by Cytonics to develop A2M-based therapies mimics that of Eli Lilly’s approach to develop synthetic insulin. Eli Lilly first commercialized purified insulin from the pancreas of cows for the treatment of diabetes in 1923, But it wasn’t until the advent of recombinant protein engineering that Eli Lilly produced the first engineered variant of the naturally occurring insulin molecule (sold under the brand name Humulin). The logic is simple: demonstrate the clinical efficacy of a naturally occurring molecule in treating a specific disease, then genetically engineer a synthetic form with unique properties that can be produced in large scales. Cytonics’ and Eli Lilly’s clever approach “de-risks” the development of the new drug because the clinical effectiveness of the base molecule is already known. Therefore, it stands to reason that if the synthetic, engineered version of the molecule is substantially similar to the naturally occurring version, then it will be safe to administer and have (improved) efficacy in treating the disease it was designed for. 

Concrete plan

Cytonics has a clear set of tangible milestones in the next year that will substantially increase the value of the company. The company has informed the FDA of their progress every step of the way, which is critical to de-risking the IND filing and Phase 1 human clinical trial. The recent publication of their preclinical OA study is a huge accomplishment, as it clearly shows that CYT-108 is well-tolerated and is effective in reversing the effects of osteoarthritis. The FDA will review and revert on the data, providing a clear path towards Phase 1 human trials. Furthermore, the upcoming COVID-19 discussion with the FDA will yield a definitive plan to execute a preclinical study to test CYT-108 as an anti-inflammatory agent in the lungs. There is an extremely strong scientific rationale for the efficacy of A2M and CYT-108 as a treatment for COVID-19, and the FDA will take this into consideration for Emergency Use Authorization (EUA designation will accelerate the approval process and allow CYT-108 to move into human clinical trials with preliminary safety and efficacy data). The company intends to seek a strategic partner or acquirer once CYT-108 enters Phase 2 clinical trials for osteoarthritis. However, if the preclinical data and accelerated Phase 1 study for COVID-19 is promising a partnership or buyout opportunity may arise much sooner. The company is currently raising capital via the Reg A+ exemption through the issuance of preferred equity to fund preclinical and Phase 1 trials for CYT-108 against both OA and COVID-19.

 “Frequent discussion with the FDA is a key determinant of the success of a biotech company’s drug development program. The FDA's feedback on preclinical data and proposed Phase 1 trial protocol to the FDA will increase our chances of approval by incorporating the regulatory body’s feedback into our clinical trial approach. Keeping the FDA informed of our drug development program also nurtures a relationship that can translate into better and more in-depth discussion as we progress along the path toward drug approval."

~ Joey Bose, President and CEO of Cytonics

Barriers to entry

Cytonics' core technologies, the FACT diagnostic, APIC medical device, and CYT-108 biopharmaceutical are protected by an iron-clad fortress of 22 international patents and 5 patents pending. Claims range from composition of matter, methods of use, to process development. Importantly, CYT-108 is protected by composition of matter claims that secure any protein that inhibits the OA-related proteases, within a certain % genetic similarity. The intellectual property portfolio is not the only barrier to entry... there is a reason that Big Pharma has not developed an A2M variant to treat osteoarthritis. The answer: it is technically very difficult due to the enormous size of the protein )720kD). Cytonics spent 5 years developing the expression and purification process of CYT-108. This is not in Big Pharma's interest, as they are more acquisitive than research oriented. It is highly unlikely that any other group could mimic Cytonics' innovation.

Worth the risk? 

There is no doubt that Cytonics, in its current stage of development with imminent milestones, is accurately valued at $2.00 per share ($46M EV). The company’s positive preclinical data for CYT-108 as a treatment for OA, combined with its growing patent portfolio (9 patents issued, 8 more pending) and successful out-licensing of the APIC system in both the human and veterinary markets, and the design of its recent COVID-19 preclinical study, are major value-drivers that make Cytonics a fantastic buying opportunity. A very conservative estimate of the company’s future value upon successful commercialization of the drug is at least $500M (representing a 10x multiple), and that is based upon an extremely conservative 1% market capture and aggressive drug pricing (they could easily charge up to $2,000 per dose based upon the prices of HA injections and corticosteroids). At its current stage (preclinical heading into Phase 1), I predict that the company is worth at least a $100M based upon estimated future cash flows heavily discounted for risk. 

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Learn more about the investment opportunity here.

Management and Board

Disclosure

Author owns shares of Cytonics at the time of publishing and may choose to buy or sell at any time without notice.