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SIGYN THERAPEUTICS, INC. (OTC – SIGY - $1.10)
Industry: Medical Devices
6-12 Mo. Price Target: $9.00
Sigyn Therapeutics™ is a development-stage therapeutic technology company targeting a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome and not addressed with an approved therapy. Cytokine storm syndrome is the hallmark of sepsis, the most common cause of in-hospital deaths. Virus induced cytokine storm is a leading cause of COVID-19 deaths. Other therapeutic opportunities include bacteria induced cytokine storm, acute respiratory distress syndrome and acute forms of liver failure, such as hepatic encephalopathy.
Sigyn Therapeutics, Inc.
Conclusion: SIGY peers have recently enjoyed major stock price gains and we believe that SIGY is next. Looking ahead, SIGY appears set to emerge as the top performing blood purification company in terms of leadership and wide-ranging capabilities, as well as intermediate term share price appreciation.
The Space: The blood purification therapeutic segment is in the early innings of garnering the attention of leading clinicians and physicians. Given the approach’s wide-reaching therapeutic capabilities, the power of PR is just now placing a spotlight on the space. Why? Blood purification therapies are now demonstrating the unique capability to deliver life-saving mechanisms that are beyond the reach of post-infection drugs--especially during global health pandemics such as COVID-19.
SIGY Checks Boxes its Peers Cannot: The Sigyn Therapy™ under development is designed to treat life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome (CSS), such as sepsis, COVID-19, etc. Unlike its peers, it appears that SIGY can address the source of high mortality inflammation induced by both viral pathogens bacterial toxins. Thus, the device may be the only one able to remove endotoxins and inflammatory cytokines versus the pioneering competitors who cannot accomplish both functions.SIGY Set to Reach New Highs: Recent news prompted peers Aethlon Medical and Cytosorbents to enjoy major gains in recent weeks. Targeting multi-billion markets, SIGY’s upcoming milestone events could serve as similar catalysts to move its stock 40% or more in the near term.
SIGY TODAY, SIGY TOMORROW
SIGY’s flagship platform, Sigyn Therapy™, is a proprietary blood purification technology designed to overcome the limitations of previous drug and device candidates to treat acute inflammatory conditions, notably those preceded by Cytokine Storm Syndrome. The applications and potential indications represent unmet needs and, in many cases, there is no approved drug therapy. Given that the FDA established inflammatory cytokine reduction as a clinical endpoint to ameliorate cytokine storms that are induced by viral infections, we believe that SIGY’s therapy could be cleared to treat sepsis, acute COVID-19 and other conditions---all representing vast, multi-billion-dollar markets.
In addition, since it appears that SIGY can treat high mortality inflammatory disorders induced by both viral and bacterial pathogens, SIGY may also be positioned to receive future clearance for use of its therapy for targeted indications including liver failure, such as hepatic encephalopathy and other conditions, making Sigyn Therapy™ the go-to therapy to treat acute, life-threatening inflammatory conditions.
The Big Picture
In the near term, leveraging multiple in vitro study results and future in vitro and animal model data, the Company is poised to file an Investigational Device Exemption (IDE) with the FDA later this year. In our view, this milestone is the trigger for substantial share price gains.
Meanwhile, there are two underlying themes related to SIGY that we believe could take the Company to leadership status among its peers and other medical device manufacturers. First, as evidenced by recent moves in the share prices of SIGY’s peers, blood purification therapies are now demonstrating the unique capability to deliver life-saving mechanisms that are beyond the reach of post-infection drugs--especially during global health pandemics such as COVID-19. Moreover, much like we saw the difficulty in treating late stage COVID-19 patients suffering from CSS, the use of a blood purification therapy in late-stage patients suffering from conditions precipitated by CSS could halt these conditions and extend lives during the next health pandemic.
This shift is a big positive for the narrow segment as a whole. However, while there are blood purification devices cleared by the FDA to treat some of the aforementioned conditions, we believe that they fall a little short, relative to the potential capabilities of SIGY.
The Sigyn Therapy™ under development is designed to treat life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome, such as sepsis, COVID-19, etc. Unlike its peers, it appears that SIGY can address the source of high mortality inflammation induced by both viral and bacterial pathogens. Plus, the device may be the only one able to remove endotoxins and inflammatory cytokines versus the pioneering competitors who cannot accomplish both functions. The device also establishes a therapeutic strategy to target CytoVesicles that transport inflammatory cargos throughout the circulatory system.
Separately, we should note that the Founder of SIGY peer Aethlon Medical oversaw the development of the Aethlon Hemopurifier. In our view, the convergence of his experience, along with that of co-founder Craig Roberts and his device, may have led to the development of a device to treat the full spectrum of inflammatory factors. Moreover, leveraging their collective experiences, the device is likely a superior offering with fewer components, and improved throughput.
Looking ahead, as the reach of the Company’s offering grows, so too should the attention of the medical community, with the potentially broad use of its blood purification device as a standard-bearer in treating life-threatening conditions, whether it be induced by viral or bacterial pathogens. As noted earlier, we believe that SIGY could eventually be the first company to advance a medical device to treat Cytokine Storm Syndrome as its own categorical indication, as per the FDA. Clearly, such an event would catch the attention of prospective acquirers, thereby driving value toward levels unmatched by its peers.
Our six-twelve-month price target for SIGY remains $9.00. This target reflects the value of prospective milestone achievements as the Company transitions from a development stage company to a clinical stage firm. It is affirmed by using a discounted potential value of revenue generated as an FDA-approved treatment for sepsis alone. In the near term, much like the rest of the space, we believe that major gains lie ahead for SIGY in the near term, with the shares potentially jumping by 40% based on future milestone achievements.
Senior Analyst: Robert Goldman
Rob Goldman founded Goldman Small Cap Research in 2009 and has over 25 years of investment and company research experience as a senior research analyst and as a portfolio and mutual fund manager. During his tenure as a sell side analyst, Rob was a senior member of Piper Jaffray's Technology and Communications teams. Prior to joining Piper, Rob led Josephthal & Co.'s Washington-based Emerging Growth Research Group. In addition to his sell-side experience Rob served as Chief Investment Officer of a boutique investment management firm and Blue and White Investment Management, where he managed Small Cap Growth portfolios and The Blue and White Fund.
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