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SIGYN THERAPEUTICS, INC. (OTC – SIGY - $1.80)
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.
The Bottom Line: SIGY recently published in vitro study results that serve as an affirmation of SIGY’s approach and broad capabilities. We view the results as one step closer to SIGY treating life-threatening inflammatory conditions are precipitated by cytokine storm syndrome such as COVID-19, sepsis, etc.
The Details: SIGY reported the ability of the adsorbent components incorporated within Sigyn Therapy to address viral pathogens, including COVID-19. The result of exposure to Sigyn’s adsorbent components reduced the presence of SARS-CoV-2 pseudo-typed lentivirus by 68.8% from plasma. This model was utilized to study antiviral drugs development to treat COVID-19 and to assess the efficacy of vaccines against COVID-19 variants.
What This Means: Results from earlier in vitro studies validated the capability of its therapy to address a broad spectrum of inflammatory targets. These new results validate viral depletion in combination with pro-inflammatory cytokine elimination as a promising strategy to mitigate virus-induced cytokine storms.
Higher Value In the Offing? We believe that the FDA may be on a path to establish inflammatory cytokine reduction as a clinical endpoint to ameliorate cytokine storms that are induced by viral infections. This thesis is bolstered by a number of current clinical trials seeking to demonstrate the treatment of COVID-19 and other, virus-induced cytokine storm or cytokine release syndrome conditions. If this occurs, and SIGY could leverage this endpoint in a successful clinical trial, it could dramatically change the SIGY’s future value.
Leveraging its multiple in vitro study results, the Company is poised to file an Investigational Device Exemption (IDE) with the FDA later this year. We believe that SIGY is not just poised to be awarded a potential Breakthrough Device designation in its category by the FDA in the coming year for key indications. Our thesis remains that SIGY could eventually be the first company to advance a medical device to treat Cytokine Storm Syndrome as its own categorical indication. Therefore, the aforementioned life-threatening conditions such as sepsis and COVID-19 could come under the CSS condition, offering clinicians a new weapon to fight this difficult to treat disorder. In the meantime, much of our focus is on the use of Sigyn Therapy to treat sepsis, given its large unmet need, with no approved therapy, despite the best efforts of dozens of firms. Moreover, if cleared just for sepsis, this incredibly lucrative event would be a boon to the company and its investors.
Looking ahead, if SIGY is awarded Breakthrough Device designation we believe the Company could be viewed as attractive M&A target by Tier 1 medical device players. Our confidence is rooted in our belief that the Company’s leadership is second to none in this therapeutic category. The CEO has led a NASDAQ-listed device company and co-authored submissions that resulted in two FDA Breakthrough Device awards. Plus, the co-founders oversaw the development of three devices that were approved by the FDA to treat COVID-19.
Our six-twelve-month price target for SIGY is $9.00, more than 4x its recent closing price. 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 Breakthrough Device and potential treatment for sepsis alone.
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.
I, Robert Goldman, hereby certify that the view expressed in this research report accurately reflect my personal views about the subject securities and issuers. I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the recommendations or views expressed in this research report.
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