Silo Pharma (NASDAQ: SILO) shares are catching a bid, moving 16% higher to reach $6.39 on Tuesday. The move isn’t surprising; SILO is attracting the right kind of attention by doing things differently. And in the pharmaceutical sector, where billions of potential revenue dollars are at stake, different is good. But even more than different, SILO intends to be a game-changer in how conditions like Fibromyalgia and neurological orders get treated. Mixing traditional pharmaceuticals with psychedelic compounds, SILO wants to disrupt, for the better, the treatment landscape.
The better news- SILO’s mission is in progress. This developmental stage biopharmaceutical company is advancing innovative treatment approaches centered around merging traditional therapeutics with psychedelic compound research, and things are moving quickly.
SILO engaged with Premier Consulting as its regulatory partner to assist with preparing a pre-investigational New Drug package and meeting requests with the FDA for a novel topical formulation of ketamine, designated as SPC-26, for the treatment of Fibromyalgia. It’s an expected milestone that has the potential to become a catalyst. And with Premier Consulting assisting with expediting SILO’s nonclinical, clinical, clinical pharmacology, and biopharmaceutics strategy and program, it could come sooner than later.
If so, the bullish momentum ahead of a formal filing of its clinical IND package could be the precursor to future gains.
Video Link: https://www.youtube.com/embed/l3PWWytNZfs
SP-26 Targets Near-Term Pre-IND Filing
That’s likely. The company believes its highly constructive pre-clinical work on SP-26 offers strong support for its comprehensive pre-IND package, including showing evidence of value from its time-released ketamine delivery system. The news is also good in terms of progressing through the regulatory pathway. Unlike traditional drug applications that often take years of reviews and millions in development costs, SILO intends to expedite the process by pursuing the 505(b)(2) regulatory pathway, saving considerable time and enormous amounts of money in that process.
One particular combination therapy is being evaluated in a collaborative effort with joint venture partner Zylö Therapeutics, Inc., with SILO pursuing the clinical development of ketamine using Zylö Z-pod™ technology. Pre-clinical data has shown that the Z-pod can hold and distribute ketamine in a time-released manner, putting a potential treatment for Fibromyalgia in the crosshairs as an initial indication. With Fibromyalgia affecting about 4 million American adults or about 2% of the adult population, signs of a more effective treatment could fuel further interest in SILO.
It should. The dollar potential for an effective treatment is significant. According to Fortune Business Insights, the Fibromyalgia treatment market is projected to grow from $764.1 million in 2020 to over $1.4 billion in 2027, representing a CAGR of 9.2% during the next five years. For patients with the debilitating condition, better treatment is needed.
While narcotics can ease chronic pain, more effective, less invasive, and non-addictive ways to alleviate pain associated with connective tissues throughout the body, including muscles, ligaments, and tendons, are needed. A better drug could also fill current gaps to help treat sleep difficulties, fatigue, mood disorders, and problems with memory and concentration attributable to consistent and often relentless Musculoskeletal pain. SILO’s drug candidate provides an excellent shot on goal to treat those indications.
Still, while promising on the Fibromyalgia front, SILO has more pipeline firepower. And those contributions target a generation of patients more receptive than ever to trying alternative treatment methods over prescription compounds and opioids. Those drug development programs could also benefit from expedited marketing approval pathways through 505(b) applications.
Utilizing The 505(b) Approval Pathway
Not only could that expedite approvals, but it can also help revenues to ramp quickly. Keep in mind that SILO isn’t targeting obscure indications; they are focused on developing more effective treatments for neurological disorders where the standard of care falls short. Silo Pharma expects to provide better therapeutic value to patients by merging traditional therapeutics with psychedelics to treat people suffering from symptoms associated with PTSD, Parkinson’s, and Alzheimer’s disorders. Doing so may not be as demanding on the regulatory front as many might expect.
That’s part of the development model. Cutting the time and cost, SILO identifies and licenses assets amenable to combination therapy. Once licensed, an asset is researched, funded, and if promising, a study design is created to show how that drug can better treat patients. Each trial that moves forward is another milestone reached; more importantly, they present additional catalyst potential.
Remember, too, that psychedelics are already being evaluated to treat various indications. SILO is taking that approach further by adding the pharmaceutical composition to the opportunity. That could provide first-to-market opportunities in several billion-dollar markets.
Moreover, the value proposition is enhanced with patients wanting alternatives to side-effect and addictive-prone pharmaceutical regimens leading to potential partnerships, grants, and private funding to accelerate development. That adds to revenue-generating potential and helps expose a valuation disconnect between share price and blue-sky opportunities.
Thus, while its recent run is impressive, there could be considerably more room to run for this thinly traded stock. And with only about 3.14 million outstanding shares reported at the end of last quarter, product development updates could positively benefit investors from a supply and demand perspective.
Multiple Indications In The Treatment Crosshairs
There could be several in the queue. As noted, SILO isn’t a single-shot drug company. They are advancing research targeting treatment for several unique indications, with data supporting that traditional pharmaceuticals combined with psychedelics can be an effective and safe therapeutic. And not just for its initial Fibromyalgia indication.
Silo’s path to developing and bringing to market better drugs includes finding more effective ways to treat conditions like Alzheimer’s, Parkinson’s, Multiple Sclerosis, Rheumatoid Arthritis, and Stress-Induced Psychiatric Disorders. Again utilizing the 505(b) pathway, the timeline for approval can be considerably shortened and millions of dollars saved.
Source: Silo Pharma
That’s excellent news for those needing better treatments and for SILO, which could keep a sizable part of its recently raised $5.75 million. That retained capital can instead fund multiple studies, perhaps even simultaneously. And by licensing approved therapeutics, SILO gets a head start in bringing new drugs to market and, more importantly, starts its trials understanding the risks and side effects associated with its licensed assets. Research on the psychedelics side is accruing quickly to mitigate risk on that side of the equation.
Global Trac Solutions (OTC Pink: PSYC), for example, provides an excellent forum for discussion, with volumes of research showing the benefits of psychedelic compounds in treating many conditions. Their studies support a simple premise- SILO is doing the right things, in the right markets, with the right products, at the right time.
A Compelling Portfolio Timely To Opportunities
Thus, under-the-radar Silo Pharma is a company worthy of the attention it’s getting. And considering they are innovators in a developing field of therapeutics, are funded to advance multiple studies, and are on the verge of filing their first of several expected IND applications, interest in the company should grow. With that a likely scenario, trading ahead of accruing interest may be a wise and timely consideration.
Undoubtedly, investing in dynamic companies’ intent to change the status quo comes with risks. But when the mission is well-supported and intellectually capable of reshaping an industry, investors benefit from mitigated risk with substantial upside potential. Those are boxes that Silo Pharma checks.
And by partnering with leading academic institutions to advance ground-breaking and disruptive drug development technology and innovation, they are likely to check many more. Particularly the ones accretive to value appreciation.
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