A new generation of patients can be powerful motivators for a pharmaceutical industry historically resistant to change. And if they don't respect or act on the message given, they should expect that plenty around them will. But here's the deal. Some are doing more than listening; they are taking advantage of emerging research to capitalize on what could be the most transformative periods in generations affecting the pharmaceutical sector. Silo Pharma (NASDAQ: SILO) wants to contribute to that change.
And they very well may, working hard to address the shortfalls in the pharmaceutical industry where treating symptoms has become more valuable than curing indications. That model makes sense since it provides a lifetime client in many cases. But research indicates that the lifetime patient model need not be the norm. Treatment can cure; at least, Silo Pharma thinks so. And if they prove themselves correct, they could become one of the most disruptive forces in the therapeutics landscape. That could be excellent news for Silo, patients, and investors.
The most excellent news is that SILO's mission is in progress. In fact, this NASDAQ-traded developmental stage biopharmaceutical company is advancing innovative concepts centered around merging traditional therapeutics with psychedelic compound research. Things are moving quickly. Earlier this month, SILO announced working with Premier Consulting as its regulatory partner to assist with preparing a pre-Investigational New Drug package and meeting request with the FDA for a novel topical formulation of ketamine, designated as SPC-26, for the treatment of Fibromyalgia.
It's a big step for SILO and could turn a filing milestone into a revenue-generating catalyst. In fact, that could happen sooner than later, with Premier Consulting assisting with expediting SILO's nonclinical, clinical, clinical pharmacology, and biopharmaceutics strategy and program to be proposed to the FDA. An announcement of an accepted pre-IND meeting with the FDA could be the most near-term milestone, which could fuel a rally ahead of a formal filing of its clinical IND package thereafter.
Confidence Is High On SP-26
Management commentary on its planned filing is encouraging. They expect that its highly constructive pre-clinical work on SP-26 offers strong support for its comprehensive pre-IND package, which seeks to advance and evaluate its time-released ketamine delivery system. And unlike traditional drug applications that can take years of reviews and hundreds of millions in development costs, SILO is positioning to expedite the process by pursuing the 505(b)(2) regulatory pathway, which saves considerable time and enormous amounts of money.
The combination therapy being evaluated is 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 studies have 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. If results post as expected, SILO shares could soar, noting Fibromyalgia affects about 4 million American adults or about 2% of the adult population.
The dollar potential for an effective treatment is also 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. The better news for SILO, its partners, and investors is that better treatment is needed.
While narcotics ease chronic pain, more effective, less invasive, and non-addictive options are needed to alleviate pain associated with connective tissues throughout the body, including muscles, ligaments, and tendons. 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.
The more excellent news is that SILO isn't a one-drug proposition. SILO expects to have multiple shots on treatment goals. With a generation of patients more receptive than ever to trying alternative treatment methods over prescription compounds and opioids, monetizing its creations can happen faster than many expect.
Advancing An Innovative And transformative Mission
In fact, not only can results come quickly by exploiting the 505(b) pathway, but so can the dollars. That's because SILO focuses on developing more effective treatments for rare neurological disorders where the standard of care falls short. Silo Pharma believes they can better treat patients by merging traditional therapeutics with psychedelics to treat people suffering from symptoms like PTSD, Parkinson's, and Alzheimer's disorders.
And doing so may not be as demanding on the regulatory front as many might expect. That's the intended result of SILO identifying and licensing assets amenable to combination therapy. Once licensed, an asset is researched and funded, putting into motion a study designed to show transformative results in favor of the well-being of patients. Investors have reasons to be optimistic.
In addition to presenting value not reflected in its share price, Silo Pharma is valuable from advancing an original concept and blazing an innovative treatment trail by merging traditional therapeutics with psychedelic compounds. Psychedelics are already being evaluated to treat various indications, but SILO appears to have a head start on adding the pharmaceutical element to the opportunity. That gives them first-to-market opportunities in several billion-dollar markets.
With that being the case, and with patients asking for alternatives to side-effect-prone pharmaceutical regimens, partnership, grant, and private funding should become part of the consideration when appraising the intrinsic and inherent value of SILO stock. There is certainly room to grow from its roughly $5.35 a share and market cap of $16.6 million today. And because the stock is thinly traded, with only about 3.14 million outstanding shares reported at the end of last quarter, a bullish bias could send SILO stock appreciably higher on positive news. Announcements could be imminent.
Multiple Shots On Revenue-Generating Goals
Remember, too, that SILO isn't advancing a single shot on drug and revenue-producing goals; they are advancing research for several, showing 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 includes finding better ways to treat conditions like Alzheimer's, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, and Stress-Induced Psychiatric Disorders. The path for approvals on those indications from using the 505(b) pathway can also be short.
That's good news for those needing the treatments and for SILO, which could keep a sizable part of its gross proceeds of $5.75 million raised. That retained capital can facilitate 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.
Regarding the psychedelics contribution, little evidence exists showing detrimental side effects from controlled and measured use. Global Trac Solutions (OTC Pink: PSYC) has volumes of research showing the benefits of psychedelic compounds to treat host indications. Their studies support that SILO is doing the right things, in the right markets, with the right products, at the right time.
A Timely And Compelling Consideration
Thus, is under-the-radar Silo Pharma a company and investment opportunity too good to ignore? 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, that answer is often a resounding yes. And being partnered with leading academic institutions to accelerate product development targeting millions of patients receptive to therapeutic alternatives, more yesses may get added to the ledger.
Indeed, 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. Silo Pharma checks those boxes, which, for growth, momentum, and value investors, makes them ripe for investment consideration.
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