Silo Pharma, Inc.
(Nasdaq:
SILO) (“the
Company”), a developmental stage
biopharmaceutical company focused on merging traditional
therapeutics with psychedelic research, today issued a letter to
shareholders highlighting the Company’s progress and potential for
its portfolio of novel, IP-protected technologies and assets
developed in collaboration with world-class medical research
partners. The letter, in its entirety, is reprinted below.
Dear fellow Silo Pharma shareholders,
The healthcare market continues to build momentum as science and
technology lead to new developments for therapeutics. Nowhere is
this more evident than in the growing body of scientific research
supporting the therapeutic potential of psychedelics. More than
ever, alternative new therapies for numerous diseases and mental
health disorders are needed to address the health challenges of
today.
Our Company, Silo Pharma, Inc. (Nasdaq: SILO) is working
diligently to make further advances in the medical and psychedelic
space. To date, the research conducted has shown encouraging
promise in the delivery, efficacy, and safety of our pipeline
therapeutics and technologies.
This has been an exciting year where we have achieved numerous
milestones and anticipate upcoming
updates as our pipeline progresses. The purpose of this
letter is to provide shareholders with an update on our current
business. With over $12 million in cash, we are prepared to advance
our pipeline, and believe, with our strong balance sheet, no debt,
and recent listing on Nasdaq, that we are in a position to further
advance the Company and create shareholder value.
Valuable Intellectual Property and
Collaboration
We are focused on advancing traditional therapeutics with
psychedelic research to treat underserved large markets. We believe
that our novel IP-protected technologies and assets, developed in
collaboration with world-class medical research partners, offer
disruptive market potential.
The unique assets in our portfolio are well protected with
issued and numerous provisional patents pending. We obtained these
assets through exclusive drug development collaborations, including
a joint venture with Zylö Therapeutics, Inc.; a license and option
agreement and an investigator-sponsored study agreement with the
University of Maryland, Baltimore; a sponsored study agreement and
a licensing option agreement with Columbia University; and a
sponsored research agreement with the University of California, San
Francisco.
Several of our therapeutics may qualify us to pursue the FDA’s
streamlined 505(b)(2) regulatory pathway for drug approval. This
new drug application (NDA) process avoids unnecessary duplication
of studies already performed on a previously approved drug,
potentially saving clinical time and providing significant cost
savings.
Potentially Transformative Assets with Disruptive Market
Opportunity
SP-26 —
Fibromyalgia
With our joint venture with Zylö Therapeutics, we are developing
ketamine for sustained release
which utilizes our partner’s Z-pod® technology, a topical drug
delivery system developed at the Albert Einstein College of
Medicine. Preclinical studies have already shown that the Z-pod can
hold and distribute our proprietary ketamine formulation in a
time-released manner. Topical administration of ketamine using this
technology (designated as SP-26 by Silo Pharma) yielded neuropathic
nerve pain reduction in a small animal study — positive results
that could be promising for patients suffering from fibromyalgia,
our initial indication. A safety evaluation study is currently
underway to determine the maximum tolerated dosing data to be
utilized in future trials.
We recently began working with our regulatory partner to prepare
a pre-Investigational New Drug (IND) package for submission to
support getting SP-26 into the clinic.
SPU-16
—Multiple
Sclerosis (MS)
Last year, we entered into a license agreement with the
University of Maryland, Baltimore (UMB) to examine a patented novel
homing peptide for CNS also known as central nervous system
(CNS) homing peptides (SPU-16), designed to access through
the blood-brain barrier and then home to specific damaged tissue.
Animal study results of the homing peptides have shown potential
improved delivery of therapeutics and decreased toxicity. Our
initial indication is MS.
SPU-21 —
Rheumatoid
Arthritis (RA)
Under a separate commercial evaluation license agreement (CELA)
with UMB, we are exploring the use of joint
homing peptides (SPU-21) to deliver targeted
therapeutics for the treatment of rheumatoid arthritis (RA), an
autoimmune disorder. SPU-21 has been shown to inhibit arthritic
progression in a preclinical animal model.
SPC-14 — Alzheimer’s Disease (AD)
Last year, we entered a CELA with Columbia University for two
therapeutics. The agreement includes an option to license an
Alzheimer’s disease therapeutic currently under development.
We recently announced proof-of-concept data supporting the
therapeutic potential of this drug candidate (SPC-14) as a
treatment for Alzheimer's disease, as demonstrated in a mouse
model. With safety data already available from the FDA-approved
therapeutics in the compound, we believe that SPC-14 should be
eligible for development under the FDA’s 505(b)(2) regulatory
pathway.
SPC-15 — Stress
Induced anxiety disorder and PTSD
Our second study with Columbia University examines a
targeted prophylactic using ketamine compositions
as a method of treatment and prevention for stress-induced
affective disorders including post-traumatic stress disorder
(PTSD). This treatment (SPC-15) predicts levels of severity or
progression of such disorders, and their metabolomic biomarkers
response to pharmacological treatments. Based on the research to
date, SPC-15 could have an impact on treating stress and anxiety
disorders.
Clinical Study
— Effects of
Psilocybin on
Inflammatory
Activity
We have sponsored a clinical study on the effects psilocybin may
have on inflammation in the body under a sponsored research
agreement with the University of California San Francisco. The
study aims to support the implementation of psilocybin as a
potential therapeutic for inflammation. The data from this study
could provide support for the anti-inflammatory effect of
psilocybin.
Therapies Target Underserved Medical
Markets
The burgeoning psychedelic drugs market was valued at $2.8
billion in 2021 and is projected to grow at a compound annual
growth rate (CAGR) of 17% to $9.8 billion in 2029.1 Against this
landscape, the disease targets for our drug candidates represent
large, underserved medical markets. Following are some facts and
figures.
- Our initial indication for SP-26 is fibromyalgia, a disorder
affecting about 4 million American adults, or about 2% of the adult
population. It is a chronic condition causing pain to the
connective tissues throughout the body including muscles,
ligaments, and tendons. Musculoskeletal pain is often accompanied
by sleep difficulties, fatigue, mood disorders, and problems with
memory and concentration. According to Fortune Business Insights,
the fibromyalgia treatment market is projected to grow from $764.1
million in 2020 to $1.4 billion in 2027, at a CAGR of 9.2% in the
2020-2027 period.2
- SPU-16 targets multiple sclerosis, a debilitating neurological
condition that causes the disruption of signal transmitting by the
nervous system. Damage to the nerve fibers may cause fatigue,
numbness and tingling, weakness, poor coordination, pain,
depression, and problems with memory and concentration. As the most
widespread disabling neurological condition of young adults, MS
affects nearly a million Americans and approximately 2.8 million
people worldwide. A report by Fortune Business Insights states
that the global multiple sclerosis drugs market is projected to
grow from $25.4 billion in 2022 to $33.2 billion by 2029, at a CAGR
of 3.9%.3
- SPU-21 targets rheumatoid arthritis, the most common autoimmune
disease in the U.S. affecting around 1.5 million adults. RA is
a systemic disease, but most often the immune system will attack
the inner lining of the joints bringing pain, swelling, and
stiffness that can be debilitating. A 2022 report published by
Precedence Research states that the global rheumatoid
arthritis drugs market size is expected to reach $70 billion by
2030 with a CAGR of 1.7% in that time period.4
- Targeted by SPC-14, Alzheimer’s disease is an irreversible,
progressive brain disorder that is the leading cause of dementia in
older adults. AD and related diseases affect more than 6.5 million
Americans over the age of 65, or about one in every nine Americans
aged 65+. The loss of memory from AD is due to plaque, tangles, or
loss of connections within the neural brain cells, which can also
affect language, reasoning, visual/spatial skills, and
mood. According to Growth+ Reports, the U.S. market for AD
drugs is growing at a CAGR of over 7% and is expected to reach $9.7
billion by 2031.5Targeted by SPC-15, anxiety, PTSD, and other
stress-related disorders are becoming more frequent in Americans
aged 18+. According to the World Health Organization in 2019, 300+
million people were living with an anxiety disorder, and according
to the National Center for PTSD, around 12 million adults in the
U.S. alone are reported to have PTSD.6,7 According to Fortune
Business Insights, the global treatment market size for anxiety
disorders and depression is projected to reach $13.0 billion in
2027.
Our financial position and balance sheet are strong with zero
debt. We own intellectual property and technology rights. We
believe our diversified therapeutic candidates have disruptive
market potential and offer potentially groundbreaking treatment
options for some of the most debilitating diseases and
conditions.
We are deeply grateful to our shareholders and appreciate your
continued support. We look forward to keeping you informed about
the progress of our studies as we advance our programs toward the
clinic. This is an exciting and transformative time for our
Company.
With best regards,
Eric WeisblumChief Executive Officer
About KetamineKetamine is an
FDA-approved fast-acting general anesthetic administered through
intravenous injection or nasal spray (milder form). Scientific
research has shown that ketamine’s interactions with certain brain
chemicals may be connected to its pain management,
anti-inflammatory, and antidepressant effects. Since 2000,
increasing research on ketamine has demonstrated significant
results as a treatment for pain conditions including chronic
neuro-inflammatory disorders and for mood disorders including
depression, PTSD, and anxiety.
About Psilocybin Considered a
serotonergic hallucinogen, this substance is an active ingredient
in some species of mushrooms. While classified as a Schedule I
controlled substance under the Controlled Substances Act (CSA),
there is an accumulating body of evidence that psilocybin may have
beneficial effects on depression and other mental health
conditions. The U.S. Food and Drug Administration (FDA) and the
U.S. Drug Enforcement Agency (DEA) have permitted the use of
psilocybin in clinical studies for a range of psychiatric
conditions.
About Silo PharmaSilo Pharma. Inc. is a
development-stage biopharmaceutical company focused on merging
traditional therapeutics with psychedelic research for people
suffering from indications such as PTSD, Alzheimer’s disease, and
other rare neurological disorders. Silo’s mission is to identify
assets to license and fund the research which we believe will be
transformative to the well-being of patients and the healthcare
industry. For more information, visit www.silopharma.com.
Forward-Looking StatementsThis communication
contains forward-looking statements concerning the Company’s
collaborations, business and development plans, and statements
regarding the Company’s product candidates, their development,
regulatory plans with respect thereto and therapeutic potential
thereof, planned interactions with regulatory authorities, and
planned clinical development. Statements in this press release that
are not purely historical are forward-looking statements. Such
forward-looking statements involve known and unknown risks and
uncertainties and are based on current expectations and projections
about future events and financial trends that the Company believes
may affect its financial condition, results of operations, business
strategy, and financial needs. Investors can identify these
forward-looking statements by words or phrases such as "may,"
"will," "expect," "anticipate," "aim," "estimate," "intend,"
"plan," "believe," "potential," "continue," "is/are likely to" or
other similar expressions. Actual results could differ from those
projected in any forward-looking statements due to numerous
factors. Such factors include, among others, the Company’s ability
to raise the additional funding it will need to continue to pursue
its business and product development plans, the inherent
uncertainties associated with developing product candidates and
operating as a development stage company, the Company’s ability to
identify additional product candidates for development, the
Company’s ability to develop, complete clinical trials for, obtain
approvals for and commercialize any of our product candidates,
competition in the industry in which the Company operates and
market conditions. Investors should consult all of the information
set forth herein and should also refer to the risk factor
disclosure set forth in our Annual Report on Form 10-K for the year
ended December 31, 2021, and other periodic reports filed with the
Securities and Exchange Commission available at www.sec.gov. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and we specifically disclaim any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Contact 800-705-0120investors@silopharma.com
1 Data Bridge Market Research. September 20222 Fortune Business
Insights; Fibromyalgia Treatment Market Size, Share and Trends.
September 2022.3 Fortune Business Insights; Multiple Sclerosis
Drugs Market Size, Share... May 2022.4 Precedence Research;
Rheumatoid Arthritis Drugs Market, Report 2022-2030. June 2022. 5
Growth+ Reports; Alzheimer’s Drugs Market by Drug Type … Global
Outlook & Forecast 2021-2031. March 2020.6 World Health
Organization; Mental disorders. June 2022.7 U.S. Department of
Veterans Affairs, PTSD: National Center for PTSD; How Common Is
PTSD in Adults?
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