Wall Street’s Next Obsession? Alzheimer’s Drugs Could Rival Weight Loss Boom

•  Alzheimer’s disease affects millions globally, with cases expected to double by
  2060 to nearly 14 million adults against the backdrop of minimal treatment options
•  In clinical trials today, Tiziana Life Sciences’ intranasal Foralumab shows
  promise in addressing neuroinflammation associated with Alzheimer’s
• Doctors and Brigham & Women’s Hospital are eager to expand indications and
  the number of Alzheimer’s patients being treated with Foralumab
• Analysts are calling for average price targets for TLSA between $2.35-$3.06,
  compared to the current price at $0.79.

In the time it takes you to read this sentence, two more people have been diagnosed
with some form of dementia, perhaps Alzheimer’s Disease (AD), representing one of the
most formidable challenges in modern medicine. Dr. Ronald Petersen, director of the
Mayo Clinic Alzheimer’s Disease Research Center, has emphasized that dementia’s
impact will continue to grow without major advancements in treatment and prevention.

Characterized by progressive cognitive decline, memory loss, and behavioral changes,
AD not only devastates patients but also places immense emotional and financial
burdens on families and healthcare systems. Despite its prevalence, effective
therapeutic options remain scarce, underscoring a pressing need for innovative
treatments.

AD knows no boundaries. It has afflicted Presidents like Ronald Reagan, Academy
Award-winning actors such as Charlton Heston and Rita Hayworth, legendary coaches
like Pat Summitt, and champion athletes like Sugar Ray Robinson. Yet, beyond these
famous names, it devastates millions of everyday people and their families, who endure
the heartbreaking journey of watching their loved ones fade into a shadow of who they
once were.

The Growing Alzheimer’s Crisis

As populations age, the incidence of Alzheimer's continues to rise. In the U.S. alone, an estimated 6.9 million individuals aged 65 and older are living with Alzheimer’s dementia today, with projections suggesting this number could escalate to 13.8 million by 2060. Globally, over 55 million people are affected by dementia, with nearly 10 million new cases emerging annually—approximately one every three seconds.

The human toll is profound, but the economic impact is equally staggering. In 2021,
Alzheimer’s and other dementias cost the U.S. an estimated $355 billion, a figure
expected to soar as the baby boomer generation ages. This trajectory mirrors the
obesity epidemic, where the demand for effective treatments has led to blockbuster
drugs generating billions in revenue, while handsomely rewarding investors with the
foresight to get in early.

The Lucrative Market for Alzheimer’s Treatments

The pharmaceutical industry has recognized the vast potential in developing
Alzheimer’s therapies. Recent advancements have led to the approval of drugs like
Leqembi (lecanemab), developed by Eisai and Biogen (NASDAQ: BIIB). Although
uptake has been slower than expected do to pricing , efficacy, and side effect concerns,
Leqembi was projected to achieve total sales of approximately $12.9 billion between
2023 and 2028, averaging around $2.15 billion annually. Similarly, Eli Lilly’s (NYSE:
LLY) donanemab is anticipated to reach peak annual sales close to $5 billion. These figures underscore the substantial market opportunity for effective Alzheimer’s
treatments.

Tiziana Life Sciences: Pioneering a Novel Approach

Amidst this landscape, Tiziana Life Sciences (NASDAQ: TLSA) emerges as a beacon of innovation. The company is developing Foralumab, a groundbreaking intranasal
immunotherapy (an anti-CD3 monoclonal antibody) designed to reduce
neuroinflammation, a hallmark of Alzheimer’s and other neurodegenerative diseases.
Reversing inflammation is critical to care, as inflamed cells put out toxic chemicals that
damage the brain.

Foralumab operates by targeting the immune system. Delivered intranasally, it binds to
T cells in the cervical lymph nodes, promoting the development of regulatory T cells
(Tregs) that produce anti-inflammatory cytokines like IL-10. These Tregs migrate into
the central nervous system, crossing the blood-brain barrier to mitigate inflammation by
modulating microglial activation and suppressing other inflammatory cells. These
mechanisms help defend the CNS against chronic inflammatory damage and holds
promise not only for Alzheimer’s but also for conditions like multiple sclerosis (MS).

In December 2024, Tiziana achieved a significant milestone by dosing the first patient
with moderate Alzheimer’s disease using intranasal Foralumab at Mass General’s
Brigham & Women’s Hospital in Boston. A video detailing the treatment with the first patient, Joe Walsh, his wife, Karen, and doctors involved in the trial, provides clarity on the simplicity of administration and is available for viewing at:
https://www.youtube.com/watch?v=vj6GGzbJfOk.

As explained in the video, Dr. Howard Weiner, Brigham & Women’s Co-director, Ann
Romney Center for Neurologic Disease and Director, Multiple Sclerosis Program, is
leveraging existing data on Foralumab for different indications with highly compelling
data collected to date. Nearly all of the 10 patients suffering from progressive Multiple
Sclerosis treated with Foralumab demonstrated a halt in disease progression. The
success in MS patients has spurred interest in exploring Foralumab’s efficacy across a
broader spectrum of neuroinflammatory and neurodegenerative diseases.

A Broader Implication for Neurodegenerative Diseases

The potential of Foralumab extends beyond Alzheimer’s. Neuroinflammation is a
common thread in various neurodegenerative disorders, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and MS. By addressing the inflammatory
component, Foralumab offers a unified therapeutic strategy that could revolutionize
treatment paradigms across these conditions.

To that point, Tiziana in November learned that its grant application to the ALS
Association was approved for funding as part of the Hoffman ALS Clinical Trial Awards
Program. The grant will fund a 20-patient clinical trial of two doses of Foralumab aimed
at evaluating the safety and early-stage parameters of disease improvement in ALS,
also known as Lou Gehrig’s disease.

Moreover, Tiziana’s approach exemplifies the growing trend of repurposing
immunotherapies for neurological applications. By leveraging the body’s immune
system to combat neuroinflammation, this strategy aligns with the broader movement
towards personalized and targeted medicine.

Spinal Cord Injury Too

Last month, Tiziana Life Sciences highlighted additional opportunities to leverage the
therapeutic potential of Foralumab. Preclinical research demonstrated promising results
for its intranasal anti-CD3 monoclonal antibody in treating traumatic spinal cord injury
(SCI), a condition with significant unmet medical need.

Dr. Saef Izzy, Associate Professor of Neurology at Harvard Medical School,
commented, “Treatment with nasal anti-CD3 not only dampened microglial activation
but also led to marked improvements in motor function among the injured models.
These results hold promise for a transformative therapeutic approach in SCI.”

The Investment Opportunity

For investors, the burgeoning Alzheimer’s treatment market presents a compelling
opportunity. The parallels to the obesity epidemic are striking. Just as the rise in obesity
rates led to the development of blockbuster weight-loss drugs, the escalating
prevalence of Alzheimer’s is driving demand for effective therapies. Doctors have not
been shy to prescribe GLP-1 drugs approved for diabetes, such as Novo Nordisk’s
(NYSE: NVO) Wegovy (semaglutide) and Eli Lilly’s (NYSE: LLY) Mounjaro (tirzepatide),
for weight loss. Both companies have seen a massive surge in stock price as a result of
the new blockbuster sales.

Alzheimer’s has the same, perhaps even greater, dynamic potential.

Tiziana Life Sciences, with its innovative approach and recent clinical advancements, is
well-positioned to capitalize on this demand. The company’s focus on neuroinflammatory mechanisms addresses a critical aspect of Alzheimer’s pathology that has been relatively underexplored. As Foralumab progresses through clinical trials, positive outcomes could not only transform patient care but also yield substantial financial returns.

If so, the days of an $80 million market cap will likely be long gone.

What are Analysts Saying?

Analysts have shown a growing interest in TLSA, particularly following recent
developments in their Alzheimer’s disease research. In September 2024, the company
announced a $4 million grant from the National Institutes of Health to study Foralumab
against AD.

This and other advancements have led to positive analyst sentiment. According to
ChartMill, 83% of analysts covering Tiziana have issued a “Buy” rating, reflecting strong
confidence in the company’s prospects. Additionally, Fintel and ChartMIll both report an
average one-year price target of $3.06 for TLSA, suggesting a significant upside from its
current trading price. In fairness, MarketWatch data is a little less optimistic, with an
average price target of $2.35, although still far above the current price at $0.79.

Overall, the combination of strategic research initiatives and positive analyst evaluations
positions Tiziana Life Sciences as a compelling consideration for investors interested in
the biotechnology sector.

A Final Word

Alzheimer’s disease remains a formidable adversary, inflicting profound suffering on
patients and their loved ones. The urgent need for effective treatments has created a
fertile ground for innovation and investment. Tiziana Life Sciences’ Foralumab
represents a promising frontier in this battle, offering hope for a future where
Alzheimer’s and other neurodegenerative diseases can be effectively managed, and –
while it is a taboo word – maybe even cured. For now, arresting disease progression
upon diagnosis would be groundbreaking in neurogenerative disease.

As the global population continues to age, the demand for innovative Alzheimer’s
treatments will only intensify. Companies at the forefront of this research, like Tiziana
Life Sciences, are not only advancing medical science but also poised to reap
significant financial rewards. For stakeholders, the convergence of humanitarian need
and market potential makes this an opportune moment to engage with the evolving
landscape of Alzheimer’s therapeutics.