At Acesis, we are on a mission to transform the way low-T or deficiency is treated.

Our unique solution is rooted in the science, developed by Dr. Vassilios Papadopoulos D.Pharm., Ph.D., D.S.C., a leading expert in the steroid biochemistry field, Professor of Pharmacology and Pharmaceutical Sciences and Medicine at the University of Southern California. His research has led to a better understanding of the pathways leading to steroid hormone synthesis, the pharmacology of steroid formation in the periphery and brain, and the identification of new molecules targeting key elements in diseases where steroids play a determining role.

He has discovered a novel mechanism of action and developed a drug pipeline of short peptides targeting testosterone biosynthesis which can induce the cells of the testis to produce the natural hormone. His work has been published extensively in peer-reviewed publications and cited over 32,000 times. The drug pipeline of peptides is protected by two patent families owned by Acesis. The patent covering our lead compounds is valid until the year 2040 in the US.

It is our goal to provide a novel treatment to men to restore low testosterone; unlike traditional testosterone replacement therapies, where synthetic hormones are introduced to the body via gels, injections, pellets, pills, nasal sprays, etc., with known side effects, our solution is focused on signaling the body to produce its own natural testosterone.

Despite affecting millions of men over the age of 30, low testosterone remains widely under-diagnosed due to stigma, lack of awareness, and concerns over side effects of current treatment – leaving many men with diminished quality of life.

Testosterone, a key male hormone, plays a vital role in men's health by regulating muscle and bone mass, enhancing red blood cell production, affecting fat distribution, supporting libido, fertility, and impacting mood, energy, levels, and cognitive function.

Low testosterone (hypogonadism) can be caused by genetic factors (e.g., Klinefelter syndrome, Kallman syndrome, etc.), testicular defects or trauma, radiation, chemotherapy, brain injury, diseases of the hypothalamus or pituitary gland, chronic alcoholism, drug use (e.g., opioids), aging, or co-morbidities like type 2 diabetes and obesity. 

Low testosterone or deficiency affects 10 to 40% of men globally, with prevalence rising after age 30–40 years old, with even younger men (18-30 years) experiencing prevalence rates of 2-5%. Diagnosis typically involves measuring serum testosterone levels and clinical assessment.

Late-onset hypogonadism (LOH) in aging men presents with diverse physiological, psychological, and sexual symptoms, yet the severity of symptoms does not always correlate with testosterone levels, complicating diagnosis and treatment. The FDA approved testosterone replacement therapy (TRT) only for medically diagnosed hypogonadism, not specifically for LOH.

Novel Low Testosterone Treatment

At Acesis, we aim to transform the way testosterone deficiency is treated. The discoveries by Dr. Papadopoulos, a world-renowned expert in steroid biochemistry with 35+ years of experience, have resulted in a novel mechanism of action that restores the body’s natural ability to produce testosterone (based on our current preclinical data)—a breakthrough protected by two patent families owned by Acesis.

A Game-Changing Innovation and Benefit of our Approach

Unlike TRTs (traditional testosterone replacement therapies), which rely on synthetic hormones via gels, injections, and pills, our first-in-class therapy and potentially safer approach aims to minimize the risks associated with conventional treatments—an advantage that will need to be rigorously validated in clinical trials.

The Future of Men's Health: Unlocking the Body's Ability to Restore Testosterone

By empowering the body to naturally restore testosterone levels, our drug pipeline could redefine Low-T treatment, giving physicians a revolutionary new treatment option for men to regain their vitality and quality of life. At Acesis, we are committed to delivering science-backed, innovative solutions that push the boundaries of men’s healthcare.

Advancing Our Drug Pipeline – From Preclinical to Clinical Trials

We are laser-focused on advancing our drug pipeline from current preclinical studies to Phase I/First-in-Man clinical trials for low testosterone (Low T). Our strategy involves partnering with a pharmaceutical or biotechnology company post-successful Phase I trials to advance our product candidate to Phase II for male hypogonadism and other disease indications.

We plan to form strategic alliances with leading experts in research institutions and academic centers.

• Drive innovation in additional disease indications (type 2 diabetes, obesity, non-alcoholic fatty liver disease).
• Validate our scientific approach in disease models.

We plan to submit grant applications for non-dilutive funding to fund such studies.

• This approach may allow us to out-license to industry partners our pipeline for these indications early in the development cycle, securing upfront fees, milestone payments, and future royalties. 


We plan to out-license our drug pipeline to Pharma

• Advance our pipeline further in models of type 2 diabetes, fatty liver disease, and obesity.
• Leverage the licensee's expertise in testosterone replacement therapy and related fields & expand market position in several disease indications.

We aim to position our drug pipeline as a market differentiator with a novel mechanism for Low T restoration, offering a potentially safer profile compared to existing TRT interventions. A safer treatment such as Acesis's solution will potentially expand use to other comorbidities of low T (e.g., type 2 diabetes, fatty liver disease and obesity) which expands the potential market size.

The testosterone replacement therapy (TRT) market represents a significant healthcare segment addressing a widespread medical need. Currently valued at $2.04 billion in 2024, this market has demonstrated steady growth with a 2.3% CAGR since 2019.

Industry analysis from The Business Research Company (December 2024 Edition) projects the market to reach $2.53 billion by 2029, growing at 4.32%, and potentially expanding to $3.06 billion by 2034.

This growth reflects an increasing unmet medical need in men's health. With rising life expectancy and growing awareness of testosterone deficiency's impact on quality of life, more men are seeking treatment options. The market expansion is driven by several key factors:

A Market Primed for Innovation & Growth


Importantly for investors, this market combines stable growth characteristics with clear opportunities for innovation. Current treatments, while serving a vital need, leave room for improved solutions that could address known safety concerns and delivery challenges. This creates a defined space for new approaches that can capture market share by offering better alternatives to existing options.

Shifting Market Dynamics & Unmet Needs

• Growing Demand: TRT is recognized for benefits beyond hypogonadism, including weight management, cognitive improvement, diabetes risk reduction, and cardiovascular health.
• Regulatory & Market Challenges: Generic competition, safety concerns (heart attack risk debates, Black Box warnings), and a lack of true innovation have left a gap in the market.
• Non-U.S. Expansion: International growth is expected as medical guidelines evolve and more patient populations gain access to TRT.

Acesis’s Disruptive Approach


The next frontier in Low-T treatment lies in therapies that stimulate natural testosterone production rather than relying on external hormone supplementation.

Acesis’s drug candidate pipeline is designed to fill this critical gap, offering a potentially safer, effective, and convenient oral alternative to traditional TRTs by inducing the body (testis) to restore its own testosterone. With encouraging preclinical data supporting its unique mechanism of action (MOA), Acesis is developing a major opportunity to reshape the TRT landscape and capture market share.

• The Business Research Company references Acesis as an Innovator in the T-field:
  Testosterone Replacement Therapy Global Market Report 2025
  
• Bio Science Today
  Acesis breaks new ground with novel therapy solution to low testosterone
  
• BioWorld
  Acesis Biomed takes on hypogonadism with testosterone replacement therapy
  
• BioPharmaTrend
  The First Innovation in Treatment of Low Testosterone in Men Since 1930th
  
• GlobeNewswire
  Testosterone Replacement Therapy Global Market Report 2023
• USC Schaeffer
  Vassilios Papadopoulos, DPharm, PhD, DSc (hon)
  

A Widespread and Growing Concern


Low testosterone (Low-T) affects 10% to 40% of men globally, with prevalence rising after age 30-45. Beyond impacting energy and well-being, it is closely linked to serious health conditions.

Strong Correlations with Major Diseases

• Type 2 Diabetes & Obesity – Up to 50% of men with these conditions have Low-T, affecting insulin resistance and metabolic health.
• Cardiovascular Disease – Increased risk of heart attacks and strokes.
• Metabolic Syndrome – Low-T contributes to high blood pressure, excess belly fat, and abnormal cholesterol levels.
• HIV, chronic obstructive pulmonary disease (COPD) and renal failure have been associated with hypogonadism.

Expanding Market Potential


Emerging research connects testosterone deficiency to additional diseases, including brain injury, dementia, lupus, and multiple sclerosis. These conditions create a significant opportunity for intervention with a safer alternative like Acesis’s solution, while also paving the way for new partnerships and potential revenue growth.

The Company may consider in the future an initial public offering (IPO) to accelerate and expand our drug pipeline’s clinical development in additional indications.

Strategic Growth & Licensing Model


Acesis aims to out-license its drug candidate pipeline for these expanding indications, forging strategic partnerships to drive innovation while creating new revenue opportunities in multi-billion-dollar markets.

Invest in Acesis and support a breakthrough in low-T treatment with the potential to transform the well-being of millions of lives and disrupt a multi-billion-dollar industry. Our novel approach for testosterone restoration aligns with the growing demand for safer, targeted therapies for men's health. Backed by a strong scientific platform and experienced leadership, we plan to execute a scalable business model with diverse revenue streams, including out-licensing and strategic partnerships. As we advance through pre-clinical, clinical and regulatory milestones, we aim to unlock significant market opportunities.