THE COGNIGENICS APPROACH

Genetic therapeutics represent a transformative advancement in biopharmacology, enabling the precise manipulation of DNA (permanent) or RNA (temporary) sequences. This new class of medicines can insert, delete, or modify specific genetic sequences, allowing for more effective mental health treatments.

Unlike traditional pharma drugs, which are taken systemically and can cause undesirable side effects, genetic medicines offer the promise of targeting only those neuronal receptors or neuronal circuits in the brain that are responsible for the disorder, vastly reducing possible side effects. In addition, unlike genetic-based vaccines, these therapeutic medicines do not introduce foreign proteins into the body, so they do not provoke immune responses, and nor do the RNA treatments affect DNA.

LIMITATIONS OF CURRENT TREATMENTS IN ANXIETY AND DEPRESSION

• Outdated Pharmacological Options
  Current anxiolytic and memory drugs were developed in the 1980s and 1990s. This presents a significant opportunity for innovative breakthroughs in treatment approaches.
• Limited Effectiveness and Adverse Side Effects of SSRIs
  Common SSRIs like Prozac, Celexa, and Zoloft offer limited efficacy and are associated with a range of serious side effects. More effective and safer treatment alternatives are needed.
• Inadequate Response Rates to SSRIs
  Research indicates that 30% to 50% of patients suffering from anxiety disorders do not find adequate relief with SSRIs.
• High Relapse Rates
  Individuals with anxiety disorders often face relapse rates between 50% to 80% over several years, even with ongoing treatment.
• Adverse Effects of Long-Term Medication Use
  Prolonged use of benzodiazepines can lead to drug dependence. Side effects of SSRIs, such as sexual dysfunction, chronic nausea, impaired digestion, dry mouth, weight gain, sleep disturbances, and in extreme cases, increased suicidal ideation, further complicate treatment adherence and effectiveness.

These challenges point to a pressing need for novel, more effective, and safer therapeutic interventions in the realm of mental health.

ADVANTAGES OF THE COGNIGENICS METHOD

• Enhanced Cost-Efficiency and Accelerated R&D Process
  Our strategy involves forming strategic alliances with carefully selected Contract Research Organizations (CROs) for laboratory research. This collaboration not only significantly reduces R&D expenses it also accelerates development.
• Accurate Targeting of Neuronal Receptors
  Our approach is characterized by its remarkable precision in targeting specific neuronal receptors. This enhances therapeutic efficacy while substantially reducing the likelihood of unintended side effects.
• Demonstrated Safety in Preclinical Models
  Our preclinical trials using mice and rats have observed no side effects (i.e., no behavioral changes or weight changes). This suggests a high safety profile, which is being investigated in more detail through formal safety and toxicology studies.
• Alignment with Current Neuroscientific Foundations
  Our methodology approach is based on contemporary findings and hypotheses within the disciplines of neuroscience, neuroanatomy, molecular biology, and genetic engineering.

KEY MILESTONES

1. Initiation of Preclinical Research
   Our journey began in 2020 with the commencement of comprehensive preclinical studies, laying a solid foundation for our program.
2. Progress Toward Clinical Trials
   We are in the late pre clinical stage of development and are working to enter phase one trials in late 2024. The company will pursue breakthrough designation and accelerated review with a goal of speeding time to market.
3. Anticipated Market Introduction
   We are optimistic about introducing our product to the market by early 2026, provided our R&D continues as planned and we gain FDA approval for clinical trials. This projected timeline is consistent with industry norms.