Noya Therapeutics Limited is a diversified pharmaceutical company

Biotech R&D projects reflect on the core values of the company, but the line-up of products that makes our independent work on innovative projects possible is much broader. Noya is a trusted provider of technological solutions for multiple advanced fields: High Purity Aluminum, Photo& Diazo-Type Paper, Colloid Materials; Photo Emulsions, Medical-grade Polymers, Muon Radiography.

By combining the power of boron compounds and neutron beams, we aim to destroy cancer cells with precision, minimizing damage to surrounding healthy tissues. Our end goal is the ultimate victory in the age-long fight with cancer. By supplying world’s leading medical professionals, we can help modern oncology to visualize and treat a variety of diseases at the molecular level by means of Radiopharmaceuticals.

Medical Isotopes is the heart of modern nuclear medicine. We stand as a trusted supplier of medical-grade isotopes to ensure that healthcare providers have the tools they need for accurate diagnosis and effective treatment, enhancing patient care on a global scale. As for the Orphan Diseases, we believe that every patient deserves a chance at a healthier life, regardless of the rarity of their condition. Repurposing existing compounds in accordance with the FDA standards fuels this race against time.

Biotech R&D projects reflect on the core values of the company, but the line-up of products that makes our independent work on innovative projects possible is much broader. Rafarma is a trusted provider of technological solutions for multiple advanced fields: High Purity Aluminium, Photo& Diazo-Type Paper, Colloid Materials; Photo Emulsions, Medical-grade Polymers, Muon Radiography.

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Business development on the basis of high-tech industries within the concept of Industry 4.0

Production of biotechnology drugs and substances

Innovative lithium and boron-neutron-capture therapy for cancer treatment

R&D in the most promising segments of the biotech market autoimmune diseases, cancer, nervous diseases

High-purity and innovative materials, including colloidal chemistry products for various markets

Medical polymers;

Pharmaceutical substances and antibodies;

Photographic paper, diazo paper, holographic film;

Plates for muon spectrography;

Emulsion and colloidal photo materials;

Super pure materials on the basis of aluminum A5N and A6N (99,9999%) for microelectronics;

Micron wire based on A5N aluminum;

Packaging materials for pharmaceuticals

Market Overview

The use of radioisotopes in nuclear medicine is expected to grow rapidly due to the rising incidence of cancer, increased public knowledge of nuclear therapy, and simplified applications of the technology.

Market size- 2023..................$8.82 B
Market size- 2033..................$19.04 B
Yearly growth (2023-2033)..8% CAGR

Current Results

Kazakhstan deal
Reached a deal with Kazakhstan to get access to a 6 MGW nuclear reactor

Equipment purchase
The purchase of $12million worth of equipment for the Hong Kong plant has been completed, and the design of the equipment permit is underway

Isotopes selection
The most perspective isotopes have been selected for production

The production of isotopes and isotope-based products is the main focus of the company at the moment.

The deal with the Government of Kazakhstan will allow Noya Therapeutics Limited to occupy a unique position in the global market due to the combination of logistics, production capacities and competencies.

Risks of conventional radiotherapy

More than 50% of cancer patients receive radiotherapy as part of their treatment. With high efficiency in most cases, today the technology is far from being perfect.

Side Effects:

• Damage to healthy cells in addition to tumor cells (radiation burns, hemorrhages, vascular fragility);
• Radiation reactions during the decay of healthy cells;
• The ingress of decay products of healthy cells into the blood, cascade reactions, nausea, weakness, a significant decrease in the quality of life.

Boron neutron capture therapy(BNCT)

Radiotherapy limitations

Although effective in most cases, conventional radiotherapy is not as effective in the difficult forms of cancer:

• Metastases in the later stages of the development of the disease;
• Glioblastoma (GBM);
• Melanoma;
• Tumors of the head and neck;
• Osteosarcoma;
• Tumors of the mammary gland;
• Brain tumors;
• Pancreas cancer.

BNCT benefits & efficiency

BNCT is the advanced method of radiotherapy based on the reactions of radiosensitive drugs with isotopes inside tumor cells and the neutron beam.

In comparison with conventional radiotherapy methods, BNCT is significantly less toxic, more comfortable for the patient, and more effective:

• Less damage to healthy tissue
• Less severe side effects
• Short treatment (requires only 1-2 sessions)

BNCT technology — explained

Targeted delivery of radiosensitive non-toxic drugs based on stable isotopes of boron (BNCT) and lithium with subsequent irradiation with an epithermal neutron flux significantly increases efficiency and eliminates risks:

BNCT trials & results

2+

Glioblastoma

years in life expectancy

5 studies on 269 patients. The best results with BNCT are an increase in life expectancy after treatment up to two years.

76%

Brain and Neck Tumors

up to

5 studies on 220 patients. Complete response in primary cancers: 76%, in relapses: 36%, partial response: 68%. Reducing the size of tumors, improving the quality of life.

75%

Melanoma

up to

2 studies on 8 patients. The presence of a response to BNCT - 75% of cases. Currently, a clinical trial (NCT02759536) is being conducted in China on 30 patients, cases of complete recovery are described.

BNCT Market analysis

Noya Therapeutics Limited is the second publicly trading company in the world to have a working BNCT prototype and competencies to work in the field. In total, 6 companies have access to the technology:

Market size 2022 — $11,37 M.
Predicted market size by 2028 — $265,26 M.
Yearly growth — 69,04% CAGR

BNCT market potential

The technology is focused on the treatment of the most complex forms of cancer, including the most aggressive ones:

• Tumors of the brain, thyroid gland
• Tumors of the head, neck, testicles
• Melanoma.

Potential market coverage - more than 1,480,000 cases of these forms of cancer per year:

Current Results

BNCT system testing
Prototype is ready, the necessary tests are completed

Portable version
The development of the portable BNCT system is in progress

Lithium capture therapy
R&D in Lithium Capture Therapy as a more effective alternative to boron

BNCT is a technology with a high entry threshold and minimal competition as a result. At the same time, the development of technology will ensure an average annual market growth of more than 69%.

Noya Therapeutics Limited is in a unique position in the market: we already have the plant, the expertise, the experience and the ability to commercialize the equipment.

Assembly of products at factories in Hong Kong and Israel, and the concept of entering the market will allow the company to vigorously advance in it.

Promoter solutions

In addition to access to the BNCT accelerator itself, the company has the expertise and capacity to create the production of radiosensitive drugs to improve the effectiveness of radiotherapy based on stable boron isotopes. In the future, the line can be expanded.

The production of isotope-based products, combined with the production of a particle accelerator for their use in the treatment of the most difficult forms of cancer, will allow the company to establish a unique position in the radiotherapy market.

01. Boron-10 based products
Allow to achieve the concentration of isotopes in a cancer cell 3-5 times higher in comparison with healthy cells.

02. Lithium-6 based products
With a similar principle of action, the energy release of lithium in the affected cell is around 100% (84% in the case of boron isotopes).

Listeria-based solutions

Listeria bacteria can play a role in the selective delivery of isotopes to cancer cells. These bacteria have the ability to penetrate metastases and tumors, while being eliminated by the immune system in healthy cells.

In radiotherapy, Listeria can be utilized for precise delivery of isotopes such as Phosphorus-32 and Rhenium-188 to metastatic sites. Studies have shown that the achieved concentration of isotopes in cancer cells can go up to 15 times higher compared to healthy tissues.

The result is a significantly enhanced effectiveness of radiotherapy, both in early and advanced stages of cancer, with minimal or negligible side effects and harm to healthy tissues.

NOYA has been conducting research for over 10 years on a targeted drug based on radioactive Listeria (L. monocytogenes and L. welshimeri) for enhancing the effectiveness of radiotherapy.

We possess expertise, manufacturing capabilities, and the ability to advance the methodology to effectively treat the most challenging cancers.

The research on the technology is limited. The pace of studying the impact of different strains of Listeria on the effectiveness of radiotherapy has declined since 2017.

Currently, the methodology:

• Is not commercialized
• Is not being applied
• Lacks progress towards testing the effectiveness in vivo
• Lacks a foundation for human trials approval

noya’s Solution

Orphan drugs market size

Rare (or orphan) diseases are diseases with a prevalence of no more than 10 cases per 100,000 population.

North America currently dominates the market for rare diseases medications, and it is expected to maintain its leadership position.

Market size 2022 - $128.42 B
Market size 2030 - $ 335.84B
Growth Rate - 12.8% CAGR

With the increasing number of diseases and the rise in the number of cases each year, several smaller players are entering the market, holding a significant share.

Competitive landscape

Current Results

The agreement in South Korea
We’ve achieved the agreement on establishing a biotechnological drugs manufacturing facility in South Korea

Search & acquisition
We’ve initiated the search for potential partners in the global market, with a focus on metabolic diseases treatment

At the moment, Noya Therapeutics Limited has no plans to invest resources in entering the highly competitive orphan drug market “from scratch”. Instead, we have initiated a search for companies already registered in the global market that are open to collaboration.

By acquiring a biotech company with a portfolio of developments in the orphan drug segment, combining our expertise and leveraging the manufacturing capabilities, Noya Therapeutics Limited aims to establish a strong market position with reduced risks.

Current state and statistics

Stroke is ranked as the second leading cause of death worldwide with an annual mortality rate of about 5.5 million.

According to the World Health Organization, from 1990 to 2019, the number of recorded stroke cases has increased by 70%. Fatalities from stroke have increased by 43%, prevalence has risen by 102%.

According to World Stroke Organization estimates, every year stroke takes away 143 million years of healthy life globally due to the consequent death and disability.

Rapid multifocal stroke and TIA test

Limitations of current stroke diagnostics techniques

20%

Misdiagnosis probability with reliance on the FAST technique

1 of 10

Misdiagnosis occurrence with MRI and CT scans

4 hours

The window for effective thrombolytics therapy

Competitive landscape

Currently, there are no rapid and effective multifactorial tests available for stroke/TIA (Transient Ischemic Attack) on the global market.

Existing analogs are limited in their distribution, relying solely on one factor, and are confined to a single market (the United States).

60+

Of effective markers are not patented, not commercialized

90-95%

Precision of TIA / stroke detection based on the multifactorial use of the unpatented markers

Main goals

Primary objective is the development of a fast, accurate, and user- friendly multifactorial test with unique properties:

• Quick results — results within a few minutes;
• User-friendly interface — similar to glucometers and pregnancy tests;
• Multifactorial analysis — determining the result based on 4-5 markers and their ratios, rather than just one;
• Guaranteed 90% + accuracy — with the appropriate selection of proven effective markers and their proper analysis.

NOYA has successfully navigated a challenging geopolitical period and is prepared for new opportunities. We believe that our level of expertise, investments, and unique positioning at the intersection of multiple emerging fields will enable us to establish a dominant market position and make a significant contribution to the advancement of biotechnological industry.

our 2024 GOALS

Starting early summer of 2022, the management team has been developing a strategy that will tackle current market changes, maintain the company's scale and ensure investment security.

BNCT
Entry into the global market with BNCT equipment and solutions for neutron capture therapy.

Company strategy 2024-2028

MANUFACTURING
Establishment of at least 2 fully equipped facilities for the production of nuclear medical isotopes.

RADIOTHERAPY
Registration, commercialization of radiotherapy promoters on the global market.

FACILITIES
Commencement of the production of the ranostic devices and products in Hong Kong.

THERANOSTICS
Regulatory approvals, entry into the global market with the ranostic device drugs.

Moving projects and expertise to open market
Instead of unsafe operations with Russia-based assets, we will transfer our expertise to a more stable markets. Production lines will be moved to Hong-Kong, Kazakhstan and South Korea

Halting the project in Uzbekistan
The project in Uzbekistan has been halted until there is certainty in the legislation. We continue looking for acquisitions on the global market to further expand our portfolio

Completion of the audit
The compromise have been reached and the audit will be completed.

Additional investment
The company's management invests its own funds to implement new projects through an increase in the company's raised capital without increasing the number of voting shares

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