Glycanostics - Giasay®

Glycanostics’ patented technology enables the diagnosis of up to 11 types of cancer. In a new investment round on the Crowdberry platform, the company will use the targeted $10m in capital to develop an already existing, painless and reliable diagnostic method by transferring this tested prototype to new indications such as breast cancer, as well as to cover the associated costs or mass production of the diagnostic test.

Discussions are currently underway with several investment funds for a potential €5m co-investment to complement the €5m funding of this investment opportunity from Crowdberry investors. This creates unique conditions for private investors to participate in the financing of this Slovak Life Sciences company with global potential. This brings the total investment to €10m of growth capital.

• Cost of transfer of the test to the manufacturing site and start-up of mass production
• Coverage of operating costs
• Costs associated with expansion into new markets

After a successful first investment round on the Crowdberry platform, which enabled the development of a unique prostate cancer diagnostic and its launch on the market, the Slovak biotech company Glycanostics is developing a diagnostic for other indications such as breast cancer.

The company was founded in 2017 by two renowned Slovak scientists – Ján Tkáč and Tomáš Bertók. With experience at prestigious foreign universities, more than 160 research papers and 3,900 citations, they are among the world's most respected scientists. They focus on the field of cancer diagnostics through specific biomarkers in the blood, which are also the subject of research by leading pharmaceutical companies. Joining the team as CEO is Eva Kováčová, who has over 28 years of global experience in the pharmaceutical industry.

The company's goal is to bring accurate, non-invasive and affordable blood-based cancer tests to the market, without unnecessary, painful and costly biopsies.

Proof of the company's success is the recent successful launch of the Giasay® PROSTATE product – a prostate cancer diagnostic that is already being actively used by Slovak urologists and patients. The principle on which this diagnostic method is based has the potential to detect other types of cancer, such as breast cancer and nine other types of cancer. The company is currently conducting a pharmacoeconomic study as a basis for future discussions with health insurance companies. After obtaining the CE mark, the company plans to launch the Giasay® test on the Austrian and German market and expand sales through a network of well-known laboratories.

Their innovative method shows increased accuracy compared to procedures currently available in Europe. Glycanostics works with international partners and has the support of experienced professionals from the world of science and business. The company's potential for business success is confirmed by the high scalability of the product and the global commercial potential.

Experienced scientific and commercial team

The Glycanostics team consists of internationally recognized top scientists and managers in the field.

Product

Blood-based diagnostics, compatible with existing laboratory infrastructure worldwide. Affordable, time-saving, accurate and highly scalable. Each test is protected by four different patents (layered patent protection) and two registered trademarks.

Results

Successful launch of the Giasay® PROSTATE diagnostic test and its commercial use in practice after two years.

Market

Early diagnosis of cancer is an unmet medical need. The market potential for breast cancer is close to €7bn. In addition to early diagnosis, the test has potential as a companion diagnostic during the development and clinical testing of new drugs.

Commercial partners

The company is negotiating to include the tests in the Unilabs and Medirex laboratory offerings, and has support schemes for entry into the German market from the German government and also from the EU for the US market.

Exit potential

The profitability similar to pharmaceuticals and the company's low-cost profile are an excellent combination for potential acquisition by various pharmaceutical companies, with which management is already in active discussions.

Confidence of institutional investors as well

Successful first investment round with 39 Crowdberry investors as well as support from institutional investment funds in total value of €1 million.

The Glycanostics team consists of renowned scientists and managers with international experience in the field. The company was founded by a pair of prominent Slovak scientists who have received numerous international awards and prestigious grants for their scientific work. The company's strategic direction and commercialization is led by a CEO with many years of experience in senior positions in the largest pharmaceutical companies.

Ján Tkáč, Chief Science Officer, has 28 years of experience in biotechnology. He has worked at prestigious universities around the world, including three years as a postgraduate at Oxford University. He is the recipient of numerous scientific awards, scholarships and grants; until recently, he was the only Slovak to ever win a prestigious European ERC grant, twice.

Eva Kováčová, CEO, brings an extensive 28 years of experience in M&A, financial management and licensing from top management positions in the pharmaceutical industry in Europe, including London headquarters of GSK. Her knowledge of complex pharmaceutical M&A and licensing has made her a recognised industry expert. She has led multi-billion-dollar post M&A integration projects and transformations for major pharmaceutical companies such as GSK, Pfizer, Novartis, and Johnson & Johnson in EMEA and Latin America.

Tomáš Bertók, Chief Technology Officer, has 17 years of experience in the biotech industry. He focuses on technology and diagnostic preclinical testing as well as implementation and design of innovative diagnostic tests. He has also won several major awards and has been ranked in the Forbes 30 under 30 as a science personality.

Glycanostics provides an innovative solution based on a patented method of analyzing molecular changes in the structure of glycans (complex sugars) on the surface of antigens in the blood that change as the disease progresses.

Such changes in glycans are associated with many cancers, making Glycanostics more reliable in detecting cancer than current methods. The test is characterized by its high sensitivity, specificity and diagnostic accuracy. It is designed to assist in deciding if a confirmatory invasive biopsy is needed.

The Glycanostics method is unique in that it does not take into account the quantity of the antigen, but looks at the qualitative changes in its structure that are only affected by the cancer. It can provide a comprehensive picture of the current state of the tissue and thus enables, for example, patient monitoring during treatment.

Glycanostics has developed a non-invasive blood-based diagnostic that has a reliability of 81-83% and detects cancer at a much earlier stage than conventional tests. Moreover, this diagnosis is much cheaper than biopsies, which are often unnecessary.

In the case of breast cancer diagnosis, commonly used methods have low sensitivity. Mammography routinely fails to detect approximately 2 out of 10 breast cancers, and more than half of all women have so-called false positive results and undergo avoidable biopsies. In addition, current serological biomarkers are used only in patient monitoring but not in diagnosis.

Giasay® Breast monitors changes in glycans on a tissue-specific biomarker, and can detect cancerous changes in tissue to refine diagnosis with mammography or MRI. This method is also useful for monitoring the effectiveness of treatment. Results are available within two hours. It is the only (serological) blood test on the market that analyses glycans and detects breast cancer. The test has been validated on more than 800 blood samples.

Market

• Estimated capitalization of the global cancer diagnostics market is $311bn by 2032.
• The growth of the global market is driven by the rising number of cancers, an ageing population, and the development of new technologies or R&D of new, original molecules for cancer treatment.
• The WHO estimates that, as a result of the pandemic, cancer deaths will rise by 10-15% in the coming years due to delayed diagnosis and treatment. This will lead to an increased demand for new methods and solutions that will make diagnosis and screening more efficient and accurate, and enable early diagnosis of cancer.
• Breast cancer incidence is expected to grow at 40% (3m new cases) per year through 2040; the market for breast cancer diagnostics is projected to reach approximately $8.7bn by 2032, growing at a CAGR of 7.1% per year, with the primary growth coming from demand for screening in developing countries.
• Given the prevalence of cancer and the underserved medical need for diagnostic tools, the incentive to enter the market is high – there are multiple players in the market that provide tests, but they are on a different basis and not as accurate.
• The market for innovative diagnostics is relatively young and dynamic. It includes both established companies with a long history, built infrastructure and strong market position, as well as young, innovative start-ups that bring a new, more modern approach to diagnostics with the ambition to replace outdated, expensive and unreliable processes.

Market trends in terms of acquisitions in the biopharmaceutical sector are mainly influenced by:

• The need to optimize and manage the portfolio of pharmaceutical companies through mergers, acquisitions or new partnerships to expand the "pipeline".
• Divestiture and expiration of patents, or mitigation of patent expirations.
• Anti-monopoly rules in the market that create barriers to larger acquisitions, resulting in pharmaceutical conglomerates targeting small and medium-sized innovative companies.

Competition

In the field of prostate cancer diagnostics, the Giasay® PROSTATE test stands out due to its accuracy, its suitability for mass screening, its low cost, its organ specificity, its compatibility with equipment used in laboratories worldwide, and, most importantly, its ability to avoid the highest percentage of avoidable biopsies (73% of avoidable biopsies with Giasay® PROSTATE vs. 43% of avoidable biopsies in case of competing solutions competing solutions).

In the field of breast cancer diagnostics, current competing solutions focus primarily on supporting radiology and histology through artificial intelligence. Only 12 companies are developing a blood test to diagnose breast cancer. Most of them analyse DNA/RNA, which requires highly skilled personnel and thus high costs. The only blood tests currently in use are from Roche and bioMérieux and quantify proteins. However, this method is suitable for prognostic purposes and has low accuracy. Glycanostics is the only company in the world that uses glycans for cancer risk assessment and for early diagnosis or treatment monitoring. It also stands out from the competition for its time-saving, low cost and reliability.

Due to its high scalability, the Glycanostics diagnostic test has global commercial potential through outlicensing of the final product to multinational pharmaceutical companies. The solution will bring significant savings to the entire healthcare system, which will be in increased demand worldwide following the pandemic.

• Glycanostics focuses on exclusive licensing of its patented technology to multinational companies in the pharmaceutical industry and, secondarily, through direct sales.
• The development of diagnostic methods is a very lengthy, costly and risky process, which is why it is interesting for pharmaceutical companies to obtain a final product that has already passed the risky phase of development and is ready for commercialization. This typically takes the form of a licence, whereby the licensing partner receives the right to sell and distribute the test worldwide and the patent owners receive license fees, such as an upfront fee, a milestone payment when certain milestones are reached, or a percentage of the sales of the tests, called royalties. This makes it cheaper and faster to get a product to market.
• Thanks to its CEO, Glycanostics has not only detailed know-how but also extensive contacts in the industry, and has a good chance of attracting licensing partners after successful transfer of the product to mass production and gaining the CE mark. .

• Scaling risk: high 🔴
  Recruiting the right team members, setting up structures and processes, and managing a large team across multiple markets can be challenging and presents a managerial risk. We expect this risk to be mitigated by the merit of the company's management and sales team, as its members have experience in scaling and managing the company gained from working for multinational companies.
• Technological risk: medium 🟠
  Unexpected pitfalls can often arise during the development and testing of cancer diagnostic products. The risk is partly mitigated by the fact that the core technology, covering 11 cancer types, is already patented and that tests for prostate and breast cancer diagnostics have already undergone a retrospective study and are being optimised for mass production. In order for the company's tests to be mass-produced, it will be important to prepare for large-scale production, obtain CE marking and FDA certification, successfully complete the prospective study, and achieve inclusion in European diagnostic guidelines.
• Financing risk: medium 🟠
  There is a risk of delays or failure to achieve revenues or further funding, either from the licensing partner, or investors in planned further rounds, or from public institutions that provide grants and subsidies for R&D. This risk may adversely affect the growth curve and value development of the company and its shareholders. This risk can be mitigated in part by strict medium-term planning of financial resources.
• Business model risk: medium 🟠                                                          
  The company focuses on exclusive licensing of its technology. However, there is some risk that licensing partners would not be interested in licensing Glycanostics' technology. However, the company has sufficient know-how as well as contacts to start direct distribution of the product on its own. Yet, this alternative would require additional financial resources and a longer time horizon.
• Market risk: medium 🟠
  The evolution of the company's market risk is largely outside management control, with factors such as the geopolitical situation and the financial situation of health insurance companies dependent on the performance of the regional and global macro environment. The diversification of the test offerings across cancer types and indications, the provision of global customer service, the suitability of the test for a private market independent of health insurer resources and the planned collaboration with a licensing partner are factors that significantly reduce this risk.
• Risk of competition: low 🟢
  The market for innovative diagnostics is diverse and fragmented, with multiple major players and new innovative companies. The risk of competing against competitors is to some extent reduced by the intellectual property protection provided by five patents and four trademarks, and by the gradual commercialisation of products, which is not common for competitors at such an early stage of development. In addition, the company is the first in the world to have unique patent protection for the analysis of glycans, which has great potential in the diagnosis of various diseases. The company plans to expand its product portfolio, with a focus on the diagnosis of various types of cancer. This effectively diversifies its offering, differentiates it significantly from competitors, and makes it more attractive as a potential acquisition target, for example for pharmaceutical companies

The investment opportunity is available on the Crowdberry platform one year after the launch of the investment campaign itself. The campaign is therefore scheduled to close from a regulatory perspective by 9 February 2025 at the latest.