2024-13-005 + 2023-12-006 - X-Ra FINE-02 - X-Ra biomarker For agIng, caNcer and fErtility

X-Ra FINE-02

2024-13-005 + 2023-12-006

First gonosome (sex chromosome) based biomarker of cancer risk and ageing in women, called X-Ra. We have shown that X-Ra is a general marker of female cancer

Environmental: reduction in the resources consumption Social: health and safety for the whole population

Aging populations are becoming a global phenomenon, with the number of people aged 65 years and older projected to reach 1,5 billion by 2050. Given that our marker is addressing women, which would represent half of the population described, and given that women's lifespan is higher than men's, the expected impact of our product will be huge in terms of increasing a healthy lifespan. The main advantages of X-Ra aim at diagnosing and prognosing health outcomes, anticipating personalized treatments (drugs, diet, lifestyle) to revert the expected negative health impacts revealed by X-Ra.

Abnormal variations in the chromosomes can have a huge impact on the health of human beings. Some alterations in the genes can generate a lower number of active cells and proteins needed for the normal functionality of the body. These changes may increase the risk for some diseases such as cancer, and other diseases. There is a need to find new biomarkers that help to identify people who can be at higher risk for some particular diseases and prepare actions to mitigate the negative impact. Our biomarker could also be useful to prognose the patient's response to certain cancers, paving the way to targeted treatments. Our new biomarker, X-Ra, circumscribes in the framework of personalized medicine, thus analyzing the genetic profile of women individuals and preparing a customized response aimed at maximizing health outcomes.

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qGenomics commercializes tests such as qExpect®, a pre-conception genetic screening that assesses the risk of transmitting 300+ hereditary diseases via a simple at-home saliva sample, and qChip® Pre, a prenatal test detecting 300+ genetic alterations linked to developmental disorders. Their revenue model is primarily B2B, charging hospitals per test ordered by clinicians, while also offering B2C solutions where patients pay out-of-pocket. By integrating out technology into the product portfolio of companies like qGenomics, X-Ra can leverage existing distribution channels, accelerating market entry while minimizing production and customer acquisition costs. Our technology can be offered both in hospitals (via physician-ordered tests) and directly to consumers through at-home kits.

We target three key markets with strong growth potential: the reproductive genetics market ($14.5B by 2031, CAGR 12.2%), the fertility test market ($680M by 2025, CAGR 7.5%), and the karyotyping test market ($535M by 2032, CAGR 5.8%). X-Ra’s business model follows a B2B2C approach, aiming to partner with established industry leaders like qGenomics, which already provides genetic testing services to hospitals and patients.

According to Fortune Business Insights, the main market for women's health is the US, followed by Australia, Europe and China as the fastest-growing markets. Developed economies would be our main target due to the fact that lifespan is higher and people have more resources (time, money) to spend in taking care of their health. Moreover, these regions present the highest ratio of cancer prevalence.

We would need 0,5M-1M in the following 2-3 years for X-Ra validation for fertility outcomes.

Competitive funding opportunities such as la Caixa Health, la Caixa CRI, Campus Clinic Innova, AGAUR Producte-Llavor

X-Ra validation for fertility: to be completed in the following 1-2 years. We have teamed up with qGenomics and Dexeus Mujer to have access to their data

Some attempts have been made in the literature to provide global values of XCI in particular cell types, for example, by measuring Xist mRNA levels or visualizing Barr bodies (a small, well-defined body which stains intensely with nuclear dyes) through the microscope. However, these approaches provide poor quantitative values and are generally not reliable, which has hindered the assessment of XCI or X-Ra as a potential marker in women's health. More recently, it was described that chromosome X to autosome (X:A) allelic ratios could be used to measure the XCI status of individual cells. However, this value is not useful for measuring XCI in complex samples including different cell types, such as whole blood or tumor biopsies. Our new marker is able to calculate the global X-Ra level in a female subject using complex samples containing different cell types, such as whole blood or tumor biopsies, a great advantage to the design of practical diagnostics and for testing blood samples from other studies. Additionally, our new marker provides more information than other known ageing biomarkers based on general methylation levels: female age, shorter telomere length, cancer, Alzheimer's disease, survival of breast cancer patients, recovery from COVID-196 infections, stage of pregnancy and female fertility.

Some expected barriers may include: - IP issues: some competitors might have patented a similar marker - Technology development: more validation needs to be done with more relevant data - Market differentiation: there are other similar products in the market, need to highlight the distinction - Negotiation affairs: need to settle fair and reasonable licensing conditions with future licensees

Our next steps include: 1. X-Ra validation for women's reproductive health 2. Definition of the best IPR strategy and roadmap 3. Business strategy and technology license

The EP application was submitted on 19th July of 2023, and will be abandoned. PCT submitted on july 2024. National phases are expected in January 2026.

The EP application (priority patent) was abandoned, and in July 2024, we applied for the PCT (national entrance finalizes in January 2026).

Know-How on personalized medicine, data analytics and genomics

We have teamed up with influencing industrial (TruDiagnostic) and research partners in cancer (Instituto Catalán de Oncología, Hospital del Mar) that will boost the good prospects for X-Ra development and its commercial use. Sex is one of the most important predictors of cancer risk and prognosis, therefore there is an urgent need for sex-specific biomarkers. X-Ra will be the first female-specific biomarker of cancer risk and ageing based on gonosome function and regulation. X-Ra will have profound implications for understanding ageing and disease risk in women, particularly breast cancer. For all these reasons, we are asking for financial support to cover the expenses incurred between May and July 2023 in relation to the patentability studies and submission of the priority patent to ensure a robust intellectual property strategy that allows to maximize X-Ra's commercial perspectives