We are seeking to complete phase 1/2 trial in order to test safety and efficacy in mesothelioma patients. To that end we are actively seeking series A investment up to 10 Milion euros.

We have completed the preclinical package for a novel anticancer compound, proving the efficacy in vivo in mesothelioma models, scalability potential in other asbestos-related indications, completed GMP manufacture of drug substance, complete pharmacology, safety and tolerability in vivo according GLP-regulatory rules. We have also maintained conversations with regulatory agencies and outlined the clinical trial plan, to advance into indication achievement. As a result we are now ready to advance into clinical trials.

To that end we foresee the following steps:

• To complete production of final drug product (clinical batches, with complete formulation for in-human trials)
• To complete regulatory dossier and achieve the regulatory approval (IND) to start clinical trials.
• To conduct phase 1/2 clinical trials in advanced mesothelioma patients, proving safety, tolerability and efficacy in these patients
• Advancing on newer data for further scalability in other asbestos-related tumors like lung cancer.
• Targeting agreements and partnerships with our natural clients, the pharma company while completing the financial rounds.

From a technological view point, we have proved the scalability potential of the compound:

1. We have proved the efficacy in vitro in several cancer models, including refractory models to platinum and pemetrexed therapies.
2. We have also completed the efficacy in vivo in a range of orphan (mesothelioma) and non-orphan (ovarian, colorectal) cancer indications.
3. We have also completed GMP manufacture process for the drug substance and complete pre-formulation studies of drug product
4. Product addresses a well-known target in oncology, which not only diminish the inherent clinical development risks but also being a relevant target in many advanced solid tumors, expands the capability of the compound to be used in other larger indications.

From commercialization viewpoint, licensing out the technology to a global pharma will ensure the highest scalability of the busines, by establishing a collaboration with a larger pharmaceutical company with the production capacity and the established distribution network to sell the drug in targeted markets. By establishing specific agreeement, Aromics will be able to gain access to the capital and the expertise required to enable us to take the clinical programmes to the next milestone.

From business perspective, it is important to note that R&D is the main core value of the company. Present compound belongs to a novel family of compounds with activity in cancer, that are advancing in preclinical development and that have a common mechanism of action (silencing aberrant proteins expressed in cancer). Bermes lead product is advancing into clinics. A sucessful clinical trial will not only propel the development of this compound but also reinforce the evolutiion of our R&D pipeline profile, that will allow us to diversify the pipeline and de-risk the business while sustaining innovation.

Our goal is to develop a small molecule drugs that address RNA as therapeutic target, and capable of changing patient outcomes for oncology conditions where treatment options for patients are limited, unefficient and with side-effects, as in the case of advanced mesothelioma tumors. Indeed, NAX035, targets thymidylate synthase (TS) a well-known target, clinically validated as relevant prognostic and predictive marker in mesothelioma as well as in many other cancers. Current inhibitors of TS (such as pemetrexed, standard therapy in mesothelioma and lung cancer), target the protein and are currently in clinical use as first-line therapy treatment in many solid and haematological tumors. One of the main problems of these inhibitors in clinical setting, is the emergence of chemoresistance due to overexpression of the protein. We propose a disruptive solution, by silencing the protein to overcome this therapy limitation: A novel compound that prove efficient, safe and well tolerated in preclinical setting and that is advancing into clinical trial. As first indication we have selected mesothelioma. If effective in patients, it will become an alternative for both, naive but more importantly refractory patients to standard therapies.

The business model follows a typical biotech business model that consists of in-house development of the product, followed by co-funded clinical trials, and out-licensing to pharma after completing efficacy trials. Our prefered route to market then, is to establish a collaboration with a big pharmaceutical partner with capacity to perform later and more expensive clinical trials (additional Phase 2B/ Phase 3 clinical trials) and with market penetration and commercial experience to bring oncology products to market. A licence agreement with a pharmaceutical company would typically cover exclusive rights to develop and market NAX035 for a certain indication (e.g. mesothelioma) or territory. Revenues would come from: Upfront and milestone-based fees (~€50m from mid-stage developed drugs, expected at the end of efficacy trial) and milestone payments and tiered sales royalties. 

At this point, we will reinvest a major share of our net income in the company for developing further clinical indications for the drug, thus increasing the company’s value. We will also keep working on expanding/advancing our current oncology product portfolio, that include addtional compounds of the same family, targeting different and revelevant oncology targets by the same mechanism of action (targeting mRNA and silencing aberrant proteins involved in cancer progression and drug resistance). This will propel the growth of the company.