Subsequent to comprehensive pre-launch activities in the first half of 2020 and detailed discussions with oncologists at the ESMO congress, we have finalized a commercialization roadmap on how to implement the IndiTreat® test at European hospitals. The first IndiTreat product is targeting patients with Colorectal Cancer. Later products will cover Ovarian, Pancreatic and Breast cancer patients. Our market analysis has shown that there is a clear need for a functional test like IndiTreat in clinical practice. We now look forward to see IndiTreat® in action at different European cancer clinics.
Ole Thastrup, CEO
Our ESMO activities and marketing initiatives turned a page in terms of our commercialization efforts and momentum for the company. With a strong product development plan and clinical data around the corner 2cureX is in a very interesting and exciting phase of its journey. I feel very confident that we as a company have grown and are geared ready for a successful outlook ahead.
Maarten van der Linden, CBO
This is an important moment for our company
Ole Thastrup, CEO
2cureX is the first company in the world to offer a CE IVD validated functional cancer drug sensitivity test based on patient derived microtumors
Maarten van den Linden, CBO
with the positive assessment we have met another important milestone of our Horizon 2020 project. The EU-grant is based on our business strategy and supports both the clinical validation and the Early Access Program for IndiTreat®, that will be introduced to the market in the second half of 2020.
Ole Thastrup
I have had the pleasure of following 2cureX closely for a number of years as member of the company’s Clinical Advisory Board. I am truly impressed with what the IndiTreat® test can do for very ill cancer patients. I am therefore excited to become a member of the 2cureX team. To help each patient in getting his/her own treatment and to make the society utilize the many medical treatment options in a rational and cost-effective way, so there is for sure a need for 2cureX’s technology
Henrik Harling, CMO
We are very grateful for the interest in our rights issue. I would like to thank our existing shareholders for their trust and thank all interested parties who have signed up for the rights issue. We have several exciting years ahead of us and the issue proceeds will enable us to realize our market launch of IndiTreat® in the best possible way. I look with great confidence on 2cureX's continued journey.
Ole Thastrup, CEO
2cureX is currently preparing the pre-launch of IndiTreat® and through the recruitment of Carit as CFO we further strengthen the organisation for the market launch. Carit contributes with extensive experience and will be an important part of the exciting journey we have in front of us
Ole Thastrup, CEO
We have come across a major obstacle on the road of becoming a commercial MedTech company by receiving CE-IVD labelling of IndiTreat® in October 2018. IndiTreat® is currently being validated clinically in three major cancer indications. The next step is to continue working with our strong clinical partners, more Key Opinion Leaders and potential customers to prepare the markets in the Nordic countries, Germany and the UK before launching IndiTreat®, which is planned in 2020.
Ole Thastrup, CEO
Cancer in the pancreas is one of the most serious cancer diseases, and therefore we need to improve our treatment. In the clinical trial we will clarify the ability of IndiTreat® to predict the efficacy and resistance of the medical treatments in incurable pancreatic cancer patients, and we aim at personalized, tailor-made treatment of each patient. In addition to finding the most effective life-prolonging treatment, there is also a very important perspective in identifying an effective neo-adjuvant treatment, which can down-stage the cancer, and thereby bringing more patients to surgery. It will increase the chance of survival.
Principal Investigator and Chief Oncologist Lars Henrik Jensen, University Hospital Vejle
We have past the first half-year of 2018 and 2cureX has successfully further developed its operations and made a number of progresses in the second quarter of 2018. Among other things, we have expanded and opened a screening laboratory in Germany and initiated a study in ovarian cancer with well-reputed physicians at the hospitals in Copenhagen and Hamburg. In addition, we have also presented positive study results from the ongoing clinical validation study of IndiTreat®.
Ole Thastrup, CEO
This is an important recognition of 2cureX’s central role in the design of efficacious treatments for individual cancer patients. The IndiTreat technology has already shown its capacity in colorectal cancer and ovarian cancer patients showing its potential to become an important tool for individualized treatment design in the very near future.
Grith Hagel, Head of Development
By running our first interventional trial in late stage metastatic CRC, we have put IndiTreat® to a tough test. Since it has never before been tried to prepare 3D micro-tumors from needle biopsies of liver metastasis, it is a great pleasure to see that we have been able to do that with a 71% success rate. Further we have in some patients been able to identify alternative treatment options that goes beyond standard treatments. With the present positive clinical results our CRC clinical trial is progressing according to the previously presented plan
Ole Thastrup, CEO
Ovarian cancer is a disease where the patient unfortunately most often is diagnosed in a late stage with a disseminated disease which requires extensive surgery and chemotherapy. Unfortunately, approx. 75% of the ovarian cancer patients are diagnosed with extensive metastatic disease and up to 80% of these patients will later recur and develop chemo resistance. We hope that the IndiTreat® test will enable us to avoid treatment with non-effective chemo therapies and instead enable us to offer the patients individualized effective treatments. We expect the feasibility trial will be finalized in 2018. A successful trial is planned to be followed by a prospective randomized trial to validate the ability of the IndiTreat® test to predict resistance or effectiveness of a specific oncologic treatment
Professor Claus Høgdall, Rigshospitalet, Copenhagen
I am enthusiastic about the preliminary clinical results observed in ovarian cancer. It is of particular importance in ovarian cancer that we chose the right drugs and the right sequence once standard therapeutic options are exhausted. With a technology such as IndiTreat® we will even be empowered to put standard regimens for the individual patient into question if the particular tumor responds much better to currently used off-label drugs. UKE has since 2012 collaborated with 2cureX in developing a predictive tool for the treatment of colorectal cancer. It is exciting to discover that the IndiTreat® technology will have a much broader applicability
Consultant Andreas Block,University Medical Center Hamburg-Eppendorf, Hamburg
It is further a pleasure for me to see that we only six months after the listing of 2cureX at Nasdaq Stockholm First North stock exchange has been able to deliver on one of the very important future perspectives being moving into other solid cancer beyond colorectal cancer. This is a major strategic step forward in the development of our organization and expands the foundation for success with IndiTreat®”
Ole Thastrup, CEO 2cureX
Q1 2018 was the first full quarter for 2cureX as a listed company. I am very pleased with the clinical development of our IndiTreat® test for colorectal cancer patients and the progress we’re making in building an organization with strong capabilities in order to capitalize the market opportunity. The planned European launch of the IndiTreat® product in 2020 is being supported by an intensified marketing effort and launch of a commercial screening laboratory in Germany.
Ole Thastrup, CEO
We feel honored to be seen as one of the new innovative Bio-Tech companies and to share our experience and best practices in building 2cureX, in order to help define prerequisites that will increase innovation and business opportunities within the Life Science sector
Ole Thastrup, CEO
It is an important milestone for 2cureX that we now open a commercial, screening laboratory in Hamburg
Jürgen Kupper, Managing Director for 2cureX GmbH
We have previously obtained grants from the EU; but the conditions of the Horizon 2020 SME Instrument grant are simply outstanding. In discussions with the EU in February and March, we have been met with a high degree of flexibility and a clear interest in supporting 2cureX to become a success. It is clear that this grant provides more than financial means
Ole Thastrup, CEO
The ESMO World Congress on Gastrointestinal Cancer is by far Europe’s most important clinical conference within the colorectal cancer field, it is therefore a great pleasure for us and our clinical partners to be invited to present IndiTreat® and our clinical findings at this conference
Ole Thastrup, CEO
With this prestigious grant from the EU’s Horizon 2020 program, we have today met an important milestone. The funds will ensure that we can fully execute our multinational clinical validation in colorectal cancer. Further we will be able to establish presence in the key European countries and initiate market launch of IndiTreat™. The EU-grant fully supports our business model and is a powerful endorsement of IndiTreat™ and of our business concept
Ole Thastrup, CEO
Successful launch of this clinical validation trial is a major milestone reached for 2cureX
Ole Thastrup, CEO
Mr. Maarten van der Linden is an excellent addition to our management team: his comprehensive business expertise in preparing organizations for new product launches and in building the market for such products in the oncology field is of paramount importance to 2cureX
Ole Thastrup, the CEO of 2cureX
I am very pleased and excited to join the newly listed 2cureX
Maarten van der Linden, newly appointed CBO
I would like to start by thanking all who showed interest to subscribe for shares in 2cureX. It is gratifying that the interest for our company is so big and that we can welcome many new owners. With the proceeds, we will be able to finance all the preparatory activities before the market launch of IndiTreat™, for example. CE marking and ISO certification, building the sales organization and establishment of additional test-sites.
CEO Ole Thastrup
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