Vänligen berätta lite om dig själv och din bakgrund
– I have a technical and financial background as an engineer and certified public accountant, respectively, as well as supplemented with an MBA in strategy and innovation. This also reflects my business career beginning in PWC as an accountant followed by a career in the industry - including more than 10 years as a partner in 2 Danish private equity funds. I was Executive Vice President of BIOFAC Group, which specializes in manufacturing products for the pharmaceutical, veterinary, and nutraceutical industries before I joined Curasight in January 2016, first as an investor and board member - shortly after as CFO and business developer and subsequently also as CEO. Besides, I’m a member of the Board in few other tech companies.
Kan du beskriva Curasights och Er verksamhet för Stockpickers läsare?
– Curasight is developing a platform for high precision diagnosis of cancer (uTRACE®) and anti-cancer radiotherapy (uTREAT®). By combining anti-cancer radiotherapy uTREAT® (therapy) with uTRACE® (diagnostics), the technology is known as Theranostics, Curasight is developing a new cancer technology that is expected to detect and treat cancer and metastases in a much more gentle and efficient way than today’s method of external radiation therapy. uTRACE® will specifically seek and bind cancer cells (uPAR expressing) predicting where the anti-cancer radiation treatment, uTREAT®, will bind and work.
– Since the IPO, Curasight has met its objectives and valuable clinical and preclinical results have been obtained. Curasight’s uTREAT® technology has prior to the IPO already shown promising results in academic preclinical studies in prostate and colorectal cancer, proving that Curasight’s therapeutic technology is working. Recently, results from the investigator-initiated Phase II study with uTRACE® in prostate cancer patients gained attention in the March issue of the Journal of Nuclear Medicine, the highest-rated scientific journal within nuclear medicine globally. Furthermore, the article was also named as the best clinical investigation article. This publication underscores the quality of the demonstrated proof-of-concept for the idea of using uPAR-PET as a non-invasive measure of cancer aggressiveness in prostate cancer. The results also support the idea that imaging may replace some of the invasive biopsies currently being taken, something Curasight will take into consideration when planning for a future Curasight sponsored phase III clinical trial in prostate cancer.
Hur ser er affärsmodell ut?
– Curasight aims to establish uTRACE® as the gold standard for risk stratification in prostate cancer. The geographic markets with the highest prevalence of these cancers are the US and Europe. The Board and management of Curasight assess that the market potential for uTRACE® as an integral component of a new and fast-growing market for active surveillance is substantial. Importantly, as a result of the unique patient benefits and its compelling business model, Curasight expects uTRACE® to catalyse the market for active surveillance to grow it rapidly.
In brain cancer, Curasight expects its Theranostic solution uTREAT® to be game-changing and to obtain a substantial market share. The orphan (rare) disease status of this disease is expected to enable a “fast track” route to FDA approval. By establishing an advanced pipeline in multiple cancer indications, Curasight’s Board and management believe the Company will be an attractive candidate for partnership or out-licensing agreement with Big Pharma. The area within Nuclear Molecular Imaging/Therapy has experienced strong traction with significant exit benchmarks over the recent period.
Just nu har man möjlighet att teckna eller utnyttja sina redan förvärvade teckningsoptioner i Curasight. Målet är att ni kommer få in cirka 48,8 miljoner DKK vid full teckning. Vad ska ni använda likviden till?
– If all warrants are exercised, Curasight will have a good financial position, which will be used to accelerate the plan and unfold the full potential of our platform.
Curasight’s first goal is to advance its lead products uTREAT® (used for therapy) and uTRACE® (used for diagnosing) to improve outcomes for the approx. 65,000 patients in the US and EU that are diagnosed annually with brain tumours. Accordingly, approximately 30,000 patients are diagnosed with high-grade glioma where the prognoses are very poor. Glioblastoma is a rare disease in both markets, qualifying for Orphan Drug Designation; moreover, because of the high unmet need, products targeting it are more likely to qualify for e.g. Priority Review, Breakthrough Therapy Designation, or Accelerated Approval. Besides, due to the very encouraging results from the finalised investigator-initiated clinical phase-II study in Prostate Cancer, Curasight will look into how to accelerate the product development within Prostate Cancer in order to improve the outcomes for more than half of millions new prostate cancer patients that are diagnosed annually in the US and EU. Furthermore, Curasight is looking into how to unfold further and broadening the mission to realize the vast potential of uTRACE® for diagnosing and uTREAT® targeting radionuclide therapy in other cancer types where uPAR is also expressed.
The key remaining milestone for 2021 is the first results from phase II clinical study in brain cancer with uTRACE® which are expected in Q4.
Vilka är de största riskerna i Er verksamhet?
– They key risk is that clinical trial do not demonstrate the anticipated effect. However, with the results obtained so far and with the potential of further indications being added we believe the future is bright for our technology.
Curasight’s potential future competitors are companies working in areas that may substitute for our technology in one or more indications. However, as uPAR-PET and u-PAR radionuclide therapy is a platform that work across cancer types, we see very limited risk that we will not succeed within one or more indications. Within the uPAR field, our platform is based on more than 10 years of focused research giving us a a clear competitive edge. However, currently Curasight has not currently identified any direct competitors in relation to the cancer indicationswe are working on.
The pharmaceutical industry and clinical trials are associated with great uncertainty and risks regarding delays and results in studies. There is a risk that results from early clinical trials do not match results in more extensive clinical trials. There is a risk that Curasight’s current and planned future clinical trials and controlled studies will not indicate sufficient safety and efficacy for the Company to be able to out-license or sell the pharmaceutical projects according to plan. Thus, there is a risk that this leads to a reduced or a lack of cash flow for the Company. That said - we have a strong cash position and well-proven technology that has been tested on more than 400 patients at Rigshospitalet in Copenhagen, which is why we expect to enter the market with the first product uTRACE® in 2025.
Hur ser Er konkurrens ut och vad skiljer Er från denna?
– To the best of our knowledge, there are no other companies currently pursuing peptide based uPAR targeting for PET scans and radionuclide therapies. No other companies have uPAR-PET technologies that have been tested clinically in patients.
Hur stor är Curasights potentiella marknad?
– It is estimated that the global nuclear medicine market is expected to reach up to USD 26 billion in 2030, a figure estimated based on major changes, trends, and investments in this area. It is expected that radiotherapeutics will represent more than 60% of the USD 26 billion nuclear medicine market by 20301.
Avslutningsvis, vilka är de främsta skälen till att man skall investera i Curasights?
– Curasight‘s technology is tested in a broad pipeline with six ongoing phase II clinical trials (investigator-initiated) and two completed phase II studies in prostate and breast cancer.
According to our assessment, there is currently no other early-stage biotech Company in the field of PET tracer development that has their technology tested in a broader portfolio of investigator initiated clinical trials, in many different cancer indications. In 2017 a phase l/lla first-in-humans clinical trial with uTRACE® was completed. In 2018 and 2020 phase llb clinical trials with uTRACE® in breast and prostate cancer were completed, respectively.
Curasight is developing the therapeutic ligand, uTREAT®, that binds to all cancer cells in the body (expressing uPAR – breaking down the normal tissue around the tumour) and locally irradiate cancer with limited irradiation of healthy tissue. This concept represents a more gentle form of radiotherapy compared to traditional external radiation therapy. Combining anti-cancer radiotherapy uTREAT® (therapy) with uTRACE® (diagnostics), the technology is known as Theranostics, is expected to detect and treat cancer and metastases. The Theranostic principle will select the right therapy to the right person at the right time, creating substantial benefits for both patients and the healthcare system.
Erbjudandet i sammandrag
Nyttjandeperiod: 16 september 2021 till 7 oktober 2021.
Lösenpris: En (1) teckningsoption ger innehavaren rätt att teckna en (1) ny aktie i Curasight till en kurs om 17,20 DKK.
Värdering (pre-money): Cirka 294 miljoner DKK.
Emissionsvolym: Nyttjas samtliga teckningsoptioner tillförs bolaget cirka 48,8 miljoner DKK före emissionskostnader.