Would you please tell us a bit about yourself and your background?
– I have had most of my career in the pharmaceutical industry, including 15 years with Lundbeck. During the pre-IPO/IPO process with Cessatech, I also had a great opportunity to work independent for a number of biotech/pharma companies – some of these contacts are now in our board of directors. Besides that, I am a father of three children, all of them could have used CT001 for acute pain management as they have been playing as children do which often results in minor accidents….
Can you please describe Cessatech and your operations in short?
– Initially Cessatech was a spinout project from Rigshospitalet, a project lead by experts within paediatric anesthesia and pain treatment, who recognized a need for fast-acting and easy to use needle-free pain treatment for children. Children, like adults, have a right to the highest attainable standard of health, but continue to be under-represented in medication research, as well as drug development.
Today Cessatech is a Danish pharmaceutical company committed to developing evidence-based and innovative medicines with the ambition of improving the treatment for children of paediatric acute pain.
The lead asset (CT001) is an analgesic nasal spray for treatment of acute and planned painful procedures in children. The advantages include needle-free administration, being easy to administer, a fast-acting therapeutic effect and, when it has obtained regulatory approval, also being medically approved for children.
Also, the company has two follow-on concepts for children, a sedative nasal spray (CT002) for medical and diagnostic procedures (e.g., MRI scanning) and a local anesthetic gel (CT003) that can be applied to open wounds (e.g., before stitching in the emergency room). With the recent success of obtaining an approved paediatric investigation plan (PIP) for the Company’s lead asset, it is the Company’s ambition to apply for a similar development program as the one recently granted for CT001.
How might the potential business model of the company look like?
– Cessatech’s business model offers unique, scalable economic value creation by identifying and developing drugs with a short time to market and risk-reduced profile. The drugs that are developed by Cessatech should be proven effective in adults and represent a medical unmet need in children where a focused development plan can be applied for documenting good effect in children.
We collaborate with leading university hospitals to ensure that products that we include in our development also have a large unmet need or have off-label use today. This is a good entry model and collaboration model, which also includes leading experts within the relevant disease areas. Later we will evaluate what the best commercialization model will be, in the early phases we will most likely focus on partnerships but later we may want to be more aspirations depending on the geographical scope.
How does the lead asset (CT001) differ from other treatment methods?
– Today’s analgesic solutions often require an intravenous access which is not always feasible or easy and can be painful. In contrast, CT001 has a fast onset and is easy to use. Its composition includes a fixed combination of the two well-known analgesics ketamine and sufentanil (an opioid), which are already approved treatments for injection in adults. The two compounds are also used separately for analgesia but only intravenously in children. The potential advantages of the fixed combination of sufentanil and ketamine include improved analgesia with approx. 30 percent lower dose of sufentanil and consequently the avoidance of undesirable side effects such as prolonged sedation and risk of respiratory depression.
Through the warrant series with an exercise period running between 25/11 and 16/12, you may be attributed approx. 25.2 MDKK. What are your plans for the issue proceeds?
– The issue proceeds from the warrant series are expected to finance the finalization of the first three trials of the CT001 late stage clinical program. Also, the proceeds will be used in order to finalize the two simulation models, studies 0207 and 0208, as well as the final study 0202. Lastly, the proceeds are expected to keep the organization developing.
CT001 is based on more than ten years of clinical experience and has been proven effective and safe in a clinical Phase II trial in 50 children. In Europe alone, it is estimated that approximately 25 million children are exposed each year to acute procedural pain.
According to you, what are the main reasons of investing in Cessatech?
– Cessatech has a reduced risk profile as there is a lot of clinical experience with its assets, all focusing on paediatric formulations with large unmet needs and relative short development timelines – following the EMA guideline. The company has a lot of potential, both in terms of assets but also geographical scope. The Cessatech team is a key asset and extremely important for the long-term journey, not only medical and clinical experts but also Management and Board of Directors.
Lastly, looking five years into the future – what’s the status of Cessatech by then?
– Hopefully CT001 is on the market with a good traction and available across major markets – and hopefully more assets are under development or already on the market. Cessatech will be a company based on collaboration with university hospitals, strong partnerships and a flexible business setup to minimize risk and cost deployments. At the end of the day the aspiration is to help children across the world – rethinking child treatments.
Summary of the consideration free warrants
Exercise period: 25 November - 16 December 2021.
Exercise price: One (1) warrant gives the right to subscribe for one (1) new share at DKK 10.00.
Issue volume: If all warrants are exercised during this period, the company will receive an additional approx. DKK 25.2 million before issue costs.
Ticker, ISIN: CESSA TO 1, DK0061416849.