Our investor event was held on 24 May 2023 with a room full of interested investors and shareholders. Link to the event recording can be found here:
https://vimeo.com/event/3310525/011b208c22
Event agenda was the following:
4:30-5:15 PM CEO review and panel discussion
5:15-5:45 Q&A
Answers to questions from the online audience:
Which alternative treatments to COPLA are in clinical use or under development and how do you expect the competitive landscape to develop?
As the unmet medical need is massive, we are not the only ones trying to solve the issue. Thus, competition exists. And it should, as the needs of the patients are diverse and different methods are needed to fulfil these needs. Surgical knee cartilage repair treatments can broadly be categorized in four different methods: (1) conservative surgery (debridement and bone-marrow stimulation), (2) scaffolds (e.g., Chondro-Gide, Hyalofast and Agile-C), (3) cell and combination therapies (e.g., MACI), and (4) tissue grafts (e.g., organ transplants, minced cartilage grafts). COPLA belongs to the scaffold category. Shortly, the European market is dominated by scaffolds and the US by tissue grafts. The regulatory pathway for medical devices used to be lighter in the EU compared to the US, which had led to more scaffolds being available in the EU. In the US, surgeons have better access to grafts from organ donors as their European colleagues. In both markets conservative surgery has been the standard of care but lately, given the poor long-term results, this category is losing its position. Cell and combination therapies are extremely expensive, and therefore not available for all patients in need.
The cartilage repair and joint preservation field is going towards simple single-stage procedures with off-the-shelf and affordable products. The more complicated and costly cell-based treatments have their limitations, and the rise of evidence-based medicine is driving the market towards more cost-effective and impactful treatments. All the methods available, or, as far as we know, under development, require a partial weight-bearing period after the operation, giving COPLA a solid differentiation against competition. COPLA is well positioned to answer needs in the field and, thus, it has the potential to become the global standard of surgical cartilage repair.
What does COPLA stand for?
CO = collagen
PLA = polylactide
CO and PLA are biodegradable polymers that COPLA is made of.
What are the biggest possible issues and risks on your way forward? How to mitigate those?
Product development in the medical device field is time and resource consuming and is vastly controlled by the authorities, and therefore involves significant risks. Turnover only begins to accumulate after the device has been subjected to the necessary tests, including clinical trials, to demonstrate its safety and performance in compliance with the regulatory requirements and finally, has received regulatory approvals and reimbursement.
Askel Healthcare has obtained the Breakthrough Device Designation from the FDA (U.S. Food and Drug Administration). The Breakthrough Device Program is a voluntary program for certain medical devices that are aimed at providing more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. It offers Askel the opportunity to engage with FDA on a prioritized basis to efficiently address topics as they arise during the premarket review phase, ultimately enabling patients’ faster access to new therapies. Due to the current and most likely quite lengthy difficulties in the European market authorization process, we focus on the FDA approval and the US market entry first.
The main risks in any pre-revenue medical devices’ companies are related to clinical trials and the above-mentioned regulatory approvals. Askel’s management is constantly mitigating these risks, by consulting the world’s most recognized researchers and key opinion leaders in knee cartilage repair in all of the aspects related to clinical studies to be able to design a successful study. Despite the extensive mitigation plans, the risks related to our clinical trial success prevail, as always when conducting research in humans. In case these risks materialize, they will have a direct impact on market authorization, commercialization, and the company valuation.
Askel will require additional funding in the future, but the necessary funding might not be available (on time). Askel Healthcare has a strong track record in raising both non-dilutive (grants/subsidies) and dilutive (equity capital) financing from both public and private sources. The company is constantly seeking and applying for major non-dilutive financing to cover part of the costs of the clinical trials and corresponding R&D work.
You target a total of 5MEUR of financing and mention that that the round will continue after the crowdfunding phase to reach the full target. What is the valuation after the crowdfunding period?
If Askel does not reach the full target, we will keep raising additional funds after the crowdfunding period with the help of Cenitz as a lead investor. The financing mix might also include either debt financing or non-dilutive grant financing. Askel has already established a good network and working relationship with some of the major European Life Science VCs to prepare for the forthcoming funding needs. The valuation of the next financing after the crowdfunding period is dependent on the funding raised and the milestones reached. The next valuation upticks are seen as the following:
- Proof of safety of the COPLA implant (Pilot Trial, 10 patients, 6-months follow-up data)
- Authority approval to start the Pivotal trial in EU
- Authority approval to start the Pivotal trial in the US
- Final dataset from the Pilot Trial (20 patients, 2-year follow-up data)
- Market authorization in the US
- Market authorization in EU
- Reimbursement in the US and selected European countries
- Successful market entry (~50M€ revenue)
