Summary of the period October–December 2022
- Net turnover was SEK 20,347 (403,257)
- Cash flow from operating activities amounted to SEK -6,126,772 (-5,331,784)
- Profit/loss after financial items was SEK -8,078,967 (-7,191,338)
- Profit/loss after tax was SEK -8,078,967 (-7,191,338)
- Earnings per share were SEK -0.05 (-0.05)
Summary of the period January–December 2022
- Net turnover was SEK 108,517 (882,046)
- Cash flow from operating activities amounted to SEK -24,979,043 (-20,336,340)
- Profit/loss after financial items was SEK -27,942,965 (-21,766,276)
- Profit/loss after tax was SEK -27,942,965 (-21,766,276)
- Earnings per share were SEK -0.18 (-0.19)
COMMENTS FROM CEO ANDERS WEILANDT
MORE AND MORE PARTS FALL INTO PLACE IN THE STRATEGIC PLAN
When I look back at 2022, the obvious high point is that our migraine study was completed and undeniably demonstrates that K.O.S is an effective and safe alternative for preventive treatment of chronic migraine. This is the single most important milestone in Chordate’s history and marks that we have now entered the final phase in building value in the Company prior to a successful exit.
- The migraine study has been delivered – strong significant results.
- Agreements with market experts for introduction of K.O.S in Germany, Israel and Finland.
- Agreement with one of Saudi Arabia’s leading medical device companies for neurology.
- Reinforced cash position due to the outcome of the rights issue, which generated SEK 37.3 million before expenses in January 2023.
In 2023, focus will be on marketing and sales to deliver in accordance with the announced strategic plan. The goal is to show that we can build market shares on one or several of the selected markets (proof-of-concept) since this is a crucial step toward a successful exit for our shareholders.
New agreements set the stage for more market launches
During the second half of 2022, we took key steps forward with three new agreements with consultants for market penetration in Germany, Israel and Finland (and one agreement in the UK signed in February 2022). Equally important is the distributor agreement in December 2022 with Janin Medical Company in Saudi Arabia. Together with Janin and its existing position in the neurology segment, we can continue to move our K.O.S position forward in the region, and we are one step closer to proof of concept.
Complete results from the migraine study will be presented in the spring
In August 2022, we completed our crucial clinical study on chronic migraine. It would be hard to overemphasize the importance of the statistically significant results from the subgroup analysis that were announced in September. We have now delivered on what may be the most important of our interim goals for an exit, which already gives us access to the market with a sought-after alternative to medicinal treatment. Because it is important for the Company's value for the complete study to be published in a well-respected scientific journal, we must wait until such an article is approved for publication before we can announce the results in their entirety.
In addition, we are starting another two planned migraine studies. PM009 is an open pilot study to evaluate the efficacy of K.O.S in the preventive treatment of chronic migraine on patients not responding to treatment with CGRP inhibitors. This open pilot study is being conducted at King's College in London with three to four referring clinics assisting with recruitment of suitable subjects for the study. PM010 is an open clinical post-market surveillance study to follow long- term performance and safety of K.O.S in patients with chronic migraine during regular clinical treatment. The study will recruit 200 patients and be conducted at approximately 15 clinics in three to four European countries. The follow-up is 12 months.
Additional patent and continued work to receive marketing authorization in the USA
In June 2022, the US Patent Office granted our third US patent for headache treatment in the USA. The intellectual property rights defense for our technology as support for our continued business development is one of the Company’s core values. The project for marketing authorization for K.O.S from the US Food and Drug Administration (FDA) is progressing in parallel.
Marketing authorization for rhinitis indication in China
The project work with Nanos Medical for product registration of K.O.S in China continued in 2022, and the submission of an application for marketing authorization for the rhinitis indica- tion was started after the start of the new year. What is left in the project is fully dependent on the answer Nanos receives from the Chinese regulatory authority’s review work, so the scope cannot currently be assessed.
Financing
The rights issue conducted in December 2022 was subscribed to approximately 73 percent and raised approximately SEK 37.3 million for the Company before expenses. With the improved cash position, we can now finance the continued market and sales work. The show of support for the Company’s journey toward an exit from our shareholders is a clear rating of the strength of Chor- date’s offer, in particular given the current climate on the stock exchange and the state of the global economy. The implementation plan will naturally be adjusted by the outcome of the issue.
Focus 2023
- Sales and marketing on select markets for proof of concept
- Projects for marketing authorization in the USA and China
- The studies PM009 and PM010
Kista, February 2023
Anders Weilandt, CEO
