Chordate Medical is one of the medtech companies participating at the Biostock Investor Meeting on March 16^th. CEO Anders Weilandt will present the company at 11:00 a.m. and talk about the company’s focus in 2023 and beyond. After the presentation, he will answer questions in an interview. The presentation will be in English, and the interview will be held in Swedish.

Anders will, among other things, talk about the positive results from the recently completed migraine study, as well as the ongoing work to create proof-of-concept in the selected markets.

The event is streamed online on BioStock’s website and YouTube channel. Read more about the event

Chordate Medical is one of the companies participating at this years’ Life Science Day in Gothenburg on March 8th. Chordate CEO Anders Weilandt will present the company and how K.O.S can become a global and valuable treatment option for people with chronic migraines.

The Life Science day takes place at the Wallenberg conference center next to Sahlgrenska in Gothenburg and consists of presentations by 15 companies active in the Life Science and Medtech sector, as well as professors and researchers.

The event is live streamed and can be seen afterwards at https://www.lifesciencedagen.se/

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

Read the report here

Kista, February 2023
Anders Weilandt, CEO

Chordate’s Italian distributor Ve.Di.Se. Hospital S.P.A. now has installations offering K.O.S treatment for chronic rhinitis in eleven clinics around the country, from Tradate and Verona in the north to Bari in the south. At the same time, Vedise’s work with the introduction of K.O.S also as a treatment for chronic migraine in Italy continues.

“K.O.S is now starting to establish itself as a medical treatment in Italy and we expect that the number of clinics offering K.O.S for chronic rhinitis will continue to increase. The standstill of almost two years that Covid19 caused in Italy was longer than in most markets, the accumulated healthcare backlog is still tangible. Vedise’s long experience and large network of clinics are also of great value in their ongoing work to introduce K.O.S as a treatment for chronic migraine”, says Chordate CEO Anders Weilandt.

Chordate and Vedise began their collaboration at the end of 2018 when the parties signed an exclusive distribution partnership for Italy. The K.O.S treatment is now offered for chronic rhinitis in eleven clinics, and the plan is to increase the number of clinics further in 2023. Since August 2022, Vedise is investing large resources in being able to start offering K.O.S also for chronic migraine.

“The positive results from the migraine study have given further momentum to this project. Italy is an important market for us, partly because it’s one of Europe’s largest medtech markets and partly because we expect that K.O.S will soon be offered both for chronic rhinitis and chronic migraine in the country. That makes Italy a strong example of proof-of-concept for us”.

Vedise is a well-established player in the Italian market, having supplied medical devices to public hospitals and private clinics for over 30 years. The distributor has a close collaboration with the medical profession.

Read more about Vedise Hospital: https://vedise.com/

See where Vedise offers K.O.S for chronic rhinitis in Italy: https://vedisekos.it/ (the eleventh clinic, located in Rome, is not yet marked on the map).

Chordate Medical announces that the Saudi Food and Drug Authority (SFDA) has approved the application for registration of Janin Medical Company (“Janin”) as the company’s Authorized Representative in KSA. This means, among other things, that Chordate now can fill waiting purchase orders from customers.

“The formal bureaucracy can be extensive in some markets and Saudi Arabia is no exception. We as exporters need to have an Authorized Representative registered with the competent authority in most markets. It is satisfactory that the application was approved relatively fast this time, a clear sign of effective collaboration between our General Manager for the GCC area and the new distributor. We have customer orders that have had to wait for this registration, and which are now possible to deliver near term, says Anders Weilandt, CEO of Chordate.

Chordate entered into the agreement with Janin, one of Saudi Arabia’s leading medical device companies, in December 2022. The agreement means that Janin started as exclusive distributor in Saudi Arabia and Bahrain for both the migraine and rhinitis indications at new year. The company is a focused importer and distributor of advanced medical devices in neurology, pulmonary medicine, cardiology, speech therapy/audiology and urology. Janin also has the status to bid for public tenders.

More information about Janin Medical Company: https://janinmedical.com/index.html

Chordate Medical and Nanos Medical’s joint venture Changyong Medical Technology Co. has submitted an application for product registration for the K.O.S treatment for chronic rhinitis in China.

“This is an important step towards market access in China. The next step in the project is entirely dependent on the answers we get from the Chinese supervisory authority’s review work”, says Anders Weilandt, CEO of Chordate.

Chordate and Nanos Medical started a joint venture in 2018, forming the jointly owned company Changyong Medical Technology Co in Shanghai with the intention of marketing the K.O.S technology in the Chinese market. Nanos Medical owns two-thirds of this company and is the party that finances marketing and sales. Chordate owns the remaining third and will supply the Chinese patents when market authorization and product registration are in place.

Västra Hamnen have released a new analysis of Chordate Medical, as a result of the comapny’s Q3 report from November and the recently completed rights issue.

“The positive study results represent an important step in the process towards an exit”, Västra Hamnen in the analysis.

Västra Hamnen further write:

“Chordate’s report for the third quarter was characterized by positive study results from the migraine study (PM007). The results support the company’s scientific evidence and the focus will now be on the company’s commercial proof of concept. During the quarter, the company commenced a market introduction in Finland and participated in five international neurology congresses. We increase the probability of an exit, which in turn increases the value of the company, but due to dilution from the rights issue, the corresponding valuation range is reduced to SEK 1.46 – 2.17 from the previous SEK 1.70 – 2.70 per share.”

Västra Hamnen Corporate Finance is Chordate’s Certified Adviser, you can find the full analysis here (in Swedish).