Summary of the period April–June 2023

• Net turnover was SEK 163,316 (19,538)
• Cash flow from operating activities amounted to SEK -6,320,325 (-5,812,210)
• Profit/loss after financial items was SEK -7,292,267 (-5,962,508)
• Profit/loss after tax was SEK -7,292,267 (-5,962,508)
• Earnings per share were SEK -0.03 (-0.04)

Summary of the period Jan–June 2023

• Net turnover was SEK 283,737 (88,170)
• Cash flow from operating activities amounted to SEK -14,800,251 (-13,228,791)
• Profit/loss after financial items was SEK -14,405,401 (-13,341,661)
• Profit/loss after tax was SEK -14,405,401 (-13,341,661)
• Earnings per share were SEK -0.06 (-0.08)

INCREASED ACTIVITY ON SEVERAL KEY MARKETS
The second quarter of the year centered around the presentation of the final results from Chordate Medical’s crucial clinical study PM007 at international arenas for the industry in the USA and Germany. Interest in the study’s results is strong and growing, and when I meet doctors active in the migraine field it becomes clear that there is a considerable need for alternatives and complements to the medications that are normally used. We are also continuing to see strong and increasing activity in our key markets, where one highlight was that in May we received an order for rhinitis treatment from a private hospital chain in Jeddah, Saudi Arabia.

• Presentation of study results in the USA and Germany
• Breakthrough order from Saudi Arabia
• Ethical approval from NHS for new migraine study
• Fully subscribed incentive program for the Board of Directors and management
• PM007 presentation at IHC2023 in Seoul – we will have an exhibition
• Submission of article manuscript for PM007

Presentation of study results in the USA
The crucial clinical study PM007 was presented at the American Headache Society Scientific Meeting in Austin, Texas, by coordinating principal investigator Dr. Jan Hoffmann from Kings College in London. It was the first time the primary parts of the final results from the study were presented at a scientific congress, and Dr. Hoffmann’s lecture was attended by approximately 300 migraine specialists. Judging by the subsequent questions from the audience, the presentation was received with great interest. The questions asked mainly pertained to the study design, patient population, and the ease of use of the K.O.S product.
 
Article submitted for PM007
We are pleased to report that the authors of this crucial article have now submitted a manuscript to a prominent scientific journal. After publication, the article will be a valuable tool in our marketing and sales effort. Published results are also a necessary basis for success in various reimbursement processes.
 
Breakthrough order from Saudi Arabia
At the beginning of May, our new distributor in Saudi Arabia, Janin Medical, received its first key order for equipment and supplies for the treatment method K.O.S for chronic rhinitis. The customer is the private healthcare company Nahdi Care Clinics, which has four hospitals located in the country’s second largest city, Jeddah.

In addition to the installations we already have in Saudi Arabia, three publicly owned hospitals in Jeddah, Makkah and Dammam have evaluated K.O.S, and Janin Medical is expecting orders from all three. In addition to the efforts to increase the business within chronic rhinitis, Janin Medical is also driving the process of registering a market authorization for K.O.S for chronic migraine.

Ethical approval from NHS for new migraine study
At the beginning of May, the ethics committee of the National Health Service (NHS) in the UK approved the study design for our upcoming scientific study PM009, which aims to evaluate the efficacy of K.O.S in the preventive treatment of chronic migraine on patients not responding to treatment with monoclonal antibodies targeting the CGRP pathway. Any level of positive outcome in the study will likely mean a great opportunity for the Company since the patient group in question has very few treatment options left. The first patient can be expected in mid-September.
 
Fully subscribed incentive program for the Board of Directors and management
The Company’s two newly established incentive programs were fully subscribed in May by management and the Board of Directors. The aim of the incentive programs is for current and future employees and consultants at Chordate Medical to be able to become long-term owners and benefit from and advocate for a positive value development in the share in the Company during the period covered by the proposed program and that the Company will be able to keep and recruit competent and engaged staff. Subscription to the programs entails an increase in share capital by SEK 1,000,000 and SEK 375,000, respectively if the warrants are fully used to subscribe shares in the subscription period.
 
Focus during the rest of the year
Through the end of the year, work will continue on sales in all our focus markets: Finland, Germany, UK, Italy, Israel and Saudi Arabia. Our marketing specialists are pursuing a number of prospects with the goal of receiving final orders. Marketing to support these efforts will primarily take the form of exhibitions at specialist congresses:

• IHC2023, Seoul, South Korea, 9/14–17
• Deutscher Schmerzkongress 2023, Mannheim, Germany, 10/18–21
• Neurologdagarna 2023, Helsinki, Finland, 11/1–3
• Regional symposiums and congresses

Kista, August 2023
Anders Weilandt, CEO

Summary of the period January–March 2023

• Net turnover was SEK 120,421 (68,633)

• Cash flow from operating activities was SEK -6,499,823 (-6,765,843)

• Profit/loss after financial items was SEK -7,133,134 (-7,379,153)

• Profit/loss after tax was SEK -7,133,134 (-7,379,153)

• Earnings per share were SEK -0.03 (-0.04)

INCREASED ACTIVITY ON SEVERAL KEY MARKETS
From the start of the year through May 2023, we have seen increased activity on all key markets, both from us and from potential and existing customers. We recently received a breakthrough order in Saudi Arabia for the rhinitis treatment, British NHS approved the design of our pending migraine study, 11 clinics in Italy are now offering K.O.S treatment for chronic rhinitis, and the American Headache Society’s (AHS) scientific conference in June accepted the study results from PM007 for presentation in a lecture format. In addition, we started the year with a rights issue that was subscribed to approximately 72 percent, which shows continued strong confidence from our shareholders.

• Abstract with completed study results from the migraine study accepted for presentation in lecture format at AHS.

• Yet another step on the path to product registration in China.

• New patent granted by the European Patent Office—reinforces the company’s position on the market.

• Cash reinforced by SEK 37.3 million before expenses following the rights issue.

Several successes in Saudi Arabia
At the end of February, the Saudi Food and Drug Authority approved Janin Medical as our authorized representative in the country. Since then, we have received a breakthrough order for rhinitis systems from the private healthcare company NahdiCare Clinics for the first of their four clinics, and our distributor Janin Medical is simultaneously pursuing registration for marketing authorization for the migraine indication. While we wait for this authorization, Janin’s sales staff are busy increasing the number of rhinitis installations in both private and public clinics that are on our target list.

AHS has accepted the migraine study for presentation
The primary results from migraine study PM007 – “Kinetic Oscillation Stimulation (K.O.S) for the preventive treatment of chronic migraine: results from a randomized-controlled trial” – were published as an abstract on the AHS website in April. Dr. Jan Hoffmann, Kings College, will present the study’s results at the AHS congress in Austin, Texas, in mid-June this year.

This is very important for us; only select scientific works are invited for presentation in lecture form, which we can only interpret to mean that the scientific committee at AHS has judged the material to be very interesting.

Key advancement on the Chinese market
In February, our Chinese joint venture company Changyong Medical Technology Co. submitted an application for product registration in China for the K.O.S treatment for chronic rhinitis. This is a key step forward toward entry into the Chinese market.

Another patent reinforces our market position
The European Patent Office approved at the beginning of the year another patent application regarding development of the K.O.S treatment. Continuing to expand the patent portfolio makes it more difficult for a potential competitor to enter our market and enables exclusive access to the market, which is a pillar in the ownership value the company is building.

Focus during the rest of the year
We are continuing to follow up on the established sales and marketing plan in our select markets, with a special focus on the migraine area.
 
Kista, May 2023
Anders Weilandt, CEO

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

Summary of the period July–September 2022
• Net turnover was SEK 0 (211,461)
• Cash flow from operating activities amounted to SEK -5,623,481 (-4,308,572)
• Profit/loss after financial items was SEK -6,139,836 (-3,719,371)
• Profit/loss after tax was SEK -6,139,836 (-3,719,371)
• Earnings per share were SEK -0.04 (-0.03)

Summary of the period January–September 2022
• Net turnover was SEK 88,170 (478,789)
• Cash flow from operating activities amounted to SEK -18,852,271 (-15,004,556)
• Profit/loss after financial items was SEK -19,481,497 (-14,574,938)
• Profit/loss after tax was SEK -19,481,497 (-14,574,938)
• Earnings per share were SEK -0.12 (-0.13)

MIGRAINE STUDY – CRUCIAL SUCCESS
The migraine study has been completed – the most important milestone in the company’s history. We are now entering the final phase of the build-up of the company’s value for a successful exit.

• The migraine study has been delivered – strong significant results
• Market introduction in Finland
• Five international congress exhibitions held
• The company intends to strengthen its cash with a rights issue

Clinical study on migraines completed – an unequivocal success
We have now completed our crucial clinical study on migraines. The analysis of the complete study data shows that the primary effect goal of reducing the number of headache days was achieved with statistical significance. A subgroup analysis of the German patient group was presented as a poster at Migraine Trust International Symposium MTIS 2022, September 8–11, in London. The authors’ summary:

“The subgroup analysis shows that KOS is an effective and safe alternative for preventive treatment of chronic migraines. KOS will be a valuable non-pharmacological treatment alternative with a more beneficial side-effect profile than systematic treatments [medicine].”

The subgroup analysis shows a reduction in headache days by around 2.5 days more after KOS treatment than for the group that received the placebo. The difference was statistically significant with a so-called p-value of 0.014 (<0.05 is significant). To put this in context, it is accepted practice for a one-day reduction to be considered clinically relevant. A reduction of 2.5 days is therefore very good.

Another important aspect that the subgroup analysis published was the percentage of patients that respond to the treatment. Under international guidelines for migraine studies, a chronic migraine patient who experiences more than 30 percent fewer headache days is considered to have responded to the treatment. The subgroup analysis shows that 41.4 percent responded to active KOS treatment, and 14.9 percent in the placebo group. The difference of 26.5 percent is therefore very good.

We have recently been able to announce that the statistical analysis of the entire study has now been completed, and the results published in the subgroup analysis have now been confirmed to be at least as good or better with statistical significance.

It is very important for the company's value for the complete study to be published in a well-respected scientific journal. For this to happen, the results may not have been published in any other way prior to this. We are therefore being careful not to reveal the results in detail. Once the submitted article has been approved for publication, we will be able to report the full results. It is not possible to predict how long this will take, but it should take a only a few months.

It would be hard to overemphasize the importance of these strong and clear study results for us. Not just that we have now delivered on what may be the most important of our interim goals for an exit, but mainly because this now gives us access to the market with a sought-after alternative to medicinal treatment.

Roll-out at five neurology congresses
The premier for the subgroup analysis was at MTIS in London. We then repeated the presentation at the Italian migraine congress SISC 2022 in Palermo, the German pain congress in Mannheim, the Israeli migraine association's meeting in Tel Aviv and, finally, Neurological Days in Helsinki during the first week of November. We attracted a lot of interest at all of the events, and we held many sales pitches together with each market actor.

Going forward
To continue to deliver on the strategic plan, we will focus on marketing and sales in 2023. According to our analysis, being able to show that we can build market shares in several carefully selected markets (proof-of-concept) is a crucial step for a good exit for our shareholders.

The projects on market authorization in the USA and China continue.

The Board has convened an Extraordinary General Meeting to resolve on a rights issue for financing the next step in the strategic plan. The subscription period is in December 2022. Information about the general meeting and the issue is available in the notice and the prospectus that will be published on our website within the prescribed period of time.

Kista, November 2022
Anders Weilandt, CEO