An essential part of Chordate Medical’s exit strategy is to clearly demonstrate proof of concept in several selected focus markets. These include Germany, Saudi Arabia, Switzerland, and Italy, where Ozilia is offered as a treatment for chronic migraine and chronic rhinitis by hospitals and specialist clinics.

“The availability of Ozilia as a treatment option for chronic migraine and chronic rhinitis in these markets adds significant value to the business for a potential acquiring company,” says Anders Weilandt, CEO of Chordate.

Chordate’s focus markets stand out in two distinct ways. First, they have a well-developed private healthcare sector with an insurance system that, over time, could allow treatments like Ozilia to secure reimbursement codes. Second, the regulatory pathway for obtaining market approval for medical devices like Ozilia is considered favorable.

Germany

Ozilia is currently offered as a migraine treatment at six clinics in Germany.

In November 2023 and January 2024, Chordate Medical signed agreements with two specialist clinics in Hamburg and Munich for Ozilia. In addition to these two clinics, Ozilia is available as a migraine treatment at four other clinics, including those in Freiburg and Frankfurt.

Since August 2022, Chordate has been in partnership with MedTech Innovation Germany (MTIGER) to introduce Ozilia to key opinion leaders in neurology across both private and public healthcare sectors in Germany.

Saudi Arabia

Ozilia is currently offered as a rhinitis treatment at nine clinics in Saudi Arabia.

In September 2024, Chordate received its first order for Ozilia migraine treatment in Saudi Arabia. Shortly thereafter, the Saudi Food and Drug Authority (SFDA) approved the market authorization application for the migraine indication. This enabled Chordate and its partner, Janin Medical, to commence a broad market launch of Ozilia as a migraine treatment in the country. Clinical evaluation with patients is currently ongoing or scheduled at three public hospitals and a major private clinic.

In mid-2023, Chordate received its first order for Ozilia for chronic rhinitis via its new distributor in Saudi Arabia, Janin Medical. The customer was the private healthcare company Nahdi Care Clinics, which operates four hospitals in the country’s second-largest city, Jeddah. Altogether, Ozilia is offered as rhinitis treatment at six clinics in Jeddah and three in Riyadh. Clinical evaluation with patients is also underway at two additional public hospitals, and a demonstration has been scheduled at a private hospital chain in Jeddah.

Italy

Ozilia is currently offered as a rhinitis treatment at eleven clinics in Italy.

Since 2019, Chordate Medical’s distributor, Vedise Hospital, has been treating patients with chronic rhinitis using Ozilia. While Ozilia has been in use as a rhinitis treatment for five years, Vedise is actively working on introducing the migraine treatment to the Italian market.

Switzerland

Ozilia is currently undergoing clinical evaluation for migraine treatment at three clinics in Switzerland.

In June 2024, Switzerland was added to the list of focus markets. At the same time, Chordate signed a partnership agreement with Neurolite AG. Neurolite has specialized for many years in delivering cutting-edge medical technology solutions in neurology to hospitals and private clinics. Shortly after the signing of the partnership agreement, Neurolite placed its first order for Ozilia products with a value of approximately SEK 370,000.

Finland

As four of the nine trial clinics in the pivotal PM007 registration study for migraine were located in Finland, it has also been designated a focus market. Chordate is working to initiate clinical use at three of the trial clinics and believes this is likely to happen.

Chordate Medical has secured trademark registration for Ozilia® in Japan. The company has previously registered the trademark in the EU, China, and the United Kingdom. Active applications are currently ongoing in the United States and Brazil.

“Securing global trademark protection is valuable and important for creating long-term opportunities, even though Japan is not currently one of our focus markets. Having registered trademarks in key markets makes the business more attractive to potential buyers,” says Anders Weilandt, CEO of Chordate Medical.

Ozilia was introduced in September 2023, replacing K.O.S as the brand name across all markets where Chordate operates. The rebranding aimed to simplify and harmonize the company’s global market presence while enhancing awareness of its technology and treatments.

The registration in Japan is part of Chordate Medical’s ongoing efforts to safeguard intellectual property rights in strategic markets worldwide.

Chordate’s exit strategy involves demonstrating clear market penetration in selected markets. The company’s value is built on three pillars: robust scientific evidence from clinical studies, demonstrable sales success in several selected markets, and a comprehensive portfolio of intellectual property assets such as patents and trademarks. Since October 2024, Chordate has engaged Partner International Switzerland GmbH as an advisor to identify an international buyer for the business.

Kalqyl has published an updated analysis of Chordate Medical following the company’s Q2 report, which was released on November  5. In the analysis, Kalqyl comments on Chordate’s partnership agreement with Partner International Switzerland to initiate the exit process and the company’s increasing business activity.

“The most substantial news of the quarter was the company’s decision to hire Partner International Switzerland (PIS) to initiate the exit process. The assignment is to find a buyer for Chordate’s operations, marking the start of a more intensive phase in the final step of the company’s strategy,” writes Kalqyl.

Read the full analysis (In Swedish)

Chordate Medical has so far received formal notifications from four of the company’s ten largest shareholders: Sifonen, Hawoc, the Brandberg family, and Tommy Hedberg, who, together with the management team, have announced that they will exercise their warrants in TO8 at 100 percent. Once this is completed, approximately 42 percent of the series TO8 warrants will have been exercised.

These four of the ten largest shareholders, together with the company’s management team, control approximately 40 percent of the shares in Chordate.

It is possible to redeem TO8 for subscription of new shares from November 4, 2024, until November 18, 2024, or to sell the options before November 14, 2024. If all TO8 series warrants are exercised, the company will receive approximately 6.1 MSEK before issuance costs.

“The support from our largest shareholders – and my colleagues in the management team – is a very important vote of confidence in achieving a positive outcome from TO8. It is crucial that we secure as much capital as possible from the options, and every shareholder’s contribution is equally important,” says Anders Weilandt, CEO of Chordate.

Yesterday, November 5, Chordate’s CEO, Anders Weilandt, presented the company’s Q3 report for 2024 on Finwire TV. He also answered viewer questions, discussing topics such as the ongoing exit process and the two current studies, PM009 and PM010.

“It’s essential that we enter this exit process with a strong cash position. I don’t think any shareholder wants us to sit down and negotiate the sale of the business with a weak cash position, as that will immediately affect the counterparty’s behavior in the negotiation. So now it’s crucial that we strengthen our finances and are well-prepared to carry out the entire exit process.”

What are the key milestones in PM009 and PM010, and how might they impact valuation in the exit process?

“Both studies have the potential to significantly impact the sales process. PM009 aims to determine if there are indications that Ozilia is effective for patients who have no other options. Those who have started CGRP treatment have exhausted several other preventative drugs without success. If we can identify patients who respond to Ozilia, it will be an interesting finding, as it would suggest that we are as effective or better for these patients than the highly advanced and expensive drugs available.”

“PM010 is long-term and important for that very reason. It provides a much longer and broader understanding of Ozilia’s effect pattern and how frequently patients would want treatment. The results will guide doctors on what to expect regarding patient behavior and the necessary treatment frequency. This impacts the volume per patient and, essentially, billing potential. So, it clearly affects a sales process.”

Watch the full interview below (in Swedish)

Chordate Medical Holding (publ) released its interim report for Q3 2024 today at 08:30. At 13:00, the company invites you to a webcast presentation of the report with CEO Anders Weilandt on Finwire TV.

The presentation can be viewed through the following link:  https://www.finwire.tv/webcast/chordate-medical/q3-2024/

Following the presentation, there will be a Q&A session where viewers can submit questions.

A recording of the presentation will be made available afterwards on the company’s website www.chordate.com and on Finwire TV’s YouTube channel.

Summary of the period July–September 2024

• Net turnover was SEK 147,993 (210,947)
• Cash flow from operating activities was SEK -5,126,552 (-4,325,051)
• Profit/loss after financial items was SEK -5,681,292 (-4,938,361)
• Profit/loss after tax was SEK -5,681,292 (-4,938,361)
• Earnings per share were SEK -5.80 (-10.62)

Summary of the period January–September 2024

• Net turnover was SEK 578,611 (494,684)
• Cash flow from operating activities was SEK -19,747,872 (-19,761,647)
• Profit/loss after financial items was SEK -18,850,105 (-19,564,732)
• Profit/loss after tax was SEK -18,850,105 (-19,564,732)
• Earnings per share were SEK -21.39 (-42.48)

Final step of the strategy

The reporting period has been impacted by three key events. Because the SFDA has now announced market authorization for the migraine indication in Saudi Arabia, the Company can immediately start the introduction of Ozilia®Migraine, which further strengthens our Proof-of-Concept. Our post-market surveillance study PM010 shows promising results in monitoring collected data—so far the objectives of the study have been confirmed. Partner International Switzerland GmbH was recently appointed as an advisor to find an international buyer for the business. Overall, these three events entail that we have now taken a large step forward in the final step of the Company’s exit strategy.

• Market authorization for the migraine indication and a first migraine order from Saudi Arabia
• Positive results from the ongoing migraine study PM010
• Swiss advisor appointed to initiate exit process
• Commencement of TO8 subscription period

Market authorization for the migraine indication and a first migraine order from Saudi Arabia

We received the first order for two Ozilia systems from Saudi Arabia at the end of September. Several weeks later, the Saudi Food and Drug Authority also approved our application for market authorization for the migraine indication with the product system Ozilia®Migraine. Following the successes with Ozilia® for chronic rhinitis in Saudi Arabia, we are pleased that we can now immediately follow up with the introduction of Ozilia® in the migraine area as well. Given the approved market authorization for the migraine indication, our distributor Janin Medical can now immediately roll out on a broad front the introduction of the migraine treatment that was prepared in the spring.

Positive results from the ongoing migraine study PM010

After having recruited approximately 25 percent of the patient population to the long-term open study PM010, the decision was made to perform a monitoring session of the data collected so far. The study is still ongoing, and recruitment of patients is not affected by this data summary.

The conclusion reported by the study statistician is that the results are promising, which was also supported by the sensitivity analyses performed for each objective.

What is important in this post-market surveillance study is how the patients’ perception of their difficulties changed during the twelve-month period that they were monitored. More data needs to be accumulated before the conclusion can be reported in its final form.

Swiss advisor appointed to initiate exit process

In mid-October, the Company announced the Board of Director’s resolution to appoint Partner International Switzerland GmbH as an advisor to find an international buyer for the business. This marks the initiation of the final step in the Company’s strategy. Partner International is a group with offices in Switzerland, Canada, USA and Australia that over 24 years has built a strong reputation as an advisor in numerous international deals in licensing, partnerships, and corporate sales, focusing on the life sciences sector.

We have made significant progress in establishing clear market validation in our focus markets, and this work will continue at the same rate in parallel to Partner International initiating its work to find the best buyer for the business.

Consolidation of shares completed

At the end of August, the Company’s Board of Directors set August 30, 2024, as the record date for the previously decided consolidation of shares. Through the consolidation, the total number of shares in the Company decreased from 490,111,500 to 980,223. In conjunction with this, the Company’s shares changed ISIN code to SE0022726139.

Commencement of TO8 subscription period

The subscription period for shares with the support of warrant series TO 8 commenced on November 4, 2024, and will run until November 18, 2024. The Company will primarily use the raised capital for the ongoing exit process, continued establishment of market validation, and the ongoing studies.

Focus during the rest of 2024

• Market introduction of the migraine indication in Saudi Arabia and Switzerland
• Exit process development
• The studies PM009 and PM010

Kista, November 2024
Anders Weilandt, CEO

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Cell: +46 733-874277

About Chordate
Chordate Medical Holding AB (publ) is a medical technology company that has developed, patented and CE-marked Ozilia® Migraine, a neuromodulation and drug-free treatment technology for chronic migraine and chronic rhinitis. The treatment has clinically proven efficacy according to a recent study, and is marketed in selected markets in the EU and the Middle East. Chordate Medical is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com

The company’s Certified Adviser on Nasdaq First North Growth Market Stockholm is Vator Securities AB.

N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.

This information is information that Chordate Medical Holding is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-11-05 08:30 CET.

Chordate Medical Holding (publ) Interim Report January–September 2024

The first demonstration with Ozilia® Migraine was conducted yesterday at King Abdulaziz Medical City, a National Guard hospital in Jeddah. The company’s distributor, Janin Medical, has been preparing for the launch since this spring – and this marks the first step after receiving market approval from the SFDA (Saudi Food and Drug Authority) a week ago.

King Abdulaziz Medical City, with 751 beds, is a significant part of the Ministry of National Guard Health Affairs’ approximately 3,000+ beds across the kingdom, responsible for the healthcare of National Guard personnel and their families. Out of the country’s nearly 500 hospitals, about 335 are publicly owned or belong to various defense ministries, with the remainder being privately operated. The demonstration was carried out at the department of Dr. Abdullah Attar, head of neuroscience, by Janin’s sales manager Mohamad Ibrahim and Chordate’s General Manager Alain Durante, based in Jeddah.

“It’s a great feeling to finally get started after a period of preparation for the migraine introduction, and that we managed to secure product registration faster than expected,” says Alain Durante, Chordate General Manager, MEA area.

Chordate CEO Anders Weilandt talks with Biostock about the last stage of the company’s exit strategy, Ozilia’s position within the migraine market, and the recent migraine market authorization in Saudi Arabia.

When can the shareholders expect an exit?

“All we can say is we’ve decided now that we’ve built up enough substance in our prior four steps in the strategy to reach this point where the assignment of Partner International is sensible to start.”

And Saudi Arabia will be a perfect proof of concept for this process?

“Yes, Saudi Arabia is a perfect proof of concept, and the reason is the fact that we’ve come so far. We have governmental approval for the product in public healthcare. We have reimbursement from major global insurance companies. And those are tick boxes of what you like to see when you are looking at market penetration. So Saudi Arabia, right now, is in the lead of our proof building.”

What kind of buyer will be the perfect fit, considering the huge potential that Chordate has?

“The perfect buyer is of course someone with the highest valuation of the opportunity. Obviously, that could be a buyer in the medtech field, certainly in the neuromodulation or the neuro diagnostic field. They do exist in the medtech industry. It could of course be someone in the pharma industry, certainly with some mix of business models. But there is also a third one, and that is portfolio building companies that are financially driven, that build up strong therapy focused companies for probably a later divestiture. So, there are a number of types of buyers.”

See the interview in full below

At investor event Aktieportföljen Live, on October 15th, Chordate CEO Anders Weilandt talked about the appointment of Partner International Switzerland GmbH as an advisor to find a buyer for the business.

“If we focus on the exit, is it a partner (buyer) within the field of migraine or more of a medtech company or a distributor?”

“We are quite agnostic about who the best buyer could be. The easy answer is the one who pays the most, but it’s somewhere in the area you’re talking about. I would add besides the two obvious segments of the pharma industry and the medtech industry, a portfolio building structure that builds up product portfolio. It could very well be a company or outfit that we are unaware of. We do not really point our advisors in any specific direction. It’s their job, which they are good at, to comb the market for people with the strategic thinking that see a reason to invest in this kind of very clear cut, specific technology, to add to a probably already existing portfolio”, said Anders Weilandt till Aktieportföljen Live.

View the presentation and Q&A in full