Chordate Medical Receives First Order for Ozilia Migraine Treatment from Saudi Arabia

Chordate Medical has received its first order for the Ozilia migraine treatment from Janin Medical, the company's distributor in Saudi Arabia. The order is for two Ozilia systems that can be used for migraine treatment as soon as marketing approval for Ozilia's migraine indication is obtained in the country.

"Following the success of Ozilia for chronic rhinitis in Saudi Arabia, it is encouraging to see results also in the migraine segment. This order is a result of hard work by Janin Medical, who are also working on securing the registration for the migraine treatment as soon as possible," says Anders Weilandt, CEO of Chordate.

Saudi Arabia and the rest of the Gulf region have long been among Chordate's priority markets to demonstrate proof of concept, and Ozilia has been used for a longer period by several private hospitals for rhinitis treatment.

Chordate reports conclusions from first data monitoring of the ongoing long term open study on chronic migraine: PM010

As this Post Market Surveillance study is open (uncontrolled) it is possible – as well as the responsibility of the sponsor – to actively monitor the study data during the ongoing trial. It is regulatory and scientifically permitted to summarise both efficacy and safety data.

At approximately twenty-five percent of the population recruited to the study it was decided to perform a monitoring session of the data collected so far.

The purpose of the monitoring was to summarize parts of the data – focusing on some of the efficacy data – recorded in the study from start of inclusion until August 23, 2024. The study is still ongoing, and recruitment of patients is not affected by this data summary.

The conclusion reported by the study statistician was as follows:

  • Results regarding the primary endpoint/objective: the “reduction of days with moderate or severe headache” are promising.
  • The sensitivity analysis of the primary objective shows results in the same magnitude/direction as the main analysis.
  • The major secondary efficacy objective: “Change from Baseline in proportion of migraine days” shows promising results as well – also supported by the sensitivity analysis.

“I am very satisfied that PM010 thus far confirms the results from the pivotal randomized controlled trial PM007. The results are surprisingly clear, already at this early stage,” says Anders Weilandt, Chordate CEO, and continues:

“This is a long study with twelve-months follow up, and a lot more data needs to be accumulated – but it is very good to get this confirmation that the study is on track.”

Finwire Interview: CEO Anders Weilandt on Chordate Medical’s Q2 Report 2024

Today, August 30th, Chordate's CEO Anders Weilandt presented the company's Q2 report for 2024 on Finwire TV. He also answered questions from viewers and discussed, among other things, the expectations for Switzerland as a new focus market and the results of the company's participation in investor conferences around the world.

"It's clear that the market is very responsive; it reacts extremely well. I have the impression that it is a decentralized healthcare market where decisions can be made at much lower levels than, for example, in Sweden or England for that matter. And on top of that, we can add that Neurolite, our distributor, are very active in building and penetrating the market. They focus solely on neurology, so they are very knowledgeable and have well-established contacts and good trust from the healthcare side. I expect things to happen relatively frequently in Switzerland."

"What has opened up through the conferences is a network of contacts that we were looking for in connection with the final steps in our exit process and our strategy in general. It's important to ensure that the Chordate project and this rather fantastic treatment technology become well-known both among industrial stakeholders and partners, and among financial partners."

Watch the full interview (in Swedish): https://www.youtube.com/live/fQqIm04dijA

Recalculation of terms for warrants series TO 8

At the annual general meeting in Chordate Medical Holding AB (publ) (“Chordate” or the "Company") held on 15 May 2024, it was resolved to implement a consolidation of shares 1:500, meaning that five hundred (500) shares are combined into one (1) new share. The annual general meeting authorised the board of directors to determine the record date for the consolidation. The board of directors have, with support of the authorisation from the annual general meeting, decided that the record date shall be today, 30 August 2024.

Due to the reverse split above, a recalculation will be made in accordance with the terms and conditions of the Company's warrants series TO 8 regarding the subscription price and the number of shares that each warrant entitles to subscribe for. Other terms and conditions of the warrants series TO 8 will remain unchanged, such as the time of exercise of the warrants etc. and the total number of outstanding warrants will not change as a result of the consolidation and recalculation.

The new subscription price per share for warrants of series TO 8 shall correspond to 70 percent of the volume-weighted average price of the Company's share on Nasdaq First North Growth Market during the period from and including 16 October 2024 to and including 29 October 2024, however, not less than the share's quota value (SEK 10) and not more than SEK 75 (previously SEK 0.15), and the new number of shares that each warrant entitles to subscribe for amounts to 0.002 shares (previously 1 share) after the recalculation. Subscription cannot be made by part of a share, which means that 500 warrants of series TO 8 will be required for subscription of 1 new share in the Company. Subscription of shares with the support of warrants of series TO 8 can take place during the period commencing 4 November 2024 up to and including 18 November 2024.

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

Summary of the period April–June 2024

  • Net turnover was SEK 172,941 (163,316)
  • Cash flow from operating activities was SEK -6,999,204 (-6,320,325)
  • Profit/loss after financial items was SEK -7,023,261 (-7,292,267)
  • Profit/loss after tax was SEK -7,023,261 (-7,292,267)
  • Earnings per share were SEK -0.01 (-0.03)

Summary of the period January–June 2024

  • Net turnover was SEK 430,617 (283,737)
  • Cash flow from operating activities was SEK -12,907,262 (-14,800,251)
  • Profit/loss after financial items was SEK -13,042,462 (-14,405,401)
  • Profit/loss after tax was SEK -13,042,462 (-14,405,401)
  • Earnings per share were SEK -0.03 (-0.06)

Breakthrough on new focus market and extensive international interest
The major highlight of the second quarter of the year was the first order from Switzerland after the Company decided to make the country a new focus market. Work also continued during the quarter to introduce Ozilia at different types of investor congresses throughout Europe.

Another highlight was the decision from the United States Patent and Trademark Office (USPTO) that it will grant another patent application from the Company. This means the Company can add a fourth US patent to its growing patent family.

  • Switzerland new focus market, first order received
  • The USPTO will approve another patent application
  • Strong interest in Ozilia at international investor conferences
  • Ozilia presented to national specialist associations from Germany, Switzerland & Austria

Switzerland new focus market, first order received
In mid-June, Chordate added Switzerland to its focus markets for the Ozilia treatment and signed an agreement with Neurolite AG to be the Company's distributor and regulatory representative in Switzerland and Liechtenstein. At the end of June a first order was received with a value of approximately SEK 370,000.

We have been noting considerable interest in Ozilia in Switzerland for some time, and we have been engaged in discussions with a number of interested parties. This, combined with Switzerland’s manageable decision-making processes, which have relatively short paths to remuneration codes for insurance payments, makes Switzerland a very suitable focus market for the Company.

The USPTO will approve another patent application
At the beginning of May, the USPTO issued a decision that it intends to approve our patent application US 17/942,912 from 2022. The patent application is related to treatment of headache with a focus on protecting the Company’s product Ozilia Migraine. The approved application means that a fourth US patent is added to the growing patent family the Company has been building since 2011 to target headache treatment.

The Company thus currently has 79 patents distributed between 32 countries and 9 patent families related to different aspects of the Company's treatment techniques. The intellectual property rights defense for the Company’s technology as support for continued business development is an important part of what we consider to be the Company’s core values.

Strong interest in Ozilia at international investor conferences
During the quarter, we introduced Ozilia at investor congresses in Oslo, London, Basel and Lund, where we saw strong interest in the technology and came home with a number of strong leads.

Given the order we received from Switzerland, we now have a first concrete result that can be directly traced to our marketing activities. The plan is to continue to work to introduce Ozilia in our focus markets during the rest of the year.

Ozilia presented to national specialist associations from Germany, Switzerland & Austria
In April, we also participated at the headache conference Dreiländertagung Kopfschmerz in Switzerland, which was arranged jointly by specialist associations in Germany, Switzerland and Austria. This presented us with an excellent opportunity to present Ozilia to a large number of migraine and headache specialists from three significant European markets at one location.

In addition to increasing awareness for Ozilia among potential investors and buyers of the Company, it is important that we continue to develop the profession as well. Interest in neuromodulation as a treatment technique among specialists and neurologists is growing, and in this area Ozilia is a unique alternative that an increasing number of migraine care providers are considering.

Focus during the rest of 2024

  • Development of focus markets
  • Generate attention in industry and investor circles
  • The studies PM009 and PM010
  • Ongoing product registrations

Kista, August 2024
Anders Weilandt, CEO

Chordate Medical presents interim report for Q2 2024 on Finwire TV

Chordate Medical Holding (publ) is releasing its interim report for Q2 2024 on Friday, August 30th, at 08:30. On the same day, at 11:00, 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/q2-2024/.

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.

Chordate Medical announces timetable for consolidation of shares

At the annual general meeting in Chordate Medical Holding AB (publ) (“Chordate” or the "Company") held on 15 May 2024, it was resolved to implement a consolidation of shares 1:500, meaning that five hundred (500) shares are combined into one (1) new share. The annual general meeting authorised the board of directors to determine the record date for the consolidation. The board of directors have, with support of the authorisation from the annual general meeting, decided that the record date shall be 30 August 2024.

The last day of trading in the Company's shares before the consolidation is 28 August 2024 and the first day of trading in the Company's shares after the consolidation is 29 August 2024. The Company's share price will thus reflect the effect of the consolidation from 29 August 2024. The consolidation will be carried out automatically by Euroclear Sweden AB, and shareholders do not need to take any measures.
 
Through the consolidation, the total number of shares in the Company will decrease from 490,111,500 to 980,223.
 
As a result of the consolidation, the Company's share will from 29 August 2024 change ISIN code. The new ISIN code for the Company's share is SE0022726139.
 
The shareholders in the Company will automatically receive a new, lower, number of shares in proportion to their shareholdings at the record date. Those shareholders whose shareholding, on the record date, is not evenly divisible by five hundred (500) will receive shares free of charge for their shareholding to be evenly divisible by five hundred (500). The distribution of shares takes place through Euroclear Sweden AB without additional measures needed to be taken by shareholders.

Chordate Medical receives first order from Switzerland worth approximately KSEK 370

Chordate Medical's regulatory partner and distributor in Switzerland and Liechtenstein, Neurolite AG, has made a first order for Ozilia products with an order value of approximately KSEK 370. In connection with the order, Neurolite also announced that the registration of Neurolite as the regulatory representative for Chordate is now complete.

“The registration means that Neurolite can now freely sell Ozilia Migraine in Switzerland and Liechtenstein, and it is of course pleasing that they immediately secured a first order. As I have said before, we see interesting potential for Ozilia in Switzerland and this rapid process leading to a first order is proof of that”, says Anders Weilandt, CEO of Chordate.

Chordate added Switzerland as a new focus market for the Ozilia treatment, and signed an agreement with Neurolite AG as distributor and regulatory representative in Switzerland and Liechtenstein earlier in June.

Chordate Enters New Partnership Agreement with Neurolite, Switzerland – Adjusts List of Focus Markets

A part of Chordate Medical’s strategy is to demonstrate proof-of-concept in a number of selected focus markets. The company is now adding Switzerland as a new focus market for the Ozilia treatment and has signed an agreement with Neurolite AG as distributor and regulatory representative in Switzerland and Liechtenstein. At the same time, efforts in the UK are being phased out.

“There is significant interest in Ozilia in the Swiss market, which we have observed during several of the congresses we’ve attended. Currently, we are in discussions with several strong leads and interested parties, and we believe that a number of these can result in installations in the near future. Therefore, it is natural that Switzerland becomes one of the company’s key markets,” says Anders Weilandt, Chordate CEO.

Chordate's focus markets stand out in two distinct ways. Firstly, they have a well-developed private healthcare sector with an insurance system that allows treatments like Ozilia to receive reimbursement codes. Secondly, the path to market approval for medical devices like Ozilia is favorable.

“Obtaining a reimbursement code that allow patient insurance to cover the cost of Ozilia treatment, which we have previously achieved in Saudi Arabia and partially in Italy, is a key factor for us. Similar to Germany, Switzerland is characterized by manageable decision-making processes and a relatively short path to reimbursement code for insurance payment.”

Chordate’s distributor and regulatory representative in Switzerland and Liechtenstein will be Neurolite AG, which specializes in delivering the latest medical technology solutions in neurology to hospitals and private clinics in the two countries.

“They have previously, with great success, introduced products in the same segment as our treatment, and they are assessed to have the right expertise and network to succeed with Ozilia as well.”

As Chordate adds Switzerland as a focus market, the UK is being removed from the list.

“The UK’s public healthcare system, NHS, has been shown to have excessively long decision-making processes and significant challenges in implementing new medical technology, which has affected our operations in the country."

Read more about Neurolite AG

Kalqyl in updated Analysis of Chordate Medical: ”Making Progress in All Areas of the Market Plan”

Kalqyl has published an updated analysis of Chordate Medical following the company's Q1 report released on May 24. In the analysis, Kalqyl comments on Chordate's continued sales growth, and states that the company is on the right track towards achieving measurable market penetration in selected markets:

"Chordate continues on its current path by making progress in all areas of the market plan, which in the long term should enable the sale of the company. At this stage, we particularly view the increase in sales over five consecutive quarters and the sustained growth rate positively. The company also received a net liquidity of SEK 18.7 million through a rights issue, which provided increased opportunities to continue market and sales efforts. Overall, the company meets our expectations, and our valuation remains unchanged."

Read the full analysis (in Swedish)