Klaria Pharma Holding AB (publ) ("Klaria" or the "Company") today publishes a status update regarding licensing partner CNX Therapeutics' ("CNX") upcoming launch of Sumatriptan Alginate Film ("SAF") for migraine treatment in Europe, Klaria's completed strategic plan for a potential US launch with a partner, and how these activities will advance the collaboration with BDO's UK Life Science M&A team ("BDO") to sign licensing agreements, or complete other transactions to maximize shareholder value, for markets outside Europe such as the US and globally.
Klaria is in a crucial phase in the Company's history. After having developed pharmaceutical drug projects formulated in its patented, fast-acting Alginate Film for several years, Klaria now has a first market-approved product, Sumatriptan Alginate Film for migraine treatment, and a first license agreement with CNX for leading European markets where a launch is expected in the near future.
As the Company recently announced in a separate press release, potential annual peak sales for SAF are estimated at approx. USD 500 million in a valuation report by L.E.K. Consulting.
The upcoming commercial phase for SAF in Europe
Below is a summary of the status of the commercial phase for SAF in Europe:
- SAF is market approved for the leading markets in Europe, including Germany, Spain and Italy, and CNX is now completing the final commercial preparations for a launch in the near future.
- CNX has invested significant resources in its commercial preparations, including scaling up to large-scale commercial manufacturing of the product at a large contract manufacturer with factories in multiple regions, including in the US. CNX specializes in licensing and distribution/sales of pharmaceutical products with a focus on the central nervous system (CNS), and the company has a good track record of previous similar launches in Europe.
- CNX and Klaria aim to take 10-30% of the sumatriptan market in Europe, which is valued at approx. SEK 1 billion per year. This is achievable by offering the only sumatriptan product based on Klaria's Alginate Film that delivers the correct dose in a fast and gentle way via the oral mucosa.
- The agreement with CNX entitles Klaria to milestone payments for established cost reimbursement levels in each individual country covered by the agreement, as well as double-digit royalty on sales. The company expects significant revenue from these two revenue streams over the next 12 months.
Completed strategic plan for a potential US launch of SAF with a partner
Below is a summary of the status for completed and remaining activities ahead of a potential US launch of SAF:
- In Klaria's bioequivalence study with SAF, a US-approved comparator product was included, which means that no additional bioequivalence study is required ahead of a US launch.
- Klaria has completed all necessary preparatory meetings with the US Food and Drug Administration (FDA) prior to a potential registration application. Based on feedback from these meetings, the Company has finalized a complete strategic plan for a potential US launch with a partner.
- The FDA has clearly indicated that they have a positive view of Klaria focusing on children and adolescents with migraine in addition to adult migraine patients, as there is no registered sumatriptan product in the US for this significant patient group. The FDA has also indicated that it is possible to aim to have SAF classified as a quality of life enhancing product, which could be financially beneficial for the Company.
- The only study remaining before the registration application in the US is a minor tolerability study. Based on the preferences of a potential partner, such a study can be conducted either in the US or with patients in Europe who received the product from their doctor following the SAF launch in Europe.
Progress related to Europe and the US advances strategic collaboration with BDO's UK Life Science M&A team
Klaria announced in December 2025 that the Company has initiated a strategic business development collaboration with BDO's UK Life Science M&A team. The objective is to sign license agreements or carry out other transactions, potentially regarding most or all of Klaria's assets, to maximize shareholder value for SAF and the Company's Alginate Film technology in markets outside Europe such as the US and globally.
Below is a summary of the status of this process:
- As Klaria has mentioned earlier, there is a large and growing interest in SAF and Klaria's Alginate Film technology among different types of potential commercial partners. Their interest varies from potential license agreements for individual markets to potential transactions that could include most or all of the Company's assets.
- As is customary in this type of transaction-related processes, several interested companies have conducted due diligence processes of the Company's assets to varying degrees and thereafter remain as interested parties.
- Klaria has as a deliberate strategy, in line with advice from BDO, to ensure a launch of SAF in Europe and to finalize a complete strategic plan for a potential US launch in order to achieve a good negotiating position and obtain the best possible bids in the strategic process with BDO.
- Klaria and BDO expect that the strategic process will advance further and become more concrete when SAF is launched in Europe in the near future. However, the Company cannot provide a time frame for the completion of one or more potential transactions, and bids received will be evaluated on an ongoing basis from a value-maximizing perspective.
Klaria's Chairman of the Board Fredrik Hübinette comments:
"Klaria has achieved something that few other Swedish pharmaceutical companies have been able to manage: to take an innovative product that makes a big difference in patients' everyday lives all the way from invention to market approval, license agreement and an upcoming launch in Europe. The SAF launch in Europe, together with our completed strategic plan for the US, is expected to clarify the value of SAF and our Alginate Film technology and thereby accelerate our strategic process together with BDO. We look forward to Klaria's continued journey with humility and great assurance."
Klaria Pharma is currently carrying out a rights issue with a subscription period from 14 October 2026 up to and including 6 November 2026. The proceeds will significantly strengthen the Company's balance sheet and thereby create room for manoeuvre, improved negotiating position vis-à-vis potential partners and thereby good conditions to maximize value for Klaria's shareholders.
More information about the rights issue can be found on the Company's website, www.klaria.com, and on the issue page www.ii.se/klaria-rights-issue-of-units-2026/
For more information, visit the Klaria Pharma Holding website klaria.com or contact:
Fredrik Hübinette, Chairman of the Board of Directors
info@klaria.com
Tel: +46 (0) 8-446 42 99
This is Klaria Pharma Holding AB
Klaria (Klaria Pharma Holding AB) is a Swedish listed pharmaceutical company that develops innovative, rapid-acting products. By combining patented technology of a film that attaches to the oral mucosa and well proven pharmaceuticals, the company has developed a drug distribution concept with many benefits and potential uses. Klaria is listed on Nasdaq First North Growth Markets under the short name KLAR. FNCA Sweden is Certified Advisor (info@fnca.se, +46(0) 8-528 00 399) for Klaria Pharma Holding AB. For more information, see www.klaria.com.
