Klaria Pharmas vd kommenterar den pågående kapitalanskaffningen

Klaria är på väg att gå från forskningsbolag till en aktör redo att ta plats på den globala migränmarknaden. Migrän drabbar cirka 15 procent av världens befolkning, och bolagets huvudprodukt Sumatriptan Alginate Film (SAF) adresserar ett betydande medicinskt behov, särskilt för de 80 procent av patienterna som upplever illamående i samband med migränattacken.

Produkten är baserad på Klarias patenterade alginatbaserade filmteknologi, som möjliggör snabb och effektiv läkemedelsleverans via munslemhinnan. Teknologin kombineras med väletablerade läkemedelssubstanser för att skapa nya produkter som erbjuder tydliga fördelar jämfört med traditionella administrationsformer som tabletter, nässprayer och injektioner.

På väg ut i Europa

SAF är sedan förra året marknadsgodkänd i Europa och den kommersiella resan inleddes på allvar i januari när Klaria tecknade ett licensavtal med CNX Therapeutics. Avtalet ger CNX rätt att marknadsföra och sälja SAF i Europa och Storbritannien under eget varumärke. I gengäld fick Klaria en up front-betalning på 750 000 EUR och avtalet inkluderar även milstolpsbetalningar på 500 000-1 250 000 EUR baserat på prissättning per marknad, samt en tvåsiffrig royalty på försäljningsintäkterna. Lanseringen inleds i Tyskland, Spanien och Italien under andra halvan av 2025, med planer på expansion till ytterligare europeiska marknader under 2026.

När SAF nu är på väg ut på marknaden har produktionskapacitet säkrats genom ett samarbete med den fransktyska kontraktstillverkaren AdhexPharma. Just nu ligger den årliga kapaciteten på 200 miljoner enheter och de båda parterna har planer på att skala upp den kapaciteten ytterligare.

Siktet inställt på vidare expansion

Utöver Europa har Klaria även ställt in siktet på USA och har i det arbetet anlitat Healthcare Capital Mergers som rådgivare för att identifiera en lämplig licenspartner. Med en EU-godkänd produkt, stark IP-portfölj och en tydlig plan för amerikansk marknadsregistrering ser bolaget goda möjligheter att hitta en partner för projektet. Detta arbete intensifieras under 2025, med målet att teckna minst ett ytterligare licensavtal utanför Europa.

Emissioner för finansiell stabilitet och global expansion

För att stärka kassan och finansiera lanseringen genomför Klaria nu två emissioner. Dels en konvertibelemission om 9,7 miljoner kronor, som riktas till investerare som Lars Hörnqvist, Promenaden Invest AB, Gerhard Dal, Munkekullen 5 Förvaltning AB och Buntel AB. Huvuddelen av kapitalinjektionen kommer i form av en företrädesemission om upp till 65,1 miljoner kronor. Bolaget har säkrat teckningsförbindelser och garantiåtaganden om totalt 58,3 procent av emissionen. Likviden kommer att användas till att stärka den finansiella ställningen genom amortering av befintliga lån, samt till att driva lansering av SAF och expandera till nya marknader.

Vd kommenterar

BioStock har kontaktat Klarias vd Scott Boyer för att få hans syn på teknologins möjligheter att slå sig in på migränmarknaden.

What specific advantages does Klaria’s alginate film technology offer over other transmucosal delivery systems, such as starch-based films or oral sprays, and how do these benefits translate into a better patient experience for SAF?

– The key to an effective uptake of sumatriptan and thus an effective treatment of migraine is to keep the dose concentrated in one place. Sprays apply a dose inconsistenly over a large area and starch-based films dissolve too rapidly and do not adher. Both of these treatment options spread the dose too randomly and inconsistently for efficient uptake. We see this effect clearly in our comparitive clinical data and it will affect clinical outcomes. Our film gave a consistent strong uptake in the vast majority of subjects.

The alginate film platform is described as enabling rapid and precise drug delivery via the oral mucosa. Can you elaborate on how this precision impacts the efficacy and onset time of SAF compared to traditional sumatriptan formulations like tablets or nasal sprays?

– Precision is important because patient confidence in the product is important. This is particulary critical in migraine which carries the added burden of anxiety. Migraine patients’ anxiety is not only based on a lack of control of their condition, but a lack of confidence in the effectiveness of their medication. We aim to return that control to every migriane patient.

For migraine patients, nausea is a significant barrier to effective treatment. How does SAF’s mucosal delivery address this challenge, and what feedback have you received from clinical studies or partners like CNX on this aspect?

– Nausea and vomiting is a common symptom. This makes tablets impossible to take and ineffective if the patient vomits. Nasal sprays exacerbate the vomiting response as well. The film requires no water – it is simply applied to the inside of the mouth and allowed to begin its work. The film represents the most gentle intervention possible, but delivers the right dose at the right time.

– The difficulty in effectively administering sumatriptan to migraine patients is a recognised problem with physicians, patients and with our current and future license partners.  Sumatriptan is also THE most effective acute treatment of migraine. The product concept is simple to understand: ‘There must be a better way to take sumatriptan’. We have succeeded in that ambition.

Lets turn to the migraine market. What does the current treatments landscape look like and what part of the market are you aiming for with SAF?

– First and foremost, the market for sumatriptan worldwide is huge – in the multiple billions of dollars per year. This reflects the large percentage of the population who suffer from migraine and the wide acceptance of sumatriptan as a treatment.  The majority of the market is tablets, which, as discussed above, are not particularly effective and must be given in large doses.

– A smaller part of the sumatriptan market is for nasal sprays and injections. Sumatriptan tablets are usually the first presciption migraine treatment patients receive. When those do not work, which they often do not, injections or nasal sprays are prescribed. Injections work well, but patients do not want to use them, or use them too late in the migraine attack. Nasal sprays can be effective, but are extremely variable – even in the same patient.

– Klaria’s film aims to take significant portions of all three of these patient groups. Independent assessments made after interviewing physicians, payors and patients place our product between 10 percent and 30 percent of market share. This, we feel, is a conservative estimate of market penetration.

What market potential do you envision for SAF in the migraine treatment space, in the short and long run respectively?

– The patient journey is important. Early administration in the migraine attack is important. And, as discussed above, confidence is important. Migraine patients need to have the medication with them (which we solve by making it compact) to treat their migraine early, they need to feel that it has worked (which we have geat confidence in after seeing our clinical data) and they need to feel like they can rely on the product to have the same effect every time (which they most certainly do not with current products). We aim to halt the ‘circus’ many migraine patients experience wherein they are asked to try a number of different products until they find one that seems to work. That is a burden these patients do not need and a medical problem we aim to solve.

With the upcoming launch in Europe, how is Klaria preparing to ensure SAF stands out in a competitive migrane market, particularly against established treatments like triptans and newer therapies?

– Part of the profile of this product is its format. It is new, compact, effective and non-invasive.  Migraine patients switch products frequently, trying to find a better treatment. This turnover allows a new product like ours to access a willing patient base and a frustrated physician group.  Newer treatments have their place, particularly in prophylaxis, but no prophylactic migraine treatment is 100 percent effective and no other triptan has the track record of effectiveness that sumatriptan has.  Sumatriptan is the best acute treatment and we have now launched the best preparation of sumatriptan.

Klaria’s pipeline includes projects like adrenaline and sirolimus alginate films, which target different therapeutic areas. How adaptable is the alginate platform to these diverse molecules, and what does this versatility mean for future product development?

– The platform is very versatile. We have successfully integrated a very wide variety of drugs into the film format.  One can think of the film as a ‘dry solution’. The active ingredient in our various products is held in a ‘molecular dispersion’. This keeps the active substance away from water until application in the mouth thereby increasing the long-term stability of the active drug. This is a distict advantage in the supply chain and once patients receive the medication. Patients and pharmacies do not need to store our films under special conditions. This is particularly important for biologicals and sensitive drugs like epinephrine.

While prioritizing SAF’s European launch, what are the key updates from the rest of Klaria’s product portfolio?

– Focus has understandably been on launching sumatriptan and we hope to provide a more detailed update on the other projects in the portfolio shortly.

With SAF’s launch and the current capital raise, when do you anticipate Klaria achieving positive cash flow?

– Klaria has never had extremely expensive operations and we will keep it that way. Against this background of continued operational efficiency, we are anticipating a positive cashflow either in 2026 or in 2027.