Sanionas samarbete med Acadia Pharmaceuticals, som undertecknades i november, markerade en viktig milstolpe för bolaget. Avtalet har ett potentiellt värde på 610 MUSD, vilket bidrar till finansiering för både pågående och framtida forskningsinsatser. Nyligen besökte vd Thomas Feldthus och tillträdande styrelseordföranden John Haurum BioStocks studio för att besvara investerarnas frågor. I denna skriftliga intervju adresserar Feldthus ytterligare frågor, samt sådant som inte hann behandlas under direktsändningen.

Det danska bioteknikbolaget Saniona specialiserar sig på behandlingar av sällsynta och neurologiska sjukdomar. I november nådde bolaget en viktig milstolpe genom samarbetsavtalet med Acadia Pharmaceuticals.

Saniona erhöll 28 miljoner USD i förskottsbetalning, med en potential på ytterligare 582 miljoner USD i milstolpsbetalningar samt royalties på den globala nettoförsäljningen av SAN711. Saniona är dessutom berättigat till trappstegsbaserade royaltybetalningar från medelstora ensiffriga till låga tvåsiffriga procenttal på den globala nettoförsäljningen. Läs mer här.

Acadias åtagande att finansiera den kliniska fas I-studien och förbereda för fas II har inte bara tillfört kritisk finansiering, utan möjliggör också för Saniona att fokusera på sin bredare pipeline – vilket skapar förutsättningar för ett produktivt 2025.

Acadias planer för SAN711

Samarbetet med Acadia kommer initialt att fokusera på SAN711 för behandling av essentiell tremor, ett tillstånd som kännetecknas av okontrollerbara skakningar som kan ha en stor inverkan på det dagliga livet. Acadia planerar att inleda en fas II-studie 2026 och kommer att använda sin expertis inom neurovetenskap för att leda de kliniska, regulatoriska och kommersiella processerna. Strukturen på avtalet indikerar också att ytterligare indikationer utöver essentiell tremor kan komma att utforskas i framtiden.

Saniona behåller en nyckelroll på kort sikt och ansvarar för den pågående fas I-studien samt bistår i förberedelserna inför nästa fas.

Sanionas vd om 2025: framsteg, partnerskap och pipeline-planer

Nyligen deltog Sanionas vd, Thomas Feldthus, och tillträdande styrelseordförande John Haurum i en livesänd intervju i BioStocks studio där de svarade på investerarnas frågor. Se intervjun här: 2025 Goals & Strategy: Saniona’s Plan Moving Forward | Live Q&A with BioStock.

BioStock kontaktade Thomas igen för att få svar på ytterligare frågor, samt för att adressera de investerarfrågor som på grund av tidsbrist inte hann tas upp under den livesända sessionen.

Thomas, the landmark deal with Acadia is one of the largest agreements of last year and one of the biggest ever in Scandinavia. In hindsight, what are your reflections on this partnership and its significance for Saniona?

– We share Acadia’s excitement about SAN711’s potential as a promising new treatment for essential tremor, where there is a significant medical need. The collaboration is off to a strong start—we have formed a joint steering committee for the first year, initial meetings have taken place, and Acadia’s team is diving into the details. Everything is running smoothly, which bodes well for the future.

– While we had previously positioned SAN711 for other indications, our scientific team generated data supporting its potential in essential tremor. Acadia sees broader possibilities as well, but it was the essential tremor opportunity that drove their interest and the financials of this deal. Through our discussions with Acadia and other potential partners, we also gained insights into how market size, competition, and risk perception make essential tremor a particularly attractive indication for a Phase 1 asset. This demonstrates the value of an open dialogue in maximizing an asset’s potential.

– As for the significance of this deal for Saniona—it’s transformative. The day we signed marked the end of our turnaround period and validated our business model. Beyond securing SAN711’s development, it enables us to advance our three promising internal assets—SAN2355, SAN2219, and SAN2465—toward Phase 2 proof-of-concept studies over the next 2–3 years.

– This creates new strategic options for Saniona. By then, we could replicate the Acadia deal for one of these assets and use the proceeds to progress the other two through Phase 2. Alternatively, we may explore an exit opportunity with three Phase 2-ready assets or raise financing through institutional investors to fund all three programs internally.

How will the agreement impact Saniona’s operations in 2025?

– We do not anticipate significant changes in our research department or administration. However, we expect to add resources in non-clinical and clinical development, and potentially in business and corporate development, to support our advancing pipeline. That said, we remain committed to staying lean, cost-effective, and maintaining a disciplined financial policy.

In December, Saniona fully repaid its debt to Fenja Capital II. What was the primary goal behind this decision?

– The loan was originally due in July 2026 but repaying it in December eliminates interest expenses and reduces our financial costs, which have been high over the past two and a half years.

Beyond SAN711, are there other assets in Saniona’s pipeline that could benefit from similar partnerships?

– Yes, we have positioned SAN903 and Tesomet for partnering, as they fall outside our core focus on epilepsy and neuroscience. Tesofensine could also be included in this group, but we are awaiting the outcome of the regulatory process in Mexico before determining the next steps.

How do you envision 2025 shaping up for Saniona in terms of business development and partnerships?

– We are actively advancing business development efforts both for programs positioned for partnering and for those we are developing internally. For our internal programs, the goal is to ensure that potential partners are lined up for a deal similar to Acadia’s once we have topline phase 1 data.

Could you highlight any other collaborations or areas of focus for Saniona in the coming year?

– In 2024, we have focused on how to maximize the potential value of tesofensine if it receives approval in Mexico. The obesity market has evolved significantly over the past five years, and we see promising opportunities that warrant further exploration and preparation. However, it is still too early to share details.

What message would you like to share with investors about Saniona’s potential in the neuroscience space?

– Saniona is advancing three neuroscience assets – two for epilepsy and one for major depressive disorder – each with potential in additional indications.

– We are a leader in ion channel drug development, a field critical to neuroscience, as ion channels regulate neuronal signaling and influence every thought, perception, movement, and feeling. Our expertise spans neurology, psychiatry, and neurodegenerative diseases, enabling us to create highly selective therapies with broad patient potential.

– Leveraging our robust ion channel platform, we advance both proprietary and partnered programs addressing epilepsy, major depressive disorder, bipolar disorder, schizophrenia, Alzheimer’s disease, migraine, essential tremor, pain, anxiety, sleep disorders, and more.

Additional questions

In this section, Thomas responds to investor questions that could not be addressed during the live session due to time limitations. These questions were collected separately to ensure that all key topics and concerns from the audience receive proper attention.

We did not have time to address all investor questions during the studio interview. Let´s dive into them. First: Can you speak about SAN711 and its status with Acadia? There are some indications that the study has been halted.

– This is a regulatory step in preparation for Acadia’s Phase 2 study. We have paused our clinical study after successfully completing the planned Phase 1 biomarker cohorts. This allows us to file an amendment with the regulatory agency to conduct additional clinical investigations for Acadia’s Phase 2 study in essential tremor. Otherwise, we would have had to complete the study and submit a new protocol for a second clinical trial. This approach saves up to six months in obtaining the additional clinical data.

How are tesofensine’s price, disease effect, and side effect profile compared to the competition?

– Tesofensine is expected to be the most effective obesity treatment in Mexico. It is well tolerated, with dry mouth and insomnia as the most common side effects. Medix plans to price it affordably for consumers.

– Tesofensine may also compete with the new GLP-1s if they are introduced for obesity in Mexico. Many patients may prefer tesofensine over GLP-1s due to key differences, including its mode of action, side effect profile, fat-lean-mass weight loss, and administration.  One example is administration, tesofensine is an oral tablet, whereas GLP-1s require injections. While some patients are comfortable with injectables, most people prefer oral treatments, and some struggle with needles, making tablets a more accessible option.

Regarding Tesomet, what is the reason that you have not been able to find any partner for this yet? Some time ago you mentioned you might go for Tesomet in HO yourself if you had the funds, how much money would it require for you to go for this?

– It has been a buyers’ market, with significant competition for deals due to the broader financial situation in biotech. With limited business development resources, we have prioritized programs with the highest likelihood of securing a deal, and this strategy has been successful.

– A phase 2b program for HO would likely cost over $40 million over two years, plus additional internal development expenses.

As the stock price sits at the moment you stand to get in around 130 m in additional funding, will your plans change depending on how much money you receive?

– Our plans will depend on the financial resources available, including proceeds from TO4. We have the flexibility to adjust accordingly.

SAN903 is ready for phase 1, do you consider a phase 1 study for this, if you do not find a partner for it in the near future? To my understanding it is not that costly to do a phase 1, and would  further derisk this compound and be able to get an even bigger deal down the road, or would this delay the progress of the rest of the pipeline?

– We are financing three programs aligned with our strategic focus on neurology and neuroscience. SAN903 does not fit within this focus, and we are not the right company to take it through Phase 2. Any Phase 1 investment would depend on the potential value increase, perceived risk reduction, and improved chances of securing a partnership.

Regarding tesofensine, is there a path where it would be possible, to get a new patent in Europe and US, making it interesting for partnering in these areas?

– Potentially, but I can’t go into details for obvious reasons.

You mention that current funds would get you to start of phase 2 of San2219, San2355 and San2465. How much money would you Think it would require to take just 1 of these through a phase 2 study?

– Costs vary by study size and complexity. A Phase 2a proof-of-concept study might cost $10–20 million, while a larger Phase 2b study—closer to a direct path to market—could be double that amount.

You mention other companies who are further along with their KV7 compounds, Can you explain why you think SAN2355 is superior to these?

– Xenon’s XEN1101, in Phase 3, activates multiple Kv7 channels, including Kv7.2, Kv7.3, Kv7.4, and Kv7.5. The therapeutic targets for epilepsy and other indications are Kv7.2 and Kv7.3, while activation of Kv7.4 and Kv7.5 leads to unwanted, dose-limiting side effects.

– Published Phase 2 data and Xenon’s Phase 3 design suggest they cannot fully leverage the Kv7 concept due to these side effects. SAN2355 is, to our knowledge, the first compound that selectively activates only Kv7.2 and Kv7.3, potentially avoiding these limitations. Our preclinical studies support this, showing a 10-fold improved therapeutic index in animal models—approximately 2x for XEN1101 vs. 25x for SAN2355—suggesting a superior efficacy and safety profile.

The AstronautX deal included an option to receive worldwide rights, is there a deadline for when they have to exercise this option?

– There are mechanisms in place to prevent the program from being shelved without a license agreement. These safeguards are part of our agreement with AstronauTx. That said, we are open to extending the arrangement if our partner remains diligent. Research timelines can be unpredictable.

Can you explain how this funding of Cephagenix you just announced affect Saniona? Do you expect to start getting money again to provide research for Cephagenix like with the BI and AstronautX collaboration?

– Cephagenix remains a virtual company, with all scientific work conducted at Saniona’s and Jes Olesen’s laboratories. Saniona will be compensated on a fully loaded basis for its activities.

– Additionally, we retain a significant ownership stake, with the right to participate in future funding rounds. We also hold success-based warrants that could further increase our ownership, along with certain commercial milestone payments.

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