Saniona’s collaboration with Acadia Pharmaceuticals, signed in November, marked a significant milestone for the company. With a total potential value of $610 million, it provides crucial funding for ongoing and future research initiatives. Recently, CEO Thomas Feldthus and incoming Chairman of the Board John Haurum visited our studio to address investors’ questions. In this written interview, Feldthus addresses additional questions and those that were not covered during the live session.

Saniona, a Denmark-based biotech company specialising in treatments for rare and neurological diseases, reached a turning point in its history with the November 2024 collaboration with Acadia Pharmaceuticals.

The agreement provides Saniona with USD 28 million upfront, with the potential for USD 582 million in milestone payments and royalties on global net sales of SAN711. Saniona is also eligible for tiered royalties ranging from mid-single digits to low double digits on global net sales. Read more here.

Not only did Acadia’s commitment to funding the phase I clinical study and preparing for phase II development add critical financial value. It also enables Saniona to focus on its broader pipeline, setting the stage for a productive 2025.

Acadia’s plans for SAN711

The Acadia collaboration will initially focus on SAN711 as a treatment for essential tremor, a condition characterised by uncontrollable shaking that can severely impact daily life. Acadia plans to initiate a phase II study in 2026, leveraging its expertise in neuroscience to lead the clinical, regulatory, and commercialisation processes. The agreement’s structure also suggests that further indications beyond essential tremor may be explored in the future.

Saniona retains a key role in the near term, overseeing the ongoing phase I study and assisting with preparations for the next phase.

Saniona CEO talks 2025: Progress, partnerships, and pipeline plans

Recently, Saniona’s CEO, Thomas Feldthus and incoming Chairman of the Board John Haurum participated in a live interview at BioStock’s studio, where they answered investors’ questions. Watch it here: 2025 Goals & Strategy: Saniona’s Plan Moving Forward | Live Q&A with BioStock.

BioStock reached out to Thomas again to get answers to additional questions and to address investor questions that were not covered during the live session due to time constraints.

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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