Regulatory press release

Saniona publishes its interim report for the first quarter of 2025

Saniona

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Q1 2025 (Q1 2024)

Revenue was SEK 9.8 M (6.0 M)

Operating profit/loss was SEK -16.5 M (-13.7 M)

Net profit/loss was SEK 19.0 M (-9.2 M)

Cash and cash equivalent SEK 260.7 M (71.4)

Basic earnings/loss per share was SEK 0.17 (-0.08)

Diluted earnings/loss per share were SEK 0.16 (-0.08)

Business highlights in Q1 2025

On January 10, Saniona’s Nomination Committee proposed John Haurum as New Chairman of the Board of Directors.
On January 15, Saniona’s joint venture, Cephagenix, secured seed funding from AdBio Partners and AbbVie ventures, with up to EUR 9 million.
On February 10, Medix initiated a revision of the tesofensine application based on COFEPRIS’s feedback. Medix now sees a clear path to regulatory approval, and on February 20, Medix resubmitted tesofensine application to COFEPRIS.
On March 3, Saniona initiated GMP manufacturing and toxicology studies for SAN2355. The objective is to finalize the data package for a clinical trials application by year-end 2025.
On March 3, Acadia Pharmaceuticals and Saniona announced initial positive results from ACP-711 Phase 1 study.
On March 10, Saniona appointed Pierandrea Muglia, M.D. as Chief Medical Officer.
On March 11, Saniona announced that the ongoing research collaboration with Boehringer Ingelheim has been extended with one year.
In March, Saniona announced the following regarding warrants series TO 4: the exercise price has been determined to SEK 4.88, an agreement on guarantee commitments free of charge is entered, and that Saniona’s board and CEO will exercise 964,334 TO 4 warrants.
On March 26, Saniona announced initiation of scale-up and manufacturing of toxicology batches for SAN2219.

Significant events after the reporting period

On April 3, Saniona announced final outcome of exercise of warrants series TO4, corresponding to a total of approximately SEK 115 million before issue costs, which corresponds to 100 percent of the total number of TO 4.
On May 12, Saniona appointed Johnny Stilou as Chief Financial Officer.

Comments from the CEO
“We’ve entered 2025 with strong momentum – we have restarted all three internal development programs and bolstered our financial position through the successful TO4 financing. With a focused pipeline, a validated business model, and promising regulatory progress on tesofensine, Saniona is now well-positioned to deliver continued value-building in the quarters ahead.”

About Saniona
Saniona (OMX: SANION) is a clinical-stage biopharmaceutical company focused on neurological and psychiatric diseases. Its internal pipeline includes SAN2219 and SAN2355 for epilepsy and SAN2465 for major depressive disorder. Saniona has two strategic collaborations: one with Acadia Pharmaceuticals, which has licensed worldwide rights to ACP-711 and is preparing it for Phase 2 in essential tremor, and one with Productos Medix, which holds the rights to tesofensine for obesity in Mexico and Argentina and has submitted a market authorization application in Mexico. Saniona also has two clinical programs available for partnership: Tesomet™, ready for Phase 2b in rare eating disorders, and SAN903, ready for Phase 1 in inflammatory bowel disease. Saniona’s partners also include Boehringer Ingelheim, AstronauTx, and Cephagenix. Based in Copenhagen, Saniona is listed on Nasdaq Stockholm Main Market.
For more information, visit www.saniona.com.