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Saniona Announces Oral Presentation of Tesomet Data in Hypothalamic Obesity at ENDO 2021

PRESS RELEASE

March 15, 2021

Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that data from its Phase 2 clinical trial of Tesomet for hypothalamic obesity (HO) will be presented at the Endocrine Society’s 2021 Annual Meeting (ENDO 2021), which is being held virtually March 20-23, 2021.

ENDO is the leading meeting for endocrinology research and clinical care worldwide. Saniona’s Tesomet data will be featured in a live oral presentation titled, "Weight Loss, Improved Body Composition and Fat Distribution by Tesomet in Acquired Hypothalamic Obesity," presented by Professor Ulla Feldt-Rasmussen, M.D., DMSc., Department of Medical Endocrinology and Metabolism, Rigshospitalet Copenhagen University Hospital, and Principal Investigator on the Phase 2 study. The presentation will be given on March 23 at 2:15 pm EDT as part of session OR02: What’s New in Weight Management Through the Lifespan? The data are embargoed until the time of presentation.

"We are thrilled to have Dr. Feldt-Rasmussen share the data from our positive Phase 2 trial of Tesomet for the treatment of hypothalamic obesity with the medical community through an oral presentation at such a prestigious medical conference as ENDO," said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. "There is currently no medicine approved for hypothalamic obesity, a rare disease characterized by intractable weight gain and complicated by uncontrollable hunger. Saniona is committed to pioneering the clinical path forward and addressing this significant unmet need."

For more information, please contact
Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: trista.morrison@saniona.com

The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CET on 15 March 2021.

About Saniona
Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. The company’s lead product candidate, Tesomet, is in mid-stage clinical trials for the rare diseases Prader-Willi syndrome and hypothalamic obesity. Saniona also has a broad pipeline derived from its proprietary ion channel discovery platform, with lead candidate SAN711 entering Phase 1 studies for rare neuropathic disorders. Saniona intends to develop and commercialize its rare disease products internally. The company has out-licensed other programs, which may provide future supplemental revenue. Saniona is based in Copenhagen, Denmark and Boston, Mass., U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

About Tesomet
Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. The programs are currently in clinical development. Saniona holds worldwide rights to Tesomet and is actively evaluating opportunities to advance this treatment globally.

About Hypothalamic Obesity (HO)
Hypothalamic obesity (HO) is a rare disorder caused by injury to the hypothalamus, most commonly sustained during surgery to remove a rare, noncancerous tumor called a craniopharyngioma (CP). HO is characterized by rapid, excessive and intractable weight gain that persists despite limited food intake. Patients may have hyperphagia, an uncontrollable hunger, and may display abnormal food seeking behaviors such as stealing food. Additional symptoms may include memory impairment, attention deficit, excessive daytime sleepiness and lethargy, issues with impulse control, depression, and suicide. HO patients are also at increased risk of developing obesity-related comorbid conditions such as type 2 diabetes, non-alcoholic fatty liver disease, hypertension, stroke, and congestive heart failure. Ultimately CP survivors with hypothalamic injury report at least three times higher 20-year mortality than CP survivors without hypothalamic injury. There are no medications approved specifically for HO, and there is no cure for this disease. Many HO patients are treated with approaches used for general obesity such as surgery, medication and lifestyle counseling, but these are often ineffective. The prevalence of HO is estimated to be between 10,000 and 25,000 in the U.S. and between 16,000 and 40,000 in Europe. It occurs most often in children and older adults, creating a burden for both patients and families.

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