Press Release: Santhera Announces Half Year 2025 -3-

The Santhera Half Year Report 2025 (English only) is available for download on the Company's website at https://www.globenewswire.com/Tracker?data=ZKRJvI-osI_ZYyiOUPBh3ShJHDb1QonGtShF0KpIpmghgjMsPzp4xQ8eTnC6k71KmQuDBQ-vWcJvTOx8YbANchRro-TC7k2GHs-6jAJkDcJJPzN4vTXgzZ5BxYVl-eIL9UoMFzrvTEi9808cWHHGSA== www.santhera.com/financial-reports.

Analyst Briefing

Santhera's management team will be hosting a briefing for analysts and investors via a webcast at 14:00 CEST (08:00 ET) on 23 September 2025.

Register here: https://www.investormeetcompany.com/santhera-pharmaceuticals-holding-ag/register-investor

A recording of the webcast and the results presentation will be made available on the website following the event.

For further information please contact:

Catherine Isted, Chief Financial Officer: IR@santhera.com

ICR Healthcare: Santhera@icrhealthcare.com

About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE(R) (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Commission (EC), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in China by the National Medical Products Administration (NMPA) and Hong Kong by the Department of Health (DoH). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China and certain countries in Southeast Asia to Sperogenix Therapeutics. For further information, please visit www.santhera.com.

AGAMREE(R) is a trademark of Santhera Pharmaceuticals.

About AGAMREE(R) (vamorolone)

AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11--hydroxysteroid dehydrogenase (11-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [1-4]. This mechanism has shown the potential to 'dissociate' efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [1-4].

In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [1, 4]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity.

Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth [5] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [6].

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

References:

[1] Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link https://www.globenewswire.com/Tracker?data=o9DwUHxci2bWOrnLhlsVDSxPbqszw-lI8naj1jJ0xVejgNHYl_poZ--Nozb67zz5el7E__SjAf_Pbd9w6flnaZ_vMElkvT6CcztYUlGStxn05bGUVVuqahfs7o1fOFoc.

[2] Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link https://www.globenewswire.com/Tracker?data=o9DwUHxci2bWOrnLhlsVDZQnam1vmL8Nq8y3fLuPvmQLmYnWBfpOKJPWAX6l2OEBu0BHSHAFCBV4FJ51q12gzG8q3Fs51uYLpSyT_cTHt04T4iPIx7BpPquQhZAxzBCHazn2VwTX6SVdkza_oqcHVVAXS0wvstcpr89O7zKKo4jDvj8yELkDt1jrdNqwNxAH-xUOVD9K0g_IB1S8Ch7U95fldnWFrXcuxa30UxGqpO8iej4ss5XWKpnv0WBM5OY3oyg6-JkCjzd_RDlZGk7sRQ==.

[3] Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293

[4] Heier CR et al (2019). Life Science Alliance DOI: 10.26508

[5] Ward et al., WMS 2022, FP.27 - Poster 71. Link https://www.globenewswire.com/Tracker?data=o9DwUHxci2bWOrnLhlsVDR9dfujdjSCxpMpfFprc4ZgSSjCW0UdMYhDR-WMuMHW_0wrTe_Fp6hELuPxHd-6a-GZ_0q-T8yBlu7DgafMhNh5PfQVXcWuZUMDqtI3npjuFWHyhmwWcwSZwu_T0TkD0svKAItPktZ_n0Lk2n7S8XHJS5Vv9QvHfhMU_PUSTDbk33M2ZfaEc2aNDIFeegNIu9bkSgrQW6dMhoM-SJCprhZg=.

[6] Hasham et al., MDA 2022 Poster presentation. Link https://www.globenewswire.com/Tracker?data=o9DwUHxci2bWOrnLhlsVDbeXhrY-B9MSUI5trkr0RJ631RYYODhxHOROwTNi_0v6oLjo8m-lBepypnYILNKaUr8RhHPLedRLpjaxrqQMZFjigoezjIliPZPF8Vwk2ZW_gE9U1DqEKy4PFu5Js1GF2CjzEEw098HwBc_WKYZqOUSodjbD2Juw6mni_0mdW-Rs.

Disclaimer / Forward-looking statements

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

# # #

Interim Consolidated Balance Sheet

In CHF thousands Jun 30, 2025 Dec 31, 2024

(unaudited) (audited)

Assets

Tangible assets 2,311 2,571

Intangible assets 66,439 68,946

Financial assets long-term 249 245

Noncurrent deferred loss on financial

instruments 2,967 4,913

Noncurrent assets 71,966 76,675

Current deferred loss on financial

instruments 2,739 3,103

Prepaid expenses 437 373

Inventories 26,030 17,527

Trade and other receivables 11,199 13,885

Cash and cash equivalents 18,397 40,925

Current assets 58,802 75,813

Total assets 130,768 152,488

Equity and liabilities

Share capital 1,358 1,343

Capital reserves and share premium 647,812 644,410

Accumulated losses (653,525) (614,693)

Employee benefit reserve 2,116 (3,025)

Treasury shares (63) (65)

Translation differences (261) (272)

Total equity (2,563) 27,698

Noncurrent payables 7,745 -

Noncurrent term loans 32,123 31,729

Noncurrent royalty purchase agreements 27,294 33,165

Noncurrent derivative financial

instruments 1,917 2,216

Noncurrent lease liabilities 1,662 1,940

Noncurrent contract liabilities 1,850 1,925

Pension liabilities 2,959 7,672

Noncurrent liabilities 75,550 78,647

Trade and other payables 24,441 9,224

Accrued expenses 16,583 19,345

Income tax payable 37 144

Current royalty purchase agreements 5,856 3,810

Current lease liabilities 592 553

Current convertible bonds 6,845 6,398

Current contract liabilities 89 56

Current derivative financial instruments 1,408 2,323

Current warrant financial instruments 1,930 4,290

Current liabilities 57,781 46,143

Total liabilities 133,331 124,790

Total equity and liabilities 130,768 152,488

(MORE TO FOLLOW) Dow Jones Newswires

September 23, 2025 02:29 ET (06:29 GMT)