ReveraGen BioPharma, Inc.

Pratteln, Switzerland, September 24, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the marketing authorization application (MAA) for AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD). Santhera asked Swissmedic to assess AGAMREE® as part of Article 13 TPA (therapeutics product act) procedure, allowing it to consider the results of foreign regulatory authorities’ assessments when reviewing a medicinal product for authorization in Switzerland. In the case of AGAMREE, Swissmedic will consider the EU approval of the drug received in December 2023. This can streamline the approval process by leveraging existing evaluations from countries with comparable regulatory standards. The outcome of the Swissmedic review is expected in late H1-2026 with the possibility to be accelerated to early 2026 if the Article 13 is accepted. Swissmedic approval in addition to EMA/FDA/MHRA approvals will leverage the access for this orphan drug to other markets through an abbreviated review. “Submission of AGAMREE for DMD to Swissmedic is an important milestone, following approvals from the U.S. FDA, the European Commission in the EU, and the UK MHRA, in addition to acceptance for priority review from China’s NMPA,” commented Shabir Hasham, MD, Chief Medical Officer of Santhera. “We look forward to working closely with Swissmedic to address the high unmet need for improved treatment options for patients suffering from DMD in Switzerland.” About AGAMREE® (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-β-hydroxysteroid dehydrogenase (11β-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].AGAMREE (vamorolone), an orphan medicinal product, is approved for use in the United States (Prescribing Information), the European Union (Summary of Product Characteristics) and the United Kingdom. References:[1] Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.[2] Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.[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.[6] Hasham et al., MDA 2022 Poster presentation. Link. About Duchenne Muscular DystrophyDuchenne muscular dystrophy (DMD) is a rare inherited X-chromosome-linked disease, which almost exclusively affects males. DMD is characterized by inflammation which is present at birth or shortly thereafter. Inflammation leads to fibrosis of muscle and is clinically manifested by progressive muscle degeneration and weakness. Major milestones in the disease are the loss of ambulation, the loss of self-feeding, the start of assisted ventilation, and the development of cardiomyopathy. DMD reduces life expectancy to before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for the treatment of DMD. About SantheraSanthera 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® (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 Medicines Agency (EMA), and in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. For further information, please visit www.santhera.com. AGAMREE® is a trademark of Santhera Pharmaceuticals. For further information please contact: public-relations@santhera.com orEva Kalias, Head Investor Relations & CommunicationsPhone: +41 79 875 27 80eva.kalias@santhera.com 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. # # # Attachment 2024 09 24_SwissmedicMAA_e_finalx

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on September 12, 2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Revenue from contracts with customers of CHF 14.1 million (H1-2023: CHF 3.9 million)Operating result of CHF -17.7 million (H1-2023: CHF -20.3 million) and net result of CHF -15.3 million (H1-2023: CHF -23.3 million)AGAMREE® (vamorolone) launched in Germany and Austria as first European markets; North America partner has launched in the U.S.Approval of AGAMREE in the UK for the treatment of Duchenne muscular dystrophy (DMD); new drug application (NDA) in DMD under regulatory priority review in China Cash and cash equivalents of CHF 16.5 million (June 30, 2024); bolstered by financing of up to CHF 69 million (closed in August 2024) to provide funding into 2026 when cash flow break-even is expectedBusiness now fully focused on European commercialization and further geographic expansion of AGAMREE in DMD Pratteln, Switzerland, September 12, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the Company’s financial results for the six months ended June 30, 2024, reports on progress with AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) and provides updates on its corporate and financing initiatives. “We are extremely encouraged by the strong early uptake of AGAMREE in Germany and Austria, which has exceeded our expectations. Our North American partner, Catalyst Pharmaceuticals, has also seen a successful launch in the U.S., further validating the potential of AGAMREE in treating DMD,” said Dario Eklund, CEO of Santhera. “While we are delaying the decision on a new indication for AGAMREE until at least the end of 2025 to allow Catalyst to conduct additional exploratory clinical work, this strategic pause gives us an exciting opportunity. We are reallocating resources and are intensifying our efforts in DMD by expanding our launch into the Nordics, Portugal, and Ireland, hereby retaining full control of all the markets in western Europe. Additionally, we have decided to invest in additional studies to further strengthen the evidence behind AGAMREE’s differentiated safety profile and drive continued growth in the DMD space.” BUSINESS AND CORPORATE UPDATE Half-year 2024 key events and post-period events AGAMREE approved in the UK for the treatment of DMD, following prior approvals in the U.S. and EU The UK MHRA, in accordance with EU regulators, acknowledged safety benefits of AGAMREE with regards to preserving bone health and maintaining growth compared to standard of care corticosteroidsLaunches of AGAMREE in Germany and Austria (by Santhera) and the U.S. (by Catalyst Pharmaceuticals) as first markets, experiencing strong market uptakePreparations for market entry are advancing across Europe, with pricing negotiations currently underwayExpansion of self-commercialization reach (to include the Nordics, Ireland and Portugal) and new distribution agreements established, representing coverage of all of EU and some non-EU markets in EuropePriority review for AGAMREE NDA in DMD granted by China’s regulatory authority; early access program started by Sperogenix AGAMREE approved across the U.S., EU and UK—NDA under priority review in ChinaOn January 11, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK approved AGAMREE for the treatment of DMD, following earlier approvals in the U.S. (by FDA on October 26, 2023) and the European Union (by the European Commission on December 18, 2023). AGAMREE became the first DMD treatment approved across these three territories. In the EU, AGAMREE is the first and only approved medication for treating all patients from age 4 years with DMD. The European Medicines Agency (EMA) and the MHRA acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, while demonstrating similar efficacy. In March 2024, the National Medical Products Administration (NMPA) in China accepted the new drug application (NDA) filing for AGAMREE in DMD for patients aged 4 years and older, incorporating it into both the Priority Review Program and the Breakthrough Therapy Program. Subject to a positive review outcome, approval could be obtained by Q1-2025. First launches in Germany and the U.S. met with strong market acceptanceThe first market launch of AGAMREE (available as a 40 mg/ml oral suspension) for the treatment of DMD occurred on January 15, 2024, in Germany, where around 2,300 patients are affected by DMD. In the following month, AGAMREE became available in Austria. The reception in both markets has been very positive, evidenced by strong demand and proactive inquiries from patients and caretakers. Currently, after only a few months of availability, AGAMREE has been prescribed to around 300 patients in Germany and Austria. In March 2024, Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX), executed the U.S. commercial launch of AGAMREE and reported yielding solid results and surpassing initial expectations by the end of June 2024. Catalyst Pharmaceuticals holds an exclusive license for AGAMREE for North America. Further, in July 2024, Catalyst entered into an exclusive license, supply, and commercialization agreement for AGAMREE with a partner in Canada, marking a pivotal strategic milestone in expanding the product's North American footprint. Paid early access programs started in first countries—broader interest expressedSanthera received a number of named patient requests from European as well as global markets and is exploring sustainable supply mechanisms with a selection of partners. Meanwhile, programs have started in Spain and China. In June, Santhera started a paid-for named patient program (NPP) in Spain. Under a well-defined regulatory framework, with the approval of the national as well as regional regulatory bodies, this allows patients with serious or life-threatening conditions to access medicines, even before they are commercially available in the country. In China, partner Sperogenix Therapeutics has launched a paid-for early access program (EAP) for AGAMREE for patients with DMD. In April 2024, the Hainan Medical Products Administration (HMPA) authorized the EAP for AGAMREE in China, where approved treatments are currently unavailable, based on local policies, AGAMREE’s existing overseas approvals (U.S., EU, UK) and its demonstrated ability to address urgent clinical needs in DMD. The EAP started in the Bo’ao Lecheng Pilot Zone, located in Hainan Province, in mid-May, where strong interest has been received and approximately 70 patients are currently on active treatment with AGAMREE. Pre-commercialization measures advancing across Europe—pricing negotiations ongoingSanthera plans to make AGAMREE available to patients across Europe. After Germany and Austria, the build-up of a core commercial organization is well advanced in UK, France, Italy, Spain, and Benelux. Activities surrounding market access, stakeholder and key opinion leader engagement in the target countries advanced throughout the period under review. Across key European markets, Santhera is currently engaged in various national processes of health technology assessments (HTA), pricing negotiations, and reimbursement decisions. In Germany, considering that Santhera launched AGAMREE on January 15, 2024, the pricing negotiations are expected to be concluded by January 15, 2025. Owing to the complex and lengthy nature of these evaluations, anticipated timelines for upcoming market entries are likely to be slightly later than previously indicated. The UK is expected to be concluded later this year, France and Spain by mid-2025 and Italy by late 2025. Meanwhile, mid-sized European countries will progress in parallel with the big five markets. Self-marketing territory expanded—additional distribution agreements securedMarket uptake in the first launch countries has been strong and exceeded Santhera’s expectations. On this basis, Santhera has decided to expand its self-marketing strategy for AGAMREE to include the Nordic countries (Denmark, Sweden, Finland, Norway, and Iceland), along with Portugal and Ireland, and the organizational build-up has started. This approach reflects confident economic projections, while ensuring that margins are kept in-house, and allows the Company to maximize value and revenue potential from Agamree in DMD. For all other markets in Europe, Santhera has signed up GENESIS Pharma as its distribution partner. GENESIS Pharma, with domiciles in Greece and Cyprus, is a regional biopharma company specialized in the commercialization of innovative medicines targeting severe and rare diseases in Central and Eastern Europe. The company will market AGAMREE in DMD in Greece, Cyprus, Malta, Romania, Bulgaria, Slovenia, Croatia, Poland, Czech Republic, Hungary, Slovakia, Lithuania, Latvia, Estonia, Serbia, North Macedonia, Bosnia & Herzegovina, Montenegro, Albania, and Kosovo. A supply and distribution agreement has also been signed with Megapharm Ltd. Megapharm is a leading specialty marketing and distribution company in Israel’s healthcare sector and will market AGAMREE for the treatment of DMD in Israel and the Palestinian territories. In addition, Santhera has entered into discussions with multiple potential partners for additional territories outside of Europe. Clinical programs with AGAMREE AGAMREE has been developed to provide an anti-inflammatory and muscle preserving treatment with a favorable safety and tolerability profile as an alternative to the current standard of care with glucocorticoids. In addition to long-term efficacy and safety data with AGAMREE, recent publications and presentations further characterized AGAMREE’s differentiated profile mainly with regard to bone health. Clinical studies with AGAMREE in Duchenne muscular dystrophy (DMD) were initiated to investigate its effects in a broader patient age group and additional clinical work was started to differentiate the safety profile over the next couple of years. The clinical development program for AGAMREE until now included patients 4 to <7 years old and, as part of the pediatric investigational plan (PIP) requested by EMA, a new Phase 2 study aims at collecting information on AGAMREE outside this age range through inclusion of patients starting at an age of 2 years and up to 18 years. In addition, a Phase 1 study in healthy volunteers aims to confirm AGAMREE's mineralocorticoid antagonistic properties, a key mechanism in current standard therapies to slow cardiomyopathy progression, further distinguishing AGAMREE as the only corticosteroid that may offer early cardioprotective benefits alongside its proven efficacy in DMD. Separately, a Phase 2 pilot study in Becker muscular dystrophy (BMD) is evaluating the safety, tolerability and exploratory clinical efficacy on motor function outcome. Santhera is committed to fully realizing AGAMREE’s potential in the treatment of DMD by investing in its market potential and refining its clinical development priorities for potential new indications. While the Company initially planned to provide more details on the development of a second indication in Q4 this year, Catalyst Pharmaceuticals, the partner in North America, will begin further clinical exploratory and development studies in 2025 to inform the strategy for future indications thereafter. FINANCIAL PERFORMANCE Half-year results Revenue from contracts with customers of CHF 14.1 million (H1-2023: CHF 3.9 million)Operating result of CHF -17.7 million (H1-2023: CHF -20.3 million) Net result of CHF -15.3 million (H1-2023: CHF -23.3 million)Cash flow from operating activities of CHF-15.3 million (H1-2023: CHF -15.4 million)Cash and cash equivalents of CHF 16.5 million (Dec 31, 2023: CHF 30.4 million) Subsequent events and financing outlook Close of financings with Highbridge and R-Bridge (August 12, 2024) provided initial receipt of CHF 58 million net of transaction costs with future sales milestones of up to USD 8 millionRepayment of maturing listed convertible bonds (CHF 14 million including interest)Extension of CHF 7 million private convertible bond until August 2025Cash reach into 2026 when cash flow break-even is expected Net RevenueIn the first half-year 2024, Santhera reported revenue from contracts with customers of CHF 14.1 million (H1-2023: CHF 3.9 million). Net sales amounted to CHF 6.5 million following the launch of AGAMREE in Germany and Austria (H1-2023: CHF 1.0 million arising from RAXONE which ceased following the disposal during H2-2023). Additionally, Santhera recognized CHF 7.7 million (H1-2023: CHF 3.0 million) from partners in China and North America reflecting milestones and product supply. Cost of goods soldCost of goods sold amounted to CHF 5.2 million and increased on the prior year level (H1-2023: CHF 1.9 million), reflecting initiation of commercial supply and the amortization of intangible assets. Cost of goods for the six months includes non-cash intangible amortization of CHF 2.5 million (H1-2023: CHF 1.5 million), royalties payable of CHF 1.0 million (H1-2023: nil) as well as early-stage logistics and CMC set up expenses. Operating expenses and resultOperating expenses of CHF 26.7 million (H1-2023: CHF 22.5 million) were 20% higher year-on-year, primarily due to an increase in activities to support the commercialization of AGAMREE. Development expenses amounted to CHF 13.8 million (H1-2023: CHF 9.7 million). The increase of 40% arises from additional longer-term studies and CMC (chemistry, manufacturing, and controls) development activities to further enhance the commercial success of AGAMREE. Marketing and sales expenses were CHF 4.7 million (H1-2023: CHF 4.3 million). This represents a slight increase due to higher activities for AGAMREE in Europe to support launches offset by reduction in expenses incurred in H1-2023 to support pre partnering US activities. General and administrative expenses amounted to CHF 8.3 million (H1-2023: CHF 8.4 million), with activities focused in 2024 on supporting commercial growth. The operating result amounted to a loss of CHF 17.7 million (H1-2023: loss of CHF 20.3 million). Financial income and expenses The financial income amounted to CHF 8.6 million (H1-2023: CHF 5.7 million). The increase was predominantly related to net positive changes in fair value of financial instruments, interest receivable and in (un)realized foreign exchange gains. Financial expenses were CHF 6.0 million (H1-2023: CHF 8.8 million), primarily driven by interest payable and in (un)realized foreign exchange losses. In summary, this resulted in a net financial income of CHF 2.7 million, compared with a net expense of CHF 3.1 million for H1-2023. Net resultThe net result in 2024 was a loss of CHF 15.3 million, compared to a net loss of CHF 23.3 million for H1-2023. Cash balance and cash flows As of June 30, 2024, the Company had cash and cash equivalents of CHF 16.5 million compared to CHF 30.4 million as of December 31, 2023, a decrease of CHF 13.9 million (H1-2023 an increase of CHF 0.3 million) Net cash flow used in operating activities amounted to CHF 15.3 million (H1-2023: net cash outflow of CHF 15.4 million). There was negligible cash flow from investing activities (H1-2023 income of CHF 5.7 million from proceeds of sale of shares). Net cash flow used in/from financing activities was CHF -0.4 million (H1-2023: CHF 10.0 million). There were no financing inflows during the period due to the available cash balances, while additional finance was raised following the period end. Assets and liabilitiesIntangible assets decreased by CHF 2.5 million to CHF 71.5 million reflecting amortization in the period. Total assets decreased by CHF 1.4 million to CHF 108.2 million as a result of a reduction in cash of CHF 13.9 million, offset by an increase in inventory and trade receivables following initial commercialization and milestones receivable. Total liabilities increased by CHF 10.5 million to CHF 60.2 million mainly due to increase in trade payables relating to inventory purchases. Shareholders’ equityTotal consolidated equity as of June 30, 2024, amounted to CHF 48.1 million compared to CHF 59.9 million as of December 31, 2023. Financing activitiesAs previously announced, additional funding was required to support ongoing activities and service debt obligations. In August, Santhera closed two financing agreements that provided the Company with gross funding totaling approximately CHF 69 million. CHF 35 million received from Highbridge under a new term loan agreement Santhera received CHF 35 million from a term loan financing from certain funds managed by Highbridge Capital Management, LLC (Highbridge). The loan has a four-year maturity with amortization in the amount of 15% per year, commencing after 24 months, and will pay a cash interest of 3-month SARON (floor of 2%) plus 9.75% per year. The transaction includes changes to the existing Highbridge private convertible bonds, extending CHF 7 million with a strike price of CHF 10 by 12 months to August 2025, and converting CHF 4 million, with a strike price of CHF 5 as well as issuing the new warrants to Highbridge. USD 30 million received from R-Bridge for partial and capped royalty monetization Upon closing of the royalty monetization financing agreement, R-Bridge paid an upfront of USD 30 million to Santhera and will make staged sales-related milestone payments that, if achieved, would result in total payments to Santhera of a further USD 8 million. The royalty agreement with R-Bridge is partial and capped. Santhera is monetizing 75% of the future royalty income streams (net of any agreed payment obligations of Santhera to ReveraGen and Idorsia) from its licensing agreements for AGAMREE with Catalyst Pharmaceuticals, Inc. and with Sperogenix Therapeutics Ltd., in respect of net product sales occurring from July 1, 2024. Once the agreed threshold or duration of royalty payments is met, the North America and China royalty payments will revert back to Santhera. In addition, Santhera retained certain rights to buy back the royalty income stream. Following closing of the financings, the proforma cash balance was CHF 72 million (August 13, 2024) after receipt of CHF 58 million net of transaction fees. After repayment of the maturing listed convertible bonds and interest in the amount of CHF 14 million, the remaining cash balance is expected to provide for a cash runway into 2026 and to expected cash flow break-even. 2024 Half-year Financial Information Interim condensed consolidated income statement(for the six months ended June 30, in CHF thousands, except per share data)H1-2024(unaudited)H1-2023(unaudited)Net sales6,464969Revenue from out-licensing transactions6,3611,921Net sales to licensing partner1,2891,049Revenue from contracts with customers14,1143,939Cost of goods sold of which amortization intangible assets(5,215)(2,487)(1,928)(1,519)Development(13,771)(9,748)Marketing and sales(4,660)(4,257)General and administrative, other(8,276)(8,452)Operating expenses (26,707)(22,457)Operating result(17,741)(20,305)Financial result, net2,652(3,115)Income tax (expense)/benefit17484Net result(15,263)(23,336)Basic and diluted loss per share (in CHF) (1.35)(2.09)Interim condensed consolidated balance sheet (in CHF thousands)Jun 30, 2024(unaudited)Dec 31, 2023(audited)Cash and cash equivalents16,49130,370Other current assets17,1494,287Noncurrent assets74,60674,972Total assets108,246109,629Equity48,05759,943Noncurrent liabilities7,1395,371Current liabilities53,05044,315Total equity and liabilities108,246109,629Interim condensed consolidated cash flow statement(for six months ended June 30, in CHF thousands)H1-2024(unaudited)H1-2023(unaudited)Net cash flow from/(used in) operating activities (15,282)(15,358)Net cash flow from/(used in) investing activities 105,682Net cash flow from/(used in) financing activities (358)9,979Cash and cash equivalents at January 130,3701,353Cash and cash equivalents at June 3016,4911,674Net increase/(decrease) in cash and cash equivalents(13,879)321Share capital(number of shares with par value of CHF 0.10)Jun 30, 2024(unaudited)Dec 31, 2023 (audited)Ordinary shares issued 12,620,37612,620,376Treasury shares918,8141,305,167Conditional capital for employee participations (Art 3b)542,450542,450Conditional capital for financing purposes (Art 3c)5,500,0005,500,000 Half-year ReportThe Santhera Half-year Report 2024 is available for download on the Company’s website at www.santhera.com/financial-reports. Conference Call Santhera will host a conference call on September 12, 2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. CEO Dario Eklund, CFO Andrew Smith and CMO Shabir Hasham, MD, will discuss the 2024 half-year financial results and comment on ongoing corporate developments. Participants are invited to call one of the following numbers (no dial-in code is required): Switzerland/Europe: +41 58 310 50 00United Kingdom: +44 207 107 06 13USA: +1 631 570 56 13 A replay will be accessible at https://www.santhera.com/ad-hoc-news from about two hours after the call has ended. References Publications and applicable drug labeling to which this press release makes reference to: Labeling: United States Prescribing Information; European Union Summary of Product CharacteristicsDang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293Heier CR et al (2019). Life Science Alliance DOI: 10.26508Ward et al., WMS 2022, FP.27 - Poster 71. Link.Hasham et al., MDA 2022 Poster presentation. Link. About SantheraSanthera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (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 Medicines Agency (EMA), and in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. For further information, please visit www.santhera.com. AGAMREE® is a trademark of Santhera Pharmaceuticals. For further information please contact: public-relations@santhera.com orEva Kalias, Head Investor Relations & CommunicationsPhone: +41 79 875 27 80eva.kalias@santhera.com 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. # # # Attachment 2024 09 12_HY2024_e_finalz

Pratteln, Switzerland, September 10, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive distribution agreement with GENESIS Pharma for AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in 20 markets in Central and Eastern Europe. Santhera Pharmaceuticals and GENESIS Pharma have signed a distribution agreement for 20 markets in Central and Eastern Europe. This strategic collaboration aims to address unmet medical needs by allowing GENESIS Pharma to commercialize AGAMREE in Greece, Cyprus, Malta, Romania, Bulgaria, Slovenia, Croatia, Poland, Czech Republic, Hungary, Slovakia, Lithuania, Latvia, Estonia, Serbia, North Macedonia, Bosnia & Herzegovina, Montenegro, Albania, and Kosovo. “This distribution agreement with GENESIS Pharma marks a significant achievement for Santhera as we expand the global availability of AGAMREE. By partnering with expert organizations with a strong understanding of specialist markets, we ensure optimal patient access,” said Geert Jan van Daal, MD, PhD, Chief Commercial Officer of Santhera. “This is a further step in our strategy to allow focus on key European markets with dedicated Santhera teams while partnering with the best companies for non-core European markets.” Constantinos Evripides, Managing Director of GENESIS Pharma, stated: “Our company has a strong focus on rare diseases and an established expertise of more than twenty years in the commercialization of orphan therapies. We are delighted that Santhera has trusted our capabilities across the CEE region, giving us the opportunity to add Vamorolone to our broad and robust orphans’ portfolio. We will work closely and diligently with Santhera to ensure a smooth and unhindered access to all patients that can benefit from this innovative treatment.” The European Commission approved AGAMREE for the treatment of DMD, in patients 4 years of age and older, in December 2023. This was based on data from the positive pivotal DMD study and three open-label studies. Patients treated with AGAMREE or placebo showed normal and similar growth while growth stunting was observed in children treated with prednisone. In addition, patients who switched from a standard of care corticosteroid to AGAMREE maintained the efficacy benefit while recovering their growth and bone health. About AGAMREE® (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-β-hydroxysteroid dehydrogenase (11β-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]. AGAMREE (vamorolone), an orphan medicinal product, is approved for use in the United States (Prescribing Information), the European Union (Summary of Product Characteristics) and the United Kingdom. References:[1] Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.[2] Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.[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.[6] Hasham et al., MDA 2022 Poster presentation. Link. About Duchenne Muscular Dystrophy Duchenne muscular dystrophy (DMD) is a rare inherited X-chromosome-linked disease, which almost exclusively affects males. DMD is characterized by inflammation which is present at birth or shortly thereafter. Inflammation leads to fibrosis of muscle and is clinically manifested by progressive muscle degeneration and weakness. Major milestones in the disease are the loss of ambulation, the loss of self-feeding, the start of assisted ventilation, and the development of cardiomyopathy. DMD reduces life expectancy to before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for the treatment of DMD. About SantheraSanthera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (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 Medicines Agency (EMA), and in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Santhera has out-licensed rights to vamorolone for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. For further information, please visit www.santhera.com. AGAMREE® is a trademark of Santhera Pharmaceuticals. About GENESIS PharmaGENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharmagroup.com. For further information please contact: public-relations@santhera.com orEva Kalias, Head Investor Relations & CommunicationsPhone: +41 79 875 27 80eva.kalias@santhera.com For more information about GENESIS Pharma, please contact:Natalia Karahaliou, Communications Manager nkarahaliou@genesispharma.comPhone: +30 210 87 71 605 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. # # # Attachment 2024 09 10_Partnering Genesis_e_final