A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of MI226 Injection in Subjects With Abdominal Fat Accumulation

This is a Phase 1, randomized, double-blind (with open-label sentinel cohorts), placebo-controlled, single-ascending-dose study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of MI226 Injection in participants with abdominal fat accumulation.

Start Date28 Jul 2026

Sponsor / Collaborator

Nanjing Minowei Pharmaceutical Technology Co., Ltd.

CTR20253271

/ RecruitingPhase 1

去氧胆酸注射液在中国颏下脂肪堆积过多人群中皮下脂肪层注射治疗的随机、盲法、平行、阳性对照的I期临床试验

[Translation] A randomized, blinded, parallel, positive-controlled phase I clinical trial of deoxycholic acid injection in the subcutaneous fat layer of Chinese patients with excessive submental fat accumulation

主要目的：评价去氧胆酸注射液在中国颏下脂肪堆积过多人群中皮下脂肪层注射治疗的安全性。次要目的：评价去氧胆酸注射液在中国颏下脂肪堆积过多人群中皮下脂肪层注射治疗的药代动力学特征及临床疗效。

[Translation]

Primary objective: To evaluate the safety of deoxycholic acid injection (DCA) injected into the subcutaneous fat layer in Chinese patients with excessive submental fat accumulation. Secondary objective: To evaluate the pharmacokinetic characteristics and clinical efficacy of DCA injection (DCA) injected into the subcutaneous fat layer in Chinese patients with excessive submental fat accumulation.

Start Date22 Oct 2025

Sponsor / Collaborator

Beijing Novotel Biotechnology Co., Ltd.

ChiCTR2500107600

/ SuspendedPhase 1IIT

Randomized, blind, parallel, and positive-controlled Phase I clinical trials of subcutaneous fat layer injection treatment in people with excess subcutaneous fat accumulation in Chinese jaws

Start Date01 Jul 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

[+1]

100 Clinical Results associated with Deoxycholic Acid

100 Translational Medicine associated with Deoxycholic Acid

100 Patents (Medical) associated with Deoxycholic Acid

7,611

Literatures (Medical) associated with Deoxycholic Acid

31 Dec 2026·Gut Microbes

Gut microbes mediate the synergistic effects of dietary cholesterol and saturated fat in driving fibrosing MASH

Article

Author: Hermanson, Jake B. ; Chrisler, Evan A. ; Kaur, Manpreet ; Sidebottom, Ashley M. ; Amador-Noguez, Daniel ; Leone, Vanessa A. ; Rey, Federico E. ; Tolba, Samar A. ; Liu, Yongjun ; Gazi, Md Amran ; Martinez-Boggio, Guillermo ; Lucas, Lauren N.

Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately one-third of the global population and can progress to metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis, increasing the risk of cirrhosis, hepatocellular carcinoma, and mortality. Gut microbes driven by diets high in saturated fat, simple sugar, and cholesterol contribute to disease progression, yet the underlying mechanisms remain undefined. We explored the independent and synergistic effects of dietary saturated fat and cholesterol on MASH development using specific pathogen-free (SPF) and germ-free (GF) mice. We demonstrate that (1) both dietary cholesterol and saturated fat are required to induce fibrosing MASH in SPF mice, whereas GF mice are protected, (2) saturated fat and cholesterol individually alter gut microbial membership, potentially via altered bile acid metabolism, while their combination promotes a distinct composition, including an increase in Parasutterella spp. which correlates with hepatic fibrosis, and (3) diluted cecal contents from SPF, but not GF, mice fed high-fat, high-cholesterol diets are enriched in deoxycholic acid and activate human hepatic stellate cells in vitro, suggesting a mechanistic link between dietary lipid-induced microbiota and liver fibrogenesis. These findings reveal how specific Western dietary components shape the gut microbiota and contribute to hepatic fibrosis via stellate cell activation, offering potential targets for therapeutic interventions against MASLD/MASH.

31 Dec 2026·Virulence

Article

Author: Ouyang, Zirou ; Yang, Huimin ; Qin, Pu ; Niu, Yanan ; Wen, Baojiang ; Qiang, Cuixin ; Zhao, Jianhong ; Wang, Weigang ; Zhao, Min ; Zhao, Jiafeng ; Yang, Jing

Clostridioides difficile infection (CDI) is a major cause of antibiotic-associated diarrhea, with frequent recurrences closely linked to antibiotic-induced dysbiosis of the gut microbiota and bile acid metabolism. Parabacteroides distasonis, a potential probiotic capable of converting primary to secondary bile acids, has shown therapeutic promise in several metabolic and inflammatory diseases. This study evaluated the preventive and therapeutic effects of P. distasonis against CDI and explored the underlying mechanisms. We characterized the probiotic properties of four P. distasonis strains and investigated the inhibitory activity of strain 1190003 against C. difficile, as well as its protective and therapeutic efficacy in mouse models. Gut microbiota structure and bile acid metabolic profiles were analyzed by integrating 16S rRNA gene sequencing and metabolomics. The four P. distasonis strains exhibited strong acid and bile salt tolerance as well as auto-aggregation ability. Supernatants from P. distasonis co-cultured with cholic acid (4 mM and 8 mM) significantly inhibited C. difficile growth, toxin expression and spore formation, with deoxycholic acid identified as the key inhibitory metabolite. Both live P. distasonis and its culture supernatant alleviated disease severity in CDI mouse models and ameliorated gut microbiota dysbiosis. Notably, the relative abundance of Parabacteroides goldsteinii was increased following supernatant treatment. Furthermore, intervention with either live P. distasonis or its supernatant elevated the level of hyodeoxycholic acid. In summary, P. distasonis acts as a potential probiotic that alleviates CDI by ameliorating gut microbiota dysbiosis and remodeling bile acid metabolism. These findings provide experimental evidence for its use as a microbiota-based therapeutic strategy.

01 Dec 2026·JOURNAL OF MEMBRANE BIOLOGY

Peptide-Assisted Membrane Permeabilization: Effects of Waveform Polarity, Inter-Monopulse Interval, and Surface Charge in Red Blood Cells and Planar Lipid Bilayers

Article

Author: Lemeshko, Victor V ; Alvarez-Bustamante, José Alexander ; Ortiz-Mejía, Diego

Permeabilization of biomembranes by polycationic peptides is known to depend on the membrane potential, although the exact mechanism of this process is not yet completely defined, to be effectively controlled. We quantified peptide-assisted permeabilization of red blood cells (RBCs) using a custom system that delivered microsecond bipulses configured as bimonopolar (BMP; same polarity) or bipolar (BP; opposite polarity), varying the inter-monopulse interval ([Formula: see text]). In RBC suspensions, bulk light transmittance at 650 nm showed that BMP yielded higher permeabilization effect than BP at short [Formula: see text], whereas lengthening [Formula: see text] mitigated bipolar cancellation and increased BP responses. Membrane surface charge modulation by moderate concentrations of deoxycholate and spermine increased and decreased, respectively, membrane permeabilization effects of polycationic peptides. Complementary measurements in planar lipid bilayers (BLMs) under an applied command voltage ([Formula: see text]) with polarity alternation showed remarkable conduction at negative bias, essentially decreased in the presence of 1 mM Mg²⁺. Infrared thermometry over RBC suspension revealed modest heating (≈ 2.5-6 °C), equal for BMP and BP applications, indicating an electrical rather than thermal origin for waveform effects. Finally, the designed electroporation protocols allow controlled short-time permeabilization of cell membrane that might be useful for biotechnological applications and therapeutic delivery.

News (Medical) associated with Deoxycholic Acid

14 Apr 2026

·www.adhexpharma.com

Buccal delivery of peptides: a new publication from the BUCCAL-PEP consortium

by Nicolas Rollet on Apr 14, 2026 8:43:48 AM A new scientific article has been published in Carbohydrate Polymers as part of the European BUCCAL-PEP consortium, of which AdhexPharma is a partner. This study, led by Sandeep Karki from University College Dublin in collaboration with several consortium partners, including AdhexPharma and Dr Nicolas Rollet, presents the development of a pullulan-based bilayer film for the buccal delivery of a GLP-1 peptide analogue. This approach uses epithelial permeation enhancers to improve peptide absorption. Read the article: https://doi-org.libproxy1.nus.edu.sg/10.1016/j.carbpol.2026.125064 Figure 1 : Design of an oral bilayer buccal film (OBF) [1] Therapeutic peptides offer significant clinical potential, but their administration is still often limited by the need for injection or by the challenges associated with conventional oral dosage forms. The buccal route represents a promising alternative, as it can partially bypass gastrointestinal degradation and first-pass hepatic metabolism. In this study, researchers developed a bilayer buccal film designed to improve the local delivery and permeation of a GLP-1 analogue across the buccal mucosa. The buccal route can help overcome gastrointestinal degradation and first-pass metabolism, offering several advantages: Painless, non-invasive administration No complex fasting or water intake requirements (unlike oral semaglutide) Rapid mucosal absorption Reduced dosing variability However, peptides generally show very low permeability across the buccal epithelium, which makes the development of new formulation technologies essential. [4] [5] The innovation behind the bilayer film [6], [7] The researchers developed a bilayer film made of two complementary layers: 1. Mucoadhesive Layer (facing the cheek mucosa) Polymers tested: Pullulan, HPMC, PVA Selected combination: Pullulan + Sodium Carboxymethyl cellulose (NaCMC) GLP-1 RA peptide Sodium glycodeoxycholate (GDC), a bile salt permeation enhancer GLP-1 RA peptide Sodium glycodeoxycholate (GDC), a bile salt permeation enhancer 2. Backing Layer (saliva repellent) Made with Eudragit® RLPO Directs drug release toward the epithelium, preventing loss via saliva Encouraging ex vivo results [8] Pullulan-based film outperformed all others Best mucoadhesion, mechanical strength, and surface morphology Fastest disintegration of the mucoadhesive layer Highest and most consistent drug release profile Best mucoadhesion, mechanical strength, and surface morphology Fastest disintegration of the mucoadhesive layer Highest and most consistent drug release profile Optimal peptide–enhancer ratio identified Using ex vivo porcine tissue: A 1:2 ratio (GLP-1 RA:GDC) produced the highest peptide permeation (~6% at 3 h). A 1:2 ratio (GLP-1 RA:GDC) produced the highest peptide permeation (~6% at 3 h). Effective ex vivo permeation from films Single-layer films (no backing): ~4.5% flux at 3 h Bi-layer films (clinical candidate): ~2% flux at 3 h Backing layer reduces immediate release but enhances controlled, unidirectional absorption. Single-layer films (no backing): ~4.5% flux at 3 h Bi-layer films (clinical candidate): ~2% flux at 3 h Backing layer reduces immediate release but enhances controlled, unidirectional absorption. Minimal tissue damage The bi-layer architecture moderated GDC exposure Histology showed preserved epithelial integrity Confocal imaging confirmed controlled penetration The bi-layer architecture moderated GDC exposure Histology showed preserved epithelial integrity Confocal imaging confirmed controlled penetration Chemical and structural stability Both peptide and GDC remained stable for at least 1 month at 4°C Circular dichroism confirmed preserved αhelical peptide structure Both peptide and GDC remained stable for at least 1 month at 4°C Circular dichroism confirmed preserved αhelical peptide structure An important milestone for non-invasive peptide therapies [9], [10] This study represents the first demonstration of co-formulating a GLP-1 analogue and sodium glycodeoxycholate in a pullulan-based bilayer film capable of improving buccal permeation. This technology could help advance therapeutic approaches in: Type 2 diabetes Obesity Other peptide-treated conditions It may also help address adherence challenges associated with injectable therapies and the strict administration requirements of oral semaglutide. Conclusion This pullulan-based bilayer film platform represents a promising and patient-friendly approach for the controlled buccal delivery of non-injectable therapeutic peptides. Thanks to its robust mechanical properties, excellent mucoadhesion, and significant improvement in peptide permeation, it could pave the way for a new generation of peptide therapies. [1] S. Karki et al., « A pullulan-based bilayer film for buccal delivery of a GLP-1 peptide analogue », Carbohydr. Polym., vol. 380, p. 125064, mai 2026, doi: 10.1016/j.carbpol.2026.125064. [2] B. J. Teubl, M. Absenger, E. Fröhlich, G. Leitinger, A. Zimmer, et E. Roblegg, « The oral cavity as a biological barrier system: Design of an advanced buccal in vitro permeability model », Eur. J. Pharm. Biopharm., vol. 84, no 2, p. 386‑393, juin 2013, doi: 10.1016/j.ejpb.2012.10.021. [3] B. J. Teubl, M. Absenger, E. Fröhlich, G. Leitinger, A. Zimmer, et E. Roblegg, « The oral cavity as a biological barrier system: Design of an advanced buccal in vitro permeability model », Eur. J. Pharm. Biopharm., vol. 84, no 2, p. 386‑393, juin 2013, doi: 10.1016/j.ejpb.2012.10.021. [4] F. Veuillez, Y. N. Kalia, Y. Jacques, J. Deshusses, et P. Buri, « Factors and strategies for improving buccal absorption of peptides », Eur. J. Pharm. Biopharm., vol. 51, no 2, p. 93‑109, mars 2001, doi: 10.1016/S0939-6411(00)00144-2. [5] S. Malhotra, T. Lijnse, E. O. Cearbhaill, et D. J. Brayden, « Devices to overcome the buccal mucosal barrier to administer therapeutic peptides », Adv. Drug Deliv. Rev., vol. 220, p. 115572, mai 2025, doi: 10.1016/j.addr.2025.115572. [6] S. Karki, H. Kim, S.-J. Na, D. Shin, K. Jo, et J. Lee, « Thin films as an emerging platform for drug delivery », Asian J. Pharm. Sci., vol. 11, no 5, p. 559‑574, oct. 2016, doi: 10.1016/j.ajps.2016.05.004. [7] D. J. Brayden et V. Stuettgen, « Sodium glycodeoxycholate and sodium deoxycholate as epithelial permeation enhancers: in vitro and ex vivo intestinal and buccal bioassays », Eur. J. Pharm. Sci., vol. 159, p. 105737, avr. 2021, doi: 10.1016/j.ejps.2021.105737. [8] S. Karki et al., « A pullulan-based bilayer film for buccal delivery of a GLP-1 peptide analogue », Carbohydr. Polym., vol. 380, p. 125064, mai 2026, doi: 10.1016/j.carbpol.2026.125064. [9] Z. Zheng et al., « Glucagon-like peptide-1 receptor: mechanisms and advances in therapy », Signal Transduct. Target. Ther., vol. 9, no 1, p. 234, sept. 2024, doi: 10.1038/s41392-024-01931-z. [10] « Glucagon‐like peptide agonists: A prospective review - Mariam - 2024 - Endocrinology, Diabetes & Metabolism - Wiley Online Library ». [En ligne]. Disponible sur: https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/10.1002/edm2.462

18 Mar 2026

·www.biospace.com

Sensorion Reports Full-Year 2025 Results, Provides Corporate Update and Announces Release of Annual Report

GJB2-GT (SENS-601) CTA/IND-enabling studies progress, supported by regulatory interactions with FDA and EMA since Q3 2025, and on track for CTA submission in H1 2026 SENS-501 Audiogene trial ongoing; six-month efficacy data expected in Q1 2026 Strengthened balance sheet and shareholder registry via €60m financing in January 2026, including a €20m strategic investment from Sanofi; cash runway extended to end of H1 2027 MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reported its full-year 2025 results, provided a corporate update, and announced the availability of the annual report. “This past year has been an exceptional period of progress across our pipeline and on the corporate development front.” commented Amit Munshi, Chairman and Interim Chief Executive Officer of Sensorion . “Our GJB2 gene therapy program continued to advance toward CTA/IND submission, supported by regulatory interactions with the FDA and EMA, targeting the largest cause of genetic congenital deafness, responsible for approximately 50% of autosomal recessive non-syndromic congenital hearing loss. With no approved gene therapy currently available for GJB2-related hearing loss, SENS-601 has the potential to be the first-in-human gene therapy addressing GJB2 mutations. On the financial side, we executed a successful financing totaling over €60 million, led by a strategic investment from Sanofi with participation from existing and new investors, strengthening our balance sheet and shareholder registry to finance the next steps of our gene therapy development. We welcome Sanofi, a renowned pharmaceutical player active in the gene-therapy space, and some of the healthcare sector’s leading institutional investors to our shareholder registry. I would like to thank former CEO, Nawal Ouzren, for her contributions to Sensorion. The Board and management team remain fully focused on execution and we head into 2026 well positioned to deliver on our clinical and corporate plan, and on behalf of the entire team, I extend my gratitude to our longstanding shareholders, to the patients, and to the physicians for their continued support as we remain committed to bringing transformative therapies for patients suffering from hearing disorders.” Pipeline Highlights and Upcoming Milestones Gene Therapies for Hereditary Monogenic Hearing Loss In 2025, Sensorion advanced its portfolio of gene therapies developed in collaboration with the Institut Pasteur. The Company achieved several notable milestones with SENS-501, for the treatment of hearing loss caused by otoferlin deficiency. SENS-501: Gene therapy program to restore hearing in OTOF patients Sensorion’s SENS-501 dual vector AAV (adeno-associated virus) gene therapy product aims to restore hearing in patients with mutations in OTOF gene who suffer from severe to profound sensorineural prelingual non syndromic hearing loss. Otoferlin related hearing loss is responsible for up to 8% of all cases of congenital hearing loss, with around 20,000 people affected in the US and Europe 1 . Following the completion of the first Cohort enrollment in December 2024, the Audiogene Phase 1/2 clinical trial of SENS-501 received a positive recommendation from the Data Monitoring Committee (DMC) in February 2025 after a review of initial safety data. Preliminary results announced in July 2025 confirmed that the intracochlear administration of a low dose of SENS-501 (1.5E11 vg/ear) was well-tolerated in infants and toddlers aged 6 to 31 months, with no serious adverse events reported, and early clinical efficacy signals were observed, including positive ABR and PTA responses in Cohort 1. Sensorion completed enrollment for the second Cohort in July 2025 and received a further positive DMC safety recommendation. As announced in December 2025, early directional improvements were observed in Cohort 2, with two of the three treated patients showing hearing threshold gains by Month 3 reaching approximately 60 and 70 dB HL at best-performing frequencies respectively. The Company announced it will review the upcoming six-month efficacy data and will communicate during Q1 2026 once the dataset has reached sufficient maturity. GJB2-GT: Gene therapy program to restore hearing in GJB2 patients Sensorion's AAV-based GJB2 gene therapy program developed in collaboration with the Institut Pasteur, has the potential to address three pathologies related to GJB2 mutations: pediatric congenital deafness, progressive forms of hearing loss in children, and early onset of presbycusis in adults. The Company first released GJB2-GT Proof-of-Concept data at the European Society of Cell & Gene Therapy (ESGCT), which took place in October 2024, in Rome, Italy, and has since been advancing the program towards the clinic. In September 2025, as part of its half year results announcement, the Company indicated that to support the CTA submission, Sensorion started preliminary discussions with the American and European regulatory agencies in Q3 2025. The CTA enabling studies are progressing well and the program is on track for CTA filing during H1 2026. SENS-401, Sensorion’s small molecule for the treatment and prevention of hearing loss SENS-401 (Arazasetron) is a small molecule that Sensorion develops in three indications: (i) to treat Sudden Sensorineural Hearing Loss SSNHL (Phase 2b completed), (ii) to prevent residual hearing loss following cochlear implantation, in partnership with Cochlear Limited (Phase 2a completed), and (iii) to prevent Cisplatin-Induced Ototoxicity (Phase 2a completed). SENS-401 is orally available and aims to protect and preserve the inner ear tissue from damage, responsible for hearing impairment. SENS-401 has been granted Orphan Drug Designation by in Europe for the treatment of SSNHL, and in the U.S. for the prevention of Cisplatin-Induced Ototoxicity in pediatric population. In 2019, the French government awarded the PATRIOT consortium a Structuring Research and Development Project for Competitiveness (“Projet de recherche et développement Structurant pour la Compétitivité” - PSPC) non-dilutive funding for the development of the SENS-401 program for the treatment of SSNHL. As such, Bpifrance granted Sensorion a repayable advance and a grant in connection with its participation, as part of a consortium, in the “PATRIOT” Project. During the second half of 2025 following a request by the consortium to adjust the project scope, Bpifrance and the consortium were unable to reach agreement on revised terms, resulting in the conclusion of the project and its related funding. In January 2026, a review of eligible expenses under the project identified an amount of €0.3 million, to be returned by Sensorion. Sensorion is currently in discussions with Bpifrance regarding the terms for the repayment of the €1.3 million repayable advance received (net of the above adjustment). SENS-401 to prevent Cisplatin-Induced Ototoxicity (CIO) Cisplatin and other platinum compounds are essential chemotherapeutic agents for many malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to 50-60% 2 of adult patients and 90% of pediatric patients who survive cancer. The NOTOXIS Phase IIa trial is an exploratory, multicenter, randomized, controlled, open-label study designed to characterize the natural history of cisplatin-induced ototoxicity, to document oncologist prescribing practices, and explore whether SENS-401 may have a potential role in preventing ototoxicity in adult patients with neoplastic disease four weeks after completion of cisplatin-based chemotherapy. End of study data confirmed the favourable safety pro all patients treated with cisplatin with no new adverse event or serious adverse events related to SENS-401 reported after 23 weeks of twice-daily oral exposure. Primary analysis showed comparable change in hearing thresholds from baseline to the end of treatment in both arms. Subgroup and post hoc analyses reproduced the trend observed at the World Congress of Audiology (WCA) 2024, suggesting a potential benefit of SENS-401 in patients exposed to the highest cumulative cisplatin doses. These insights are intended to inform potential next steps for the overall development plan for SENS-401. Board of Directors and senior leadership On April 2, 2025, Sensorion announced the appointment of Amit Munshi as Chairman of the Board and Independent Director, succeeding John Furey who stepped down as Independent Board Member. Mr. Munshi also replaced Khalil Barrage, who had served as interim Chairman since March 31, 2023 and continued as a Board director. This appointment was performed by way of co-optation and subsequently ratified by shareholders at the Company's General Meeting in May 2025. Mr. Munshi brings over 35 years of healthcare industry experience, with a track record of leading biotech companies through transformational growth and landmark exits. He most recently served as CEO of Orna Therapeutics (and previously ReNAgade Therapeutics, acquired by Orna in May 2024). As President and CEO of Arena Therapeutics (Nasdaq: ARNA) from 2016, he led the company's transformation into a late-stage clinical organization culminating in its $6.7 billion acquisition by Pfizer in March 2022, having also spun-out assets into Longboard Therapeutics (Nasdaq: LBPH; acquired by Lundbeck for $2.6 billion). Earlier, as co-founder and Chief Business Officer of Kythera Biopharmaceuticals (Nasdaq: KYTH), he identified the lead asset Kybella®, led multiple financing rounds, and completed a $370 million ex-North America license with a Bayer division, before KYTH's $2.1 billion acquisition by Allergan in June 2015. Mr. Munshi also held leadership roles at Amgen Inc., including General Manager of European Nephrology based in Switzerland. He holds an MBA from The Peter Drucker Graduate School of Management at Claremont Graduate University and a BA in History and BS in Quantitative Economics from UC Riverside. On February 17, 2026, Sensorion announced that Nawal Ouzren, Sensorion’s Chief Executive Officer and a Director on the Company’s Board, was stepping down from both roles due to a personal matter incompatible with serving as Chief Executive Officer. Amit Munshi, who is serving as the Chairman of Sensorion is also assuming the role of Interim Chief Executive Officer and Ms. Ouzren will remain temporarily as a consultant to the Company to ensure an effective transition. The Board has commenced its search for a permanent Chief Executive Officer. Strengthening Sensorion’s capital position On January 28, 2026, Sensorion announced a €60 million offering reserved to specific categories of investors through the issuance of 214,285,714 new ordinary shares of the Company at a price per New Share of €0.28 to the benefit of Sanofi for €20 million, and Redmile Group, Artal, which is advised by Invus, and Sofinnova Partners, existing shareholders, and other investors including Cormorant Asset Management, Coastlands Capital and Sphera Healthcare, for €40 million. Expected future milestones and estimated timelines Q1 2026 – SENS-501: Cohort two 6-months follow-up data of Phase 1/2 Audiogene trial H1 2026 – SENS-601 (GJB2-GT): Clinical Trial Application Submission Full Year 2025 financial highlights Cash Position Cash & Cash Equivalents amounted to c. €47.5m as of December 31, 2025, compared to €77.0m as of December 31, 2024, which included at year‑end 2024 a €10.2m short‑term deposit classified as other current assets. Research And Development (R&D) Expenses R&D expenses increased by 12 % from €25.7 million in 2024 to €28.8 million in 2025. General And Administrative (G&A) Expenses G&A expenses were €7.7 million in 2025, compared to €9.4 million in 2024. Net Loss Net loss was -€29.4 million in 2025, compared to -€26.0 million in 2024. Financial guidance Based on cash and cash equivalents of €47.5 million as of December 31, 2025, and a private placement of €60 million, with net proceeds of around €56 million (received on January 30, 2026) announced on January 28, 2026, at the date of the closing of the accounts, the Company has sufficient net working capital to meet its cash requirements beyond the next twelve months, i.e. until the end of June 2027. Financial results The annual accounts as of December 31, 2025, were prepared according to IFRS standards and approved by the Board of Directors on March 17, 2026. The simplified income statement as of December 31, 2025, is as follows: In thousands of Euros – IFRS standards 31.12.2025 31.12.2024 Operating income 5,814 6,653 Research & Development expenses -28,840 -25,664 General & Administrative expenses -7,727 -9,390 Total operating expenses -36,567 -35,054 Operating loss -30,753 -28,401 Financial result 1,328 2,555 Corporate Income Tax -4 -126 Net loss -29,429 -25,972 The simplified balance sheet as of December 31, 2025, is as follows: In thousands of Euros – IFRS standards 31.12.2025 31.12.2024 Non-current Assets 2,997 3,574 Other Current Assets 7,433 18,934 Of which short term deposit - 10 214 Cash & cash equivalent 47,457 66,769 Total Assets 57,887 89,277 Equity 44,479 72,138 Non-current Liabilities 1,441 3,486 Current Liabilities 11,966 13,653 Total Liabilities 57,887 89,277 2025 certified accounts On March 17, 2026, the Board of Directors approved the Company’s full year results as of December 31, 2025. The Full Year Report can be found on Sensorion’s website ( ) in the investor section under financial information. The full year accounts of 2025 have been subject to an audit by the Company’s statutory auditors, and an unqualified report is being issued. About SENS-501 SENS-501 (OTOF-GT) is an innovative gene therapy program developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. This gene plays a key role in the transmission of auditory signals between the hair cells of the inner ear and the auditory nerve. When this gene is defective, affected individuals are born with severe to profound hearing loss. The aim of SENS-501 (OTOF-GT) is to restore hearing by introducing a functional copy of the OTOF gene directly into hair cells via viral vector technology (AAV). This therapy aims to restore the normal process of converting sound into electrical signals, enabling patients to regain their hearing ability. Currently in the clinical research phase, this gene therapy program represents significant hope for families affected by this rare form of genetic deafness. SENS-501 (OTOF-GT) embodies a commitment to scientific innovation in the field of hearing, with the potential to dramatically improve the quality of life of patients suffering from genetic deafness. This gene therapy for patients suffering from otoferlin deficiency has been developed in the framework of RHU AUDINNOVE, a consortium composed of Sensorion with the Necker Enfants Malades Hospital, the Institut Pasteur, and the Fondation pour l’Audition. The project is partially financed by the French National Research Agency, through the “investing for the future” program (ref: ANR-18-RHUS-0007). About the Audiogene Trial Audiogene aims to evaluate the safety, tolerability and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing loss in infants and toddlers aged 6 to 31 months at the time of gene therapy treatment. By targeting the first years of life, when brain plasticity is optimal, the chances of these young children with pre-linguistic hearing loss acquiring normal speech and language are maximized. The study comprises two cohorts of two doses followed by an expansion cohort at the selected dose. While safety will be the primary endpoint of the first part of the dose escalation study, auditory brainstem response (ABR) will be the primary efficacy endpoint of the second part of the expansion. Audiogene will also evaluate the clinical safety, performance and ease-of-use of the delivery system developed by Sensorion. About SENS-401 SENS-401 (Arazasetron), Sensorion’s clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion developed SENS-401 in three Phase 2 clinical trials: (i) for the prevention of Cisplatin-Induced Ototoxicity, (ii) to prevent residual hearing loss in patients scheduled for cochlear implantation, and (iii) to treat sudden sensorineural hearing loss. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population. About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve the diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion’s small molecule progressed in three Phase 2 proof of concept clinical study: firstly, in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing, completed in Q1 2026. Secondly, with partner Cochlear Limited, a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation, completed in 2024. Thirdly, a Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in 2022. Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2025 full year report published on March 18, 2026, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. 1 Rodríguez-Ballesteros M, Reynoso R, Olarte M, Villamar M, Morera C, Santarelli R, Arslan E, Medá C, Curet C, Völter C, Sainz-Quevedo M, Castorina P, Ambrosetti U, Berrettini S, Frei K, Tedín S, Smith J, Cruz Tapia M, Cavallé L, Gelvez N, Primignani P, Gómez-Rosas E, Martín M, Moreno-Pelayo MA, Tamayo M, Moreno-Barral J, Moreno F, del Castillo I. A multicenter study on the prevalence and spectrum of mutations in the otoferlin gene (OTOF) in subjects with nonsyndromic hearing impairment and auditory neuropathy. Hum Mutat. 2008 Jun;29(6):823-31. doi: 10.1002/humu.20708. PMID: 18381613. 2 JCO Oncology practice, ASCO, volume 19, Issue 5/ CIO: a concise review of the burden, prevention and interception strategies, May 2024 Chattaraj. Contacts Investor Relations Sensorion Nicolas Bogler, Investor Relations and Communication ir.contact@sensorion-pharma.com Press Relations Maarc Communication Bruno Arabian / 00 33(0)6 87 88 47 26 bruno.arabian@maarc.fr

Phase 2Executive ChangeAcquisitionClinical ResultOrphan Drug

01 Aug 2024

·www.prnewswire.com

Sirnaomics Announces a Partnership with Gore Range Capital for Establishment of a JV, Sagesse Bio, to Advance Its RNAi Therapeutics into Aesthetic Medicine

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, July 31, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the " Company", Stock Code: 2257.HK, together with its subsidiaries, the " Group" or " Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced a partnership with Gore Range Capital LLC (" Gore Range Capital") (Dallas, TX, USA) for establishment of a joint venture, Sagesse Bio, Inc., to advance its novel RNAi therapeutic products into aesthetic medicine. Sagesse Bio, Inc., a Delaware corporation (" Sagesse Bio"), combines the strength of Sirnaomics' leadership in RNAi-based technology and product development for focal fat reduction and Gore Range Capital's world leading expertise in skin health industry and financial resources, to accelerate clinical development of the company's innovative products for addressing a fast-growing aesthetic medicine market. Sagesse Bio will rapidly advance Sirnaomics lead compound that is IND-enabled and currently in Phase II clinical trials for other indications. Initial indications of interest include body contouring and fat reduction. The founders, board of directors, and newly established executive management team of Sagesse Bio are comprised of a group of well-accomplished senior executives from skin health industry, world-renowned clinicians in dermatology and aesthetic medicine, and leading experts in RNAi medicine. The strategic goal of Sagesse Bio is to become a world-leading aesthetic medicine company with innovative technologies and aesthetic products. Frederick Beddingfield, MD, PhD, serving as Chairperson of the board of directors of Sagesse Bio, is an internationally renowned dermatologist and expert in biopharma and the aesthetics industry, who has led the development of global leading brands such as BOTOX®, JUVEDERM®, LATISSE® and KYBELLA®. He served as Chief Medical Officer of Allergan Medical and Kythera, and as CEO of Sienna Bio and Kira Pharmaceuticals, and currently serves on the board of directors of Cytrellis Biosystems. Dr. Beddingfield stated: "I could not be more excited to help lead and build Sagesse Bio. We have an amazing team with the right experience and a unique opportunity based on the finding of adipocytolysis with good tolerability in human clinical studies, to rapidly advance our IND-approved lead product." Mr. Humberto Antunes, co-founder of Sagesse Bio, partner of Gore Range Capital, former Chairman and CEO of Galderma/Nestlé Skin Health, an internationally renowned executive in skin health industry, comments: "The strategic goal of Sagesse Bio is to deliver innovative and life changing therapies to patients with an initial emphasis on focal fat destruction." "We are thrilled to build this historic partnership: RNAi therapeutic candidate is moving into medical aesthetic product development for body contouring," commented Dr. Patrick Lu, founder, Chairman of the board, executive director, President and CEO of Sirnaomics. "The joint expertise and resources from both Sirnaomics and Gore Range Capital are setting up a strong foundation for a tremendous growth potential of Sagesse Bio with its accelerated product development speed." The board of directors of the Company has approved, and the board of directors and the stockholders of Sagesse Bio have approved, a series of agreements in relation to the partnership (the "Agreements"). The Company and Sagesse Bio have signed the Agreements, which shall become effective only upon being approved by the shareholders of the Company at an upcoming general meeting. Under the partnership arrangement, Sagesse Bio will initiate a clinical evaluation immediately for its leading product candidate, SGY-101, with scientific and technical support from Sirnaomics, receiving assignment and licensing of certain relevant intellectual property rights for the licensed product. In return, Sirnaomics will receive milestone payments of up to US$33 million and a majority equity position of Sagesse Bio with value of approximately US$36 million upon successful equity or debt financing in the future at a minimum pre-financing valuation of Sagesse Bio at US$60 million. Gore Range Capital is responsible for initial funding and building the executive management team and advisory board. In addition, with its well-built domain expertise and extensive networks in the skin health industry, Gore Range Capital is able to provide a hands-on approach for Sagesse Bio's fundraising and business development challenges. About Gore Range Capital Gore Range Capital is focused on investments in the skin health businesses. Gore Range's approach is simple: "We invest in what we know." Over the course of their respective careers the Gore Range team has built domain expertise and extensive networks across multiple areas of healthcare. Through Gore Range Capital, capabilities are channeled to focus on the largest organ and the most visible manifestation of personal identity: the skin. At Gore Range, the hands-on approach of operationally focused private equity is blended with the early-stage guidance needed in venture capital. Formed in 2015, Gore Range works closely with portfolio companies and industry leaders to bring skin health innovations to market. To accomplish this mission, Gore Range leverages its team of experienced healthcare investors, leaders, and practitioners to bring strategic, financial and scientific expertise to its investments. Learn more at: . About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Company's GalAhead™ mxRNA technology, is currently in Phase I development. STP237G is the first dual-targeted drug based on a GalAhead™ muRNA technology and is in the late stage of preclinical development. The Company has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the establishment of the it manufacturing facility in China, Sirnaomics is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: . CONTACT: USA Media Contact: George Ji, MBA Head of Finance and Administration Email: [email protected] Asia Media Contact: Johnson Shen, M.A. Senior Business Manager for Investor Relations Email: [email protected] SOURCE Sirnaomics

Phase 1Phase 2

100 Deals associated with Deoxycholic Acid

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KEGG	Wiki	ATC	Drug Bank
D10781	Deoxycholic Acid	D11AX24	DB03619

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Localized obesity	United States	AbbVie, Inc.	29 Apr 2015

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Lipoma	Phase 2	United States	Kythera Biopharmaceuticals LLC	01 Nov 2007
Lipid Metabolism Disorders	Phase 1	United States	Kythera Biopharmaceuticals LLC	01 Nov 2008

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03510598 (CMK, CTgov)	Phase 4	Lipid Metabolism Disorders	16	Kybella	riskgvnygm = eixkaasbkp wqvmxnrhyg (iilrucxsng, wsxcvienbc - zjjlfatmjn) View more	-	30 Dec 2021
NCT03712449 (CTgov)	Phase 4	-	59	SkinMedica+BELKYRA®+BOTOX Cosmetic® (BELKYRA Treatment)	avqcxhidjt(uqhnllnazb) = nyjayeeyxj gypcvlobhg (rhouoirtid, 16.79) View more	-	25 Aug 2021
NCT03712449 (CTgov)	Phase 4	-	59	SkinMedica+BOTOX Cosmetic® (Non-BELKYRA Treatment)	avqcxhidjt(uqhnllnazb) = dqyiixdapf gypcvlobhg (rhouoirtid, 10.96) View more	-	25 Aug 2021
NCT02163902 (REFINE, Pubmed \| Aesthet Surg J)	Phase 3	Maintenance	224	ATX-101	nlvhxjkqoe(flzeshbavz) = nijcwixcwq fyiesbnqiz (unnobychfz ) View more	Positive	22 Feb 2021
NCT02163902 (REFINE, Pubmed \| Aesthet Surg J)	Phase 3	Maintenance	224	Placebo	nlvhxjkqoe(flzeshbavz) = niwcffdhoi fyiesbnqiz (unnobychfz ) View more	Positive	22 Feb 2021
NCT03425253 (JAWLINE, CTgov)	Phase 4	-	58	Juvéderm® VOLUMA™ with Lidocaine+BELKYRA®	ohvakvztrs = hgjeunwcki ghdnipqqle (gegpaofayh, vooifyhloe - xyntonwkic) View more	-	31 Dec 2020
NCT04054011 (CTgov)	Early Phase 1	Obesity	15	Deoxycholic Acid	kkznskqjfu = qrjnuasxdj beerktahhk (uccjtsdtxw, uyjoxzavxr - pjqgmcfylp) View more	-	13 Nov 2020
NCT02163902 (REFINE, CTgov)	Phase 3	-	224	Placebo	okrcxsseir = gjhcwbotuy vclncwzikw (vnmxofhcdz, ndauvabslx - pcdmeuhloa) View more	-	17 Feb 2020
NCT02035267 (CTgov)	Phase 3	-	93	ATX-101 (Deoxycholic Acid) (ATX-101 (Deoxycholic Acid) Injection - Grade 1)	loiwqvtcrk = uvuswzanho iyujiceewd (kaffcmdcwf, ounhoxjcrc - gadlzfxikj) View more	-	17 Feb 2020
NCT02035267 (CTgov)	Phase 3	-	93	Placebo (Placebo Injection - Grade 1)	loiwqvtcrk = stlnrsfzii iyujiceewd (kaffcmdcwf, siniuvkmit - mrkzohhaua) View more	-	17 Feb 2020
NCT02123134 (CTgov)	Phase 3	-	55	Placebo	qkfnshrbyu = vgfferdrth lfumimwazl (peyqkuarfj, huqzpyjdfp - zgdzciiytm) View more	-	17 Feb 2020
NCT02159729 (CTgov)	Phase 2	-	205	Placebo	tcjpbeihiv = gzuncbhwib dqehcgqrfl (ethelcydbb, tkigmfqefc - lkxoffvlfb) View more	-	17 Feb 2020
NCT03361176 (CTgov)	Phase 4	Tumescence \| Pain \| Obesity	30	Injectable sodium deoxycholate (Control)	blylwwqeoa = veunhddffn phnxguresf (kkerhjlwch, xbgqkauraq - izobgzzcow) View more	-	09 May 2019
NCT03361176 (CTgov)	Phase 4	Tumescence \| Pain \| Obesity	30	sodium deoxycholate+Triamcinolone acetate (w/ Triamcinolone)	blylwwqeoa = zfkpmkmqzb phnxguresf (kkerhjlwch, tjxxlwtbzi - irxpuhaidg) View more	-	09 May 2019

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