Saniona OM:SANION Stock Report

Saniona’S Preclinical Candidate San903 Shows Robust Dampening of Fibrosis in Chronic Kidney Disease Model

Saniona announced that professor Helle Prætorius, Univ. of Aarhus, Denmark, made a presentation at the ECM conference,2022, which shows that SAN903 protects against fibrosisin a chronic kindneydease model. Chronic kidney disease (CKD) is a devastating, progressive deterioration of renal function that significantly impacts the quality of life for the individual and represents a substantial cost for the society. Regardless of the cause of CKD, renal fibrosis is a major component of the disease and is the best predictor of progression to CKD-associated renal failure. Saniona’s collaborator professor Helle Prætorius, MD-PhD, Univ. of Århus, Denmark demonstrated in her presentation that Saniona’s KCa3.1 inhibitor SAN903 dampened renal fibrosis in a mouse model of CKD. When SAN903 was administrated daily during unilateral urinary obstruction the total fibrotic area was reduced by up to 43% (p>0.0001). SAN903 was well tolerated at all doses. SAN903 is a novel, potential first-in-class medicine based on inhibition of the calcium-activated potassium ion channel, KCa3.1. This ion channel is found in immune cells and fibroblasts where it participates in the control of cell proliferation and migration as well as cytokine and collagen production. Previous studies have indicated that KCa3.1 inhibition may reduce inflammation and fibrosis in various diseases. Saniona expects to complete regulatory preclinical development mid 2022 and to initiate Phase 1 clinical trials end 2022 or early 2023.

Saniona Provides Update on Ongoing Review of Tesofensine in Mexico

Saniona announced that the Mexican regulatory authority Comisión Federal para la Protección contra RiesgosSanitarios (COFEPRIS) has published on Twitter that its technical committee on new molecules (El Comité de MoléculasNuevas) was unable to provide a favorable opinion on tesofensine following a meeting held on May 18, 2022. The statement on Twitter does not provide any details or explanation for the position taken. As part of the ongoing review process, the tesofensine application was reviewed by a COFEPRIS technical committee on new molecules on May 18, 2022. Saniona’s partner Productos Medix, S. A de S.V, (Medix) has not received any official statement from COFEPRIS yet. Therefore, Medix is not able to comment on this statement and the possible implication for pursuing the process of seeking approval for tesofensine in Mexico.

Saniona Appoints Anita Milland as Chief Financial Officer, Effective April 30, 2022

Saniona Announces Voluntary Pause of Phase 2B Clinical Trials of Tesomet for Hypothalamic Obesity and Prader-Willi Syndrome

The board of Saniona has resolved to implement multiple actions including a voluntary pause of the Phase 2b clinical trials of Tesomet for hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) and a workforce reduction of approximately 30%. The decision to voluntarily pause the Phase 2b clinical trials of Tesomet is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The decision to voluntarily pause the Phase 2b clinical trials of Tesomet for HO and PWS is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The Tesomet programs previously achieved highly encouraging results in initial Phase 2 trials, and the international Phase 2b trials were by far the largest expenditure for the company. Saniona will continue its ongoing Phase 1 clinical trial of SAN711, which is expected to deliver data by the end of the first half of 2022. The company will also continue to invest in its ion channel drug discovery engine, including SAN903, which is expected to enter Phase 1 clinical trials in the second half of 2022, and discovery research efforts, which are expected to result in a new ion channel modulator advancing into the preclinical pipeline in 2022. Saniona will also continue to pursue strategic financing options and expand its business development efforts to include opportunities that could allow Tesomet to advance.