With a clear path forward for Tesomet in HO and PWS, we look forward to initiating our phase IIb trials in the first half of this year, as planned. We also plan to initiate a phase I trial of SAN711 in the first half. Further, our partner Medix has stated that they are confident that the Mexican health authority’s review of tesofensine for weight management is moving forward, and they expect a decision in early 2021

As part of our process of submitting for Orphan Drug Designatiuons, we have recently conducted new analyses to verify the size of the PWS and HO patient populations. We do believe both of these indications, while clearly rare diseases, may impact more people than we initially suspected

Saniona is currently in the strongest position this company has ever been in. We have a cash runway to last us to the second half of 2022, we have the financial and operational support as well as the expertise on board that we need to advance our strategic activities

We are in communication with the FDA on both the PWS and HO clinical programs, and we are also working with our team of clinical research organizations and contract manufacturers to prepare to initiate these studies. We look forward to starting the trials as expeditiously as possible

We have been engaging in encouraging discussions with the FDA regarding the design of our pivotal programs. We expect to initiate these studies in Q1 2021, with the goal of bringing to market the first approved medicine to treat these diseases

As we continue to advance Tesomet through late-stage clinical trials, I anticipate adding additional key roles and building out key functions to be able to achieve our goals

Tesomet provides its effect via an established mechanism of action that is relevant to both syndromic and nonsyndromic forms of obesity, providing an avenue to potentially developing the compound across multiple obesity disorders

This is a fantastic milestone for Saniona. We now have proof of concept for Tesomet in two independent severe rare diseases: Prader Willi Syndrome and Hypothalamic obesity – we have hit the goal twice with Tesomet. This not only takes a lot of the clinical risk out of Tesomet but also opens up a much broader market opportunity for us

Detta är ett helt nytt och oberoende avtal, med ett nytt jonkanalmål och med separata milstolpsbetalningar och royalties

Vi har en viktig milstolpe precis runt hörnet: avläsningen av våra fas II-data från Tesomet-studien hos patienter med hypotalamisk fetma. Alla kliniska aktiviteter har avslutats så nu väntar vi bara på topline-data

I en tid av osäkerhet och störningar runt om i världen är vi mycket nöjda med att denna fas IIa-studie av Tesomet fortsätter enligt plan. Studien är en viktig del av det kliniska paket som Saniona sammanställer när vi nu snabbt avancerar Tesomet mot viktiga kliniska studier i den sällsynta ätstörningen hypotalamisk fetma, som en del i vår långsiktiga strategi att bli ett globalt kommersiellt bolag.

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