Senseonics files to go public on NYSE, hopes to raise up to ~$52 million; US pivotal trial underway; CE Mark still pending for implantable CGM system – January 19, 2016

In an S-1 form just filed with the SEC, Senseonics filed to go public on the NYSE, seeking to raise up to ~$52 million. The move was expected following the company’s reverse merger in December to go public on the OTCBB exchange. While the two filings are very similar, there are a few material updates in the S-1 filing. First, Senseonics is still awaiting a CE Mark for the Eversense system (90-180 day implantable CGM sensor, body-worn transmitter, and mobile app). The company now expects to launch in select European markets in the first half of 2016, potentially back slightly from “early 2016” as of the December update. Second, Senseonics has now initiated its US pivotal trial, which comes on the early side of “1Q16” expectations. The 90-patient study is currently recruiting at Diablo Clinical Research center, with another six to nine sites expected. Study completion is expected by June 2016, with an FDA filing to follow as early as 2H16. The expected 6-18 month FDA review could put US commercialization in mid-2017 to early 2018 at the earliest. As noted in our December coverage, Senseonics plans to commercialize Eversense on its own in the US via a targeted sales force and marketing team. Third, Senseonics had just $3.9 million in cash as of December 31, down from $7.0 million as of September 30. The IPO is obviously critical in funding the US pivotal trial and commercializing Eversense in the US, and we will return with coverage once the offering is priced or if the company goes public. Diabetes technology startups have had mixed IPO success in the past year (e.g., Valeritas: postponed; Asante: withdrawn; Cellnovo: successful), and we look forward to watching what happens with Senseonics. We do believe it’s important for patients to better understand their diabetes management beyond just A1c – additionally, this information is important for providers as well as for those assessing therapies via clinical trials. We believe CGM is key in refining the best therapeutic approaches for patients and while all patients (particularly type 2 patients without hypoglcyemia) do not need ongoing CGM, we do think it is extremely useful for clinical trials to better understand and show what therapies do beyond A1c (ironically, therapies that reduce hypoglcyemia tend to increase A1cs overall, thereby sometimes masking the value of various therapies.) For in-depth pipeline details and more analysis on Senseonics technology and approach, see our December coverage.


-- by Adam Brown and Kelly Close