Completes total round at $63 million after initial $50 million last year; key vote of confidence from Dexcom; no updated pivotal timing shared (presumably still 2H19 for insulin-only)
Today, Beta Bionics announced it has closed its Series B financing round with an additional $13 million, adding to the $50 million in funding announced last September. Notably, Dexcom participated as a first-time investor in this final close (amount not shared), a huge win for Beta Bionics – having the CGM company’s financial buy-in is a great sign as the system moves to submission and commercialization.
This also continues Dexcom’s investment moves in automated insulin delivery, including investing in Tandem last February ($5 million) and acquiring TypeZero in August. Abbott similarly invested in Bigfoot Biomedical’s $55 million Series B round (last March), also in the final close.
The funding will support ongoing iLet product development, pivotal studies, and PMA submission. No new pivotal trial or launch timing was shared today, so we assume the last timing shared in our AID Competitive Landscape still stands: (i) an insulin-only pivotal study to start in 2H19; and (ii) a bihormonal pivotal study to start in late 2019/early 2020. Home-use bridging studies have been completed testing the iLet Gen 3 pump with both Dexcom CGM and Senseonics Eversense CGM. The iLet Gen 4 offers an improved form factor and is the commercial device; see more from FFL 2018.
We have been impressed with Beta Bionics commitment to interoperability and patient choice, as it’s the only closed-loop system compatible with two companies’ CGMs, and plans for single hormone, dual hormone, and at least three different insulins (Fiasp, Humalog, Novolog), if all goes well. Moreover, the public benefit corporation has investment from four industry partners – Lilly, Novo Nordisk, Zealand, and Dexcom!
A Helmsley-funded crossover study is also expected to begin next month at MGH, testing Adocia’s ultra-rapid insulin BioChaperone Lispro in the iLet in a home-use, crossover study (up to 30 participants); see Monday’s Adocia announcement and the ClinicalTrials.gov listing.
--by Adam Brown and Kelly Close