Provention Bio Inc. (PRVB) Misses Q2 EPS by 17c

Provention Bio Inc. (NASDAQ: PRVB) reported Q2 EPS of ($0.45), $0.17 worse than the analyst estimate of ($0.28).

"In the past few months, we have achieved tremendous progress in support of our efforts to advance teplizumab toward the market for the delay or prevention of insulin-dependent type 1 diabetes (T1D) in presymptomatic patients," stated Ashleigh Palmer, CEO, Provention Bio. "New data presented at the American Diabetes Association conference from the "At-Risk" TN-10 study strengthened the value proposition for teplizumab, with long-term data now showing that teplizumab delays the onset of insulin-dependent T1D by approximately three years versus placebo, adding one year to the two-year delay presented in 2019. In addition, treatment with teplizumab significantly reversed the decline of C-peptide levels, providing further evidence of the disease-modifying potential of teplizumab."

"We remain laser focused on submitting the clinical module of our rolling BLA submission in Q3 2020 and completing the remaining modules in Q4 2020. We are pleased to report today that we have successfully completed the commercial-scale drug substance process performance qualification (PPQ) campaign, a key gating factor for our chemistry, manufacturing and controls (CMC) module. We strengthened our financial position with a successful financing in June, which resulted in net cash proceeds of $103.3 million. We continue to scale our organization in preparation for a potential commercial launch and we are well-positioned to execute our strategy to bring teplizumab to the T1D community as soon as possible."

For earnings history and earnings-related data on Provention Bio Inc. (PRVB) click here.

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