On November 19, 2020 Oncopeptides reported that (Press release, Oncopeptides, NOV 19, 2020, View Source [SID1234571424])
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Financial overview July 1 – September 30, 2020
Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 383.4 M (loss: 189.8)
Loss per share, before and after dilution, was SEK 5.71 (loss: 3.53)
On September 30 cash and cash equivalents amounted to SEK 1,251.6 M (1,122.3)
Significant events during the period July 1 – September 30, 2020
The FDA granted priority review of melflufen for patients with triple-class refractory multiple myeloma and set the PDUFA date to February 28, 2021
Patient enrolment in the pivotal phase 3 OCEAN study was completed including 495 patients
Patient enrolment for the phase 1/2 study in AL-amyloidosis began, this is the first study with melflufen in an indication outside multiple myeloma
The phase 2 PORT study evaluating alternative administration of melflufen and dexamethasone in multiple myeloma started
Oncopeptides further coordinated the global and US organizational structure and appointed Mohamed Ladha as General Manager of the US Business Unit
Significant events after the reporting period
Oncopeptides announced that the company intends to submit a conditional marketing authorization application for melflufen in the EU
Oncopeptides entered into a €40 M loan agreement with the European Investment Bank (EIB)
An IND application was submitted to the FDA to initiate clinical studies with OPD5, Oncopeptides’ second drug candidate
This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on November 19, 2020.