Press releases

STOCKHOLM — August 29, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the US Food and Drug Administration, FDA, has granted priority review for Oncopeptides´ New Drug Application seeking approval of melflufen (INN melphalan flufenamide), in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients). The FDA has set a PDUFA-date (Prescription Drug User Fee Act), which is the target date for their review of the New Drug Application, to February 28, 2021

Summary Financial overview April 1 – June 30, 2020 Net sales amounted to SEK 0.0 M (0.0) Loss for the period was SEK 401.0 M (loss: 171.9) Loss per share, before and after dilution, was SEK 6.79 (loss: 3.52) On June 30 cash and cash equivalents amounted to SEK 937.8 M (626.8)

STOCKHOLM — August 7, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) announced today that the first patient has been enrolled in the Immunoglobulin Light Chain (AL) amyloidosis (OP201) study. This open-label, phase 1/2 study of melflufen and dexamethasone for patients with AL amyloidosis, following at least one prior line of therapy, is the first study to explore the effect of melflufen outside of multiple myeloma

STOCKHOLM — August 4, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announced that the first patient has been enrolled in the phase 2 PORT study. The study, which is expected to be fully recruited in December 2020, is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma, RRMM. Up to 25 RRMM patients who have received at least two previous lines of therapy will be enrolled

Stockholm —July 31, 2020 — Oncopeptides AB (Nasdaq Stockholm, ONCO) today announces that the number of shares and votes in Oncopeptides has changed as a result of shares being registered due to the directed share issue which was carried out in May 2020 and due to the exercise of warrants under the company’s incentive program

STOCKHOLM — June 30, 2020 — Oncopeptides AB (publ) (“Oncopeptides”) (Nasdaq Stockholm: ONCO) announces that the Board of Directors has appointed Marty J Duvall as Chief Executive Officer, CEO. Marty J Duvall replaces Jakob Lindberg who has been CEO since the restart of the company in 2011. Jakob Lindberg assumes the role as Chief Scientific Officer, CSO, replacing MD Christian Jacques who has held the position as CSO since 2018. Christian will continue as a Senior Advisor.

Stockholm — June 30, 2020 — Oncopeptides AB (Nasdaq Stockholm, ONCO) today announces that the number of shares and votes in Oncopeptides has changed as a result of exercise of warrants under the company’s incentive programs

STOCKHOLM — June 30, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company submits a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen (INN melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody (i.e., triple-class refractory multiple myeloma patients)

STOCKHOLM — June 29, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today that the Company has agreed with Kancera to take over Kancera’s drug development facility in Solna, Sweden. The agreement is an important step in the development of Oncopeptides’ pre-clinical operations and marks an additional reinforcement of the Company´s research capacity. Oncopeptides recruits several employees with pre-clinical expertise from Kancera and takes over the lease contract for laboratory facilities as well as equipment

STOCKHOLM — June 15, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today that the full top-line results from the pivotal phase 2 HORIZON study, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM), have been presented at the ongoing 25[th] European Hematology Association meeting, EHA. The results support the NDA submission to the US Food and Drug Administration, FDA, for accelerated approval of melflufen. The Company is on track to submit the application to FDA by the end of Q2, 2020