Press releases

STOCKHOLM — October 14, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the company has entered into a loan agreement with the European Investment Bank (EIB), granting the company access to an unsecured loan facility of up to €40 M. The loan may be used to further support the clinical development of melflufen, and the company’s transition from a R&D company into a fully integrated global biopharmaceutical company

STOCKHOLM — October 12, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM)

STOCKHOLM — October 1, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) announced today that the open-label Expanded Access Program, sEAPort (https://oncopeptides-us.com/en/expanded-access-program/), for eligible U.S. patients, is formally open. Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients)

STOCKHOLM — September 8, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has eliminated an organizational layer to shorten the decision-making process in the US operations and to create closer collaboration between global and local functions. The role as CEO of Oncopeptides, Inc. will no longer be a designated Company function and as a consequence, Joseph Horvat, President of North America and CEO of Oncopeptides Inc., will leave the Company. Mohamed Ladha, current Head of US Commercial Operations, will become General Manager of the US Business Unit and a member of the global Leadership Team of Oncopeptides AB (publ)

STOCKHOLM — September 4, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the last patient has been successfully enrolled in the pivotal phase 3 study OCEAN in relapsed refractory multiple myeloma (RRMM). The original enrollment target of 450 patients was reached in May 2020, but an analysis indicated that patients were staying longer on treatment than initially estimated. Thus, a decision was made to leave recruitment open to ensure that the number of disease progression events needed to complete the study would be reached within a reasonable timeframe. An additional 45 patients have now been recruited. The company has closed enrollment and reiterates that the topline results will be available in the first half of 2021

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