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Monica Shaw appointed CEO of Oncopeptides – Jakob Lindberg assumes position as Chief Scientific Officer

STOCKHOLM — January 4, 2023 — Oncopeptides AB (publ.) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Board of Directors has appointed Dr Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides.  She replaces Jakob Lindberg, who has been the CEO since November 15, 2021. Lindberg assumes his previous position as Chief Scientific Officer.  These changes are effective immediately.The leadership changes follow a transformational year for Oncopeptides, when Pepaxti[®], was

Oncopeptides presents new scientific data at the Annual American Society of Hematology Meeting ASH

STOCKHOLM — December 12, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the company presents new scientific data including one clinical abstract and three preclinical research posters at the Annual American Society of Hematology Meeting, ASH, in New Orleans, Louisiana, USA, on December 10-13. The clinical abstract evaluated patients with multiple myeloma who were refractory to prior alkylators in the phase 3 OCEAN study. Data shows that melflufen is a

Oncopeptides provides update on Pepaxto US marketing authorization

STOCKHOLM — December 07, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto[® ](melphalan flufenamide, also called melflufen). The request is based on the outcome of the confirmatory phase 3 OCEAN study, which demonstrated an ITT overall survival HR of 1.1, but with significant survival result differences for both melflufen and the comparator

Oncopeptides’ Pepaxti has been granted marketing authorization in the UK

STOCKHOLM — November 11, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that Pepaxti[®] (melphalan flufenamide, also called melflufen) has been granted marketing authorization in combination with dexamethasone, by the Medicines & Healthcare products Regulatory Agency, MHRA, in UK.“The approval of Pepaxti in UK is one additional important milestone for Oncopeptides that further validates our science and data,” says Jakob Lindberg, CEO Oncopeptides AB. “

Oncopeptides announces the market potential for Pepaxti in Europe

STOCKHOLM — November 9, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces the estimated market potential for Pepaxti[®] in Europe. The potential assumes that the Company´s pending type 2 variation submission to the European Medicines Agency based on OCEAN data, will be approved by the agency, and enable patients with relapsed refractory multiple myeloma access to the drug in an earlier treatment line. Furthermore, the market potential assumes that price

Oncopeptides phase 3 LIGHTHOUSE study further confirms clinical benefit of melflufen

STOCKHOLM — October 26, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces data from the phase 3 LIGHTHOUSE study that further confirms the clinical benefit of melflufen in patients with relapsed refractory multiple myeloma (RRMM). The LIGHTHOUSE study investigated the efficacy and safety of the combination of melflufen plus daratumumab subcutaneous (sc) plus dexamethasone in comparison with daratumumab sc. (with supportive dexamethasone) in patients who were

Oncopeptides starts commercialization of Pepaxti in Europe – Germany first market

STOCKHOLM — October 3, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Company has submitted the AMNOG dossier to “The Federal Joint Committee” (G-BA) in Germany. This initiates the commercial launch of Pepaxti[®] (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched.On August 18, the European Commission granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European

European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma

STOCKHOLM — August 18, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the European Commission has granted Pepaxti[®] (melphalan flufenamide, also called melflufen) marketing authorization  in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38

Oncopeptides publishes year-end report 2021

STOCKHOLM — February 17, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on the development of therapies for difficult-to-treat hematological diseases, has today published the year-end report 2021.Financial overview October-December · Net sales amounted to SEK -21.7 M (0.0) · Operating profit was SEK -389.8 M (- 511.6) · Net profit amounted to SEK -394.0 M (-513.0) · Profit per share, before and after dilution, amounted to SEK -5.23 (-7.59) · Cash balances at the end of the period amounted to SEK 362.2 M (840.3)  Financial overview

Oncopeptides phase 3 OCEAN study published in the Lancet Haematology

STOCKHOLM — January 13, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the data from the randomized head-to-head phase 3 OCEAN study, evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory patients with relapsed refractory multiple myeloma (RRMM) that have received 2-4 prior lines of therapy, have been published in the Lancet Hematology. The OCEAN

Oncopeptides announces year-end cash 2021

STOCKHOLM — January 5, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces a financial update after the restructuring of the company, following the withdrawal of Pepaxto[® ](INN melphalan flufenamide) from the US market.The cash position at year-end 2021 was approximately SEK 360 M. This figure is preliminary, and the formal reporting of the cash position will be part of the year-end report 2021, to be released on February 17, 2022. Oncopeptides has taken

Oncopeptides presents new melflufen data at the Annual American Society of Hematology Meeting ASH

STOCKHOLM — December 10, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the company will present three posters on melflufen (INN melphalan flufenamide) at the Annual American Society of Hematology Meeting, ASH, on December 11-14, in Atlanta, Georgia, USA.“We are committed to gather and share updated data of melflufen with the myeloma community,” says Klaas Bakker, MD, PhD, Executive Vice-President, and Chief Medical Officer. “A continued

Oncopeptides focuses clinical development efforts to increase cash runway

STOCKHOLM — November 4, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the company has decided to reduce the activity level in the clinical development program with melflufen (INN melphalan flufenamide) to increase the company´s cash runway and at the same time support the ongoing marketing authorization application process in Europe. This will have implications on the following studies:· OCEAN study will continue with long-term follow-up and

Oncopeptides presents phase 3 OCEAN study results at the IMW meeting

STOCKHOLM — September 11, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today presents data from the phase 3 OCEAN study, a direct head to head comparison of the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone and pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma, (RRMM), who are refractory to lenalidomide and have received 2-4 prior lines of therapy. The data was presented today by Fredrik Schjesvold,

Invitation to webcast for presentation of OCEAN data presented at IMW

STOCKHOLM — September 9, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, will present data from the OCEAN study at the 18th International Myeloma Workshop (IMW) on September 11. Investors, financial analysts, and media are invited to participate in a webcast including a Q&A on September 12 at 16:00 CEST. The event will be hosted by CEO, Marty J Duvall, Klaas Bakker, CMO as well as Fredrik Schjesvold, MD, Head of Oslo Myeloma Center. The presentation will be held in English.

Regulatory update from US Food and Drug Administration

STOCKHOLM — September 2, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration, FDA, has announced a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee, on October 28, 2021 concerning Oncopeptides’ product Pepaxto. The information is in line with the FDA safety alert on July 28, where the FDA stated that a public meeting may be hold to discuss the safety findings from the OCEAN study.

Oncopeptides presents new data from OCEAN and PORT study - abstracts online

STOCKHOLM — August 27, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that data from the phase 3 OCEAN study has been accepted as an oral presentation at the upcoming 18[th] International Myeloma Workshop (IMW), and the abstract is now available online. More comprehensive data will be presented at the IMW-meeting in Vienna on September 11, at 10:00 (CET).The phase 3 OCEAN study is a head-to-head comparison evaluating the efficacy and safety of melflufen (

Oncopeptides publishes report for Q2 2021

Launch dynamics encouraging, but US regulatory situation challengingSTOCKHOLM — August 19, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, has today published the report for the second quarter 2021. Financial overview April-June · Net sales amounted to SEK 66.4 M (0.0) · Operating loss amounted to SEK 344.8 M (loss: 399.3) · Loss for the period was SEK 24.1 M (loss: 401.0) · Loss per share, before and after dilution, was SEK 0.32 (loss: 6.79) · Cash and

Phase 3 OCEAN study demonstrates that melflufen is at least as efficacious as pomalidomide, the most used medicine in relapsed refractory multiple myeloma

· According to the Independent Review Committee Assessment, melflufen was non-inferior to pomalidomide on the primary endpoint of Progression Free Survival (PFS) with a Hazard Ratio favoring melflufen of 0.817 and the median PFS for melflufen was 41% higher than for pomalidomide · According to the Investigator Assessment, melflufen was superior to pomalidomide on PFS with a Hazard ratio favoring melflufen of 0.790 and median PFS for melflufen was 42% higher than for pomalidomide · The Overall Response Rate (ORR) was 32.1% for melflufen, compared to 26.5% for pomalidomide · Melflufen

Oncopeptides presents clinical abstracts on melflufen at the 2021 American Society of Clinical Oncology

STOCKHOLM — May 19, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that three abstracts with data on melflufen (INN melphalan flufenamide) in relapsed refractory multiple myeloma, RRMM, have been accepted by the 2021 American Society of Clinical Oncology, ASCO, and have now been published online. The clinical data presentations include updates on Oncopeptides’ ANCHOR and LIGHTHOUSE studies as well as a pooled analysis of the O-12-M1 and HORIZON studies in

Oncopeptides presents new clinical and preclinical melflufen data at the upcoming European Hematology Association meeting

STOCKHOLM — May 12, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that new clinical and preclinical data have been accepted by the European Hematology Association, EHA, and been published online. The clinical data presentation contains interim results from the phase 2 BRIDGE study supporting the use of melflufen in relapsed refractory multiple myeloma patients with moderately impaired renal function. Two preclinical data presentations show the future

Oncopeptides completes patient enrollment in phase 2 PORT study

STOCKHOLM — May 5, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the Company has completed patient enrollment in the phase 2 PORT study. The PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma. Oncopeptides expects topline data in Q3

Annual General Meeting in Oncopeptides AB (publ)

The shareholders in Oncopeptides AB (publ), reg. no. 556596-6438, with registered office in the municipality of Stockholm, (“Oncopeptides” or the “Company”) are hereby given notice to attend the Annual General Meeting to be held on Wednesday May 26, 2021. Due to the extraordinary situation resulting from the covid-19 pandemic, Oncopeptides’ Annual General Meeting will be carried out through advance voting (postal voting) pursuant to temporary legislation. No meeting with the possibility to attend in person or to be represented by a proxy will take place. Hence, the Annual General Meeting

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