Back

INTERIM REPORT Q3 2020

Summary
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

 

SEK thousand 2020
Jul – Sep
2019
Jul – Sep
2020
Jan – Sep
2019
Jan – Sep
2019
Jan – Dec
Net sales  –  –  –  –  –
Operating loss -383,498 -189,597 -1,079,706 -495,148 -739,392
Loss before tax -383,784 -189,710 -1,080,653 -495,520 -739,920
Loss for the period -383,357 -189,780 -1,081,727 -495,801 -740,705
Earnings per share before and after dilution (SEK) -5.71 -3.53 -17.87 -9.90 -14.33
Cash flow from operating activities -340,841 -207,774 -939,347 -473,592 -690,566
Cash and cash equivalents at the end of the period 1,251,629 1,122,297 1,251,629 1,122,297 926,186
Research & development costs/operating expenses % 50% 80% 59% 79% 74%

Conference call for investors, analysts and the media

The Interim Report Q3 2020 and an operational update will be presented by CEO Marty J Duvall and members of Oncopeptides Leadership team, Thursday November 19, 2020 at 14:00 (CET).

The conference call will also be streamed via a link on the website: www. oncopeptides.com.

Phone numbers for participants from:
Sweden: +46 8 566 426 92
Europe: +44 3333 009 274
USA: +1 833 526 83 47

Financial calendar

Year-end Report 2020: February 18, 2021
Annual Report 2020: Week starting with April 26, 2021
Interim Report Q1 2021: May 26, 2021
Annual General Meeting 2021: May 26, 2021

For more information
Marty J Duvall, CEO, Oncopeptides
E-mail: 

Rein Piir, Head of Investor Relations, Oncopeptides
E-mail: 
Cell phone: +46 70 853 72 92

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.

About Oncopeptides

Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The lead product candidate melflufen, is a first in class peptide-drug conjugate that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is in development as a new treatment for the hematological malignancy multiple myeloma and is being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Based on the results from the HORIZON study a New Drug Application has been submitted to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for treatment of adult patients with triple-class refractory multiple myeloma. The FDA, has granted the New Drug Application a priority review, with a PDUFA date of February 28, 2021.Oncopeptides´ global Headquarters is in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on www.oncopeptides.com.