Launch dynamics encouraging, but US regulatory situation challenging
STOCKHOLM, Aug. 19, 2021 /PRNewswire/ -- 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 cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Financial overview January-June
- Net sales amounted to SEK 85.7 M (0.0)
- Operating loss amounted to SEK 692.2 M (loss: 696.2)
- Loss for the period was SEK 258.8 M (loss: 698.4)
- Loss per share, before and after dilution, was SEK 3.63 (loss: 12.20)
- Cash and cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Significant events April-June
- An application for conditional marketing authorization of melflufen in the EU was submitted in April
- Topline results from the phase 3 OCEAN study were announced in May
- Patient enrollment in the phase 2 PORT study was completed in May
- A German affiliate was established in May
- Clinical abstracts on melflufen was presented at the 2021 American Society of Clinical Oncology in June
- New clinical and preclincal melflufen data was presented at the European Hematology Association meeting in June
Significant events after the reporting period
- Updated results from the phase 3 OCEAN study were announced on July 8: melflufen met the primary endpoint of superior PFS
- Overall survival data, also released on July 8, led to the FDA requesting a partial clinical hold of all clinical studies with melflufen, pending further investigation
- FDA issued a safety alert to patients and health care professionals on July 28, regarding an increased risk of death associated with Pepaxto in the OCEAN study.
Financial overview of the Group
(SEK thousand) | 2021 Apr-Jun | 2020 Apr-Jun | 2021 Jan-Jun | 2020 Jan-Jun | 2020 Jan-Dec |
Net sales | 66,374 | - | 85,729 | - | - |
Gross profit | 63,552 | - | 82,579 | - | - |
Gross margin | 96 % | N/A | 96 % | N/A | N/A |
Operating loss | -344,836 | -399,332 | -692,167 | -696,208 | -1,591,279 |
Loss after tax | -24,116 | -401,041 | -258,780 | -698,370 | -1,594,693 |
Earnings per share before and after dilution (SEK) | -0.32 | -6.79 | -3.63 | -12.20 | -25.57 |
Cash flow from operating | -346,695 | -285,665 | -733,409 | -598,506 | -1,296,509 |
Cash and cash equivalents at the end of the period | 999,384 | 937,773 | 999,384 | 937,773 | 840,255 |
R & D costs/operating expenses, % | 41 % | 57 % | 45 % | 63 % | 54 % |
Conference call for investors, analysts and the media
Investors, financial analysts and media are invited to participate in a webcast with a Q&A session at 12:00 CEST. The event will be hosted by CEO, Marty J Duvall, CMO, Klaas Bakker and CFO, Anders Martin-Löf.
The webcast will be streamed via this link which can also be found on the website: www.oncopeptides.com.
Phone numbers for participants from:
Sweden: +46 8 566 426 51 PIN: 51415302#
Europe: +44 3333 000 804 PIN: 51415302#
USA: +1 8558570686 PIN: 51415302#
For more information, please contact:
Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB
E-mail: rolf.gulliksen@oncopeptides.com
Cell phone: + 46 70 262 96 28
Linda Holmström, Director of Investor Relations, Oncopeptides AB
E-mail: linda.holmstrom@oncopeptides.com
Cell phone: +46 70 873 40 95
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 07:00 CET on August 19, 2021.
About Oncopeptides
Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The company uses its proprietary peptide-drug conjugate (PDC) platform to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. The first drug coming from PDC platform, PEPAXTO (melphalan flufenamide), has been launched in the U.S., for the treatment of adult patients with relapsed or refractory multiple myeloma. Melphalan flufenamide is evaluated in a comprehensive clinical study program including the global phase 3 studies OCEAN and LIGHTHOUSE. Oncopeptides is developing several new compounds based on the PDC platform. In 2021 the second compound from the PDC platform, OPD5, is estimated to enter clinical development.
Oncopeptides has approximately 300 coworkers. The global Headquarters is based 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.
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/oncopeptides-ab/r/oncopeptides-publishes-report-for-q2-2021,c3399286
The following files are available for download:
https://mb.cision.com/Main/15404/3399286/1455883.pdf | The full report (PDF) |
https://mb.cision.com/Public/15404/3399286/a9abd34c8785e650.pdf | Press release (PDF) |
