STOCKHOLM, Aug. 11, 2022 /PRNewswire/ — Oncopeptides AB (publ) (NASDAQ Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today publishes the report for the second quarter 2022.
«CHMPs recommendation to grant Pepaxti a full marketing authorization approval in EU is foundational for Oncopeptides,» says Jakob Lindberg, CEO of Oncopeptides. «This is excellent news for patients, shareholders, and for the future development of Oncopeptides.»
Financial overview April-June
Net sales amounted to SEK 8.8 M (66.4)
Operating profit was SEK -61.1 M (-344.8)
Net profit amounted to SEK -59.8 M (-24.1)
Profit per share, before and after dilution, amounted to SEK -0.79 (-0.32)
Cash balances at the end of the period amounted to SEK 90.8M (999.4)
Financial overview January-June
Net sales amounted to SEK 8.8 M (85.7)
Operating profit was SEK -160.0 M (-692.2)
Net profit amounted to SEK -158.4 M (-258.8)
Profit per share, before and after dilution, amounted to SEK -2.10 (-3.63)
Cash balances at the end of the period amounted to SEK 90.8M (999.4)
Significant events April-June
CHMP, the European Medicines Agency´s Committee for Medicinal Products for Human Use, unanimously recommended the European Commission to grant a full marketing authorization approval of Pepaxti in the EU
Events after the period
Direct share issue raising approximately SEK 435.6 million (USD 41.1 million) before transaction costs
FDA has announced an ODAC, a public meeting with the Oncologic Drugs Advisory Committee, on September 22, to discuss benefit/risk of Pepaxto
Conference call for investors, analysts, and media
Investors, analysts, and media are invited to participate in a webcast and a following QnA session today at 14:00 (CET). The event will be hosted by CEO Jakob Lindberg, together with CMO Klaas Bakker and CFO Annika Muskantor. The presentation will be held in English.
The webcast will be streamed via https://tv.streamfabriken.com/oncopeptides-q2-2022, and is also available on the corporate website: www.oncopeptides.com. PIN-code for participants is 4998014#
Dial in numbers for participants:
SE: +46850516386
UK: +442031984884
US: +14123176300
Pin code for all numbers: 4998014#
For further information, please contact:
Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
-E-post: rolf.gulliksen@oncopeptides.com
Mobil: + 46 70?262 96 28
The information in the press release is information that Oncopeptides is obliged to make public pursuant to the Swedish Financial Instruments Trading Act (1991:980). The information was submitted for publication, through the agency of the contact persons above, on August 11, 2022, at 08.00 (CET).
About Oncopeptides
Oncopeptides is a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases. The company uses its proprietary PDC platform to develop peptide-drug conjugated compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. The first drug coming from the PDC platform, Pepaxto® (INN melphalan flufenamide), also called melflufen was granted accelerated approval in the U.S., on February 26, 2021, in combination with dexamethasone, for treatment of adult patients with relapsed or refractory multiple myeloma. The Company voluntarily withdrew the drug on October 22, 2021 and then rescinded the withdrawal on January 21, 2022. Due to regulatory hurdles the product is currently not marketed in the U.S. On June 23, 2022, the CHMP adopted a positive opinion recommending full approval of Oncopeptides Pepaxti® (melphalan flufenamide), in the EU in patients with triple class refractory multiple myeloma. Oncopeptides is developing several new compounds based on its technology platforms. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on www.oncopeptides.com.
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