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Forward Pharma A/S (NASDAQ:FWP) announced it received a notice from Nasdaq on December 16, 2022, stating that the company is considered a 'public shell' under Listing Rule 5101. Consequently, Nasdaq will suspend trading of Forward's American Depositary Shares on December 28, 2022, and will file a Form 25-NSE to remove its securities from listing. Forward does not plan to appeal Nasdaq's decision and intends to request suspension of its reporting obligations by filing a Form 15 with the SEC.
Forward Pharma A/S (NASDAQ:FWP) announced that the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) has denied its petition for review regarding the revocation of patent EP2801355. This outcome ends the opposition proceedings, resulting in the company not receiving royalties from Biogen for Tecfidera sales related to multiple sclerosis outside the U.S. Additionally, similar results in the U.S. Interference Proceeding mean Forward will not earn royalties from the U.S. market either.
Forward Pharma A/S (NASDAQ:FWP) reported a net loss of $1.9 million for the year ended December 31, 2021, improving from a net loss of $6.4 million in 2020. The increase in research, development, general, and administrative costs totaled $3.9 million, up from $3.4 million in 2020. A foreign exchange gain of $2.2 million from U.S. Dollar strengthening positively impacted the net loss. As of December 31, 2021, the company held $70.8 million in cash and equivalents, with no material long-term obligations. Concerns remain regarding an ongoing tax audit in Germany and outcomes related to the ‘355 patent opposition proceedings.
Curie Therapeutics has appointed Dr. Karen Smith to its Board of Directors to enhance its expertise in oncology drug development. CEO Simon Read expressed that her diverse background in medicine, law, and business will be invaluable as Curie advances its precision radiopharmaceuticals. Dr. Smith brings considerable experience from leading global product launches in major pharmaceutical companies and biotech firms. Curie aims to innovate cancer treatments, focusing on targeted radiopharmaceuticals designed for high potency and stability.
Forward Pharma A/S (NASDAQ:FWP) announced that the European Patent Office's Technical Board of Appeal has dismissed its appeal to revoke the EP2801355 patent. The decision follows an oral hearing and comes after consideration of third-party submissions. The TBA's decision may end the Opposition Proceedings, resulting in no royalties from Biogen's future net sales outside the U.S. Forward may pursue a petition for review, but success is deemed unlikely. Detailed reasons for the decision will follow.
Forward Pharma A/S (NASDAQ:FWP) reported a net loss of $6.4 million for 2020, up from $4.2 million in 2019, primarily due to a $3.0 million foreign exchange loss related to U.S. Dollar cash holdings. R&D and administrative costs decreased from $5.3 million in 2019 to $3.4 million in 2020. The company has $79.1 million in cash and expects to fund operations through 2021. A pivotal hearing regarding the opposition of the EP2801355 patent is scheduled for September 6, 2021. If unfavorable, it may halt potential royalty revenues from Biogen until at least 2024.
Forward Pharma A/S (NASDAQ:FWP) announced a rescheduling of the oral hearing regarding the appeal on the revoked EP2801355 patent to September 6, 2021, due to COVID-19 precautions. This patent is crucial for future royalty revenues from Biogen's DMF products. The opposition process started in 2018, and a favorable ruling is essential for any expected revenue, possibly commencing in 2024. An unfavorable decision would mean no royalties from Biogen for sales outside the U.S., effectively ending the Opposition Proceeding.
Forward Pharma A/S (NASDAQ: FWP) announced the rescheduling of the Technical Board of Appeal hearing regarding the EP2801355 patent to February 2, 2021, due to COVID-19 precautions. The original patent was revoked in 2018 after opposition. If favorable, the TBA may remit the case for further resolution, potentially delaying any revenue from Biogen's License Agreement until 2024. An unfavorable ruling would halt royalty payments from Biogen's sales outside the U.S. The company focuses on developing DMF formulations for neurological indications.
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