Earnings release
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Main Office : Loc . Bellaria , 35 - 53018 Sovicille ( SI ) , Italy e - mail : info@philogen.it - website : www.philogen.com Philogen innovating targeting Philogen Announces First Quarter 2021 Results and Provides Update on Pipeline Progress May 12 , 2021 Nidlegy ™ on track for Phase III European trial in stage IIIB / C melanoma . Opening of additional clinical centers to boost recruitment rate is ongoing . Emerging promising data in non- melanoma skin cancers Fibromun on track for the six ongoing trials in Soft Tissue Sarcoma and High - Grade Glioma Philogen is well capitalized , with cash & cash equivalents of about € 120 million Philogen's management team will hold a webinar to discuss the news on Thursday , 13th May at 10:00 am EST / 14:00 pm BST / 15:00 pm CEST- please find the link to this webinar here Siena ( Italy ) , 12 May 2021 - ( Globe Newswire ) - Philogen S.p.A. ( BIT : PHIL ) - a listed clinical - stage biotechnology company focused on the development of innovative medicines based on tumor targeting antibodies and small molecule ligands , is pleased to announce progress updates for its fully- owned immunocytokine and small molecule programs . " We are excited to report for the first time , after our successful Initial Public Offering in March 2021 , the progress of our late- and early - stage product candidates , " commented Prof. Dr. Dario Neri , Co- Founder , Chief Executive Officer and Chief Scientific Officer of Philogen S.p.A. " Our most advanced programs are running on track . With the proceeds of the IPO , Philogen intends to bring Nidlegy ™ and Fibromun to registration and start direct marketing in certain territories as envisaged in our Business Plan . We are also completing the construction of a second GMP facility in Rosia ( Siena ) , which will further boost our in - house manufacturing capabilities , in anticipation of our expected marketing activities . " Nidlegy ™ European Phase III trial for the neo - adjuvant treatment of locally advanced Stage IIIB / C melanoma о The study has so far recruited 164 out of 214 patients planned for the study о ○ о о Two interim analyses , foreseen by the study protocol , have been successfully passed . The independent Data Safety Monitoring Board has recommended in both occasions a continuation of the trial , without change to the statistical assumptions . Focus on pre - treated patients with locally advanced disease who now receive Nidlegy ™ in neo - adjuvant setting prior to surgery Harmonized primary endpoint ( Recurrence - Free Survival ) in both European and American Phase III clinical trials Expansion of clinical centers ( currently 18 centers in Germany , Italy , Poland and France ) US Phase III trial for the treatment of locally advanced Stage IIIB / C melanoma о о Opening of additional clinical centers in the United States Initial activities for the potential expansion of the clinical trial in additional countries , including Australia