HALF-YEAR 2019 HIGHLIGHTS, RECENT DEVELOPMENTS AND OUTLOOK
AsiDNA™ - In early January 2019, reporting of the identification of biomarkers predicting the response to AsiDNA™, which could optimize its clinical development by selecting the most responsive patients to AsiDNA™, as well as making it eligible to personalized medicine approaches. - In April 2019, presentation of 5 posters at 2019 American Association for Cancer Research (AACR) Annual Meeting with supportive data on AsiDNA™ as a therapy with strong potential for cancer treatment. - In May 2019, announcement of final positive data from DRIIV-1 phase 1 study of AsiDNA™ in advanced solid tumors and initiation of DRIIV-1b, a phase 1b clinical study of AsiDNA™ in combination with chemotherapy in patients with solid tumors - DRIIV-1b study is progressing on track to deliver preliminary results in H2 2019 and final results in H1 2020, before pursuing with a phase 2 study. - The Company plans to start a combination study of AsiDNA ™ with a PARP inhibitor, no later than in the first half of 2020 to validate the abrogation of the acquired resistance to these treatments by AsiDNA ™.
platON™ - At the end of June 2019, announcement of the pipeline expansion with an innovative & optimized lead compound, OX401, entering proof-of-concept preclinical phase. OX401 is the second candidate utilizing Onxeo's proprietary platform of decoy agonists, platON™, with differentiated and complementary properties to those of AsiDNA™. - In vivo results alone and in combination with cancer immunotherapies expected by early Q4 2019
Beleodaq® - On March 1, 2019, Spectrum Pharmaceuticals (SPPI) announced the completion of the sale of its portfolio of seven FDA-approved hematology/oncology products, including Beleodaq®, to Acrotech Biopharma L.L.C. On the basis of the information provided to date, the Company does not anticipate any significant impact of this transaction on activities and results from Beleodaq® for Onxeo.
Corporate & Financing - Following the Ordinary General Meeting of May 22, 2019, Ms. Danièle Guyot-Caparros was appointed as the new Chair of the Board of Directors, taking over Mr. Joseph Zakrzewski whose term of office ended at the date of the General Meeting. She has been an independent director of Onxeo and chairman of its audit committee since June 2013 and, since October 2015, was Senior Director in charge of good governance practices. –
In early June 2019, Onxeo renewed the equity line with Nice & Green for a maximum amount of €10.2m, in order to secure sufficient financial resources to support the Company’s operations beyond the key milestones expected in the upcoming 12 months and to extend the cash runway until Q3 2020. –
At the end of June 2019, the equity research company KEPLER CHEUVREUX has initiated the coverage of ONXEO with a “Buy” recommendation.