BioNTech (BNTX) Q2 results:
Revenues: 41.8M (+62.0%), consisting primarily from collaboration agreements signed with Pfizer and Fosun Pharma as part of BNT162 vaccine program against COVID-19.
Net loss: (88.3M) (-76.2%); loss/share: (0.38) (-58.3%).
Cash used in Operations: 70.2M (+18.1%).
2020 Guidance: As a result of increased spending related to BNT162, BioNTech now expects net cash used in operating activities to be between €450M and €600M.
The company initiated a Phase 2b/3 study for BNT162b2 in up to 30,000 participants aged 18 to 85 years at ~120 sites globally; if successful, BioNTech and Pfizer plan to file for market authorization or regulatory approval as early as October 2020.
BNTX has announced initial commercial supply agreements totaling more than 250M doses with the UK, U.S., Japan and Canada in 2020 and 2021, with an option to purchase up to an additional 500M doses.
BNT111 – BioNTech expects to initiate this Phase 2 trial with registrational potential in H2.
BNT113 – Planned initiation of a registrational Phase 2 trial in HPV16+ head and neck cancer expected in H2.
BNT122 – Two Phase 2 clinical trials are planned in the adjuvant setting. The first Phase 2 study is currently recruiting for patients with early and adjuvant stage NSCLC and first patient dosing is expected in H2.
The second Phase 2 study will be in colorectal cancer in adjuvant setting and is expected to initiate in second half of 2020.
BNT221 – Initiation of a Phase 1 dose escalation trial of BNT221 is expected in 2H 2020 for the treatment of metastatic melanoma.
BNT311 – BioNTech expects to provide a data update in H2 from the Phase 1/2 trial in multiple solid tumors for GEN1042/BNT311 (PD-L1x4-1BB). The program is partnered with Genmab.
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