InflaRx provided an update on the ongoing development of vilobelimab (IFX-1), a first-in-class anti-C5a antibody. The Company announced plans to start an open label, multicenter Phase II study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). cSCC is the second most common nonmelanoma skin cancer/keratinocyte carcinoma and represents 20% to 50% of all skin cancers. Although the majority of cSCCs are successfully excised surgically, a subset has features associated with a higher likelihood of recurrence, metastasis, and death. The non-comparative two-stage Phase II trial is expected to start in the first half of 2021 and will be a multi-national study, including sites in Europe, the US and elsewhere. The study investigates two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess the antitumor activity and safety of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm. Hidradenitis Suppurativa in the first quarter of 2021. Details on the Phase III design will be provided once an agreement has been reached with the FDA. SPA is a process in which a company may ask to meet with the FDA to reach an agreement on the design and size of a trial to determine if it adequately addresses scientific and regulatory requirements for a study that could support marketing approval. An SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) for a study intended to support a future marketing application. InflaRx believes the SPA provides the best way forward to reach an agreement on the trial design for its pivotal Phase III program with the FDA. In Europe, as previously reported in 2020, InflaRx had positive scientific advice from the European Medicines Agency (EMA) about the European pathway for regulatory approval, including supporting the use of a new primary endpoint, the International Hidradenitis Suppurativa Severity Score (IHS4). The Company is working diligently to address the additional feedback received to achieve alignment with the US strategy for a global Phase III development program in HS. The Phase III part of the global Phase II/III trial evaluating vilobelimab in mechanically ventilated patients with COVID-19 was initiated in mid-September, and recruitment is currently ongoing in Europe, with other regions in the process of being added.  The study is enrolling as planned with a total goal of 360 patients.  A blinded interim analysis is planned after 180 patients, with a potential early stop of the trial for efficacy or futility.  Topline data from the trial are expected to be available in 2021.