Due to a shortage in the US of dichloroacetic acid, a key chemical reagent necessary to synthesize NOX-A12, NOXXON has been informed by its contract active ingredient manufacturer that the NOX-A12 batches needed to initiate these two studies will only be available in Q2 2022 with first patients therefore expected to be dosed in early August 2022. These delays have impacted the overall approval timelines of NOX-A12 in glioblastoma, pushing it into early 2026, while market approval in pancreatic cancer remains unchanged and is planned in 2027.

Aram Mangasarian, CEO of NOXXON commented: "The effects of the COVID-19 pandemic continue to impact the healthcare industry in many areas, including the most essential ones like manufacturing supply chains. The NOX-A12 studies in pancreatic and brain cancer are our key clinical programs; the pancreas cancer trial is our second collaboration with MSD, a global leader in the immuno-oncology space, and the pivotal brain cancer trial is expected to deliver the data base for our first marketing authorization. We have worked with our contract manufacturer to overcome the unexpected shortages of what are usually easily sourced chemical reagents affecting these batches of NOX-A12 and are doing everything to ensure these batches will be released as soon as possible with the usual high standards of quality. We look forward to getting the trials underway and examining the potential clinical benefits of NOX-A12 in combination with Keytruda or radiotherapy for patients suffering from highly aggressive cancers."

With €13.7 million in cash and cash equivalents on June 30, 2021 and available secured financing of €10.45 million (nominal) drawable at the company’s discretion as reported on October 22, 2021 with the Half-Year Financial Report 2021, updated timing of commitments for manufacturing and clinical trials extends NOXXON’s financial visibility into July 2022.

About the GLORIA Study

GLORIA (NCT04121455) is NOXXON’s dose-escalation, phase 1/2 study of NOX-A12 in combination with irradiation in first-line glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).

About the OPTIMUS Study

OPTIMUS (NCT04901741) is NOXXON’s open-label two-arm phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.

Disclaimer

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.