TME Pharma


Dear Shareholders,

In 2021 we reached a number of significant and exciting scientific and corporate milestones at NOXXON. The company has made meaningful progress towards our goal of transforming the way cancer is treated through our highly innovative approach of targeting the tumor microenvironment (TME). We believe that TME targeting will become part of the standard backbone for treating many cancers. We continue to develop our lead asset, NOX-A12, in two indications with high unmet medical needs, brain and pancreatic cancer and are preparing NOX-E36, our second asset, to enter a cancer clinical trial in 2022.

Based on the impressive data generated so far in our GLORIA Phase 1/2 clinical trial evaluating NOX-A12 in brain cancer (glioblastoma multiforme, GBM), we have initiated expansion arms of this trial to explore further treatment options for patients who would not benefit from standard of care chemotherapy. We plan to use this clinical data to guide the design of our pivotal glioblastoma study, which we expect to initiate in the second half of 2022, leading us towards a targeted first market approval in 2026. We are also expecting to launch, in collaboration with MSD, a Phase 2 study of our pancreatic cancer program in 2022.

We recently secured additional financing capacity in our already-established convertible securities facility with Atlas to ensure our ability to execute our clinical plans for this year. With an additional €17 million of capacity now available, we have sufficient capacity, if utilized, to fund operations into December 2022, according to our current business plan.

We have strengthened our executive leadership team with the appointment of Bryan Jennings as NOXXON's Chief Financial Officer in November. Bryan has extensive financial and banking experience, a significant amount of which has been spent in the healthcare, pharmaceutical and biotech sectors, including 20 years at Morgan Stanley. Bryan has already proven to be a real asset for the company increasing contact with and interest amongst investors and companies in the US. Bryan’s appointment adds to the group of highly accomplished Supervisory Board members that joined in June: Susan Coles, Martine van Vugt, and Gregory Weaver.

We were also very active in the scientific community, including having data from our GLORIA trial presented at the Annual Meeting for the Society for Neuro-Oncology in November, as well as hosting our own successful Key Opinion Leader event. The presentations at both events were given by Dr. Frank A. Giordano, Chairman of the Department of Radiation Oncology at University Hospital Bonn, Germany, and the lead investigator of the GLORIA trial. The results represent a significant step forward in the development of NOX-A12, showing it to be safe, well-tolerated as well as demonstrating extremely encouraging signals of efficacy, with 8 of 9 (89%) NOX-A12 patients showing tumor size reductions vs. 1 in 13 (8%) of matched historical control patients.

The final, peer reviewed, publication of our NOX-A12 + pembrolizumab Phase 1/2 OPERA trial in pancreatic and colorectal cancer patients was also published in October 2021 in the Journal for the Immunotherapy of Cancer under the title: Combined inhibition of CXCL12 and PD-1 in MSS colorectal and pancreatic cancer: modulation of the microenvironment and clinical effects.

The entire NOXXON team has done a tremendous job at preparing for the next steps in the development stage, however, the effects of the COVID-19 pandemic are still impacting many areas of the healthcare industry. In our case, shortages of standard reagents at our drug substance manufacturer triggered production delays and forced us to push back the start of our two upcoming NOX-A12 clinical trials by three months. We have acted to resolve these supply shortages as quickly as possible without compromising our usual high standards of quality, and we are now looking forward to getting these trials underway.

2022 promises to be an important year for NOXXON as we push forward with our ambitious clinical programs and our overall business strategy. We believe our development of NOX-A12 can bring substantial benefit to the many cancer patients who currently have no satisfactory treatment options, while creating significant value for our company and our shareholders. We also firmly believe that the TME approach to cancer therapy is one that will become a cornerstone of treatment for many solid tumors in the years to come.

I would like to take this opportunity to thank our shareholders for their support and their belief in NOXXON and I look forward to providing further updates on our progress as the year continues.

Yours sincerely,

Aram Mangasarian
January 17, 2022

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