Fast Track Diagnostics Ltd.

NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the publication of a peer-reviewed case study by researchers at The University of Texas MD Anderson Cancer Center in Clinical and Translational Radiation Oncology. The case study reports on the first patient experience of treatment with potential first-in-class radioenhancer, NBTXR3, in pancreatic ductal adenocarcinoma (PDAC; pancreatic cancer). Given the nature of NBTXR3 as a therapeutic candidate with potentially broad applicability across solid tumor indications and therapeutic combinations, Nanobiotix and MD Anderson are collaborating to expand development of NBTXR3 beyond the Company’s priority pathways in locally advanced head and neck squamous cell carcinoma and immunotherapy. This ongoing phase I pancreatic cancer study is one of five active phase I or phase II studies currently being conducted as part of the collaboration. The phase I clinical trial is designed to determine the safety pro NBTXR3 activated by radiotherapy (RT) for patients with locally advanced or borderline resectable PDAC, and the recommended phase II dose (RP2D) for future efficacy evaluation. The case study in Clinical and Translational Radiation Oncology reports on the first patient ever to receive local endoscopic delivery of NBTXR3 to a deep visceral tumor. The patient is a 66-year-old male with unresectable, locally advanced PDAC who received local endoscopic delivery of NBTXR3 followed by intensity modulated RT. CT imaging demonstrated no visible leakage of the radioenhancer outside of the injected tumor. At initial follow-up evaluation, the lesion remained radiographically-stable, the patient did not demonstrate treatment-related toxicity, and the report concluded that the treatment was feasible. PDAC is one of the leading causes of cancer-related death in the world today. For patients with PDAC who are not eligible for surgery, RT has been shown to improve local disease control. However, safely delivering therapeutic doses of radiation remains challenging due to off-target toxicities in surrounding healthy tissues. While systemic radiosensitizers have been evaluated in this indication, these agents increase the sensitivity of both tumor tissues and healthy tissues. In contrast, due to the potential of NBTXR3 to increase the dose of RT within the tumor without increasing the dose in surrounding healthy tissues, the radioenhancer is being evaluated as a new option to address this urgent unmet need. “There is a critical need to develop an effective therapy to improve treatment outcomes while mitigating off-target toxicities for patients with locally advanced pancreatic cancer,” said Eugene Koay, MD, PhD, associate professor of Radiation Oncology at MD Anderson. “The initial feasibility for NBTXR3 injection outlined in this case study provides an important step forward as we determine the recommended phase II dose and the potential for the radioenhancer to help patients with this challenging disease.” Nanobiotix expects to establish the recommended phase II dose for NBTXR3 in pancreatic cancer in 2022. About NBTXR3 NBTXR3 is a novel, potentially first-in-class oncology product, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly, with immune checkpoint inhibitors. NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy. Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study, evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and for patients with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy, either naïve or resistant to prior PD-1 (either primary or secondary as per SITC criteria). Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, Germany and Switzerland. Nanobiotix has been listed on the regulated market of Euronext in Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. The company's resources are primarily devoted to the development of its lead product candidate– NBTXR3 —which is the product of its proprietary oncology platform and has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®.

Aptinyx (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, will host a virtual portfolio review event today beginning at 10:00 a.m. ET. Presented in a live webcast format, the company will discuss its approach to the development of novel NMDA receptor modulators and review its pipeline of four clinical development programs, with particular focus on NYX-2925 in chronic pain. NYX-2925 is an NMDA receptor positive allosteric modulator (PAM) currently under evaluation in a Phase 2b study in patients with painful diabetic peripheral neuropathy (DPN) and a Phase 2b study in patients with fibromyalgia. Today’s program will feature presentations from the Aptinyx management team as well as Richard Rauck, MD, a board-certified physician in pain medicine and anesthesiology at Carolinas Pain Institute and an investigator in the company’s ongoing Phase 2b painful DPN study. Aptinyx expects to report data from the Phase 2b painful DPN study in April or early May and anticipates reporting data from the Phase 2b fibromyalgia study in mid 2022. The event will also highlight Aptinyx’s two other NMDA receptor PAMs currently in Phase 2 clinical development. The company’s compound, NYX-783, is in development for the treatment of post-traumatic stress disorder (PTSD). The company is conducting two Phase 2b studies of NYX-783 in patients with PTSD: the first, evaluating a 50 mg dose level, initiated in 4Q 2023; and the second, which will evaluate a 150 mg dose level, is expected to commence in 1Q 2023. Aptinyx is also developing its compound, NYX-458, for the treatment of cognitive impairment. NYX-458 is currently under evaluation in an exploratory Phase 2 study in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. The company expects to report data from this study in 4Q 2022 or 1Q 2023. The Aptinyx management team and Dr. Rauck will be available for Q&A following the presentations. The live webcast and accompanying presentation can be accessed on the Investor Relations section of the Aptinyx website here and a replay of the webcast will be posted following the conclusion of the event. About NYX-2925 NYX-2925 is a novel oral NMDA receptor positive allosteric modulator currently in Phase 2 clinical development for the treatment of chronic pain. In clinical studies, NYX-2925 has demonstrated activity that affects central pain processing, resulting in alleviation of pain and other symptoms associated with chronic pain conditions. NYX-2925 has also exhibited a favorable safety and tolerability pro a wide dose range in clinical studies to date. The U.S. Food and Drug Administration has granted Fast Track designation to Aptinyx’s development of NYX-2925 for the treatment of neuropathic pain associated with DPN. About NYX-783 NYX-783 is a novel oral NMDA receptor positive allosteric modulator currently in Phase 2 clinical development for the treatment of post-traumatic stress disorder (PTSD). In preclinical studies of NYX-783, therapeutically relevant enhancement of extinction learning has been observed in models of conditioned fear and substance abuse. In an exploratory Phase 2 clinical study, administration of NYX-783 resulted in clinically meaningful improvements on PTSD symptoms. NYX-783 has also exhibited a favorable safety and tolerability pro a wide dose range in clinical studies to date. The U.S. Food and Drug Administration has granted Fast Track designation to the development of NYX-783 for the treatment of PTSD. About NYX-458 NYX-458 is a novel oral NMDA receptor positive allosteric modulator currently in Phase 2 clinical development for the treatment of cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. NYX-458 has been shown to reverse cognitive deficits in non-human primates in a model that is highly translatable to Parkinson’s disease in humans. NYX-458 has also been shown to improve cognitive performance across various other preclinical models of neurodegeneration. In a Phase 1 clinical study, NYX-458 exhibited a favorable safety and tolerability pro a wide dose range and achieved CNS exposures consistent with exposures observed at efficacious preclinical dose levels. About Aptinyx Aptinyx Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of proprietary synthetic small molecules for the treatment of brain and nervous system disorders. Aptinyx has a platform for discovery of novel compounds that work through a unique mechanism to modulate—rather than block or over-activate—NMDA receptors and enhance synaptic plasticity, the foundation of neural cell communication. The company has three product candidates in clinical development in central nervous system indications, including chronic pain, post-traumatic stress disorder, and cognitive impairment associated with Parkinson’s disease. Aptinyx is also advancing additional compounds from its proprietary discovery platform, which continues to generate a rich and diverse pipeline of small-molecule NMDA receptor modulators with the potential to treat an array of neurologic disorders.

NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the publication of new preclinical immunotherapy data for novel, potentially solid tumor- and therapeutic combination-agnostic radioenhancer NBTXR3 in the Journal of Nanobiotechnology. The Nanobiotix preclinical program aims both to provide a deeper understanding of the NBTXR3 mechanism of action and to discover new pathways for the radioenhancer to potentially improve treatment outcomes for patients. Given preclinical and early clinical data suggesting a potential immune priming effect triggered by radiotherapy (RT)-activated NBTXR3 and the medical unmet need for patients with primary or secondary resistance to immune checkpoint inhibitors, Nanobiotix and The University of Texas MD Anderson Cancer Center are exploring several therapeutic combinations involving checkpoint inhibitors, radiotherapy, and NBTXR3. “We believe that we have only scratched the surface of opportunity for NBTXR3 as a potentially-ideal combination agent with immune checkpoint inhibitors,” said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. “As the industry continues to advance development of these powerful immunotherapy agents, we feel there is an urgent need for novel combinations that can help improve efficacy for naïve patients and overcome resistance for non-responders. Our view is that the results presented in this new publication add to the growing body of data suggesting therapeutic potential for NBTXR3 in combination with immune checkpoint inhibitors, and we look forward to further investigation in the lab and in the clinic.” Following previously reported positive preclinical data on the addition of NBTXR3 to a combination of radiotherapy and anti-PD-1 in anti-PD-1 sensitive and resistant lung cancer models, this evaluation investigated the addition of NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 in an anti-PD-1 resistant model. Mice were inoculated with metastatic lung cancer cells in their right (primary tumor) and left (secondary tumor) legs. They were then treated with various combinations of anti-PD-1, anti-CTLA-4, NBTXR3, and radiotherapy in an effort to isolate the effect of adding NBTXR3, modifying the RT protocol, or both. Mice surviving after 178 days were rechallenged with tumor cells and monitored for tumor growth. The evaluation showed that both modifications to RT protocol and the addition of NBTXR3 improved outcomes of combination therapy, and that the cohorts in which NBTXR3 was included in the regimen outperformed all others. Of note, the cohort treated with NBTXR3 and modified RT together showed that the therapy had significant antitumor effects against both primary and secondary tumors, improving the mouse survival rate from 0% to 50%. None of the re-challenged survivor mice developed tumors, and they had higher percentages of memory T cells versus control, suggesting the induction of long-term antitumor immune memory. The authors concluded that NBTXR3 in combination with radioimmunotherapy significantly improved anti-PD-1 resistant lung tumor control in mice by promoting antitumor immune response. About NBTXR3 NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy. Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy either naïve or resistant to prior PD-1 (either primary or secondary as per SITC criteria). Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, Germany and Switzerland. Nanobiotix has been listed on the regulated market of Euronext in Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. The company's resources are primarily devoted to the development of its lead product candidate– NBTXR3 —which is the product of its proprietary oncology platform and has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®.