SMART-101

Smart Immune treats adult acute leukemia patient at final dose level in Phase I/II ReSET-02 trial PARIS, France, May 2, 2024 – Smart Immune, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor therapy platform to rapidly re-arm the immune system against cancers and infections, today announces the treatment of the first patient in the third and final dose cohort of the dose-escalation stage in its ReSET-02 trial. This is an important milestone in the evaluation of SMART101 in post-transplant hematology. The ReSET-02 trial (NCT05768035) is a Phase I/II multi-center, open-label, dose-escalation study to assess the safety and efficacy of Smart Immune’s lead asset, SMART101, an allogeneic T cell progenitor therapy, after allogeneic HSCT with post-transplant cyclophosphamide (PTCy), in adult patients with acute lymphoid leukemia. The trial has progressed to the final dose (9.0 x 106 CD7+ cells per kg of body weight) cohort after favorable safety profiles observed in patients treated with the first and second dose levels. The product candidate is designed to accelerate T cell reconstitution to fight relapse and infection and improve overall and disease-free survival post-transplant. Karine Rossignol, CEO and Co-founder, Smart Immune said: “We are thrilled to achieve this key milestone in our ReSET-02 trial after observing an excellent tolerability and safety pro no dose limiting toxicities or safety issues with the first two dose levels. Reaching the final dose brings us a step closer in our efforts to quickly reset the immune system with a new fit T cell compartment, improving clinical outcomes in patients with high-risk cancers. Encouragingly, all preliminary immune reconstitution data, even in patients aged 50-70 years, point in the right direction.” No related safety events have been reported to date in the ReSET-02 trial. This encouraging safety pro further confirmed by the other Smart Immune-sponsored trial data in Europe and the US. SMART101 is an allogeneic cell therapy produced from healthy donor mobilized peripheral blood stem cells (CD34+) differentiated into T cell progenitors. It has been granted Orphan Drug Designation (ODD) by the European Medicines Agency and the US Food and Drug Administration (FDA), in addition to Fast Track Designation by the FDA, as a treatment to enhance clinical outcomes in patients receiving allo-HSCT. About Smart Immune Smart Immune is a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor platform to rapidly re-arm the immune system against cancer and infection. The company aims to radically improve outcomes for patients in hematology and immuno-oncology. SMART101 is in Phase I/II trials for patients with acute leukemia or severe combined immunodeficiencies (SCID), in the EU and the US. Additional clinical applications are planned to be evaluated in combination with innovative cancer therapies. LinkedIn | X (formerly Twitter) About the ReSET-02 clinical trial SMART101 is being evaluated in the ReSET-02 Phase I/II multi-center, open-label, dose-escalation study (1.5 x 106 CD7+ cells per kg of body weight, 4.5 x 106 CD7+ cells and 9.0 x 106 CD7+ cells per kg of body weight) to evaluate the safety and activity of SMART101 after haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide, in patients with hematological malignancies. In the Phase II segment, patients are being enrolled in parallel into two cohorts according to the intensity of the conditioning chemotherapy and in two consecutive stages according to a Simon’s 2-stage design. The trial is currently conducted at multiple sites in France and Italy. For more information, visit study identifier number NCT05768035. About SMART101 SMART101 is generated ex vivo in 7 days from allogeneic blood stem cells, using Smart Immune’s ProTcell T cell therapy platform. Once injected into the patient, the SMART101 human T cell progenitors travel to the thymus where they are educated to become fully functional and self-tolerant T cells. Preclinical data suggest that the ProTcell platform could reconstitute the immune system in 100 days instead of the 12 to 18 months observed in physiology, thereby protecting patients from infection and relapse. Media contact: ICR Consilium smartimmune@consilium-comms.com

Smart Immune appoints key new members to its Board of Directors PARIS, France, 16 February 2024 – Smart Immune, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor therapy platform to fully and rapidly re-arm the immune system against cancers and infections, today announces the appointment of new Board directors, effective immediately. Markus Goebel, Grégoire Cayatte, Federico Mingozzi and Pablo Silveri will join existing directors, Dominique Costantini and Fouzia Laghrissi-Thode, to accelerate and support the growth of Smart Immune. Markus Goebel succeeds Sebastian Lombardo as Chairman of the Board of Directors. Jean-Pierre Bizzari completes the team as an observer. Karine Rossignol, CEO and Co-founder of Smart Immune, said: “We are delighted and proud to welcome such distinguished experts to the Board, led by Markus Goebel as our new Chairman. Their collective expertise will provide invaluable support in our efforts to achieve clinical and economic success, ultimately benefiting patients who need a fully and rapidly re-armed immune system to fight severe cancer and infection. We are grateful to our outgoing Chairman for his 5-year commitment and support to Smart Immune.” Markus Goebel, CEO and Founder of M&G Advisors and Chairman of Smart Immune’s Board of Directors, said: “I am thrilled to join and lead the Board of Smart Immune. The company has attracted significant investment for its thymus-empowered platform, and I am looking forward to working with the team to deliver the potentially life-changing ProTcell-derived therapies to patients.” Markus Goebel spent more than a decade in academia as a hematologist-oncologist before joining the pharmaceutical industry, spanning a 30+ year career. He held key positions at Farmitalia, at Roche, amongst others in collaboration with Amgen, and at Novartis in BD&L and corporate M&A. Between 2004 and 2019, Dr Goebel was Managing Director of the Novartis Venture Fund in the US and Switzerland/Europe, where he served as a director for several investment companies. In 2019, he founded M&G Advisors GmbH, a biotech and medtech consulting company. He has also been appointed as an expert by Innosuisse, the Swiss Innovation Agency. Jean-Pierre Bizzari is a highly experienced oncologist who has been successfully bringing innovative cancer treatments to market for over 35 years, overseeing clinical development in companies including Rhône-Poulenc, Sanofi-Aventis, Celgene, Servier and Halozyme. Dr Bizzari is a member of the Scientific Advisory Board of the French National Cancer Institute and the Board of the European Organization for Research and Treatment of Cancer, as well as serving as the Chairman of its New Drug Committee. He is on the Boards of Halozyme, ADC Therapeutics and Aprea Therapeutics and now an Observer on the Board of Directors at Smart Immune. Grégoire Cayatte is Managing Partner and Co-Founder of TechLife Capital, an independent growth equity fund that specializes in healthcare and tech industries. After spending 5 years in equity transactions at Lazard and Paribas, he became Director of Strategy, Development and Finance at Devoteam, a listed technology services company, where he led more than 50 acquisitions in 20 countries and played a key role in the creation of 7 platforms, notably in cybersecurity, cloud migration and digital transformation. In the healthcare sector, Grégoire is a member of the supervisory boards of Evolutis, Flash Therapeutics, Mitem Pharma, MyData-Trust, Quinten and XPath. He is a graduate of École Polytechnique, École des Ponts ParisTech and SciencesPo Paris. Federico Mingozzi currently serves as the CEO of a US-based biotech company and is a Non-Executive Director of Sensorion’s Board of Directors. Previously, he held the positions of Chief Science Officer and Chief Technology Officer at Spark Therapeutics. Federico's expertise in gene therapy vectors and immune system interactions is widely recognized and he has made significant contributions to the field. His previous positions include the Head of the Immunology and Liver Gene Transfer Unit at Genethon, Research Director at the French National Institute of Health and Medical Research (INSERM) in France, and Director at the Children’s Hospital of Philadelphia. Pablo Silveri is the Chief Finance Officer and Co-founder of Nuqlea, a B2B digital marketplace for construction and habitat, and Smart Immune’s former Chief Financial Officer. Pablo is a corporate finance expert who held managing roles at the Dow Chemical Company, where he worked for 25 years. Before joining Smart Immune in 2019, Pablo was the Latin America Finance Director at Dow. He is also a Board member of the Spanish company, Auravant. About Smart Immune Smart Immune is a clinical-stage French biotechnology company developing ProTcell, a thymus-empowered T cell progenitor platform to fully and rapidly re-arm the immune system against cancer and infection, enabling next-generation allogeneic T cell therapies. The company aims to radically improve outcomes for patients in hematology and immune-oncology. Smart Immune has ongoing collaborations with leading institutions in the US and Europe. SMART101 is in Phase I/II clinical trials in cancer patients with AML and ALL, in SCID in the EU and the US. Smart Immune is also developing therapies using gene-modified T cell progenitors through its ProTcell platform to provide targeted treatments like off-the-shelf CAR T. The Company is headquartered in Paris, France, at Paris Biotech Santé. LinkedIn | X (formerly Twitter) Media contact: ICR Consilium smartimmune@consilium-comms.com Attachment 240216 Smart Immune renforce son Conseil d'administration avec de nouveaux experts de l'industrie DEF