Press release

CUTISS Announces First Reconstructive Surgery under Compassionate Use and First U.S. Patient Treated with denovoSkin™ denovoSkin™, the autologous, bio-engineered dermo-epidermal skin graft developed by CUTISS AG, offers a potential viable alternative in both burn and reconstructive skin surgery to improve patients’ quality of life and alleviate the shortage of donor sites.Pediatric patient underwent reconstructive skin surgery for the resolution of burn scars and contractures, with promising outcomes at 3-months post-grafting. This marks the first use of denovoSkin™ in the U.S. and the first use of denovoSkin™ in compassionate reconstructive surgery. Boston, MA and Switzerland, 10 October 2024 – CUTISS AG, a life sciences company at the forefront of tissue engineering therapy and regenerative medicine, announced the first ever grafting of denovoSkin™, its autologous, bio-engineered dermo-epidermal skin graft, in a compassionate reconstructive procedure, with the patient also being the first ever U.S. case for the company. The procedure was authorized by the U.S. Food & Drug Administration (FDA) under single patient Investigational New Drug (IND) application and performed by the surgical team at Massachusetts General Hospital (MGH). The four-year-old patient suffered from complex scarring and contractures after the resolution of deep burn wounds affecting 90% of his body, and lacked other therapeutic reconstructive options. Following two denovoSkin™ grafting procedures, the patient is recovering well at MGH. A third procedure is being planned. Dr. Daniela Marino, CEO of CUTISS, said: “We are honored to collaborate with Massachusetts General Hospital. This procedure represents more than just an application of technology – it’s about offering solutions where options are limited and highlights the impact of collaboration between top institutions and innovative emerging companies. At CUTISS, we are dedicated to advancing treatments that can make a real difference in patients’ lives. While the journey is ongoing, we continue to explore the application of denovoSkin™ in burns and reconstructive surgery challenges.”In 2023, more than 20,000 burn patients were reported in the U.S., with 10% experiencing large burns affecting more than 20% of their body area¹. As climate change drives temperatures higher, burn injuries have been reported with increasing frequency². Most burns occur in private residences, but also represent an important injury burden in combat³ and other high-risk professions. Today’s standard of care in burn and reconstructive skin surgery is autografting: the harvesting of the patient’s own healthy skin and its grafting onto the patient’s wounds. Autografting often leads to scars that necessitate maintenance and may require follow-up surgeries. In patients with drastically limited donor sites to provide healthy tissue, other wound closure options are available in the U.S., such as cultured epithelial autografts (CEA). Jeremy Goverman M.D., Massachusetts General Hospital, stated: “A large burn that covers most of the patient’s body area requires a significant amount of reconstruction and typically there is very limited healthy skin to use for the traditional autografting process. While the current commercially available CEA for initial wound closure can be lifesaving, it consists of just the upper layer of the skin which limits growth over time and causes increased scarring. Furthermore, it is very thin, difficult to work with, and shrinks significantly while it heals. Grafting advancements that feature full thickness, with an epidermis and dermis, that help the skin to look and behave more like normal skin, will mean better outcomes for patients.”denovoSkin™ is a personalized, bi-layer graft bio-engineered from a small, thin biopsy of the patient’s healthy skin. Its bi-layer dermo-epidermal structure aims to significantly reduce the need for harvesting healthy donor sites and enables improved functional outcomes and enhanced quality of life for patients. CUTISS’ proprietary tissue engineering technology seeks to change the status quo in skin surgery, addressing the limitations of current approaches. Rob Sheridan M.D., Chief of Staff at Shriners Children’s Hospital Boston, commented: “A durable, permanent, high-quality, full-thickness skin replacement that does not require large donor sites would transform acute and reconstructive burn care, and may be particularly beneficial for younger patients who grow over time and often require extensive follow-up procedures. These advancements have remained an elusive goal despite decades of work, and we are very hopeful that this effort will succeed.”denovoSkin™, manufactured at CUTISS’ facilities in Switzerland, is the company’s lead product and has so far been grafted on over 60 patients (from neonates to adults) as part of the ongoing clinical trials in Europe, as well as on a compassionate use basis. Today’s announcement follows the successful Phase I five-year readout of denovoSkin™ published in the Journal of Burn Care & Research in 2024, the successful Phase II one-year readout in burns, and the positive Phase II interim readout in reconstructive surgery. CUTISS is transitioning towards Phase III trials of denovoSkin™ in Europe. ¹ https://ameriburn.org/wp-content/uploads/2024/08/2024-bisr-3.pdf² https://valleywisehealth.org/arizonas-2023-extreme-heat-wave-led-to-record-number-of-burn-injuries/³ https://pubmed.ncbi.nlm.nih.gov/35400523/ About CUTISS AG Established in 2017, CUTISS is at the forefront of tissue engineering therapy and regenerative medicine. Our lead product, denovoSkin™, a bio-engineered, personalized skin graft, promises to transform skin surgery. Currently transitioning to phase III clinical trials in Europe, denovoSkin™ has received Orphan Drug Designation from Swissmedic, the European Medicines Agency (EMA), and the US FDA for the treatment of burns. Moreover, CUTISS is pioneering the development of the world’s first automated platform for large-scale skin tissue production, advancing breakthrough programs in skin pigmentation restoration and expanding the horizons of tissue engineering. For more information: www.cutiss.com. Media contacts CUTISS – European and international mediaCabinet Privé de Conseils (Switzerland)Toomas Kull kull@cpc-pr.com | +41 767 480 174 CUTISS – US mediaInizio Evoke CommsDanielle Cantey Danielle.cantey@inizioevoke.com | +1 (619) 826-4657 Newsroom Link to press release

Switzerland, 9 July 2024 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced positive interim analysis on efficacy from the Phase 2 clinical trial of its lead product denovoSkin™ in patients undergoing reconstructive skin surgery due to various conditions. Dr. Daniela Marino, CEO of CUTISS, said: “We are thrilled with this first positive assessment of efficacy from the Phase 2 trial in reconstructive surgery. These results confirm CUTISS’s mission to provide access to denovoSkin™ beyond burns, improve patient outcomes, and change the status quo in skin surgery.” The Phase 2 full data analysis with the one year follow up will be available in early 2025. A total of 23 patients are included in this multicentric trial. The trial focuses on conditions that necessitate skin grafts (scars, traumatic injuries, congenital defects, surgical excisions, etc), aiming to provide solutions that reduce scarring and improve healing outcomes. The denovoSkin™ is a personalized, bio-engineered dermo-epidermal human skin graft, created from a small biopsy of the patient’s healthy skin and expanded to produce large quantities of new skin. It aims to significantly reduce the need for healthy skin harvesting, significantly reduce scarring, as well as reduce the need for follow-up corrective surgeries. Further details of CUTISS’s clinical trials can be found on the company’s website here. About CUTISS AG CUTISS is a Swiss clinical-stage, pioneering life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first-in-class personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries globally. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently transitioning towards phase III clinical trials in Europe, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine, aesthetic and other applications outside of the medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 92 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174 Newsroom Link to press release

Switzerland, 17 May 2024 – CUTISS AG, a Swiss pioneering life sciences company specializing in skin regenerative medicine and tissue engineering, is glad to announce the first closing of CHF 25 million in its Series C funding round. This milestone demonstrates strong investor confidence in CUTISS’ mission and progress to transform skin surgery. The Series C round is co-led by the family office of Giammaria Giuliani, a longstanding lead investor, and a new co-lead investor, a US family represented by Shiloh Advisors AG. This first closing allows CUTISS to enter Phase 3 clinical trials for its personalized skin therapy denovoSkin™, which recently announced positive results in Phase 2. Additionally, funds will be used to advance the industrialization and clinical readiness of the automated machine for bioengineering denovoSkin™, and to finalize pre-launch activities for the commercialization of VitiCell®, a medical device for Vitiligo treatment in-licensed from IBSA Pharma. Dr. Daniela Marino, CEO and co-founder of CUTISS, commented: “Securing the first CHF 25 million in our Series C funding round is a pivotal achievement for CUTISS. We deeply appreciate the trust and support of our existing and new investors. This funding will enable us to continue working at speed to reach our critical development milestones and bring our life-changing treatments to patients in need. The recent positive Phase 2 clinical trial results for denovoSkin™ have fueled our determination to innovate further in regenerative medicine.” The company continues to welcome new investors to join its journey towards commercialization. CUTISS is committed to change the status quo in skin surgery, advancing its groundbreaking technologies and improving outcomes for patients with severe skin injuries and defects. The Series C round of fundraising is ongoing, and we invite additional investors to support our mission. To date, CUTISS has raised a total of CHF 92 million from private investors, family offices, and public bodies, including contributions from Giammaria Giuliani (of GG1978, Giuliani Pharma, Royalty Pharma, HBM, Rothschild&Co), Zürcher Kantonalbank (ZKB), the Wyss Foundation, Yellowstone Holding, Lichtsteiner Foundation, and Cherry Bay Capital Group. The company has also received grants from the European Union, Innosuisse, and Wyss Zurich. About CUTISS AG CUTISS is a Swiss clinical-stage, pioneering life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first-in-class personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries globally. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently transitioning towards phase III clinical trials in Europe, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine, aesthetic and other applications outside of the medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 92 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174  Newsroom Link to press release

Switzerland, 14 February 2024 – CUTISS AG, a Swiss clinical-stage life science company focused on skin regenerative medicine and tissue engineering, has announced positive one-year follow-up data from its Phase 2 clinical trial of the lead product denovoSkin™, in adult and adolescent severe burn patients. Following the announced positive primary endpoint in Q1 2023, the one-year readout evaluated long term safety and scar quality. Dr Daniela Marino, CEO of CUTISS, commented: “The latest data represent a pivotal moment in our mission. It reinforces the evidence we have gathered so far that denovoSkin™ can be life-saving and can become a transformative treatment option for patients suffering from severe burns by improving overall scar quality and relief post grafting.”  The Phase 2 data and results thus far demonstrate that denovoSkin™, a living, personalized bilayer (with epidermis and dermis) bioengineered skin graft, can safely cover severe burn wounds, significantly sparing patients’ healthy donor sites while improving overall scar quality when compared to standard of care intra-patient. Prof. Dr. MD, Martin Meuli, Chairman of CUTISS, added: “The accomplishments of the past decade have placed us in the midst of an important paradigm shift in burn treatment: from mortality, that used to be the primary concern, to areas that focus on the quality of life of burn survivors. Conceptually understanding the epidermis as “life” whereas dermis as “quality of life” is maybe simplistic, but nonetheless useful to understand the impact that denovoSkin™ can potentially have in burn surgery.”   The current treatment in severe burns and reconstructive surgery – autografting – commonly results in permanent painful, debilitating, disfiguring scars that frequently require follow up corrective surgeries, psychosocial rehabilitation and intense home care. With denovoSkin™, CUTISS is seeking to revolutionize the treatment of severe burns. The Phase 2 clinical trial in adult and adolescent burns has a long-term follow-up of three years (data will be available in 2025). A total of 15 patients were included in this trial. The company is preparing for the next regulatory steps, aiming to make denovoSkin™ available to patients suffering from severe burns and skin injuries worldwide. Further details of CUTISS’s clinical trials can be found on the company’s website here. About CUTISS AG CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently in Phase II clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 65 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland)Toomas Kull kull@cpc-pr.com | +41 767 480 174  Newsroom View Press release in PDF

Switzerland, 07 November – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the successful completion of patient recruitment for the Phase 2 clinical trial of its lead product, denovoSkin™, in reconstructive surgery for both children and adults. This Phase 2 clinical trial evaluates the safety and efficacy of denovoSkin™, a personalized, bio-engineered dermo-epidermal skin substitute in reconstructive surgery. The study has a follow-up period of a total of 3 years. Clinical outcome data are expected to become available in the next 12 months. The trial is being conducted across multiple hospitals in Switzerland, Italy, and the Netherlands, encompassing patients from 1 year of age who require reconstructive skin surgery due to various conditions. A total of 20 patients were included in this trial. Dr. Daniela Marino, Chief Executive Officer and co-founder at CUTISS, said: “The end of recruitment for this pivotal clinical trial underscores our commitment to advancing the field of skin regenerative medicine beyond burns. We are eager to move to the next development phase and to analyze clinical outcome data during 2024.” The innovative denovoSkin™ graft, bio-engineered from a small sample of the patient’s healthy skin, aims to transform the landscape of skin surgery. Its potential benefits include reduced scarring, a pivotal feature for reconstructive surgery. Dr. Daniela Marino added: “Our team has worked diligently to reach this stage, and we are grateful for the trust and collaboration of our clinical partners and patients. As we progress, we remain dedicated to our mission of offering advanced solutions for skin surgery.” In addition to this reconstructive surgery clinical trial, CUTISS has a Phase 2 study in recruitment for pediatric burns (under 12 years of age) with denovoSkin™, as well as an active Phase 2 study in burns for adult and adolescent patients (total follow-up period of 3 years). A Phase 3 clinical trial for denovoSkin™ in adult and adolescent burn patients is in the planning phase. More details on CUTISS’s clinical trials and other developments can be found on the website here. About denovoSkin™ Lead product denovoSkin™ is a personalized human skin graft that can be bio-engineered in large quantities, starting from a small, post stamp-sized piece of healthy skin. It promises to grow with the patient, limit scarring, and drastically reduce the number of follow up corrective surgeries required, particularly in children. The outcome is potentially life-saving and life-changing. Following the completion of a safety clinical Phase 1 trial with a 5-year follow up, CUTISS announced in April 2023 the positive results from the Phase 2 clinical trial of denovoSkin™ in adult and adolescent burn patients. The efficacy endpoint was reached with high statistical significance. It has Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. About CUTISS AG CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently transitioning towards phase III clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine, aesthetic and other applications beyond medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 67 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174 Newsroom View Press release in PDF

Switzerland, 18 September 2023 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the launch of its Series C for the next stage of the company’s development. CUTISS seeks to raise the Series C with the participation of existing and new investors to take its personalized skin therapy denovoSkin™ into the final stages of development, having recently completed the recruitment in Phase 2 clinical trials with positive results. The company will also proceed to industrialize and get to clinical readiness the automated machine that can bioengineer denovoSkin™. Furthermore, CUTISS will finalize the pre-launch activities for the commercialization of VitiCell®, the medical device for the treatment of Vitiligo which has been in-licensed from IBSA Pharma. The Series C is co-led by the family office of Giammaria Giuliani (lead investor in CUTISS’ previous rounds) and a US family (new investor) represented by Shiloh Advisors AG. The terms are set. Existing shareholders and new investors are called in to support CUTISS’ journey in its final steps to commercialization. Dr Daniela Marino, CEO and co-founder of CUTISS, commented: “The opening of our Series C financing round is a significant step in our mission to develop and provide a life-saving and life-changing treatment for patients with severe skin injuries and defects. We are grateful for the continued support of our existing investors and the new investor from the US, and look forward to engaging with others. The recent positive Phase 2 clinical trial results for denovoSkin™ and the positive feedback from the medical community strongly motivate us to continue pushing the boundaries of innovation in the field of regenerative medicine.” CUTISS has so far raised a total of CHF 67 million from private investors, family offices, and public bodies, including Giammaria Giuliani (Giuliani Pharma, GiSev, Royalty Pharma and HBM), Zürcher Kantonalbank (ZKB), the Wyss Foundation, Yellowstone Holding, and Lichtsteiner Foundation. CUTISS has also received funds granted by the European Union, Innosuisse and Wyss Zurich. About denovoSkin™ Lead product denovoSkin™ is a personalized human skin graft that can be bio-engineered in large quantities, starting from a small, post stamp-sized piece of healthy skin. It promises to grow with the patient, limit scarring, and drastically reduce the number of follow up corrective surgeries required, particularly in children. The outcome is potentially life-saving and life-changing. Following the completion of a safety clinical Phase 1 trial with a 5-year follow up, CUTISS announced in April 2023 the positive results from the Phase 2 clinical trial of denovoSkin™ in adult and adolescent burn patients. The efficacy endpoint was reached with high statistical significance. It has Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. About the automation program CUTISS is working to scale-up the production of denovoSkin™ through automation. The company has developed its own unique approach to bioengineering human skin tissue composed of three modules: cell isolation, cell expansion, and skin tissue formation. Starting form a patient’s biopsy and working in sequence, the modules produce the personalized dermo-epidermal skin graft denovoSkin™. The denovoCast™ is the world’s first machine that can bio-engineer large, personalized skin tissue grafts, in a fully closed way. The machine has undergone R&D testing at CUTISS and the company is ready to start the process of industrialization. In May 2023, CUTISS announced that Innosuisse, the Swiss Innovation Agency, awarded a CHF 2.5 million grant to advance the pioneering automation program, and support the industrialization of the denovoCast™. About VitiCell® VitiCell® is indicated for skin re-pigmentation, for example in the case of non-evolving Vitiligo or hypochromatic post traumatic scars. It is a medical device that makes autologous cellular grafting possible in an out-patient setting by a medical professional, be it at a hospital, private clinic or a dermatologist’s cabinet. VitiCell® is a biotechnological product developed and patented by IBSA Pharma. In February 2022, CUTISS announced that it received exclusive rights from IBSA Pharma to globally commercialize VitiCell®. About CUTISS AG CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently transitioning towards phase III clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine, aesthetic and other applications beyond medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 67 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174 French version of the press release > Newsroom Link to Press Release

CUTISS announces results from Phase 2 clinical trials for denovoSkin™ in adolescent and adult burn patients, and Phase 1 in children Phase 2 clinical trial reaches efficacy endpoint with high statistical significance for lead product denovoSkin™ in adult and adolescent burn patients. Phase 1 clinical trial of denovoSkin™ is completed with 5-year follow up demonstrating product safety in pediatric and adolescent patients in burn and reconstructive surgery.   Switzerland, 3 April 2023 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced positive results from the Phase 2 clinical trial of its lead product denovoSkin™, in adult and adolescent burn patients. The efficacy endpoint has been reached with high statistical significance, demonstrating efficacy of denovoSkin™ as a personalized, bio-engineered dermo-epidermal skin substitute for patients requiring a skin graft due to a major burn. Furthermore, the Phase 1 clinical trial for denovoSkin™ completed the 5-year follow up period demonstrating the product’s safety. The Phase 1 trial included pediatric and adolescent patients requiring a skin graft due to a burn injury or reconstructive surgery. Dr. Daniela Marino, CEO of CUTISS, said: “We are thrilled with the positive results from the Phase 2 and the completion of the Phase 1 clinical trial with five-year follow-up, which confirms the safety and efficacy of denovoSkin™ in adult and adolescent burn patients. We are proud of the progress made this far, and the hard work and dedication of the entire CUTISS team. We look forward to preparing for the next regulatory steps to bring this promising treatment to patients suffering from severe burns and skin injuries.” The Phase 2 full data analysis with the three-year follow up will be available in 2025, with the last patient transplant having taken place in August 2022. A total of 15 patients are included in this trial. Further details of CUTISS’s clinical trials can be found on the company’s website here. About CUTISS AG CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently in Phase II clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 65 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174  Newsroom Press release as PDF

As part of the company’s R&D in regenerative medicine, CUTISS will observe the effects of space on skin cells and tissue culture. Research implications towards human safety in space travel and new discoveries in regenerative medicine and tissue engineering on Earth. Four-week mission conducted in collaboration with SpacePharma which specializes in space-based experiments and micro-lab technologies. Micro-lab containing CUTISS’s experiment travelled to the ISS on SpaceX’s 27th commercial resupply mission (CRS-27) for NASA. Switzerland, 15 March 2023 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the start of an advanced research and development mission on board the International Space Station (ISS), leveraging the state-of-the-art micro-lab technology developed and provided by the Swiss spacetech company SpacePharma. Daniela Marino, co-founder and CEO of CUTISS, commented: “We are thrilled to launch this advanced research and development mission with SpacePharma on board the International Space Station, enabling us to push the boundaries of innovation in regenerative medicine and tissue engineering. We are excited by the potential of this research to improve the safety of space travel as well as the likelihood of making scientific discoveries for the benefit of people on Earth.” Yossi Yamin, co-founder and CEO of SpacePharma, stated: “We are discovering new and exciting ways to help humanity in novel medical and pharmacological solutions that can be researched and developed only under micro-gravity conditions in space. SpacePharma is proud to enable such advanced research for pharma and medical players and we are especially excited about this important collaboration with CUTISS that we believe may change scarring treatments for us all.” In space, humans are known to be impacted by microgravity and space radiation, leading to changes in the structure and function of cells. Skin, like other organs, experiences changes in physical properties such as thickness and levels of hydration, and also biological properties that can impact wound healing. Building on CUTISS’s expertise in skin biology and tissue bioengineered, the company will observe the biological processes and cell behavior of skin tissue in the space environment, in comparison to Earth’s. Studying the effects of space on skin tissue and cell culture is important for developing strategies to protect astronauts during spaceflight, understanding how exposure to the space environment can affect human health, as well as developing potentially new and innovative medical treatments and technologies that can benefit people on Earth. Vincent Ronfard, Chief Innovation Officer of CUTISS, said: “As we embark on this research and development mission in space, we are excited to leverage our expertise in skin biology and tissue bioengineering and to combine it with SpacePharma’s cutting-edge technology. We look forward to observing the experiment in space and continuing our research and analysis after the lab returns to Earth.” With the SpacePharma micro-lab plugged into the ISS’s electrical and monitoring systems, CUTISS will observe in vitro the cultivation of human skin cells (keratinocytes and fibroblasts) in 2D or 3D culture systems to assess their ability to produce extracellular matrices, and also look at the cells’ properties, such as their ability to migrate and to divide. The aim is to deepen our understanding of fundamental biological processes and potentially support the development of new therapies, devices and tools for wound healing, aging, and scarring. Collaboration with cutting-edge spacetech company SpacePharma To fulfill this space mission, CUTISS has collaborated with the Swiss company SpacePharma which develops micro-laboratories for advanced R&D in space under micro-gravity conditions. These remotely controlled, fully automated labs are based on lab-on-a-chip (LOC) technology, in other words a microfluidic device that carries living cells in a nutrient-rich growth medium. With the micro-lab safely onboard the ISS, it will be connected to the station’s power and monitoring systems by NASA astronaut Dr Warren Hoburg. The data from the micro-lab will be transmitted back to Earth and overseen in real-time by the CUTISS scientific team. SpacePharma’s micro-labs technology enables the collection of unprecedented results that cannot be obtained on terrestrial setting and the CUTISS team has worked closely with SpacePharma’s mission experts to define solid preflight protocols. For SpacePharma, this is the company’s eighth flight to orbit, sixth mission to ISS, and thirtieth experiment for a commercial client. Return to Earth in about one month The ISS orbits at an average altitude of 408 kilometers above Earth. At the end of the mission, in approximately four weeks, the miniaturized lab will come back to Earth in the Dragon spacecraft near the Florida coastline. CUTISS’s cells will then be returned to company headquarters in Zurich, Switzerland, for more detailed analysis of the results of the experiments.  Research in microgravity: a new frontier Microgravity is a disruptive opportunity for several major sectors: pharmaceuticals, biotechnology, material/chemical science and nutrition. It provides companies and researchers with the ability to accelerate discovery processes for new drugs and vaccines, develop new crystals and materials and accelerate the study of human genome and origin of diseases. The potential scientific, technological and commercial benefits of microgravity research to humankind are substantial, and will revolutionize traditional Earth-bound processing methods. About the CRS-27 mission The SpacePharma micro-lab containing CUTISS’s experiment traveled to the International Space Station on SpaceX’s 27th commercial resupply mission (CRS-27) for NASA. Liftoff of the SpaceX Dragon cargo spacecraft on a Falcon 9 rocket took place on March 14, from Launch Complex 39A at NASA’s Kennedy Space Center in Florida. SpaceX’s Dragon has delivered new science investigations, supplies, and equipment for the international crew. About CUTISS CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently in Phase II clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS

Switzerland, 7 November 2022 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced that the company is invited to the upcoming Jefferies London Healthcare Conference, taking place November 15 – 17, 2022. Dr Daniela Marino, Chief Executive Officer and co-founder at CUTISS, will attend the conference and hold one-to-one meetings with registered members of the investor community which includes leading global executives, institutional investors, and private equity investors. The Jefferies Healthcare Conference is the largest healthcare-dedicated investor conference in Europe covering pharma, biotech, medtech and healthcare services. The past conference saw 550 companies and 3,000 attendees from Americas, Europe, Middle East, Africa, and Asia join the event. About CUTISS AG CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently in Phase II clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 55 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174  Nick Miles miles@cpc-pr.com | +41 796 787 626 Newsroom Press Release

PRESS RELEASE CUTISS completes recruitment for denovoSkin™ Phase 2 clinical trial in adult and adolescent burn patients Switzerland, 7 September 2022 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the completion of recruitment for the Phase 2 clinical trial of its lead product denovoSkin™ in adult and adolescent burn patients. The entire study lasts about 12 months per patient with yearly follow-up visits 2 and 3 years after transplantation. Clinical outcome data from ongoing patient follow-ups are expected to become available in Q1 2023. This Phase 2 clinical trial evaluates the safety and efficacy of denovoSkin™, a personalized, bio-engineered dermo-epidermal skin substitute (NCT03227146). The trial is conducted in hospitals across Switzerland, Italy, and the Netherlands in patients 12 years of age and older who require a skin graft due to a major burn. A total of 12 patients are included in this trial. Since the protocol allows up to 15 patients, 2 additional patients have been enrolled and treated in August. Dr. Fabienne Hartmann-Fritsch, Clinical Study Advisor and co-founder at CUTISS, stated: “We are very pleased to have completed the recruitment of patients for this ground-breaking clinical trial, a true milestone for the continued development of our lead product denovoSkin™. We now look forward to analyzing the clinical outcome data during 2023.” The personalized human skin graft denovoSkin™ that is bio-engineered in large quantities starting from a small, post stamp-sized piece of healthy skin of the patient, could take skin surgery to the next level and revolutionize current treatments. It promises to grow with the patient, limit scarring and drastically reduce the number of follow up corrective surgeries required. Dr. Daniela Marino, Chief Executive Officer and co-founder at CUTISS, commented: “In Switzerland and across Europe, this year’s particularly hot and dry summer resulted in several fire-related accidents and patients admitted to burn centers requiring skin surgery. After completing the technology transfer from Wyss Zurich, our new on-site manufacturing facility started activities in March 2022 which significantly increased our agility and capacity to produce denovoSkin™ for clinical trials as well as for patients on a compassionate use basis.”                                                                                                                                                   CUTISS is also conducting two other denovoSkin™ Phase 2 clinical trials in Switzerland, Italy, and the Netherlands: one for pediatric burns (under 12 years of age, NCT03229564), and one for reconstructive surgery of skin defects (from 1 years of age, NCT03394612). A clinical trial Phase 1 for denovoSkin™ involving children suffering from burns or skin defects requiring surgery was completed in 2021 with a 5 year follow up at the University Children’s Hospital in Zurich. Further details of CUTISS’s clinical trials can be found on the company’s website here. To see how CUTISS bioengineers denovoSkin™, its pioneer automated manufacturing program, and the promising impact that CUTISS’s product has on patients, please visit the company’s YouTube channel here. About CUTISS AG CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries. The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently in Phase II clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine.  Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 55 million from private investors, family offices and public bodies. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174  Nick Miles miles@cpc-pr.com | +41 796 787 626 Newsroom Press release (PDF)