Press release

CUTISS AG announces additional Member of the Board of Directors

Zurich, Switzerland, May 28 2020 – CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced it has further enhanced its Board of Directors with Gerard Ber as newly elected, additional and independent Member of the Board.

At the recent Annual Shareholder Meeting 2020 of CUTISS, Dr. Gerard Ber was elected as additional and independent Member of the Board of the Company for a term of one year, thus further strengthening its Board of Directors. Gerard has been acting as Co-Founder, Chief Operating Officer and Member of the Board of Advanced Accelerator Applications, an innovative radiopharmaceutical Company based in France that was acquired by Novartis in 2018. Before, he held positions as Export Area Manager for Western Europe at OM Pharma Switzerland (Vifor Pharma) in Geneva and Director of Marketing and Commerce for CIS Bio International/ORIS in Paris. Today, Gerard is Life Science Entrepreneur and Member of the Board of Directors of, among others, Ymabs (New York). He studied Pharmacy at the University of Grenoble (France). Dr. Gerard Ber is a Swiss citizen.

Daniela Marino, CEO and Co-Founder of CUTISS AG, commented: “We are pleased and honored that Gerard Ber has accepted becoming an independent Member of our Board, thereby offering his valuable and broad know-how of the Life Science industry to our emerging Company.”

About CUTISS AG
CUTISS is a Swiss Life Science Company, spin-off of the University of Zurich, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its lead product candidate, denovoSkin™, has been tested in a phase I clinical trial on pediatric patients at the University Children’s Hospital in Zurich. Phase II studies are currently ongoing in Switzerland and the European Union and are partially funded by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ aims to improve life quality of elective (reconstructive treatments) patients as well and it can further be developed in terms of complexity by adding pigmentation.

Contact
CUTISS AG, CEO Daniela Marino, +41 76 230 80 46, info@cutiss.swiss, www.cutiss.swiss

26.05.2020 – CUTISS AG announces denovoSkin™ clinical trials phase II start in Italy for burns and reconstructive patients. First associated center is Torino.

Zurich, Switzerland, October 28 2019 – CUTISS AG, an innovative Swiss life-science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced it has further enhanced its Management Team.

As per October 1, Kathi Mujynya Ludunge has been appointed Chief Operation Officer of CUTISS. She will be responsible for the Company’s operations as well as for all Manufacturing/ GMP/Quality activities (clinical and commercial products). Kathi joins CUTISS from the Skin Research Institute of Singapore /A*STAR (Agency for Sciences, Technology and Research), where she was working since 2016 as Head of Operations of the Asian Skin Bank Platform. Prior to her relocation to Singapore, Kathi held several leading positions in life-sciences, among those managing GMP manufacturing and development projects for Healthpoint Therapeutics (Switzerland and USA), as well as leading the Manufacturing, Sciences and Technology (MSAT) department at Smith & Nephew (Fort Worth, Texas).

Kathi started her professional career in Switzerland as a scientist at the Institute of Pathology of the University of Berne, followed by the position as Production Manager at the Lausanne-based LifeScience-Start Up Modex Therapeutics/Isotis, before joining DFB Pharmaceuticals (Lausanne). Kathi is a Cell Biologist by training (Neuchatel School of Health), then gained project management expertise with her MBA (University of Geneva), followed by a post-grade diploma in Management of Biotech and Pharmaceuticals venture at EPFL (Lausanne). She holds a dual citizenship (Switzerland and USA).

Kathi Mujynya Ludunge said: “I am not only happy to return to Switzerland with my husband and move our family back home to Switzerland, but also to join CUTISS, an emerging and life-science start up with a clear vision”. Dr. Daniela Marino, Chief Executive Officer and Co-Founder of CUTISS AG, commented: “We are excited that Kathi has decided to return to Switzerland after many years abroad to support us in achieving our goals. With her know-how now, the expertise in skin bioengineering of CUTISS’ management team sums up to 100 years”.

About CUTISS AG
CUTISS is a Swiss Life science Company, spin-off of the University of Zurich, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its lead product candidate, denovoSkin™, has been tested in a phase I clinical trial on pediatric patients at the University Children’s Hospital in Zurich. Phase II studies are currently ongoing in Switzerland and the European Union and are funded by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ promises to improve life quality of elective (reconstructive) patients as well and it can further be developed in terms of complexity by adding pigmentation.

Contact
CUTISS AG, CEO Daniela Marino, +41 76 230 8046, info@cutiss.swiss, www.cutiss.swiss

Zurich/Alpnach, 19 August 2019 – Swiss researchers want to develop the first-ever automated machine to bioengineer personalised skin grafts for therapy. The denovoCast project, a collaboration between life science start-up Cutiss AG and CSEM, has been awarded a grant of more than CHF 800’000 by Innosuisse.

50 million people who suffer a large skin defect every year, including burn injuries, are treated with autografting, a skin grafting method older than modern medicine, that too often leaves these patients with disfiguring and debilitating scars. Scars can impair mobility and growth and require follow-up surgeries, intense homecare and psychosocial rehabilitation.
Zurich-based Cutiss AG, a spinoff of the University of Zurich, wants to offer an alternative by bio-engineering a personalized, permanent skin graft that will minimally scar after transplantation. The company has developed denovoSkin™, which is now being tested in a multi-centric phase II clinical trial.

Produce personalized skin grafts

Using a stamp sized biopsy of the patient’s own healthy skin, Cutiss is able to produce several denovoSkin™ grafts in the good manufacturing practices (GMP) facility of Wyss Zurich in a fully manual process. The next step in tissue engineering is now to move from the time-consuming manual production process to automated production in order to minimize costs, ensure robustness and scale up the process. Automation is the only way to make denovoSkin really accessible to patients in need.
To support this project, the federal innovation promotion agency, Innosuisse, has awarded a grant of CHF 826’000 for the denovoCast project, a Cutiss collaboration with the Swiss research and technology organization CSEM. Over 18 months, the project will develop an innovative approach for automating the skin engineering process while preserving the quality of the tissue.
“At Cutiss, we are proud to receive this support from the Swiss government. We have a great chance to develop and bring to market the next excellent Swiss-made innovation product,” Cutiss CEO and Co-Founder Daniela Marino said. The Swiss grant comes on top of funding received from the European Union’s Horizon 2020 Program.
The bioengineered skin developed by Cutiss is unique in its biological characteristics. With its strong combination of advanced skills in automatization and bioengineering, Marino sees CSEM as the ideal partner to make this critical advance in scalability for an unmet medical need.

The global burn market alone is estimated to be worth at least one CHF billion. “We want to reach out globally, ensuring personalized skin graft production as close to the patient as possible. For that, we need to have a manufacturing process which is automated, quick, robust and standardized so that it can be easily transferred allowing the de-centralization of the manufacturing. The machine developed by CSEM will bring us one step closer to this goal,” Marino added.

Vincent Revol is the head of the CSEM team working on denovoCast. “The cutting-edge technology we are developing in this project has the potential to significantly increase the quality of life of millions of patients who suffer from skin defects, and, over the long term, may also be applied to other tissue engineering processes such as cornea or mucosa,” he said.

A Swiss made solution

The end result envisaged by Cutiss is a skin-tissue producing machine that will be placed in multiple manufacturing facilities, starting off with Zurich. The machine, made in Switzerland, would require minimal user interaction.
“The main challenge will be to produce skin tissues on a larger scale, on a commercially relevant scale. Burn patients need a lot of new skin, as quickly as possible. We have a team working on automation and liquid handling, and another team working on the customized labware where the skin graft will be engineered.” Revol said.

Cutiss AG, with a team of 19 people, has excelled on the start-up circuit, winning several awards and the backing of major investors. The company has secured 17 million CHF in funding since its founding in 2017.

CUTISS AG Raises CHF 7.255.000 in a Series A Financing to Advance Personalized Skin Graft Technologies

Funding brings resources to scale-up the production of denovoSkin™ and to develop the next generation skin grafts.

Zurich, Switzerland, June 20th 2018 – CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focused on the development of personalized bioengineered skin graft products for the treatment of skin defects, announces the closing of a series A financing round of CHF 7.255.000. CUTISS AG’s lead product denovoSkin™ has successfully completed Phase I in pediatric patients and is recruiting in multi-centric Phase II studies financed by Wyss Zurich. This series A financing round is succeeding a CHF 1 million convertible loan previously provided to the company by the UZH Life Sciences Fund, and now converted.

The funds raised with Giammaria Giuliani (Lead), Yellowstone Holding AG, Zürcher Kantonalbank and several private investors will be used to scale up the production of denovoSkin™ and to develop the next generation skin grafts. “Our Series A investors bring not only capital resources, but also great vision and experience in the Life Science industry and innovation. We are very glad to welcome them on board,” said Dr. Daniela Marino, CEO and co-founder of CUTISS AG.

The Lead investor, Giammaria Giuliani said: “We are thrilled to invest in a strong team that, we believe, will develop CUTISS AG’s technology into being a game changer in the cell therapy field for recon-structive and plastic surgery”. Branford Lu from Yellowstone Holding said: “It is our pleasure to work with CUTISS AG. We are confident that this technology will be of great benefit for millions of patients worldwide”.

CUTISS AG’s board of Directors is chaired by Prof. Dr. med. Martin Meuli, Director of the Surgery Department of the University Chil-dren’s Hospital Zurich. In conjunction with the financing, Giammaria Giuliani is joining the board with its other members: Prof. Dr. Ernst Reichmann, Head of the Tissue Biology Research Unit at the Univer-sity Children’s Hospital in Zurich, Dr. Anja König, Global Head of No-vartis Venture Fund and Dr. Daniela Marino.

About Skin Defects

Every year in the world, more than 50 millions of people suffer from skin defects and need surgical intervention to restore skin function. Skin defects can be either acute (burns & trauma) or elective (reconstructive and ulcers). In EU and US about 12 million patients could benefit from CUTISS AG’s technology every year. Burns are a rare disease and denovoSkin™ has received Orphan Drug Status / Designation for their treatment by Swissmedic, EMA and FDA. In many cases, standard of care leaves patients with debilitating scars. denovoSkin™ could significantly improve the life quality of patients worldwide by drastically reducing scarring after transplantation.

About CUTISS AG
CUTISS AG is a Swiss biotech company, spin-off of the UZH, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its first in line product denovoSkin™ has been tested in a phase I clinical trial on pediatric patients at the Uni-versity Children’s Hospital in Zurich. EU phase II studies have started financed by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ promises to improve life quality of elective (reconstructive) patients.

Contact
CUTISS AG, Daniela Marino, +41 76 230 8046, info@cutiss.swiss, www.cutiss.swiss

CUTISS AG receives Swissmedic approval to commence Phase IIb denovoSkin™ Trials in burns in adults and children.

Zurich, November 02, 2017 – CUTISS AG today announced that it has received approval from
Swissmedic to commence two Phase IIb Trials using denovoSkin™ in the treatment of burns in adults
and children. In Switzerland, these Trials will be recruiting patients at two centers, the University
Children’s Hospital Zurich where Phase I was recently completed, and the University Hospital Zurich.
The Trials will expand to other two centers, The Dutch Burn Center in The Netherlands, and the
University Hospital in Birmingham in UK, subject to approval by the National Authorities. The Trials
are designed to treat up to 15 burn patients each.

“The aim of these Phase IIb Trials is to validate the efficacy of denovoSkin™ against standard of care in
burns” said Dr. Fabienne Hartmann, CTO at CUTISS AG. “We are also delighted to continue the Trials
where they originated, at University Children’s Hospital Zurich. We want to thank the patients and
their families who have taken part in the trials so far and those that will support our future efforts”,
said Dr. Daniela Marino, CEO at CUTISS AG.

About Burns

Every year in the world, more than 11 millions of people burn large areas of their bodies and need
surgical intervention to restore skin function. In many cases, standard of care leaves patients with
discomforting and debilitating scars. denovoSkin™ could significantly improve the life quality of
patients worldwide by reducing scarring after transplantation.

About CUTISS AG
CUTISS AG is a Swiss biotech company, spin-off of the UZH, developing personalized skin graft
technologies for the treatment of a large spectrum of skin defects. Its first in line product denovoSkin™
has been tested in a Phase I Clinical Trial on pediatric patients at the University Children’s Hospital in
Zurich. EU Phase IIb Trials are funded by Wyss Zurich. denovoSkin™ has received Orphan Drug
Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™
promises to improve life quality of elective (reconstructive) patients, it is a scalable technology and it
can further be developed in terms of complexity by e.g. adding pigmentation.

Contact
CUTISS AG, Daniela Marino, +41 76 230 8046, info@cutiss.swiss, www.cutiss.swiss

Funding brings resources to start scale-up production of denovoSkin™.

Zurich, Switzerland, September 1st 2017 – CUTISS AG, a biotech company spin-off of the University
of Zurich (UZH), focused on the development of personalized bioengineered skin graft products for the
treatment of skin defects, announces the closing of a seed financing round of CHF 1 million. CUTISS’
lead product denovoSkin™ has successfully completed Phase I in pediatric patients and will initiate Phase
II studies in Q3/2017. The funds raised with UZH Life Sciences Fund investor will be used to launch the
development of the automation of the production process for denovoSkin™.

“The timing of this financing is perfect and puts CUTISS in a competitive position to efficiently continue
development of its proprietary technologies and personalized medicine products.” said Dr. Daniela
Marino, CEO and co-founder of CUTISS. “Launching of the scale-up activities represents a major
milestone of our process development.” added Dr. Vincent Ronfard, CIO of CUTISS. “The automation
project will bring GMP manufacturing to another level.” said Dr. Fabienne Hartmann, CTO and cofounder
of CUTISS. “We believe in CUTISS’ innovative product denovoskin™ for treating patients
suffering from skin defects,”, stated Anja König from the Novartis Venture Fund.
CUTISS’ board of Directors is chaired by Prof. Dr. med. Martin Meuli, a Key Opinion Leader in surgery
and skin tissue engineering. In conjunction with the financing, Anja König is joining the board with its
other founding members Prof. Dr. Ernst Reichmann, who leads the Tissue Biology Research Unit at the
University Children’s Hospital in Zurich where denovoSkin™ was developed, and Dr. Daniela Marino.