INVESTMENT OPPORTUNITY TO TRANSFORM SKIN SURGERY

INVESTMENT OPPORTUNITY TO TRANSFORMSKIN SURGERY
CUTISSAGisaninnovative,late-stageclinical
ZurichUniversity(UZH)spin-off,incorporatedin2017,TOP#1Swissstart-up2020
company focusing on precision regenerative
HeadquarteredattheBio-TechnoparkinZurich-Schlieren
medicine.Havingsecured>CHF 67M,CUTISS
-45employees,topnotchseniorexecutives,advisorsandinvestors
isnowraisingitsSeriesCtoadvancetowards
OwnlabsandGoodManufacturingPractice(GMP)facilitycertifiedbySwissmedic
commercializationandliquidityevent.
Afullyownedsubsidiaryworkingonaninnovationportfolioforfuturepipelines
CURRENT ACTIVE AREAS
SoC
SKIN REPLACEMENT SURGERY - Standard of care in burn and reconstructive surgery (e.g. trauma,
scar and cancer resection etc.) is scarce, leads to severe scarring and is costly. CUTISS aims to
transform skin surgery with denovoSkin , a personalised, bio-engineered skin graft. Classified as an
advanced therapy medicinal product (ATMP), it can be bio-engineered in large quantities using a
stamp-sized sample of patient's own skin. To date, our clinical data confirm long-term safety, denovoSkin
demonstrate efficacy vs standard of care, promise significant improvement in patients' quality of life
by minimizing scarring, while lowering total healthcare costs. Importantly, burns are classified as a
Healthy
rare(orphan)inCH-EU-US,offeringattractivefasttrackoptionstowardsmarketauthorization.
AUTOMATED TISSUE BIO-ENGINEERING - To secure scale-up, allow decentralization and achieve
relevant cost reduction for the in-house manufacturing of denovoSkin , CUTISS is developing first-in-
classautomatedbio-reactorswithleadingSwissandinternationalengineeringpartners.
This pioneering, proprietary platform could be used beyond skin for the next-priority human tissues
(muscle,gums,etc)andbeyondmedicineinagritechandfoodtech(leather,meat).
DERMATOLOGY - Skin color restoration in vitiligo, dyspigmented scars and grafted denovoSkin , with
innovativemedicaldevicesforpersonalized,precisioncelltherapyatpoint-of-care.
CURRENT PIPELINE
denovoSkin - developed by CUTISS - is bio-engineered on demand. Same as
one'sskin,itiscomposedofanepidermis(top,protectivelayer=life)andadermis
OUR PERSONALIZED SKIN GRAFTING
(the structural, below layer=quality of life). Key differences from the standard of
care (SoC) - autografting (thin skin sheets harvested from patient's own healthy
sitesandappliedonthewounds):
SoC denovoSkin
Thickness ideal for deep wounds
No
Yes
Expansion factor of patient's skin sample
<9x
>100x
Scarring
Significant
Minimal
VITICELL® - acquired under a global, exclusive commercialization license from
IBSA Pharma - has been CE-marked for the cell therapy-based treatment of
vitiligo and dyspigmented burn scars at point of care. We are also working on
other in-house-developed medical devices.
Together, denovoSkin (de-pigmented skin graft) and VITICELL® (pigmentation device) offer a unique complete personalized solution.
THE MARKET AND OUR BUSINESS PLAN
In early July 2023, Coloplast announced the acquisition of our peer Kerecis in a USD 1.3bn deal, a significant validation of the tissue
engineeredskinsubstitutesforburnsandtissueregeneration.Theglobalbio-engineeredskingraftmarketisexpectedtogrowatCAGR
of 11% due to increased skin injuries caused by diseases and incidents (also global warming-related), and higher number of aesthetic
procedures. The global vitiligo market is expected to grow at CAGR of 4.3%, -2% of world population is affected (cell therapy 10%
share). With 2.6M total addressable patients p.a. (burns, reconstructive, vitiligo), CUTISS' sales are expected to reach CHF 2Bn within
10 years, with stabilized margins. denovoSkin has no direct competitor on its target market segments several products in the space
(e.g.dermaltemplateslikeIntegra®artificialskin)canbeusedincombinationwithdenovoSkin .
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INTELLECTUAL PROPERTY
SUSTAINABILITY AND IMPACT
2x Patents exclusively licenced from UZH, Granted EU, US and others
- CUTISS contributes to ensuring healthy lives and
- Method and device (2013) promotes well-being for all, at all ages. It also supports
- Tissue graft (2014) social (re)integration of patients with severe skin defects.
- With our scale up plans we strongly commit to
6x Patents owned by CUTISS, in national phase
reducing inequality within and among countries.
- Automation family (2019/2020)
- Via continuous progress we commit to ensuring a
Trade secret of production process. sustainable manufacturing process.
EXCELLENT CLINICAL DOSSIER
PIONEERING AUTOMATION PLATFORM
denovoSkin : Safety (Phase 1) trial completed with 5-year follow-up
CUTISS has developed three automated modules to
on burns and reconstructive patients. Efficacy (Phase 2) endpoint manufacture large quantities of denovoSkin via 1. cell
reached in adolescent & adult burns (Q1 2023). Confirmatory (Phase isolation, 2. cell expansion, 3. tissue formation in a fully
3) trials are in planning. Efficacy trial in reconstructive is close to closed system, disposal based.
Developed with leading
recruitment completion. Six burn compassionate patients treated;
Swiss and international partners, those modules are fully
reports are published in peer-reviewed journals. active in the laboratory and are now entering the
VITICELL®: Clinical validation completed. industrialization phase, towards clinical use readiness.
CLEAR GO-TO-MARKET STRATEGY
BEST IN CLASS INDUSTRY PARTNERS
denovoSkin : produced in-house
(first manually, then
automatically), in CUTISS' regional hubs. We first target the highly
accessible, orphan burn market with direct sales, an attractive pricing
strategy and very favorable reimbursement terms. Reconstructive
and aesthetic surgery markets will follow.
VITICELL®: sold directly in CH; via distributors in other target regions.
HIGHLY EXPERIENCED TEAM
CURRENT CAP TABLE
Outstanding expertise at executive and advisory level. Extensive
Experienced investors, family offices, HNWI, foundations,
international experience and network in skin engineering and skin banks, such as: Giammaria Giuliani of Giuliani Pharma, Wyss
therapy, from bench-2-bed-2-market, manufacturing, engineering.
Foundation,
ZKB,
Yellowstone
Holding,
UZH
LF fund,
Experience in leading SME and large enterprises like MODEX (CH),
Liechtensteiner foundation,
Innosuisse,
EU commission.
L'OREAL (FR, China), HEALTHPOINT (US), SMITH&NEPHEW (US), A- Largest shareholder: 10%. Team/founders/UZH: 47%
STAR (Singapore), ORGANOGENESIS (US) etc.
Key members
SERIES C ROUND - PAVING THE WAY TO MARKET
© Wyss Zurich
Daniela Marino, Dr. CEO and Co-Founder, Board of Directors
To date, > CHF 67M was raised (dilutive and non). Post positive
Vincent Ronfard, Dr. Chief Innovation Officer efficacy results in burns, a Series C for CHF 40-60M is now open
Kathi L. Mujynya, MBA COO
(minimum ticket size CHF 250k). The round is co-led by the
Anke Gerding, CFO family office of Giammaria Giuliani (existing investor) and a US
Luc Teot, Dr. med. Medical officer family (new). A liquidity event is planned in the next 2-3 years.
Thierry Passeron, Dr. med. Medical advisor
The Round C proceeds will be used to:
Clemens Schiestl, Dr. med Medical advisor and co-founder
- complete the clinical validation of denovoSkin ;
Ralf Rosenow, Legal Counsel and BoD Secretary
- finalize the Market Authorization (incl. fast track) dossiers for
Board of Directors
Swissmedic,EMAandFDA;
- bring the automated tissue engineering modules to clinical
Martin Meuli, Dr. med. Chairman and Co-Founder
readiness and expand manufacturing capacity;
Ernst Reichmann, Dr. Co-Founder
- commercially launch VITICELL®;
Giammaria Giuliani, Investor, Royalty Pharma, HBM
- grow the management, team and board expertise in
Gerard Ber, Independent board member (Ex COO of AAA)
commercial, medical and financial.
CUTISS HAUS, Grabenstrasse 11, 8952 Schlieren, Switzerland
Tel. +41 44 244 36 60, daniela.marino@cutiss.swiss - www.cutiss.swiss
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