investment case brainrepair
TRANSCRIPT
Strictly Confidential | July 2021 2
For further contact, queries and information please contact only:
Carlsquare GmbHBrienner Straße 1480333 Munich+49 89 255 495 30
Caspar StauffenbergManaging [email protected]
Anders ElgemyrManaging [email protected]
Caroline BerglundHead of Equity [email protected]
Oskar WollertVice President [email protected]
Ulrika StrömbergSenior [email protected]
Carlsquare GmbH ('Carlsquare’), Munich, together with BrainRepair UG (‘BrainRepair’), Bochum, places
this presentation at the disposal of potential interested parties. Carlsquare gives no guarantee of the
correctness and/or completeness of the information contained therein or of other verbal or written
information made available to the interested party. Carlsquare makes no claim to having
independently checked the information made available by BrainRepair. Carlsquare accepts no liability
and makes no guarantee in relation to the plan figures and projections (also to the projections
compiled by the management of BrainRepair) that are contained in this presentation.
Each recipient of this presentation declares and agrees that all the information contained within is
strictly confidential and he will neither pass on this information himself nor through a third party,
without the prior written consent of Carlsquare. This document or parts of its content must not be
copied, duplicated or made accessible to third parties, without having obtained the prior written
consent of Carlsquare.
This presentation is non-binding and provisional and does not include a legally binding obligation
regarding the disposal or acquisition of shares in the business or other parts of the assets neither for
BrainRepair nor for Carlsquare.
The content of this presentation is not to be used as a binding basis for legal, business or taxation
matters, but merely serves as information. Each interested party should undertake his own analyses,
checks and due diligence to check the details. Recipients of this presentation, who have no intention
of pursuing this project any further, are requested to return this presentation to Carlsquare
immediately, without being asked, and to destroy any possible copies and computer documents
created.
As INVESTOR, please request fully fletched TEASER / INFORMATION MEMORANDUMfrom:
Strictly Confidential | July 2021 3
Executive Summary1
Market environment and competition2
BrainRepair therapy and regulatory affairs3
Phase III study4
Clinical data5
Organizational setup6
Business model and commercialisation7
Transaction scope8
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BrainRepair treatment of massive brain damage and coma
1 | Investment highlights
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A sequence of findings led to the discovery of the beneficial effect of Hau-UCB-mnc transplantation on functional neuroregeneration
3 | BrainRepair therapy and regulatory affaires
2002
Experimental evidence of “Homing”1 of hau-UBC-mnc in foetal sheep model
2006
Proof of principle in Levine model: specific “homing” and prevention of spastic paresis
2007 2009 2010 2012 2014 2016
Evidence of release of anti-inflammatory cytokines, chemokines & growth factors in culture
Successfultreatment of cerebral palsy in a young boy
Successful treatment of stroke in a young girl
Evidence of principal “homing” mechanism
Prevention of Glial scars by hau-UBC-mnc
First review article “bench to bedside”
Two orphan medical product designations
1) “Homing” refers to the process of proteins guiding huMNC to the lesion site
2020
Paediatric Investigation Plan (PIP) approved for pivotal trial
(RCT, Randomised Controlled Trial)
L.B. is the first documented case worldwide
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3 | BrainRepair therapy and regulatory affaires
Situation
L. B. was a 2 ½ years old healthy child when the insult incurred
He began to suffer:
− Cardiac arrest− Massive brain damage− Blind and deaf− Coma state for 9+
weeks
Prognosis of medics:
− Lifelong supportive care
− No improvement to expect
BrainRepair steps in
Parents asked for help
Cord blood was banked
Stem cells contained in unit
Infusion in vegetative state
Improvements
L. B awakes
REGAIN therapy
Week 1
recognises his parents
Week 3 Week 7
Says “Ma-ma” and is able to smile again
Enters school
Marked improvements 1st year:
Functional movements
Recovered eye sight and hearing
Comprehension and recognition
Pointing to objects
Free sitting, rolling and crawling
Refined pinch
Walking with support
Marked improvements 2nd year:
Free walking in gate trainer
Active speech of 8 words
Colour recognition
Plays “memory” game
Marked improvements 3rd year:
Fine motor skills
Free walking with retro-walker
Active speech of 200 words, four-word-sentences
Marked improvements 4th year:
Plays “Uno” game with his sister
Walking on the arm of his mother
Climbing stairs with support
Improvements from 5th year:
School enrolment (now 10th grade)
Rides bicycle (3 wheels)
Free sitting on horse back
Testimonials support the need and success of BrainRepair’s REGAIN therapy
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“We are already noticing tremendousresults with E.J., who is now able to walk(very fast!) and open/close her hand. Itis hard to believe she could not even situp eight months ago!”
- M.N.
“L.B. is developing well, can stand andwalk with crutch on rollers (upper bodyfixed). Stretching is difficult. Can sitcross-legged. Shows pictures inchildren's book when prompted. […]Sitting down, he turns the pages of thebook by himself.”
- M.B.
“Paul continues to make a lot ofprogress at his pace. [...] Paul has beengoing to school now since August. Paulis having super fun learning with hisTobii. We didn't think it would work outso well. He amazes the teachers.”
- P.R.
“Melina and our family say thank you! I did not expect a miracle tohappen, and yet, it did, thanks to you! Melina has now outgrownme, plus she is slim and slender. […] She is doing well in school. InFebruary, the eighth grade has a 10-day internship to complete.”
- I.H.
“C. is doing well. [...] Furthermore we can notice that hisperception is getting better. His eyes have become calmer, and hestays longer at fixed points. Again and again a smile comes overhis face, even if we don't actively ask him to do so.”
- H.K.
3 | BrainRepair therapy and regulatory affaires
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Locations
6 | Organisational setup
Description of location:
• BrainRepair UG is based in Bochum, North Rhine-Westphalia, Germany
• Its offices are located in the BioMedical Center (BMZ), ,Campus Clinic Gynecology’, Bochum, where Prof. Dr. Arne Jensen assumes the position of director
• BrainRepair AB is based in Stockholm, Sweden (in foundation)
Bochum
Stockholm
1) Advanced Therapy Medicinal Product – Tissue Engineered Product Strictly Confidential | July 2021 9
Today’s team of BrainRepair (I/II)
Key opinion leader in the field of autologous cord blood stem cell treatments
Awarded 23 national and international scientific prizes between 1986 and 2008
Substantial academical & entrepreneurial experience:
− Heidelberg University: MD, ECFMG
− Würzburg and Giessen University: PD, Prof. Dr. med.
− Oxford University: Research assistant
− UCSF San Francisco CVRI: post-Doc
Founding partner and majority shareholder of BrainRepair Ltd. BVI (2009-2015); achieved successful EMA product classification ATMP-TEP1) for different indications
Successful EMA Product Classification (ATMP-TEP) for Paediatric brain damage, HIE, and CP
Successful application of two EMA Orphan Medicinal Product Designations (PVL EU/3/16/1744 and NE EU/3/16/1743)
Prof. Dr. Arne Jensen, MD, MBA
Founder & CMO
Philipp Schoeller, MSc, MBA
Founder
Graduated with MSc (Hons). Electrical Engineering from ETH and an MBA from INSEAD
Previously worked for Boston Consulting Group in London and Munich
Extensive entrepreneurial experience with founding several investment vehicles: GSM Industries (PE), GCI Management (VC) and founding partner and Investor at General Capital Group with cum. total investments of more than 10bn
Chairman of Origins’ Strategic Development Board of the Excellence Cluster of LMU, TUM, ESO and Max-Planck-Institutes
Founding member of the Fragile World Foundation
Senator of the European Senate of Entrepreneurs
Honorary Consul of Finland for Bavaria & Thuringia
Member of the European Academy of Sciences and Arts
6 | Organisational setup
1) To be announced Strictly Confidential | July 2021 10
Board of Directors
Prof. Dr. Arne Jensen
Chairman
Founder & CMO of BrainRepair UG,
Bochum, Germany
Founder of QiagenDüsseldorf Hilden,
Germany
Dr. Metin Colpan
Board of Directors
Philipp Schoeller
Founder of BrainRepairUG, Munich, Germany
Prof. Ulrika Ådén
Karolinska InstituteNeonatology
Stockholm, Sweden
TBA1
Incoming CEO
6 | Organisational setup
1) High Risk Infant Follow-up2) California Perinatal Quality Care Collaborative: state-wide network of California’s neonatal intensive care units (NICUs) and High Risk Infant Follow-up (HRIF) clinics
housed at the Stanford University School of Medicine Strictly Confidential | July 2021 11
Advisory board of Directors (I/II)
Advisory board
Prof. Linda de
Vries
University of UtrechtPaediatrics
The Netherlands
Prof. Susan R. Hintz
HRIF1 Medical Director at CPQCC2, Stanford University
Neonatology, Palo Alto, USA
Prof. Georg
Schmolzer
Chairman CSAR Univ. of Edmonton, Paediatrics
Alberta, Canada
Prof. Terrie Inder
Chairman NeonatologyHarvard Medical Center
Boston, USA
Founder of QiagenHilden, Germany
Dr. Metin Colpan,
Chairman
Prof. Dr.
Michael R. Franz
Georgetown UniversityCardiology and Pharmacology
Washington, U.S.A
6 | Organisational setup
Prof. Dr. Peter Fierlinger
Chairman of Experim. Physics, TUM
Excellence ClusterMunich, Germany
Prof. Dr.
Albert Gjedde
Univ. of CopenhagenNeurobiology and
PharmacologyCopenhagen, Denmark
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Advisory board (II/II)
Advisory board
Christian Hübner
Partner at NOVACOS Law, Düsseldorf, Germany
Dr. vet.
Friedrich Röcken
President DGK-DVG (2003-2018), Munich, Germany
Prof. Dr.
Olaf Dammann
Vice Chair at Dept. of Public Health & Community
Medicine, Tufts School of Medicine, USA
Prof. Dr. Wolfgang Holzgreve
Medical DirectorUniversity Hospital Bonn
Bonn, Germany
Prof. Dr.
Harald Klüter
University HeidelbergTransfusion Medicine and
ImmunologyHeidelberg, Germany
Head of Paediatric and Adolescent Medicine,
University Bielefeld, Germany
Prof. Dr.
Eckard Hamelmann
Prof. Dr.
Robert Dracker
SUNY Health Science CenterPathology and Paediatrics
Syracuse, USA
6 | Organisational setup
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Strategic partners
CRO
Blood banks
Analytical partners
Regulatory
Patient/Parental organisations
Clinical partners
6 | Organisational setup
Strictly Confidential | July 2021 14B E R L I N C O P E N H A G E N H A M B U R G L O N D O N M U N I C H S T O C K H O L M
Carlsquare GmbHBrienner Straße 14 · 80333 Munich
www.carlsquare.com
Caspar StauffenbergManaging Partner
Anders ElgemyrManaging Partner
Caroline BerglundHead of Equity Sales
Oskar WollertVice President ECM
Ulrika StrömbergSenior Advisor