investment case brainrepair

14
Strictly Confidential Investment Case BrainRepair Brief Introduction Munich, July 2021

Upload: others

Post on 13-Mar-2022

5 views

Category:

Documents


0 download

TRANSCRIPT

Strictly Confidential

Investment Case BrainRepairBrief Introduction

Munich, July 2021

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

Strictly Confidential | July 2021 4

BrainRepair treatment of massive brain damage and coma

1 | Investment highlights

Strictly Confidential | July 2021 5

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

Strictly Confidential | July 2021 6

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

Strictly Confidential | July 2021 7

“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

Strictly Confidential | July 2021 8

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

Strictly Confidential | July 2021 12

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

Strictly Confidential | July 2021 13

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

[email protected]

Anders ElgemyrManaging Partner

[email protected]

Caroline BerglundHead of Equity Sales

[email protected]

Oskar WollertVice President ECM

[email protected]

Ulrika StrömbergSenior Advisor

[email protected]