Slide 1: Gabather: Developing the next generation therapies in mental health
Gabather Developing the next generation therapies in mental health www.gabather.com Dr Michael-Robin Witt, CEO mrw@gabather.com Dr Christine Ryan, COO cnr@gabather.com Dr Stefan Rehnmark, CSO sr@gabather.com
Slide 2: Disclaimer
Disclaimer Forward-looking information is always associated with uncertainty as it pertains to and depends on circumstances beyond Gabather's control. Therefore, no assurance is given that the assessments made in the presentation regarding future conditions will be realized, either expressly or impl
Slide 3: Gabather
Gabather • Founded in 2014 based on research at Lund University, Sweden & the University of Copenhagen, Denmark Company • Board and management with extensive experience in developing biotech companies. • Drug development in mental health • Bench to Bedside proprietary molecules to drug candidates Ar
Slide 4: Mental Health Challenges Constitute One of our Time's Largest Health Issues
Mental Health Challenges Constitute One of our Time’s Largest Health Issues • One in four people will experience mental health problems in their lifetime • 50% of all mental health problems start at age 14 • Large societal impact • Large socioeconomic impact • Large unmet medical need Gabather
Slide 5: The Problem: Available Neuropsychiatric Treatments – Room for Improvement
The Problem: Available Neuropsychiatric Treatments –Room for Improvement • Many therapies were developed decades ago and are inaccurate • Current treatments may lead to severe side effects, and it is difficult to anticipate how each patient reacts to a drug • There are currently no available treatme
Slide 6: The solution
The solution: Gabather develops high-precision compounds to minimise side effects and maximise benefit to patients • Gabather is one of few actors on the CNS market who are developing compounds modulating the GABAA receptor. • Gabather has developed a pipeline of GABAA receptor modulator drug candid
Slide 7: Gabather Management Team
Gabather Management Team Dr Michael-Robin Witt Dr Christine Ryan Dr Stefan Rehnmark CEO COO CSO • Ph.D. in Neuropharmacology • PhD in Neuroscience from University of • PhD in Physiology from the Wenner- from the Royal School of Cambridge and MBA from Stockholm Gren Institute, Stockholm University Ph
Slide 8: Gabather Board of Directors
Gabather Board of Directors Anders Lönnberg Åsa Kornfeld Dr Bert Junno Theresa Comiskey Olsen Dr Michael-Robin Witt Chairman Board member Board member Board member CEO/Board member • Former Swedish • B.Sc. in chemistry from • Founder of Gabather • Attorney at Law USA • Ph.D. in Neuropharmacology nat
Slide 9: The neurotransmitter GABA maintains the biochemical balance in the human brain
The neurotranmitter GABA mantains the biochemical balance in the human brain – + GABA Glutamate Gabather
Slide 10: GT-002
GT-002 ➢ Preclinical data: Positive effect in learning and memory models ➢ Clinical data : Three successful Phase 1 studies in healthy volunteers • Innovative clinical candidate • Safe and well tolerated • Patented Oral formulation • Product Process patented • Pharmaceutical development patented Gab
Slide 11: All mental health issues involve altered cognition (learning and memory)
All mental health issues involve altered cognition ( learning and memory) Acute Alzheimer Bipolar Anxiety Personality OCD stress Autism Depression Schizophrenia dementia disorders disorders disorders disorder Attention Attention Attention Attention Irritability Attention Attention Attention Attentio
Slide 12: Clinical strategy for GT-002: Neuroimaging as a key Biomarker
Clinical strategy for GT-002 Neuroimaging as a key Biomarker Schizophrenia EEG: Electroencelographyln Post-traumatic MRI: Magnetic Resonance Imaging Autism stress disorder fMRI:Functional Magnetic Resonance Imaging Neuro Cognitive Bipolar Dementia imaging deficits disorder Mild cognitive Major depre
Slide 13: EEG-fMRI – GT-002 Target Engagement Study
Clinical strategy for GT-002 EEG-fMRI – GT-002 Target Engagement Study 64 channel headset 3Tesla Gabather 15
Slide 14: Neuroimaging: A Window into the Brain
Clinical strategy for GT-002 Neuroimaging : A Window into the Brain EEG recordings fMRI recordings Effect of GT-002 Baseline Heat-maps from one Subject at baseline Baseline Baseline target engagement in human brain and after GT-002 drug treatment 2h 2h fMRI measures blood oxygenation levels as 4h an
Slide 15: Neuroimaging: A Window into the Brain
Clinical strategy for GT-002 Neuroimaging : A Window into the Brain 0h 2h 4h When your brain's alpha GT-002 Baseline waves are dominating, you're likely in a state of wakeful relaxation. This, in turn, may help you feel calmer, less anxious, and, Reference according to some studies, may even boost y
Slide 16: GT-002 is a First-in-class Therapeutic (GABAA Receptor Modulator)
GT-002 is a First-in-class Therapeutic (GABAA Receptor Modulator) • Phase I clinical SAD and MAD trials completed • Finalized EEG/fMRI study - analysis ongoing • Phase II studies in patients 2024 • GT compound pipeline: Two extensive patent families with immaterial protection on key markets – covera
Slide 17: Clinical Milestones in Gabather's Projects
Clinical Milestones in Gabather’s Projects Q1-Q4 2023 Q1-Q4 2024 Q4 2022 Selection of new clinical drug candidate • Licensing GT-002 Q2 2019 Initiating Phase 1b proof-of- for further development Positive outcome from • Phase 2 concept EEG study in Preparations for clinical Phase 2 study in Phase 1a
Slide 18: Inflection points & triggers Gabather 2024
Inflection points & triggers Gabather 2024 Q4 2024 Q2 2024 Selection of new clinical drug candidate NIDA studies finalized for further development Q1 2024 Patient 2 study Schizophrenia Q1 2024 Q2 2024 Q3 2024 Q4 2024 Final report: EMA/FDA Orphan drug Patient study Dementia Licensing Agreement GT-002
Slide 19: Market Snapshot
Market Snapshot • Few ongoing trials with competing €657,5 million Boehringer Ingelheim–Autifony pharmaceutical candidate drugs Cognitive symtoms in schizophrenia $590 million • Gabather target: licensing deal in Biogen–Pfizer clinical Phase 2 development Cognitive impairments in schizophrenia $575
Slide 20: Gabather Brings Long-term Value to a Deprived Market
Gabather Brings Long-term Value to a Deprived Market • Our lead candidate GT-002 is progressing into Patient studies • A library of GABAA modulators based on proprietary research results • Partnering for late-stage development and commercialisation • AI-assisted neuroimaging Gabather
Slide 21: Investment Opportunity
Investment Opportunity User: How much does it cost to develop a drug ready for phase 2 clinical trials ? ChatGPT: “The cost of developing a drug ready for Phase 2 clinical trials can vary significantly and depends on various factors such as the complexity of the drug, the therapeutic area, regulator
Slide 22: Investment Opportunity
Investment Opportunity Rights issue of units of approx. 28,6 MSEK • Subscription period: 6-20 December 2023 ➢ Nordnet: 19 dec kl. 23:59 ➢ Avanza: 19 dec kl. 23:59 ➢ Aqurat: 20 dec kl. 15:00 Use of proceeds ➢ Phase II studies ➢ Business development, focusing on partnership agreements ➢ Continued deve
Slide 23: What happens next?
What happens next ? • Pre-clinical and clinical “data packages” bundles • Top-line data : EEG MINDIG • Top-line data : fMRI • BD road show : Start Jan 2024 • Third-party and “soft money” applications - ongoing - https://brainmodel.nl/ • Patient trials 2024
Slide 24: Neuroimaging – AI connection
Clinical strategy for GT-002 Neuroimaging – AI connection GT-002, through its novel mode of action, can modulate network connectivity and as such delay the progression of disease Gabather
Slide 25: Thank you for your attention!
Thank you for your attention ! Neuroimaging : A Window into the Brain Follow- up on the ongoing transaction - interview https://www.youtube.com/watch?v=5yjygu-teg0 Follow- up on the ongoing transaction - details https://analystgroup.se/emission/emission-gabather/ Follow- up on Gabather – All Informa