Poltreg Spolka Akcyjna · GPW:PTG
Poltreg Spolka Akcyjna — PolTREG — Investor Presentation (February 2024)
28 slides from Poltreg Spolka Akcyjna's investor presentation, Feb 26, 2024
Slide 1: The promises of TREG autoimmune therapy, all in one hand
The promises of TREG autoimmune therapy, all in one hand Innovative therapies 20 11 2023 for autoimmune diseases
Slide 2: Forward-looking statements
Forward-looking statements The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "e
Slide 3: The promises of TREG autoimmune therapy, all in one hand
The promises of TREG autoimmune therapy, all in one hand • Three clinical assets that will deliver value + milestones • PTG007 = a potential disease-modifying treatment for T1D, Multiple Sclerosis (MS) • PTG-007 – ready for Phase 2/3 trial in • PolTREG is a one-stop shop Type-1 Diabetes (T1D), pendi
Slide 4: Largest, most advanced pipeline of cell therapies for autoimmune disease
Largest, most advanced pipeline of cell therapies for autoimmune disease Therapeutic area Indication Discovery Preclinical Phase I Phase II Phase III Type 1 diabetes Early onset (stage 3) PTG-007+ / rituximab Presymptomatic (stage 1/2) PTG-007+ / rituximab Multiple sclerosis Relapsing-remitting (RRM
Slide 5: Based in Poland, with a global outlook
Based in Poland, with a global outlook Shares (%) 21,31 % PAAN CAPITAL 30,22 % Venture Fundusz Inwestycyjny Zamknięty Marek-Trzonkowska Natalia Trzonkowski Piotr TFI Allianz 3,54 % 18,97 % POLAND PTE Allianz Botaniczna 20 80-298 Gdańsk 7,63 % Myśliwiec Małgorzata 5,24 % 7,85 % Pozostali 50 employees
Slide 6: PolTREG (Ticker PTG.WSE) – Market cap USD 67m
PolTREG (Ticker PTG.WSE) – Market cap USD 67m Free float 65% PolTREG Share price / Volume 1yr Share Statistics • IPO in 2021 on Warsaw Stock Exchange • Maket cap PLN 273m (USD 67m) • Shares outstanding 4,66m • Free Float 65% • Held by insiders 35,33% • Held by institutions 38,22% • Current share pri
Slide 7: Experienced leaders, front-line scientists
Experienced leaders, front-line scientists Prof. Piotr Trzonkowski Mariusz Jabłoński Paulina Kocenko-Merks Grzegorz Orlik Dan Shelly, PhD, MBA CEO, Founder & Board Director CBO, Board Director CFO, Board Director Head Medical Affairs Chief Business Development Officer Professor of medical science, 2
Slide 8: Experienced leaders, front-line scientists
Experienced leaders, front-line scientists Camilo Ricordi, Artur Tadeusz Bossowski, Agata Przemysława Chrobot, Kamil Chwojnicki Przemysława Jarosz-Chobot Iwona Kurkowska-Jastrzębska MD, Professor of Medicine MD, PhD, Professor of Medicine MD, PhD, Professor of Medicine MD, PhD MD, PhD, Professor of
Slide 9: Treg cells are a potential therapy for a range of auto-immune diseases
Treg cells are a potential therapy for a range of auto-immune diseases Brain MS Pancreatic islets Type 1 diabetes Joints Rheumatoid arthritis Gut Inflammatory Bowel Disease Fig 2. Lorem ipsum 9 poltreg.com
Slide 10: PTG007 has shown the capacity to slow progression of T1D
PTG007 has shown the capacity to slow progression of T1D A potential disease-modifying candidate therapy for early onset T1D PTG007 has MAST CELL ….through a range of cellular a potential to reduce mechanisms insulin dependance... NK VII DC VI OX40L I Suppression of antigen presentation I OX40 II In
Slide 11: Using the immune system's own police force
Using the immune system’s own police force Other drugs TREGs Other drugs TREGs TREGs keep the immune system in check and prevent other immune cells from attacking the body’s own tissues. TREGs operate at the site TREGs switch off when the of inflammation only inflammation is over 11 poltreg.com
Slide 12: Key milestones for value creation 2023-2025
Key milestones for value creation 2023-2025 Candidate H1 24 H2 24 2025 Event Approvals to use new research and production facilities Regulatory approval facility Poland in Poland for further clinical studies End of post-trial long-term safety/efficacy study (10-year follow up of PTG-007+ (T1D early
Slide 13: TREG therapy is a growth market
TREG therapy is a growth market Recent transactions: Development of therapy for inflammatory bowel disease IBD & $13.64 • 1,9 mld USD - biodollar 14 12 10 7,6% CAGR Development of TREG therapy • 75 mln USD – upfront payment & 8 $7.59 $13.64 billion $1.9 billion billion • 45 mln USD – milestone 6 4 D
Slide 14: Type-1 Diabetes: combination therapy in PTG007+ trial shows better remission
Type-1 Diabetes: combination therapy in PTG007+ trial shows better remission December 2021 data „ Any delay in the administration of insulin is significant, because it means that you „ have been successful in targeting the cause of the disease, and you need to take advantage of that. IQVIA report 14
Slide 15: T1D: Superior results from combined therapy over any monotherapy
T1D: Superior results from combined therapy over any monotherapy First loss of remission - censored Total Daily Dose of Insulin per kg b.w. TREGs + anti-CD20 TREGs + anti-CD20 1,0 TREGs TREGs 1,00 Control Control 0,8 TDD/kg b. w. (UI/kg b. w.) Remission probability 0,75 0,6 Remission border 0,50 0,4
Slide 16: What's next for early onset T1D?
What’s next for early onset T1D? Phase 2/3 study ready Potentially pivotal study 250 patients (5 x 50) Option to stop Phase 2 trial Duration to launch, requires for market authorization and start Phase 3 if one of the partner funding 5 arms interventional arms shows superior results 18 months 16 pol
Slide 17: Presymptomatic T1D: phase 2 study
Presymptomatic T1D: phase 2 study Pediatric patients with 150 patients Protocol signed, contracting Up to Planned start presymptomatic T1D of sites awaiting approval 4 arms 5 years 3Q2024 pending EMA approval 17 poltreg.com
Slide 18: A therapeutic candidate for each stage of T1D
A therapeutic candidate for each stage of T1D Triggering Genetic Active Loss of insulin Overt IDDM susceptibility autoimmunity secretion diabetes PTG-007 – polyclonal PTG-007 – polyclonal Tregs TregVAC1.0 & 2.0 trials • presymptomatic • early onset • few autoantigens • many autoantigens • HIGH volum
Slide 19: Can TREGS also be a game changer in MS?
Can TREGS also be a game changer in MS? >2.8 million There are no curative therapies Multiple Sclerosis affects more than TREGs have the potential to ameliorate MS 2.8 million people worldwide as part of a combination therapy $33.98 billion Promising early PolTREG results show remission Market expec
Slide 20: MS: Promising early signs of efficacy
MS: Promising early signs of efficacy Number of lesions 14 patients 3 years Intravenous Intrathecal Phase 1/2 RRMS study Study dates with 14 patients 2015-2018 150 Index of changes 100 Almost no increase in volume Intrathecal administration of existing lesions, almost no showed positive efficacy new
Slide 21: What's next? New phase 1/2 study in MS
What’s next? New phase 1/2 study in MS One study each in primary Each trial expected Expected start date: 2H 2024 A combined 105 patients: progressive MS (PPMS) and to have three arms for both trials relapsing-remitting MS (RRMS) 3 arms 2024 60 for PPMS 45 for RRMS 21 poltreg.com
Slide 22: Next generation Engineered TREGS
Next generation „ Engineered TREGS We […] view CART cell therapy […] in refractory autoimmune disease as the most disruptive and high commercial potential opportunity since immune-oncology re-emerged in 2011 Andrew Baum, Citi research note, August 2023 22 poltreg.com
Slide 23: CARTREGs as a platform for neurodegenerative disease
CARTREGs as a platform for neurodegenerative disease The CAR receptor directs TREG This can help the degradation CARTREGS are a platform cells to glia cells, which protect the of neural cells in a range therapy for neurodegenerative nervous system of autoimmune diseases disease 23 poltreg.com
Slide 24: The first in-patient CARTREG trial in neurodegenerative disease?
The first in-patient CARTREG trial in neurodegenerative disease? Phase I clinical trial can Two separate clinical Partnership PolTREG’s long experience Expect trial start as soon as CMC trials planned: with AZ Therapies with TREGs will make it easier launch late approval, animal studies to obtain ap
Slide 25: PolTREG achieved nearly 100% purity in TREGS expanded ex vivo
Security in one of Europe’s largest development centres PolTREG achieved nearly 100% purity in TREGS expanded ex vivo, and was the first ever to inject patients with autologous cells. 25 poltreg.com
Slide 26: Building a state-of-the art manufacturing plant
Building a state-of-the art manufacturing plant 2021 2023 PolTREG started building one of the most The new facility is now ready Production facility for third parties advanced in Europe for cell and gene and expected to receive for wide range of polyclonal and therapy manufacturing in 2021 regulator
Slide 27: Building a state-of-the art manufacturing plant
Building a state-of-the art manufacturing plant Pharma companies Clinical centres • Expand BD and Alliance • For early access therapies for Management Strategy patients with early-onset T1D • Business partnerships Pharma companies Academic partners • For R&D • Up-and-running CDMO, GMP certified • Fo
Slide 28: Contact us
Contact us [email protected] Botaniczna 20 Street, Mariusz Jablonski , Chief Business Gdansk, Poland Officer email Chris Maggos, Cohesion Bureau, Investor Relations Email….. Innovative therapies poltreg.com for autoimmune diseases