Circio Holding Asa · OSL:CRNA
Circio Holding Asa — Targovax — Investor Presentation (June 2017)
32 slides from Circio Holding Asa's investor presentation, June 2017
Slide 1: Arming the immune system to fight cancer
Arming the immune system to fight cancer June 2017 www.targovax.com
Slide 2: Important notice and disclaimer
Important notice and disclaimer This report contains certain forward-looking statements based on uncertainty, since they relate to events and depend on circumstances that will occur in future and which, by their nature, will have an impact on the results of operations and the financial condition of
Slide 3: Two novel proprietary immunotherapy platforms with promising phase I/II data
IMMUNOTHERAPY Targovax is developing two novel proprietary immunotherapy platforms, with promising phase I/II data o Genetically tailored Adenovirus ONCOS-102 o Selectively infects and lyses cancer cells Oncolytic virus o Releases cancer antigens o Triggers immune response o Cocktail of 7 synthetic
Slide 4: ONCOS-102 makes cancer antigens visible to the immune system
ONCOS TG ONCOS-102 works by making cancer antigens visible to the immune system, thus generating tumor specific T-cells Activate immune system: Train T-cells: Attack the cancer: o Virus injected directly into o APCs present tumor o Tumor specific T-cells the tumor / peritoneum specific antigens at l
Slide 5: Most patients do not respond to checkpoint inhibitors
ONCOS TG Most patients do not respond to check point inhibitors (CPIs), due to lack of T-cells in the tumor microenvironment Response rate to checkpoint inhibitors (CPIs) Melanoma ~40% Renal Cell carcinoma ~70% Complimentary Triple Negative Breast ~70%-80% immune priming medicines may make tumors re
Slide 6: ONCOS-102 phase I: Increased tumor infiltrating CD8+ T-cells
ONCOS TG ONCOS-102 phase I: Increased tumor infiltrating CD8+ T-cells in 11 of 12 cancer patients with a range of solid tumors 10000 1000 Fold-change from baseline 100 10 1 0,1 FI1-06 FI1-04 FI1-18 FI1-02 FI1-15 FI1-08 FI1-13 FI1-09 FI1-17 FI1-01 FI1-14 FI1-19 Only 1 patient 6 patients 5 patients sh
Slide 7: Initial Phase I ONCOS-102 trial: tumor specific and systemic immune response
ONCOS TG In the initial Phase I ONCOS-102 trial tumor specific and systemic immune response was observed Evidence that immune system Evidence that T-cells find the Evidence of production of recognizes tumor threat tumor and are cell killing tumor antigen specific T-cells Innate Immune System (biopsy
Slide 8: Broad ONCOS-102 clinical program of four new trials
ONCOS TG The encouraging Phase I results have triggered the initiation of a broad ONCOS-102 clinical program consisting of four new trials o Combination with PD-1 Melanoma CPI in refractory patients Phase I o Proof-of-concept 12 patients o Memorial Sloan Kettering Mesothelioma o Combination with che
Slide 9: Melanoma trial – will CPI refractory patients start responding
ONCOS TG Melanoma trial – will CPI refractory patients start responding after immune-priming with ONCOS-102? Advanced malignant melanoma patients not responsing to CPIs Setting Immune activate patients with ONCOS-102, then re-challenge with a CPI (Keytruda@) 12 patients Site Memorial Sloan Kettering
Slide 10: Agenda
Agenda Introduction to immunotherapy ONCOS-102 oncolytic virus platform TG RAS-peptide vaccine platform Targovax clinical program overview Financial highlights 10 www.targovax.com
Slide 11: RAS is mutated in 20-30% of all cancer patients
ONCOS TG RAS is a key regulator of cell cycle that is mutated in 20-30% of all cancer patients, and >85% of pancreatic cancers Incidence of RAS mutations One of the most common mutations in cancer RAS is one of the most well-defined neoantigens Results in cell division permanently switched on No exi
Slide 12: TG peptides prime the immune system to destroy RAS mutated cancer cells
ONCOS TG The TG peptides prime the immune system to recognize and destroy RAS mutated cancer cells Activate immune system: Train T-cells: Attack the cancer: o TG peptides injected into o APCs migrate to lymph o RAS specific T-cells the skin with GM-CSF nodes and present RAS identify mutated RAS adju
Slide 13: Phase I/II trial with TG01 in resected pancreatic cancer
ONCOS TG A Phase I/II trial with TG01 in Resected Pancreatic Cancer is currently being completed 32 patients in Dosage regimen Follow-up total, 2 cohorts with/without chemo boosters www.targovax.com
Slide 14: Key results from TG01 Phase I/II trial: signal of clinical efficacy
ONCOS TG Key results from TG01 Phase I/II trial in resected pancreatic cancer: Signal of clinical efficacy 13 of 19 patients (68%) alive 2 years after surgery 2 year OS Historical control 2 year OS range from 30-53%1 Median 33.1 months survival 27.6 months for SoC (Gemcitabine) in ESPAC-4 study2 Imm
Slide 15: Encouraging long-term survival data from earlier trials
ONCOS TG These results are backed by encouraging 10 year survival data and immune response correlation from earlier trials Long-term data from earlier TG mono-therapy trials – resected pancreatic cancer 100 90 80 70 4/20 (20%) patients Survival (%) 60 > 10 years survival 50 (resected patients) 40 30
Slide 16: Two platforms and six clinical trials in total
ONCOS TG Two platforms and six clinical trials in total ensures a diversified program with frequent data readouts Cancer Combined 2017 2018 2019 indication with H1 H2 H1 H2 H1 Melanoma CPI Phase l ONCOS-102 Mesothelioma Chemo* Orphan ind. Phase lb/ll Ovarian & Orphan ind. CPI Phase l/ll Colorectal S
Slide 17: Financial summary – end of Q1 2017
FINANCIALS Financial summary – end of Q1 2017 Operations Cash NOK 147m USD 17m End of Q1 2017 Net cash flow NOK -24m USD -3m Total Q1 Annual run rate NOK 104m USD 12m Last four quarters Annual opex NOK 116m USD 13m Last four quarters The share OSE: TRVX Market Cap NOK ~1bn USD ~120m At share price N
Slide 18: TRVX upgraded to the main list on OSE
FINANCIALS TRVX was upgraded to the main list on OSE in March, and has showed a positive trend in share turnover in 2017 Development in daily average share turnover (NOK million / day) • NOK ~1.2b 20 market cap • NOK 14m NOK avg. daily turnover 15 in last 3 months • NOK 850m total turnover in Q1 10
Slide 19: Strong shareholder base as per April 2017
FINANCIALS Strong shareholder base as per April 2017 Shareholder Estimated ownership Shares m Relative HealthCap Sweden 11,2 26,4 % 42.2m ordinary shares RadForsk Norway 4,1 9,7 % • Management ownership: 2.1% Nordea Norway 3,0 7,2 % KLP Norway 1,6 3,7 % • 3,586 shareholders Nordnet Livsforsikring No
Slide 20: Multiple near term value inflection points
FINANCIALS Multiple near term value inflection points ONCOS-102 Initiate phase l Ovarian/colorectal ONCOS-102 Initiate phase l/ll melanoma TG02 Initiate phase Ib in colorectal TG01 ONCOS-102 Oslo Stock Exchange ONCOS-102 Initiate phase l/ll Listing on OSE main Initiate phase l phase ll initiated mes
Slide 21: Arming the patient's immune system to fight cancer
ONCOS TG Arming the patient’s immune system to fight cancer 1 ✓ Encouraging median survival and top line two-year OS data TG in resected pancreatic cancer 2 ONCOS ✓ Important proof-of-concept trial in CPI refractory melanoma 3 Clinical trials ✓ Six shots on goal, and steady news flow www.targovax.co
Slide 22: Appendix
Appendix www.targovax.com 22
Slide 23: ONCOS-102: an adenovirus armed with immune stimulating transgenes
ONCOS TG ONCOS-102: An adenovirus armed with different immune stimulating transgenes Virus capsid is Selective replication in Enhanced modified for cancer cells inducing immune system enhanced cancer immunogenic cancer activation cell infection cell death ∆24 bp ∆6.7K/gp19K ∆Ad5 knob E1A E3 Fiber kn
Slide 24: ONCOS-102: CPI refractory melanoma trial details
ONCOS TG ONCOS-102: CPI refractory melanoma trial details Open-label Phase I trial ONCOS-102: 3 injections at day 1, 4 & 8 CPI (Keytruda) at day 22, then every 3 weeks for 5 months 3 biopsies per patient Baseline DAY 22 DAY 64 CT CT CT CT PBMC PBMC PBMC PBMC PBMC Days Weeks 1 4 8 3 6 9 12 15 18 21 2
Slide 25: ONCOS-102 in Mesothelioma – Phase I/II study design
ONCOS TG ONCOS-102 in Mesothelioma – Phase I/II study design (NCT02879669) PATIENT STUDY TREATMENT POPULATION Experimental group (n=14) Advanced ONCOS-102 (6 administrations) Non-randomised refractory Safety lead-in (n=6) SoC (6 cycles) Randomized malignant pleural mesothelioma GO ONCOS-102 plus SoC
Slide 26: Resected pancreatic cancer patients only have chemotherapy as an option
ONCOS TG Resected pancreatic cancer patients only have chemotherapy as a treatment option, and long term survival is poor No statistical Lower overall hazard difference for 2yr ratio for combination overall survival Significantly improved long-term survival >10% ESPAC-4 data; Neoptolemos et al., The
Slide 27: TG01 in Resected Pancreatic Cancer – Phase I/II study design
ONCOS TG TG01 in Resected Pancreatic Cancer – Phase I/II study design (NCT02261714) PATIENT STUDY TREATMENT POPULATION 1st cohort, main group (n=15) TG01 (26 vaccinations) Gemcitabine (6 cycles) Patients with Non-randomized resected Safety cohort (n=6) 1st cohort, concomitant group adenocarcinoma GO
Slide 28: TG02 in Colorectal Cancer – Phase I study design
ONCOS TG TG02 in Colorectal Cancer – Phase I study design (NCT02933944) PATIENT STUDY TREATMENT POPULATION * A patient can only be enrolled Non-randomized Non-randomized PART II Patients with PART I into either Part I n=10* locally recurrent n=10* GO / or into Part II of resectable NO- RAS mutated G
Slide 29: Results supported by 10 year long-term survival data from earlier TG trials
ONCOS TG The results are being supported by 10 year long-term survival data from earlier TG trials Long-term data available from previous trials 4 out of 20 patients (20%) alive after 10 years in similar trial on Historical data resected pancreatic cancer Correlation between immune response and clin
Slide 30: Investment highlights
Investment highlights 1 ✓ Two differentiated product platforms, oncolytic adenovirus Core focus on (ONCOS-102) and RAS-peptide cancer vaccine (TG) immuno-oncology ✓ Targeting refractory solid tumors with combination trials 2 Proprietary ✓ Promising Phase I/II data from both proprietary platform plat
Slide 31: Highly experienced senior management team
Highly experienced senior management team Øystein Soug, CEO Dr. Magnus Jaderberg, CMO Joined as CFO in April 2015 before being appointed CEO in More than 25 years in various R&D functions and previously November 2016. Before joining Targovax Oystein was CFO at CMO at Bristol Meyers Squibb (Europe).
Slide 32: Board of Directors
Board of Directors Jónas Einarsson, MD Johan Christenson, MD, Per Samuelsson Eva-Lotta Allan o CEO of Radiumhospitalets PhD o Partner of HealthCap o Currently Chief Business Forskningsstiftelse o Partner of HealthCap o Prior to joining HealthCap Officer at Immunocore o On the board of several o Prev