Lytix Biopharma ASA · OSL:LYTIX

Lytix Biopharma ASA — Investor Presentation (November 2017)

26 slides from Lytix Biopharma ASA's investor presentation, November 2017

  1. Slide 1: Investor Presentation – Turning cold tumors hot

    INVESTOR PRESENTATION November 2017 Turning cold tumors hot 1

  2. Slide 2: Today's presenters / Company in brief

    T O D AY ’ S P R E S E N T E R S C O M PA N Y I N B R I E F Edwin Klumper CEO, M.D., PhD, MBA Lytix Biopharma is a clinical-stage pharmaceutical company,  Life science entrepreneur with a strong combination of developing novel immunotherapies to fight cancer. scientific and business background The

  3. Slide 3: Immuno-oncology has become the most attractive pharmaceutical segment

    IMMUNO-ONCOLOGY HAS BECOME THE MOST ATTRACTIVE PHARMACEUTICAL SEGMENT THE FIRST WAVE IN CANCER IMMUNOTHERAPY IS THE IMMUNE CHECKPOINT INHIBITORS CHECKPOINT INHIBITORS, GLOBAL REVENUE USD, million 6392 Yervoy® Keytruda® Tecentriq® 3774 (BMS) (MSD) (Roche/Genentech) 2634 1369 942 1402 566 2011 2012 20

  4. Slide 4: The main challenge in cancer immunotherapy is to turn cold tumors hot

    THE MAIN CHALLENGE IN CANCER IMMUNOTHERAPY IS TO TURN COLD TUMORS HOT ONLY A SUBSET OF PATIENTS RESPOND TO CHECKPOINT INHIBITORS – HIGH T CELL INFILTRATION AIDS RESPONSE % OF MALIGNANT MELANOMA PATIENTS RESPONDING TO CHECKPOINT INHIBITORS HOT TUMORS RESPOND BETTER TO IMMUNOTHERAPY  Checkpoint inhib

  5. Slide 5: Lytix' lead candidate LTX-315 is a first-in-class oncolytic peptide

    LYTIX’ LEAD CANDIDATE, LTX-315, IS A FIRST-IN-CLASS ONCOLYTIC PEPTIDE THAT TURNS ‘’COLD TUMORS HOT’’ 88% OF EVALUABLE PATIENTS SHOWED ENHANCED CANCER SPECIFIC T CELL INFILTRATION FOLLOWING INJECTION COLD TUMOR WITH NO T CELLS HOT TUMOR WITH T CELL INFILTRATION BASELINE LT X - 3 1 5 T R E AT E D 5

  6. Slide 6: Market overview – current and planned indications

    MARKET OVERVIEW – CURRENT AND PLANNED INDICATIONS MALIGNANT MELANOMA TRIPLE NEGATIVE BREAST CANCER SOFT TISSUE SARCOMA HEAD AND NECK METASTATIC PATIENTS METASTATIC PATIENTS METASTATIC PATIENTS METASTATIC PATIENTS Incidence, USA: 30,000 Incidence, USA: 39,000 Incidence, USA: 1,900-3,700 Incidence, US

  7. Slide 7: Drug development pipeline

    DRUG DEVELOPMENT PIPELINE Indication Program Research Preclinical Phase I Phase II Phase III All solid tumors LTX-315 LTX-315 in combo with Malignant melanoma ipilimumab Triple Negative Breast LTX-315 in combo with Cancer (TNBC) pembrolizumab TNBC or malignant LTX-315 in combo with melanoma checkpoi

  8. Slide 8: LTX-315 is an optimized molecule designed from host defense peptide

    LTX-315 IS AN OPTIMIZED MOLECULE DESIGNED FROM HOST DEFENSE PEPTIDE HOST DEFENSE PEPTIDES HAVE A DUAL MODE OF ACTION: DIRECT KILLING AND IMMUNE MODULATION  LTX-315 is composed of five cationic residues and four lipophilic  LTX-315 shows specificity for cancer cells overexpressing anionic residues,

  9. Slide 9: LTX-315's unique mode of action results in effective release and reshape

    LTX-315`S UNIQUE MODE OF ACTION RESULTS IN EFFECTIVE "RELEASE AND RESHAPE" IN THE TUMOR MICROENVIRONMENT 9 Zhou, Cell Death & Disease 2016. Zhou, Oncotarget 2015. Forveille, Cell Cycle 2015. Eike, Oncotarget, 2015. Camilio, OncoImmunology 2014, Camilio, Cancer Immunol Immunother, 2014

  10. Slide 10: LTX-315 increases number and diversity of tumor infiltrating T cells

    LTX-315 INCREASES NUMBER AND DIVERSITY OF TUMOR INFILTRATING T CELLS UNTREATED B16 MELANOMA TREATED B16 MELANOMA EXPANSION OF T CELL CLONALITY IN TREATED TUMORS 10 Benzoni S, Oral presentation at World Preclinical Congress, Boston 2016.

  11. Slide 11: LTX-315 demonstrates systemic immune response – complete regression

    LTX-315 DEMONSTRATES SYSTEMIC IMMUNE RESPONSE – COMPLETE REGRESSION WITH TUMOR SPECIFIC MEMORY 2ND TUMOR 3RD TUMOR RECHALLENGE NON-INJECTED NON-INJECTED Control 1st 2nd LTX-315 3rd Days after tumor Days 3 14 19 26 3 14 19 26 inoculation 11 Rat transformed mesenchymal sarcoma model (rTMSC), Rose leuk

  12. Slide 12: Strong international collaborations demonstrating LTX-315 anti-tumor effects

    STRONG INTERNATIONAL COLLABORATIONS DEMONSTRATING LTX-315 ANTI-TUMOR EFFECTS LTX-315’s ability to reprogram tumors Prof M. Pittet LTX-315’s ability to release neo-antigens Prof R. Schreiber LTX-315 and involvement of Toll-like receptors (TLR) Dr. J. Oppenheim LTX-315’s ability to circumvent resistan

  13. Slide 13: Overview of LTX-315 clinical program

    OVERVIEW OF LTX-315 CLINICAL PROGRAM 2010-2012 2013-2016 2016-2017 Type Phase I Phase I Phase I/II - Ongoing Monotherapy arm Indication All solid tumors Combo with pembrolizumab All solid tumors All solid tumors Breast cancer (TN) Combo with ipilimumab Malignant melanoma Treatment Monotherapy One Mo

  14. Slide 14: LTX-315 turns tumors hot and ensures infiltration of CD8+ T cells

    LTX-315 TURNS TUMORS HOT AND ENSURES INFILTRATION OF CD8+ T CELLS NEEDED TO KILL THE CANCER COMBINATION WITH PEMBROLIZUMAB: 4 OUT OF 5 EVALUABLE MONOTHERAPY: 15 OUT OF 17 EVALUABLE PATIENTS (88%) PATIENTS MYO-EPITHELIOMA BREAST CARCINOMA BREAST CARCINOMA BREAST CARCINOMA BASELINE BASELINE WEEK 7 WEE

  15. Slide 15: LTX-315 turns tumors hot by upregulating key genes

    MONOTHERAPY LTX-315 TURNS TUMORS HOT COMPREHENSIVELY BY UPREGULATING KEY GENES INVOLVED IN TUMOR REGRESSION COMMENTS INCREASED KEY GENE EXPRESSION POST INJECTION IMMUNOSIGN® 21 SCORE PRE INJECTION POST INJECTION  Of the 15 patients in monotherapy where Key genes tumors turned from cold to hot, six

  16. Slide 16: Stable disease achieved in patients with large tumor burden

    MONOTHERAPY STABLE DISEASE ACHIEVED IN 8 OF 15 EVALUABLE PATIENTS WITH LARGE TUMOR BURDEN AND EXTENSIVE PRETREATMENT STABLE DISEASE WEEK 6-8 Sarcoma Melanoma SARCOMA 3/3 Melanoma Sarcoma Sarcoma MELANOMA 4/5 CANCER PATIENTS (TYPE) Melanoma Melanoma Breast cancer Vaginal SCC BREAST CANCER 1/5 Melanom

  17. Slide 17: Patient case report: anti-tumor effects in non-injected tumor

    PATIENT CASE REPORT ANTI-TUMOR EFFECTS DOCUMENTED IN NON-INJECTED TUMOR PATIENT BACKGROUND LARGE NON-INJECTED LESION PRE/POST INJECTIONS  38 year female, adrenocortical cancer, diagnosed in year 2000. BASELINE Metastasis to lung, liver, peritoneum, bone.  Multiple prior treatments: surgery, chemot

  18. Slide 18: Durable complete response in stage IV melanoma patient

    PATIENT CASE REPORT DURABLE COMPLETE RESPONSE IN STAGE IV MELANOMA PATIENT WITH PEMBROLIZUMAB POST LTX-315 TREATMENT July May September Extensive metastasis Started LTX-315 injections Progression with new lesions 2009 Chemotherapy until 34 injections in two Started pembrolizumab October 2012 tumors

  19. Slide 19: Melanoma patient in LTX-315 + ipilimumab combination in durable stable disease

    MELANOMA PATIENT IN LTX-315 + IPILIMUMAB COMBINATION IN DURABLE STABLE DISEASE FOR 38 WEEKS (ONGOING) PATIENT BACKGROUND NON-INJECTED TUMOR VOLUME DEVELOPMENT 60% 52 year old female Stage IIIC BRAF/NRAS – ive vulvular nodular melanoma (very poor prognosis) 40% 20% 2016 February 2016 0% Surgery March

  20. Slide 20: Summary of clinical trial results to date

    SUMMARY OF CLINICAL TRIAL RESULTS TO DATE MONOTHERAPY MONOTHERAPY/COMBINATIONS PHASE I PHASE I PHASE I/II - ONGOING SAFETY SAFETY SAFETY  LTX-315 dose related hypotension (drop  Low grade (mild/moderate) transient  Low grade (mild/moderate) transient allergy side-effects (flushing, rash, itch, in

  21. Slide 21: LTX-315 is the ultimate personalized cancer therapy

    LTX-315 IS THE ULTIMATE PERSONALIZED CANCER THERAPY  EFFICACY  SAFETY  DRUG PRODUCT  Comprehensive and rapid  Transient side effect profile  Short half-life of ~20min disintegration of mitochondria and intracellular organelles  Low risk of neutralizing antibodies  Low manufacturing cost  In

  22. Slide 22: Clinical development program with multiple readouts producing strong newsflow

    CLINICAL DEVELOPMENT PROGRAM WITH MULTIPLE READOUTS PRODUCING STRONG NEWSFLOW 2017 2018 2019 2020 H1 H2 H1 H2 H1 H2 H1 H2 Monotherapy Mixed tumors: LTX-315 Phase I/II Sarcoma: Adoptive T cell Phase II transfer1 Head and Neck: Neo-adjuvant Phase II Combination Malignant melanoma: Phase I/II LTX-315 +

  23. Slide 23: Phase II combination trial with LTX-315 and checkpoint blockers is in design stage

    PHASE II COMBINATION TRIAL WITH LTX-315 AND IMMUNE CHECKPOINT BLOCKERS IS IN ITS DESIGN STAGE TRIAL DESIGN IS BEING DISCUSSED WITH OUR EXPERT PANEL ADDRESSING THE LATEST INSIGHTS ASSUMPTIONS TRIAL DESIGN  Anti-CTLA-4 and anti-PD/PDL-1 are the only approved checkpoint  Indications are metastatic me

  24. Slide 24: Exploratory Phase II trials in sarcoma and head & neck cancers

    EXPLORATORY PHASE II TRIALS IN SARCOMA AND HEAD&NECK CANCERS ARE UNIQUE OPPORTUNITIES TRIAL DESIGN IS BEING DISCUSSED WITH OUR EXPERT PANEL ADDRESSING THE LATEST INSIGHTS INJECT LTX-315  Sarcoma is a known ’cold tumor’ also known as an ’immune desert’  High unmet medical need as effective therapie

  25. Slide 25: Use of proceeds

    USE OF PROCEEDS S E K Phase II combination trial with immune checkpoint inhibitors  Malignant melanoma 85m   Breast cancer Adaptive, multi-arm trial with cohorts of 10 - 15 patients. Expand cohorts with strongest efficacy signals  Arms to combine LTX-315 with anti-CTLA-4 or anti-PD/PDL-1, and se

  26. Slide 26: Lytix Biopharma investment highlights

    LYTIX BIOPHARMA INVESTMENT HIGHLIGHTS UNIQUE PRODUCT  Turning “cold tumors hot” with a broad and deep immunogenic activation  Promising clinical data in patients refractory to other available treatment 1  Ideal combination drug for checkpoint inhibitors and other modalities  Strong patent portfo

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