Oryzon Genomics Sa · BME:ORY
Oryzon Genomics Sa — Shareholder Meeting (June 2023)
36 slides from Oryzon Genomics Sa's shareholder meeting presentation, Jun 26, 2023
Slide 1: Pioneering personalized medicine in epigenetics
Pioneering personalized medicine in epigenetics JUNTA GENERAL DE ACCIONISTAS MADX: ORY 26 de Junio de 2023
Slide 2: Legal Notice
Legal Notice DISCLAMER This document has been prepared by Oryzon Genomics, S.A. exclusively for use during the presentation. Oryzon Genomics, S.A. does not assume liability for this document if it is used with a purpose other than the above. The information and any opinions or statements made in thi
Slide 3: Jun 2022-Jun 2023
An Epigenetic champion determined to bring new therapies to the patients A clinical strategy focused on registration in CNS and Oncology Jun 2022-Jun 2023 A US oriented strategy with a first-in-class US team Clinical advances with trial completions and interim analysis in our Phase IIb in BPD 2021-2
Slide 4: 2022-23 Company Milestones & Principal investment thesis
2022-23 Company Milestones & Principal investment thesis o Two uncorrelated advanced clinical assets with Multiple Shots on goal o Potentially transforming catalysts in 2024 o Focus is now on executing and setting an optimal long- run corporate strategy reinforcing the BD angle o Additional assets i
Slide 5: ORYZON, the only company developing epigenetic drugs in CNS
ORYZON, the only company developing epigenetic drugs in CNS VAFIDEMSTAT A Phase II LSD1 inhibitor for CNS diseases
Slide 6: Vafidemstat mechanism of action and key clinical data
Vafidemstat: the only LSD1 inhibitor to treat CNS indications, including large multifactorial ones such as borderline personality disorder (BPD) and schizophrenia (SCZ) • A potent (nM) oral inhibitor of LSD1 with high BBB penetration Mechanism • LSD1i induces the neuronal plasticity & downregulates
Slide 7: Borderline personality disorder: an unmet medical need & a huge commercial opportunity
Borderline personality disorder: an unmet medical need & a huge commercial opportunity A Prevalent & impairing disease Two main types of symptoms No approved drugs yet 9 million in US & EU Unstable-extreme Patients in off-label anti- interpersonal relationships psychotics + Aggression & self-aggress
Slide 8: Ongoing Study: a Phase IIb in Borderline Personality Disorder
Ongoing Study: a Phase IIb in Borderline Personality Disorder PORTICO: An adaptative randomized double blind Phase IIb trial with vafidemstat in Borderline Personality Disorder patients • PORTICO (NCT04932291): will enroll 188 patients • Double blind, placebo-controlled, with two primary independent
Slide 9: EVOLUTION, an ongoing PoC schizophrenia study with vafidemstat
EVOLUTION, an ongoing PoC schizophrenia study with vafidemstat EVOLUTION: An adaptative, randomized double-blind Phase IIb trial with vafidemstat in schizophrenia patients • Strong rationale: LSD1i restores phenotypes in various SCZ mice models • High Unmet Need: No drugs approved yet for cognitive
Slide 10: Vafidemstat Commercial Assessment (I)
Vafidemstat Commercial Assessment (I) Significant Commercial Vafidemstat could achieve NRA sales of +$6Bn at peak in 2036 Potential BPD multi-symptom treatment represents also a substantial peak revenue opportunity of +$3Bn Schizophrenia negative symptoms treatment represents also a large opport
Slide 11: Vafidemstat Commercial Assessment (II)
Vafidemstat Commercial Assessment (II) Global CNS Vafidemstat commercial expectations in the two large indications (BPD and SCZ) are in line Market with the current dynamics of the psychiatric markets and with the commercial success Dynamics achieved by other assets Invega +$3.6Bn sales in 2020 Th
Slide 12: ORYZON has an ambitious epigenetic program in Oncology
ORYZON has an ambitious epigenetic program in Oncology IADADEMSTAT Orphan Drug Designation granted for A Phase II LSD1 inhibitor AML and SCLC in Oncology
Slide 13: LSD1 inhibition is a validated epigenetic approach for targeted therapies in Oncology
LSD1 inhibition is a validated epigenetic approach for targeted therapies in Oncology • In ONCOLOGY, LSD1i MoA has been exquisitely well-defined • Class Validation: competitor LSD1i acquisition for $1.35B by MERCK, and ongoing BMS’s LSD1i Phase II program • Oryzon’s iadademstat is 20-200 fold more p
Slide 14: Iadademstat: final results of ALICE trial presented at ASH-2022
Iadademstat: final results of ALICE trial presented at ASH-2022 • Multicenter, single arm, open label PhIIa trial in elderly unfit AML patients (n=36) • Iadademstat + azacitidine Key Clinical • Final data presented at ASH-2022. Selected for Oral presentation. Data in ALICE • Shortlisted in the 25 mo
Slide 15: FLT3mut+ R/R AML, an interesting market opportunity
FLT3mut+ R/R AML, an interesting market opportunity • In a competitive market, R/R AML is an underserved population: The majority of AML patients Combo w relapse after 1L treatment and require further treatment gilteritinib, • FLT3 is the most common mutation in AML (30-40%) best route to • These pa
Slide 16: FRIDA: a Phase Ib trial in R/R AML as a foundation for an accelerated development
FRIDA: a Phase Ib trial in R/R AML as a foundation for an accelerated development FRIDA: A Phase Ib in FLT3 mut+ R/R AML patients combining iadademstat and gilteritinib (Xospata®) • Iadademstat and gilteritinib show a strong synergism, providing a strong preclinical rationale for enhanced clinical b
Slide 17: Iadademstat in SCLC and other Neuroendocrine tumors
Iadademstat: potentially first and best-in-class LSD1 inhibitor in SCLC and other Neuroendocrine tumors • LSD1 is required for the survival & proliferation of neuroendocrine/SCLC tumor cells • Iadademstat induces Notch, a well-characterized tumor suppressor in SCLC, and represses ASCL1 Mechanism • I
Slide 18: Neuroendocrine Tumors: a Collaborative PoC basket trial in NETs with iadademstat
Neuroendocrine Tumors: a Collaborative PoC basket trial in NETs with iadademstat NET: A Phase II study of iadademstat in combination with paclitaxel in platinum-R/R SCLC and extrapulmonary high grade neuroendocrine carcinomas • High unmet medical need: NETs have dismal outcomes ranging from ORR 5% (
Slide 19: Best route to Market: Combo with IO, 1L ED-SCLC
ED-SCLC, an interesting market opportunity SCLC market 4000 • Tolerability profile of both drugs suggesting high 3500 CDK4/6 inhibitors RNA polymerase II inhibitors 320 compatibility Best route to PDL1 inhibitors 3000 PDL1 and CTAl4 inhibitors • The global market for small-cell lung cancer drugs Mar
Slide 20: A future Phase Ib/II trial in 1L ED-SCLC (STELLAR)
A future Phase Ib/II trial in 1L ED-SCLC with potential for accelerated development STELLAR: A randomized controlled Phase Ib/II study of iadademstat plus a checkpoint inhibitor in 1L patients with metastatic SCLC • High unmet medical need + relatively low bar for improving efficacy due to the modes
Slide 21: Research and Clinical Development collaborations with prestigious international institutions
ORYZON Research and Clinical Development leverages on collaborations with prestigious international institutions 21
Slide 22: A Management Team with Proven Drug Development and Operational Capabilities
A Management Team with Proven Drug Development and Operational Capabilities Carlos Buesa Douglas Faller Michael Ropacki Saikat Nandi Jordi Xaus Ana Limon Sonia Gutierrez PhD MD, PhD PhD PhD PhD PhD MS CEO Global CMO CMO for CNS Global CBO CSO SVP Clinical Dev & Medical Chief of Clinical Affairs Oper
Slide 23: 2021-23 a Long Period with Financial Markets in Distress
2021-23 a Long Period with Financial Markets in Distress Unprecedented systemic crisis o Energy Prices o Inflation rates o Slower growth o ECB/FED rate hikes o War in Ukraine o Food / Cereal Crisis o Bank Bailouts/rescues (SVB, First Republic Bank, Credit Suisse) o New regulations (IRA, EU pharmaceu
Slide 24: Biotech Sector affected by negative market sentiment
In the last two years, the Biotech Sector has been affected by the negative market sentiment YTD +2,4% Source: Biopharmaceutical Sector Market Update. May 29 & June23 Stifel 24
Slide 25: M&A to play an important role in 2023
M&A to play an important role in 2023 Pharma company merger and acquisition (M&A) activity will increase later in 2023. Experts at PWC, Goldman Sachs, and Morgan Stanley agree that pharma- related M&A is expected to pick up in 2023. Source: Biopharmaceutical Sector Market Update. May 29 Stifel 25
Slide 26: In a very adverse market, Oryzon has obtained several positive clinical results
In a very adverse market, Oryzon has obtained several positive clinical results Despite the positive results and the good fundamentals, the general market conditions have resulted in a mixed performance ALICE final data in AML PORTICO’s interim presented at ASH análisis POSITIVE results -10,5% in th
Slide 27: Must-haves in current market for Biotech companies to succeed
Must-haves in current market for Biotech companies to succeed In a difficult market, access to financing has become increasingly hard for biotech companies. Several must-haves are critical to achieving this. Oryzon is well-positioned to attract the attention of investors and corporate partners YES;
Slide 28: Oryzon has continued its efforts in communicating its progresses to the markets
Oryzon has continued its efforts in communicating its progresses to the markets o To improve investors and potential corporate partners awareness of Oryzon’s progress, we maintain an ongoing communication effort o Oryzon’s scientists and executives have attended 49 International Conferences and Even
Slide 29: ORYZON Value Creation in 2023-24
ORYZON Value Creation in 2023-24 Thank you A unique dual EPIGENETIC proposition Multiple inflection points in CNS and ONCOLOGY • A validated approach with multiple • Top Line Read Out in BPD PORTICO shots on goal e4Q2023-1H2024 • One and only epigenetic company • 2L AML FRIDA trial preliminary in CN
Slide 30: Parte III Informe sobre la marcha general de la compañía
PARTE III INFORME SOBRE LA MARCHA GENERAL DE LA COMPAÑÍA HITOS FINANCIEROS
Slide 31: Evolución de la solvencia financiera (2012-2022)
Evolución de la solvencia financiera (2012-2022) FINANCIACION BANCARIA Patrimonio Neto 72,6 M€ Patrimonio Neto 70% Tesorería e inv. financieras c/p 21,3 M€ Recursos permanentes 82% • 60% de participación en la deuda financiera Endeudamiento financiero 23,3 M€ Exigible a corto plazo 18% •
Slide 32: Evolución del Balance
Evolución del Balance BALANCE ACTIVO PATRIMONIO NETO + PASIVO 100 2022 2021 2022 2021 90 5,5 Aumento de Capital 80 15,5 Desarrollo 75,8 60,3 72,6 71,3 -4,2 70 Resultado del ejercicio 60 15,5 -3,0 50 12,4 Servicio de la deuda 40 Bonos convertibles 3,9 30 -7,5 Tesorería 25,1 32,6 18,7 8,7 20 Préstamos
Slide 33: Estados Financieros – Ejercicio 2022 - Resultado
Estados Financieros – Ejercicio 2022 - Resultado Resultado 2022 Resultado 2021 Variación INGRESOS Capitalización I+D + 6,2 M ORY 1001- Iadademstat Ingresos por Subvenciones 255 168 87 + 9,4 M ORY 2001- Vafidemstat Ingresos por capitalización 15.698 10.615 5.083 + 0,1 M ORY 3001 y Otras act. en fases
Slide 34: Estado de Cambios en el Patrimonio Neto
Estado de Cambios en el Patrimonio Neto PATRIMONIO NETO A 31.12.2021 71.262 Resultado del ejercicio -4.231 Ampliaciones de Capital 5.500 Subvenciones (Neto de efecto fiscal) 714 Otras variaciones del patrimonio neto -718 PATRIMONIO NETO A 31.12.2022 72.527 Nota: Información expresada en Miles de Eur
Slide 35: Estado de Flujos de Efectivo
Estado de Flujos de Efectivo ACTIVIDADES DE ACTIVIDADES DE ACTIVIDADES DE TOTAL EXPLOTACIÓN Y INVERSIÓN FINANCIACIÓN TIPOS DE CAMBIO TESORERÍA A 31.12.2021 28.725 Cash In Subvenciones 144 144 Bonos Convertibles 7.878 7.878 Préstamos 5.114 5.114 Cash back 2.483 2.483 Cash Out Préstamos -4.426 -4.426
Slide 36: Pioneering personalized medicine in epigenetics
Pioneering personalized medicine in epigenetics