Oryzon Genomics Sa · BME:ORY
Oryzon Genomics Sa — Shareholder Meeting (June 2022)
34 slides from Oryzon Genomics Sa's shareholder meeting presentation, Jun 29, 2022
Slide 1: Pioneering personalized medicine in epigenetics
Pioneering personalized medicine in epigenetics JUNTA GENERAL DE ACCIONISTAS MADX: ORY 29 de Junio de 2022
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 2021-Jun 2022
An Epigenetic champion determined to bring new therapies to the patients A clinical strategy focused on registration in CNS and Oncology Jun 2021-Jun 2022 A US oriented strategy with a first-in-class US team Regulatory advances in US with INDs and ODD 2021-2022 a challenging period Adapting to an in
Slide 4: 2022-23 Company Milestones & Principal investment thesis
2022-23 Company Milestones & Principal investment thesis Clinical Data Milestone 2022 2023 o With multiple complementary Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 resources we expect to extend our IADADEMSTAT in Oncolgy VAFIDEMSTAT in CNS PORTICO: Phase IIb in Borderline Personality runway til
Slide 5: 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 6: Iadademstat: first and potentially best-in-class LSD1 inhibitor in AML
Iadademstat: first and potentially best-in-class LSD1 inhibitor in AML The asset • The most potent (nM) oral inhibitor of the lysine histone demethylase LSD1 in clinical development • LSD1 is required for leukemic stem cell survival and blocking leukemic cell differentiation Mechanism of Action • Ia
Slide 7: Corporate Strategy: Phase Ib trial in R/R AML (FRIDA)
Corporate Strategy: a Phase Ib trial in R/R AML as a foundation stone for an accelerated development MV(4,11) MOLM-13 IND Approved <1 denotes (B-E) In vitro synergistic effects combining FRIDA: synergism iadademstat with gilteritinib in AML cell lines (Company internal data) A Phase Ib in FLT3 mut+
Slide 8: Collaborative PoC basket trial in neuroendocrine tumors with iadademstat
Collaborative PoC basket trial in neuroendocrine tumors (NETs) with iadademstat A Phase Ib/II study of iadademstat in combination with synergistic agents in platinum R/R SCLC and extrapulmonary high grade neuroendocrine carcinomas • Label expansion opportunity • High unmet medical need: Treatment of
Slide 9: STELLAR: 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 A Proof of Concept (CLEPSIDRA) Targeting LSD1 rescues MHC class I antigen presentation and overcomes PD-L1 blockade resistance in small cell lung cancer. Nguyen EM et al., J Thorac Oncol. 2022 DOI:https://do
Slide 10: 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 11: CNS disorders: a field evolving towards Precision Medicine
CNS disorders: a field evolving towards Precision Medicine LSD1 is key for the function of the CNS and is involved in multifactorial CNS disorders and monogenic syndromes Small / rare monogenic LargeMultifactorial Large multifactorial indications Small/rare monogenic indications Indications indicati
Slide 12: Vafidemstat: LSD1 inhibitor for large multifactorial CNS indications
Vafidemstat: an LSD1 inhibitor to treat large multifactorial CNS indications including borderline personality disorder (BPD) and schizophrenia (SCZ) FiM: 110 volunteers: 87 treated with vafidemstat and • A potent (nM) oral inhibitor of the lysine histone demethylase 23 with placebo The Asset LSD1 wi
Slide 13: Borderline personality disorder: a snapshot
Borderline personality disorder: a snapshot A Prevalent & impairing disease Two main types of symptoms No approved drugs yet 9 million in US & EU Unstable-extreme Patients in off-label interpersonal relationships antipsychotics + Aggression & self-aggression Vafi improves these symptoms in PC models
Slide 14: Ongoing Study: 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 • BPD is a serious psychiatric condition affecting 1.6% in the general population. Prevalence is 9 million people
Slide 15: EVOLUTION: ongoing PoC schizophrenia study with vafidemstat
EVOLUTION an ongoing PoC Schizophrenia study with vafidemstat • Double blind, placebo controlled adaptive EVOLUTION: trial design (n=100) • Vafidemstat as add-on to SoC. 6 months of An adaptative randomized double blind Phase IIb trial treatment • with vafidemstat in schizophrenia patients Primary e
Slide 16: ORYZON is pioneering personalized medicine in CNS
ORYZON is pioneering personalized medicine in CNS VAFIDEMSTAT A Phase II LSD1 inhibitor for CNS diseases
Slide 17: Vafidemstat targeting genetically defined syndromes, e.g. Kabuki
Vafidemstat: an LSD1 inhibitor targeting genetically defined neurodevelopmental syndromes, e.g. Kabuki • Initial clinical development program focused on new study HOPE for patients with Kabuki KABUKI syndrome (KS) type1 with possible registration merits syndrome a • Approx. 6,000+ pts with KS type 1
Slide 18: HOPE: Phase Ib/II trial in Kabuki syndrome patients
Corporate Strategy: a Phase Ib/II trial in Kabuki syndrome patients with registrational potential In pre-IND discussions with the FDA • KS is a congenital, rare, multisystem disorder characterized by multiple multiorganic abnormalities including intellectual disability HOPE: • Strong preclinical rat
Slide 19: Trans-Atlantic management team with proven drug development capabilities
Trans-Atlantic 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 MD PhD PhD PhD MS CEO Global CMO CMO for CNS Global CBO CSO SVP Clinical Chief of Clinical Development &
Slide 20: Collaborations with prestigious international institutions
ORYZON Research and Clinical Deveelopment leverages on collaborations with prestigious international Institutions 20
Slide 21: 2021-22 a Period with Financial Markets in Distress
2021-22 a Period with Financial Markets in Distress Unprecedented systemic crisis o Covid-19 Pandemics and Omicron waves o Supply chains disruptions o Energy Price o Inflation rates o Slower growth o ECB/FED rate hikes o War in Ukraine o Food / Cereal Crisis 21
Slide 22: Biotech Sector specially affected by negative market sentiment
For first time the Biotech Sector has been specially affected by the negative market sentiment BTIG Healthcare ECM Dashboard: June 17, 2022 22
Slide 23: Oryzon has performed better than its US peers in Nasdaq
In a very adverse market, Oryzon has performed better than its US peers in Nasdaq 20% Cumula�ve Total Return 10% 0% -10% ORY -15% -20% -30% -40% -50% BBI -46% -60% ene-22 feb-22 mar-22 abr-22 may-22 jun-22 ORY SM BBC US Equity NBI Index BTK Index BBC US Equity - The Bioshares Biotechnology Clinical
Slide 24: In a very adverse market, Oryzon has still performed better than US peers
In a very adverse market, Oryzon has still performed better than its US peers in Nasdaq o Good progress of the clinical programs with positive results o Good regulatory news with FDA approvals of ODD and INDs o Intense communication campaign in the media in Spain o Intense Relation with Internationa
Slide 25: Intense international IR campaign drives international trading
As a consequence of an intense international IR campaign, a relevant part of the daily trading is originated internationally 25
Slide 26: The Company continues its preparations to get listed in Nasdaq
The Company continues its preparations to get listed in Nasdaq o The company has invested €1.3 Million in 2021 in o Legal Preps for the disclosures needed to list the company in Nasdaq o Auditing Preps to reconciliate the Spanish GAAPs with the US-GAAPs (PCOBs) o Today in this GSM, we propose to aut
Slide 27: Value Creation in 2022-23
ORYZON Thank you Value Creation in 2022-23 A unique dual EPIGENETIC proposition Multiple inflection points in CNS and ONCOLOGY • A validated approach with multiple • Final data for 1L AML PoC ALICE shots on goal • Read-out Phase IIb in BPD • One and only epigenetic company • Kabuki Syndrome Phase I/
Slide 28: Parte III: Informe sobre la marcha general de la compañía
PARTE III INFORME SOBRE LA MARCHA GENERAL DE LA COMPAÑÍA HITOS FINANCIEROS
Slide 29: Evolución de la solvencia financiera (2012-2021)
Evolución de la solvencia financiera (2012-2021) Patrimonio Neto 71,2 M€ Patrimonio Neto 75% Tesorería e inv. financieras c/p 28,7 M€ Recursos permanentes 91% Endeudamiento financiero 17,7 M€ Exigible a corto plazo 9% FINANCIACION BANCARIA: • 78 % de participación en la deuda financiera
Slide 30: Evolución del Balance
Evolución del Balance 2021 2020 ACTIVO PASIVO Y PATRIMONIO NETO ACTIVO PASIVO Y PATRIMONIO NETO Inmoviliado intangible (49.216 miles de euros) Inmoviliado intangible Fondos Propios (60.254 miles de euros) (65.826 miles de euros) Fondos Propios (70.523 miles de euros) ∆ de 1,3 M€ (1,4%) I.material +
Slide 31: Estados Financieros – Ejercicio 2021 - Resultado
Estados Financieros – Ejercicio 2021 - Resultado Inversión I+D (capitalizado + No capitalizado) Resultado Resultado + 3,1 ORY 1001- Iadademstat Actividades No Resultado 2021 Actividades Resultado 2020 Variación + 4,7 ORY 2001- Vafidemstat Recurrentes Ordinarias 2021 + 1,0 ORY 2001- Vafidemstat (ESCA
Slide 32: Estado de Cambios en el Patrimonio Neto
Estado de Cambios en el Patrimonio Neto PATRIMONIO NETO A 31.12.2020 75.931 Resultado del ejercicio -4.687 Subvenciones (Neto de efecto fiscal) 28 Otras variaciones del patrimonio neto -10 PATRIMONIO NETO A 31.12.2021 71.262 Nota: Información expresada en Miles de Euros. JGA – 29 de junio de 2022 6
Slide 33: 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 31.12.2020 39.605 Cash In Grant Kabuki 847 847 Subvenciones 9 9 Préstamos 7.960 7.960 Desinversión Financiera 43 43 Variaciones de tipo de cambio 348 348 C
Slide 34: Pioneering personalized medicine in epigenetics
Pioneering personalized medicine in epigenetics