Slide 1: Corporate Presentation
October 2023 Corporate Presentation World leader in the development and commercialization of anticancer drugs of marine origin
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements that include information about possible or assumed future results of the business, financial condition, liquidity, results of operation, clinical program, plans and objectives of Pharma Mar, S.A. ("PharmaMar" or the "Company"). These f
Slide 3: Management Team
Management Team We are inspired by the sea, driven by science, and motivated to improve the lives of cancer patients by delivering novel medicines. We intend to continue to be the world leader in marine D. José María Fernández, Ph.D Luis Mora medicinal discovery, development and Chief Executive Offi
Slide 4: Corporate Overview
Corporate Overview Global Fully Integrated 3 Approved Oncology Commercial Stage Biotech Products Developing marine-inspired oncology drugs Established European oncology sales force Revenue Generating & Profitable Discovery Platform Strengthening Oncology Revenues in 2022 €196.3m Pipeline EBITDA 2022
Slide 5: The Plan for growth
The Plan for growth On track to deliver value to shareholders Lurbinectedin Other drugs Corporate development development development ✦ Phase 3 trials with Lurbinectedin ✦ 2 Phase 2 trials for Ecubectedin ✦ Looking for in-licensing products in SCLC for EU approval enrolling to market and confirmator
Slide 6: Zepzelca: Transformative for PharmaMar
Zepzelca: Transformative for PharmaMar License agreement in the US/Canada $200m received upfront ✦ High teens to 30% Royalties on $100m received approval US/Canada sales $25m ✦ Enrollment completion expected received commercial ~YE2023 of Phase 3 in 1L maintenance milestone ES-SCLC in combination wi
Slide 7: Pipeline – Expanding our Expertise in Oncology
Pipeline – Expanding our Expertise in Oncology Phase 1 Phase 2 Phase 3 Market Soft tissue sarcoma 2nd/3rd line Monotherapy Ovarian cancer 2nd/3rd line + Doxil (PLD) R/R Multiple Myeloma1 3rd/4th line + dexamethasone Small cell lung cancer 2nd line US Monotherapy Small cell lung cancer Maintenance +/
Slide 8: Zepzelca – A Transcription Inhibitor Leading to Tumor Inhibition
Zepzelca – A Transcription Inhibitor Leading to Tumor Inhibition Primary Effect Secondary Effect Cancer is frequently a transcriptional disease caused by Marked effect on the tumour microenvironment by inhibiting deregulated oncogenic transcription factors the transcription and secretion of tumour-g
Slide 9: 1st FDA approved drug in over 24 years for relapsed SCLC
SCLC 1st FDA approved drug in over 24 years for Relapsed Small Cell Lung Cancer (SCLC) New Standard of Care in 2L SCLC in the US 9
Slide 10: Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer (SCLC) An high unmet medical need Among all Lung Cancers Low survival rate at 5 years Limited treatment options in both the US and Europe SCLC ~15% ✦ Highly aggressive tumor ~ 62,000 in 20202 ✦ 5-year survival rate 5-10%1 ~ 30,000 in 20202 Newly diagnosed patients each year 1.
Slide 11: Development lagging behind NSCLC; FDA approvals
Small Cell Lung Cancer (SCLC) Development lagging behind NSCLC; FDA approvals 1st Line Cisplatin + Carboplatin + Durv or Atezo + Etoposide Etoposide Carboplatin + SCLC Etoposide 2nd Line Topotecan Pre - 1993 1996 24 years 2020 NSCLC 11
Slide 12: Zepzelca (Lurbinectedin) – The SCLC Treatment Paradigm
Zepzelca (Lurbinectedin) – The SCLC Treatment Paradigm Strong positioning opportunity 1st Line 2nd Line 3rd Line 1st Line 2nd Line 3rd Line • Platinum/ • Platinum/ Etoposide + • Zepzelca Etoposide + FDA EMA • Topotecan • Topotecan Approved • Atezolizumab Approved • Atezolizumab or Durvalumab (sensit
Slide 13: Zepzelca Already Treatment of Choice in 2L SCLC
Zepzelca Already Treatment of Choice in 2L SCLC Zepzelca Demonstrated Efficacy in Sensitive and Resistant Small Cell Lung Cancer patients In relapsed SCLC as monotherapy under accelerated approval based on Phase 2 monotherapy data1 Overall Resistant Sensitive Decrease in tumor size in 65% patients2
Slide 14: Zepzelca Already Treatment of Choice in 2L SCLC
Zepzelca Already Treatment of Choice in 2L SCLC Low rate of AEs and manageable hematological safety profile despite low use of G-CSF 1,2 Safety: Related or Unknown Treatment Related (or Unknown) Adverse Events Adverse Events (AEs) ( >5% or Gr 3-4) Overall (n=105) n (%) Gr 1-2 Gr 3-4 Overall (n=105)
Slide 15: Zepzelca: Pathway to 2nd line in SCLC by EMA and Full Approval by FDA
Zepzelca: Pathway to 2nd line in SCLC by EMA and Full Approval by FDA Phase 3 (LAGOON) randomized trial Arm A Lurbinectedin 3.2 mg/m2 every 3 weeks Primary Endpoint: ✦ Relapsed SCLC Arm B ✦ One prior platinum Randomization Overall Survival containing regimen 1:1:1 Arm A vs. C ✦ CTFI ≥30 days 705 pat
Slide 16: Positioning LAGOON for success
Positioning LAGOON for success 70% of patients to have had prior IO. There is no evidence of additive or synergistic benefit for control arm. For lurbinectedin, there are three pieces of data. In prior trial, we allowed stable brain mets. Partly due to protocol violations this proved the worst subgr
Slide 17: 1st line-Maintenance Study in SCLC
SCLC 1st line-Maintenance Study in SCLC 17
Slide 18: SITC 2021
SITC 2021 Combo with IO delivers efficacy not seen for either drug as single agent • Phase I open label dose ranging trial in pts who had progressed on platinum. ECOG 0-1 • Full dose Atezo (1200 mg) + L2.5mg/m2 (n=5) followed by L3.2mg/m2 (n=21, full dose) Response N=26 CR 7.7% (2) PR 50% (13) ORR 5
Slide 19: Lurbinectedin: evidences of additive/synergistic benefit with or post IO
Lurbinectedin: evidences of additive/synergistic benefit with or post IO Basket trial: 6 of 8 had lurbi PFS ≥ PFS with prior IO including 5 CRs, 2 of which happened in 2L post PD Source: Paz-Ares, L et al. Efficacy and safety profile of lurbinectedin in 2nd-line SCLC patients: Results from a phase I
Slide 20: Lurbinectedin: First line positioning
Lurbinectedin: First line positioning Phase 3 IMforte trial for first line-maintenance SCLC Enrollment completion expected ~YE2023 Induction Phase Maintenance Phase Atezolizumab 1,200 mg q3wk + Lurbinectedin 3.2 mg/m2 q3wk Endpoints: ✦ Extensive-stage Atezolizumab + Randomization SCLC (ES-SCLC) Carb
Slide 21: Strategic importance of Zepzelca Phase 3s in SCLC
Strategic importance of Zepzelca Phase 3s in SCLC Potential treatment landscape after Phase 3s 1st Line- 1st Line- 1st Line 2nd Line 1st Line 2nd Line Mantenance Mantenance ✦ Platinum/ ✦ Platinum/ Etoposide + ✦ Zepzelca + ✦ Zepzelca Etoposide + ✦ Zepzelca + • Zepzelca FDA ✦ Topotecan EMA • Topotecan
Slide 22: Leiomyosarcoma Trial start 2023
STS Leiomyosarcoma Trial start 2023 22
Slide 23: Leiomyosarcoma
Leiomyosarcoma Incidence and treatment paradigm One of the most common soft tissue sarcoma (STS) accounting for ~ 10%-20% of all STS Incidence ~2,100(1) in USA Incidence and ~4,500(2) in Europe 1st Line 2nd Line 1st Line 2nd Line FDA ✦ Doxorubicin ✦ Trabectedin EMA ✦ Doxorubicin ✦ Trabectedin Approv
Slide 24: Zepzelca (Lurbinectedin)-Leiomyosarcoma
Zepzelca (Lurbinectedin)-Leiomyosarcoma Phase IIb/III trial Phase IIb Phase III • Metastatic Doxo 50 mg/m2 + Selected Uterine/ST LMS Lurb 2.2 mg/m2 + combination • Measurable GCSF, D1 q3w disease • No prior chemo • ECOG 0-1 IDMC Primary endpoint: Doxo 25 mg/m2 + Interim PFS by IRC n ~ 120 n ~ 120 Lu
Slide 25: Malignant Pleural Mesothelioma Trial start 2023
MPM Malignant Pleural Mesothelioma Trial start 2023 25
Slide 26: Zepzelca (Lurbinectedin) – Relapsed Malignant Pleural Mesothelioma
Zepzelca (Lurbinectedin) – Relapsed Malignant Pleural Mesothelioma A rare disease with limited available therapeutic options Aggressively growing tumor ~ 80% of cases related to asbestos exposure Incidence ~3,5001 patients diagnosed in the US per year Incidence and ~13,7001 in Europe2 1st Line 2nd L
Slide 27: Zepzelca (Lurbinectedin) Phase III trial starting 2023
Zepzelca (Lurbinectedin) Phase III trial starting 2023 Lurbinectedin 3.2 mg/m2 atezolizumab 1,200 mg + G-CSF on Day 1, q3wk. • Malignant pleural mesothelioma Primary • Progression after no endpoint: more than 2 prior Overall survival treatment lines R 1:1:1 Lurbinectedin 3.2 mg/m2 + G-CSF (OS) • Rel
Slide 28: Leveraging Commercial Infrastructure in Europe
European experience: Leveraging Commercial Infrastructure in Europe ✦ Strong KOL connections in solid tumors PharmaMar positioned as a partner of choice in Europe ✦ Navigation of EU, UK and CH regulators ✦ Logistics in place for distribution ✦ Expertise in multi-language labelling 18 Regional Partne
Slide 29: Zepzelca (Lurbinectedin) – Intellectual property
Zepzelca (Lurbinectedin) – Intellectual property Life cycle management plans under way 2023 2024 2025 2026 2027 2028+ Orphan Drug Exclusivity in SCLC New Chemical Entity Composition of Matter Patent 5 year extension to 2029 Orphan Drug Exclusivity in SCLC Composition of Matter Patent + 10 YEARS prot
Slide 30: Financials
Financials Profitable and solid and stable financial position Robust cash position (€ mn) Historical revenues evolution (€ mn) 229.8 196.3 270.0 164.9 156.0 5,0 140.6 5,0 85.8 129.4 0,3 41,0 13,0 50,3 15,7 231,8 81.6 216,5 212,6 5,5 65.0 3,1 140,3 0,2 118,9 40.4 100,7 100,8 0,2 21,3 73,0 4.2 64,8 -4
Slide 31: Key Events
Key Events Catalyst Calendar Zepzelca approved in Switzerland for SCLC Potential lurbinectedin approvals and launches Ongoing in other countries Lurbi + Irinotecan Phase 2 topline data ~YE2023 Potential in-licensing Ongoing Phase I new product First patient in Leyomiosarcoma?? 2023 IMForte PFS D
Slide 32: Building the Next Phase of Growth
Building the Next Phase of Growth 2021-2026 Leveraging proven oncology Strong Zepzelca I.P platform in new indications Zepzelca expected Clinical data Financial strength allows approvals/launches in IP 2023-25 broadening and accelerating non-EMA countries R&D engine 03 04 02 05 Profitable Biotech wi
Slide 33: www.pharmamar.com
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