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Balixafortide Execution and Pipeline Expansion POLYPHOR Corporate Update and 2019 Financial Results April 28th 2020 Forward-looking statement This presentation (the “Presentation”) has been prepared by Polyphor Ltd. (“the Company” and together with its subsidiary, “we”, “us” or the “Group”) solely for informational purposes. Certain statements in this Presentation are forward-looking statements, beliefs or opinions, including statements relating to, among other things, the Company's business, financial condition, future performance, results of operation, potential new market opportunities, growth strategies, and expected growth in the markets in which the Group operates. In some cases, these forward-looking statements may be identified by the use of forward-looking terminology, including the terms “targets”, “plans”, “believes”, “estimates”, “anticipates”, expects”, “intends”, “may”, “will” or “should” or, in each case, their negative or other variations or similar expressions. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which the Group operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting the Group’s markets, and other factors beyond the control of the Group). Neither the Company nor any of its respective directors, officers, employees, agents, affiliates, advisors or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this Presentation. Statements contained in this Presentation regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. 2 2019 Highlights and the Outlook After 2019 turnaround, 2020 is focused on Balixafortide execution and pipeline expansion 2019 Highlights: Outlook: ▪ Balixafortide – Start FORTRESS Phase III trial, followed ▪ Balixafortide – Strong Phase III trial progress in by strong progress metastatic breast cancer with enrollment ahead of plan and positive first DSMB. First co-primary endpoint ▪ Decision to halt murepavadin I.V. clinical program (ORR*) data-cut expected end Q1 2021 ▪ Inhaled Murepavadin – Completion preclinical program ▪ Plans to expand balixafortide opportunity with new dosing schedule, non IV formulation, earlier lines of ▪ POL7306 preclinical program complete - decision to not mBCa, other tumor types and combinations submit IND, but continue formulation / peptide design ▪ Explore new oncology candidates from our platform ▪ New leadership and board of directors changes following ORR data in Q1 2021 ▪ CHF 77.4 million in cash and cash equivalents as of ▪ Inhaled Murepavadin – Plan to submit CTA in Q4 2020 December 31, 2019 ▪ Renewed strategy for our research and preclinical antibiotic programs with strong focus on formulation and peptide design optimization *Objective Response Rate 3 Polyphor Pipeline and Plan Opportunity to provide multiple pipeline progress and key inflection points until 2022 Program Research Preclinical Phase I Phase II Phase III Market Metastatic breast cancer Balixafortide Other cancer/combos oncology - Solid tumors/ Oncology liquid cancers Pipeline Solid tumors/ liquid cancers Immuno Inhaled CF infections Murepavadin POL7306 / All WHO Priority 1 BamA Pathogens MDR* Antibiotics Thanatin Enterobactericaea Pipeline Today Pipeline 2022 Plan *Multidrug Resistant 4 Balixafortide Most advanced CXCR4 antagonist in clinical development for solid tumors Unlocking the potential of CXCR4 A novel immuno-oncology approach antagonism starting from a large indication ▪ Highly selective and specific CXCR4 antagonist ▪ First CXCR4 antagonist spearheading novel ▪ Clinically efficacious dose immuno-oncology approach in Phase III mBC** ▪ Clinical exposure 2000 fold above IC ▪ Large first indication in HER2 negative mBC 2nd 50 and later lines of chemotherapy ▪ Not cytotoxic at clinical doses ▪ In combination with eribulin, the most recently ▪ Low propensity of dose limiting toxicity with >5 approved chemotherapeutic in mBC fold safety margin* ▪ Potential for: ▪ Potential to improve dose and schedule in ▪ Earlier lines of therapies in combination with various combinations other chemotherapies ▪ Other tumor/oncology indications ▪ Combination with checkpoint inhibitors * comparing toxicology studies to current human doses ** Metastatic Breast Cancer 5 FORTRESS Study Timeline Flow Chart Overall population N=384 , 320 3rd line + and 64 2nd line 90% power for detecting superiority of Balixafortide + eribulin versus eribulin 6/19 -9/20 15 months recruitment monotherapy for the primary efficacy endpoint of PFS in both the 3rd line + and overall population 6 months from last pt Accelerated approval early `21 ORR* data cut enrolled option 12 months from last pt PFS* + interim OS NDA end `21 enrolled data cut filing 24 months from last pt end `22 Label extension enrolled OS* final analysis End of Study *Alpha allocation and recycling is used to ensure control of the overall Type I error rate for these formal analyses 6 FORTRESS Recruitment is Ahead of Plan 69% of patients FORTRESS Randomization Curve randomized 300 250 200 150 100 50 0 June July August September October November December January February March April (27th) Plan Patients Randomised Actual Patients Randomised ▪ Today’s randomization status n= 264 (69% of 384) ▪ Sites in all continents open. ▪ In the current situation with Covid 19 we are taking all possible measures to safeguard patients, study conductors and investigators and the study conduct in general. ▪ As of end of April, we are on plan to complete the recruitment of 384 patients in the Fortress study by end of September 2020. 7 Balixafortide Development Strategy Near and midterm goals: ▪ Completion of dossier for NDA filing ongoing: ▪ Clinical pharmacology package ▪ CMC package ▪ Non clinical safety and pharmacology package ▪ Further development strategy beyond FORTRESS: ▪ Investigate improved dosing and scheduling Key enablers for expanding ▪ Define maximum tolerated dose (MTD) beyond the initial indication and ▪ Assess tolerance and preliminary efficacy in combination with other building value for potential future chemotherapies in mBC partnerships ▪ Develop other formulations than IV ▪ Develop a CXCR4 diagnostic test 8 Oncology Pipeline Strategy Long-term targets in expanding oncology opportunity ▪ CXCR4 expression has been validated as a negative prognostic factor for other cancer types ▪ Balixafortide has therefore a potential as a novel treatment option in tumors beyond mBCa ▪ Combinations with other immuno-oncology therapies and CXCR4 antagonists are promising and open further opportunities for balixafortide ▪ Identified novel immuno-oncology targets to be addressed by peptides from the macrocycle technology platform ▪ Post ORR results, intention to identify new lead compounds in the area of immuno-oncology to be nominated as development candidates 9 Balixafortide Strategy – Initial Indication and Expansion Plan Potential US End of Today ORR PFS approval EU Approval Recruitment (accelerated) Initial Indication 2020 2021 2022 2023 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Preclinical studies in other combinations / tumors Key enablers for Improved dose scheduling study expanding beyond the initial indication to earlier lines / Phase II Study in combination with other chemo in earlier mBC other tumors and combos and building value for ExpansionPlan Future Future Indication potential future Non IV Formulation partnerships. CXCR4 Diagnostic Test 10 2023 mBCa Market Projection and Initial Opportunity (US and EU5) Large Total Addressable Patient Population Limited Competition in HR+: Balixafortide + eribulin to become new Balixafortide Can Target Projected M. Share for Novel Options standard of care in later lines of HR+ 2023 Projection On Treatment Share (Novel agents are typically in combo with chemo) 105.000 15% 9% 220.000 8% TNBC 3K 4% HR+ 20K 5% Novel Agents Chemo Monotherapy Eribulin patients Earlier lines: Abemaciclib and AKT inhibitor Later Lines: sacituzumab (primary balixa competitor) BRCA+ patients across lines: PARP inhibitors Balixafortide Novel Agents Chemo. Monotherapy penetration 29.000 46% 26% 46.000 ▪ Large market (200K patients) in 2nd line and 22% beyond in HR+ 22% ▪ Limited competition from novel treatments in HR+ 25% Balixafortide opportunity segments ▪ Eribulin is well established and can expand if PoC study results with balixafortide are replicated. Earlier lines: Avastin, checkpoint inhibitors & AKT inhibitors in earlier
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