targeted therapeutics
play

Targeted therapeutics at the forefront of oncology DEVELOPMENT - PowerPoint PPT Presentation

Targeted therapeutics at the forefront of oncology DEVELOPMENT STRATEGY PRESENTATION July 2020 Note on the presentation and forward looking statements This document does not constitute a public offering in the meaning of the Regulation (EU)


  1. Targeted therapeutics at the forefront of oncology DEVELOPMENT STRATEGY PRESENTATION July 2020

  2. Note on the presentation and forward looking statements This document does not constitute a public offering in the meaning of the Regulation (EU) 2017/1129 of the European Parliament and of the Council, or any other offer or invitation to acquire any Company's securities, nor the incentive to submit bids for the acquisition or subscription of the Company's securities. This document does not constitute information about the Company's securities and the terms and conditions of their acquisition or offering sufficient grounds to decide whether to purchase or acquire such securities. In particular, the document does not constitute an offer of securities for sale in the United States, nor may the securities be offered or sold in the United States absent registration under the Securities Act or in reliance upon an available exemption from the registration requirements of the U.S. Securities Act and in compliance with applicable state securities laws. The forward-looking statements contained in this document, such as those relating to the Company's income, results or development, are based on a number of assumptions, expectations and projections, and are subject to uncertainty and may change as a result of external or internal factors and should not be treated as binding forecasts. Neither the Company nor the persons acting on its behalf, in particular the members of the Company's Management Board, the Company's advisers nor any other person, provide any assurance that future expectations will be fulfilled, and in particular do not guarantee the future results or events of such statements and that the future results of the Company will not differ materially from the forward-looking statements. The information in this document is subject to change. Neither the Company nor any other person is obligated to update them. 2

  3. Ryvu at a glance Developing small molecule therapies which address high value emerging targets and pathways in oncology Diverse pipeline with mechanisms of action spanning kinase inhibition, RNA transcription, synthetic lethality (SMARCA2, WRN, MTAPdel cancers) • and immuno-oncology (A2A/A2B, STING, HPK1) Initial focus of pipeline on hematological malignancies, with near term expansion planned in solid tumors • Wholly owned, first-in-class, selective oral CDK8/19 inhibitor (SEL120) with therapeutic potential in multiple indications and clinical data in 2021 Applicable across indications: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), hematological and solid tumors • Trial in lead indication (AML/MDS) enrolling across 6 sites in USA with first data available in early 2021 • First-in-class dual PIM/FLT3 kinase inhibitor (SEL24) for Acute Myeloid Leukemia (AML) partnered with Menarini Dual-targeting of PIM and FLT3 designed to facilitate broader activity and potentially more durable responses • Single agent efficacy shown in relapsed/refractory AML patients with acceptable safety profile 1 • Broad early-stage pipeline delivering potential near-term clinical candidates and robust internal drug discovery engine Significant pipeline momentum with 2 programs expected to enter the clinic in 2021 (A2A/A2B, STING) and 2 near-term preclinical or late discovery targets • (HPK1, SMARCA2) Deep discovery capability and track-record in generating clinical candidates; validated by partnerships including Galapagos research collaboration • Listed on Warsaw Stock Exchange, market cap of $282m 2 One of the largest drug discovery companies in the region, headquartered in Kraków, Poland • Significant non-dilutive grant funding (>$25m secured till 2023); supportive shareholder base • 3 1 Dose escalation study in 25 patients in relapsed / refractory FLT3 negative AML with 1 CR and 1 CRi in elderly patients who had exhausted other therapeutic options 2 10 July 2020. Exchange rate (NBP): 1 $ =3.9486PLN

  4. Broad pipeline addressing emerging targets in oncology 4

  5. Team with strong track record of clinical development and shareholder value creation PAWEL PRZEWIEZLIKOWSKI, MSc, MBA SETAREH SHAMSILI M.D., Ph.D. KRZYSZTOF BRZOZKA Ph.D., MBA PETER LITTLEWOOD Ph.D. LUIGI STASI Ph.D. CEO and Founder CMO Director of DMPK Director of Chemistry CSO MONIKA DOBRZANSKA Ph.D. MATEUSZ NOWAK Ph.D., MBA TOMASZ RZYMSKI Ph.D., MBA KAMIL SITARZ Ph.D. TOMASZ NOCUN, MSc, MBA Director of Strategic Planning Director of Early Director of Biology Director of R&D Operations Director of Research Financing & Portfolio Management Discovery & Innovation Scientific Advisory Board and industry collaboration history Supervisory Board GREG NOWAKOWSKI , M.D. PIOTR ROMANOWSKI , M.D. Ph.D., CHAIRMAN ANTHONY TOLCHER, M.D. FRCPC AXEL GLASMACHER , M.D. JOSEPH TABERNERO , M.D. Ph.D. COLIN GODDARD , Ph.D. MICHAEL SAVONA , M.D. JARL ULF JUNGNELIUS , M.D. CEZARY SZCZYLIK , M.D. Ph.D. RAFAL CHWAST , MSc THOMAS TURALSKI JORGE CORTES, M.D. TADEUSZ WESOLOWSKI , Ph.D PRZEMYSLAW JUSZCZYNSKI , M.D., Ph.D 5

  6. Differentiated internally discovered small-molecule drug candidates and new programs Targeted therapies Immuno-oncology Synthetic lethality CLINICAL CLINICAL NON-GLP TOXICOLOGY LATE LEAD OPTIMIZATION LEAD OPTIMIZATION HIT-TO-LEAD SEL24/ SEL120 DUAL ADENOSINE SMALL MOLECULE SMARCA2 SELECTIVE MEN1703 SELECTIVE SYSTEMIC A2A/A2B HPK1 MTAP CDK8/CDK19 DUAL PIM/FLT3 STING ANTAGONIST INHIBITOR WRN INHIBITOR INHIBITOR AGONIST A2A/A2B HPK1 SEL24 SEL120 First-in-class unique MoA in AML: o Partnered globally o Selective, potent HPK1 inhibitors with single o The only disclosed dual, potent A2A/A2B o direct cytotoxicity and with agent anti-tumor efficacy in vivo antagonist with the potential of restoring eradication of leukemic stem cells suppressed function in multiple immune cell Designed to boost T cells activation and make o Designed to address critical o types in adenosine-rich microenvironment them resistant to immunosuppression Dual PIM/FLT3 targeting for o unmet medical need: potential broader efficacy and durable to improve responses with the responses in AML expectation for eradication of minimal residual disease, extend Potential for safe combinations STING o Synthetic Lethality a relapse free remission and with chemotherapy improve the overall survival Single agent efficacy o Small molecule STING agonists Proprietary bioinformatic platform Expansion of indications in solid o o o demonstrated in AML FLT3- for systemic delivery to discover novel synthetic lethal targets tumors: robust preclinical single wild-type, relapsed patients 1 agent efficacy in multiple solid in Phase I study Shown to induce tumor regressions with long- SMARCA2: first-in-class allosteric ATPase o o tumor types term immunological memory in vivo on par inhibitors and selective SMARCA2 PROTAC with the most potent competitors agonists degraders Opportunities for combination: o with SoC such as venetoclax, Direct STING binders across multiple human Additional discovery work on MTAP, WRN o o azacitidine, checkpoint inhibitors STING haplotypes and multiple other undisclosed targets 6 1. Dose escalation study in 25 patients in relapsed / refractory FLT3 negative AML with 1 CR and 1 CRi in elderly patients who had exhausted other therapeutic options

  7. Strong momentum from 2019 and 2020'YTD Strengthened supervisory board and management board with accomplished biotech industry veterans AUGUST First patient dosed with SEL120 SEPTEMBER 2019 Corporate split between Ryvu Therapeutics and Selvita (CRO) completed, >$100M incremental value created for Ryvu shareholders OCTOBER DECEMBER Selection of A2A/A2B antagonist pre-clinical candidate for non-GLP tox studies SEL24 – successfully completed Phase I in acute myeloid leukemia patients MARCH SEL120 – orphan drug designation in AML by FDA MARCH SEL24 – FDA approval for the initiation of Phase II MARCH 2020 Collaboration with Galapagos in inflammatory disorders announced APRIL Ryvu spin-out company NodThera raises $55 M Series B funding JUNE Clinical posters at EHA 2020 - SEL24 Phase I data, SEL120 trial in progress JUNE Data updates from SEL120 and multiple pre-clinical programs (STING, SMARCA, HPK1, A2A/A2B) presented at AACR Conference JUNE 7

  8. Executing on our mission Complete Phase I clinical development of our lead fully-owned asset, SEL120 in AML/MDS Expand the potential for SEL120 in solid tumors, and launch a new Phase I study in selected indications in parallel to the ongoing hemato-oncology studies Ryvu has one Support Phase II development by Menarini for lead partnered candidate, ultimate mission – SEL24/MEN1703 in AML discover and develop drugs that will Complete preclinical programs for A2A/A2B and STING candidates improve the lives and advance at least one program into the clinical development of cancer patients and their families Strengthen our position in novel target discovery for synthetic lethality and immuno- oncology and developing high-specificity candidates against these targets Partner selected early pipeline programs with biotech and pharma companies providing synergistic competences and resources, targeting at least one new deal in 2020 8

Recommend


More recommend