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Immunotherapy Against Metastasis

Immunotherapy Against Metastasis. Entering phase IIb placebo-controlled study in 2019. Safe Harbour Statement.

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Immunotherapy Against Metastasis

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  1. Immunotherapy Against Metastasis Entering phase IIb placebo-controlled study in 2019 BioStock Stockholm April 29, 2019

  2. Safe Harbour Statement The following presentation may include predictions, estimates or other information that might be considered forward-looking. The statements regarding the surrounding world and future circumstances in this presentation reflect RhoVac´s current thinking with respect to future events and financial performance. Prospective statements only express the assessments and assumptions the company makes at the time of the presentation. These statements are well considered, but the audience should note that, as with all prospective assessments, they are associated with risks and uncertainties. BioStock Stockholm April 29, 2019

  3. RV001 Immunotherapy against disease progression • Utilize body’s own immune system, through T-cell activation, to fight cancer cells • RhoVac’s drug candidate, RV001, targets the protein RhoC which is documented to be overexpressed in almost all cancer cells having metastatic potential ⃰ We cooperate with the body's immune system - instead of working against it ⃰Clark et al. 2000; Hakem et al. 2005; Wenandy et al. 2008; Karlsson et al. 2009; Yang et al. 2016; et al BioStock Stockholm April 29, 2019

  4. Anti-metastasis immunotherapy • RhoVac has a unique immuno-oncology product: anti-metastasis for early stage of disease progression, applicable to a broad range of cancers Adjuvant Treatment of Prostate Cancer Patients with biochemical failure, Following Definitive Local Therapy • Project has completed phase I/II clinical study and is now entering clinical phase IIb in placebo-controlled study • Every year, 1.0 million (2018) new patients are diagnosed with localized prostate cancer. Following definitive local therapy 40% of these patients are expected to metastasize. • Clinical development in an additional indication, in combination with a check-point inhibitor, is planned. BioStock Stockholm April 29, 2019

  5. Development Plan – 2019 to 2022 • Listing on AktieTorget (Spotlight) • Toxicological Study completed • Approval of CTA • Start of Clinical phase I/II Study • Completion of Clinical Study phase I/II • Immunological Analysis • Start of phase IIb trial • Late Stage CMC Development • Explorative clinical trial • Completion of Phase Ilb • Scientific Advice, EMA • Pre-IND Meeting, FDA • CTA Submission • PIP (Paediatric Investigation Plans) Ongoing Research Collaboration • Immunotherapy/immune-monitoring - University of Tübingen and Centre for Cancer Immune Therapy • Cancer stem cells – Lund University BioStock Stockholm April 29, 2019

  6. Management Anders Ljungqvist, MSc.Pharm, CEO, CSO & founder • 35+ years of experience from pharmaceutical and biotech industry • Extensive CMC, QA/GMP and project development experience • Previous successful exit with SurVacApS Henrik Stage, MSc, Finance, CFO • 25+ years of executive experience in biotech and finance • Successful exit in 2014 with Santaris Pharma AS (to Roche) • 10+ international deals in biotech Anders Månsson, BSc, Executive MBA, Business Development and Communication • 25+ years of experience from pharmaceutical and biotech industry • Substantial track record leading major divestments, licensing and acquisitions in life science industry • Substantial management experience in portfolio management BioStock Stockholm April 29, 2019

  7. Clinical and Regulatory Development Steven Glazer, MD, Medical Director • 30+ years experience from pharma-, diagnostic- and biotech industry in Europe and USA • Extensive clinical experience on both operational and executive levels. • Extensive experience is project development from pre-clinical to commercialization Malene Weis, MSc, Clinical Coordinator • 20+ years of clinical experience in pharma- and biotech industry • Extensive clinical experience on both operational and executive levels • Previous clinical experience with cancer vaccine development Ann Christine Korsgaard, MSc. Pharm, Regulatory Affairs • 20+ years of experience from pharma- and biotech industry • Extensive regulatory experience on both operational and executive levels • Extensive interaction with EMA, FDA, PMDA (Japan) and National Competent Authorities Andrew Stone, MSc Medical Statistics, Biostatistician • 25+ years experience from pharma- and biotech industry • 20+ years experience in oncology and with interactions with both EMA and FDA • Author of a number of statistical publications and invited speaker at drug development conferences BioStock Stockholm April 29, 2019

  8. T-cell Activation Concept DC capturing, absorbing and processing the antigen become “Antigen-Presenting-Cells” (APC) If cytotoxic T-cells meet cells that present the antigen fragment, they attack the these cells and eliminate them. “APC“ interact with "naïve” T-cells which are programmed to recognize the antigen fragment and thus become to cytotoxic T-cells". BioStock Stockholm April 29, 2019

  9. Targeting Cancer in Early Stage Cabazitaxel Docetaxel Sipuleucel-T Prostate Cancer Progression Time (yr) Hormonal therapy - ADT After response to ADT, nearly all patients progress to CRPC within 18 to 24 months 30-50% treated with surgery or radiation experience recurrence of disease Castrate resistant disease Tumor Volume RhoVac, 2018 Recurrent disease mCRPC 80% of CRPC patients develop metastasis. 46% within 2 years. PSA rise Localized disease Life expectancy drops from 100% to 30% from localised to metastatic disease. CRPC 1st line hormone therapy Surgery Radiation Immunotherapy Chemotherapy Monitoring 2nd line hormone therapy Non-metastatic Micro-metastasis Formation Metastatic Castration SensitiveCastration Resistant • American Cancer Society • Current Treatment Landscape In Prostate Cancer Medical, Daecher 2018 • Drug management of prostate cancer, Higano, 2010 • Prostate Cancer: Current Management and Future Directions, • Lynn Cancer Institute ADT: androgen deprivation therapy CRPC: castration-resistant prostate cancer mCRPC: metastatic castration-resistant prostate cancer BioStock Stockholm April 29, 2019

  10. Targeting Cancer in Early Stage Marketed Products and Selected Pipeline Cabazitaxel Docetaxel Sipuleucel-T Castrate resistant disease Tumor Volume Time (yr) Hormonal therapy - ADT RhoVac, 2018 Surgery Radiation 1st line hormone therapy Monitoring 2nd line hormone therapy Immunotherapy Chemotherapy Cabazitaxel Xofigo, Docetaxel Xtandi Zytiga, Erleada ADT GnRH agonists Active surveillance Watchful waiting Provenge Selected Pipeline DCVAC/Pca* Erleada+gnRH+ radiation ProscaVax* Xtandi+leuprolide ProscaVax* RV001 Darolutamide Xtandi+ADT Erleada+ADT Non-metastatic Micro-metastasis Formation Metastatic Castration SensitiveCastration Resistant * Cancer Vaccines BioStock Stockholm April 29, 2019

  11. Phase I/II Clinical Trial : Study Results Primary Objective, Safety and Tolerability Safety • Proportion of patients developing treatment related Grade 3, 4 or 5 toxicity in accordance with CTCAE • There were no treatment related Grade 3, 4 or 5 toxicity during the study Tolerability • Good compliance to treatment and no withdrawals due to safety • Patients only experienced mild (≤ Grade 2), reversible injection site reactions RV001 was shown to be safe and well tolerated in patients with prostate cancer BioStock Stockholm April 29, 2019

  12. Phase I/II Clinical Trial : Study Results Secondary Objective, Immunological Response • 18 out of 21 patients (86%) were ConfirmedImmune Responders RV001-mediated immune response is established and the selected dose is biologically active BioStock Stockholm April 29, 2019

  13. Phase IIb Clinical Study – In Progress A Double-Blind, Placebo-Controlled Study of RV001, in Men with Biochemical Failure Following Definitive Local Therapy (e.g. Prostatectomy, Radiotherapy) 150 (175) patients with biochemical (PSA) recurrence following definitive local therapy will be recruited. • First-patient-in to analysis of primary end-point is estimated to 24 months • Analysis of PSA doubling time in each patient ≤12 months treatment Primary Objective: To evaluate if RV001 can reduce prostate-specific antigen (PSA) progression compared to the control group. • Time to PSA progression will be defined as the time for each patient’s PSA to double • Well defined endpoint to monitor PSA progression and also clinical practice Secondary Endpoints: To evaluate if RV001 can delay the time to subsequent antineoplastic therapy initiation. BioStock Stockholm April 29, 2019

  14. Regulatory Strategy for RV001 SME Status EMA Sci.Adv. Ped. Sci.Adv. CTA Subm. ITF/SME meeting DK Nat. Sci.Adv. IND Fast track status Pre-IND meeting Today BioStock Stockholm April 29, 2019

  15. Anti-metastasis immunotherapy • RhoVac has a unique immuno-oncology product: anti-metastasis for early stage of disease progression, applicable to a broad range of cancers Adjuvant Treatment of Prostate Cancer Patients with biochemical failure, Following Definitive Local Therapy • Project has completed phase I/II clinical study and is now entering clinical phase IIb in placebo-controlled study • Every year, 1.0 million (2018) new patients are diagnosed with localized prostate cancer. Following definitive local therapy 40% of these patients are expected to metastasize. • Clinical development in an additional indication, in combination with a check-point inhibitor, is planned. BioStock Stockholm April 29, 2019

  16. Rights Issue, pending approval at XGM 29-May-2019 • Subscription period: June 5, 2019 - June 19, 2019 • Subscription ratio : 1:1 • Subscription price : 19,00 SEK per new share • Issue size : 180,9 MSEK (before cost of issue) • The rights issue is fully secured through • subscription commitments and issue guarantees +173% BioStock Stockholm April 29, 2019

  17. IMMUNTHERAPY AGAINST METASTASING CANCER Contact: Anders Ljungqvist, CEO or Alexandra Ellervik, CM & PJM info@rhovac.com BioStock Stockholm April 29, 2019

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