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. BioStock Stockholm April 29, 2019
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
2017
2018
2019
2020
2021
2022
Scientific Advice, EMA
Pre-IND Meeting, FDA
CTA Submission
PIP (Paediatric Investigation Plans)
Start of phase IIb trial
Late Stage CMC Development
Explorative clinical trial
Completion of Phase Ilb
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. BioStock Stockholm April 29, 2019
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 SurVac ApS
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. Castrate resistant disease
Targeting Cancer in Early Stage
Sipuleucel-T
Docetaxel
Cabazitaxel
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
PSA rise
80% of CRPC patients develop metastasis. 46% within 2 years.
Localized disease
Life expectancy drops from 100% to 30% from localised to metastatic disease.
CRPC
Surgery
Radiation
Monitoring
1st line hormone therapy
2nd line hormone therapy
Immunotherapy
Chemotherapy
Non-metastatic Micro-metastasis Formation Metastatic
Castration Sensitive Castration 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. Castrate resistant disease
Targeting Cancer in Early Stage
Marketed Products and Selected Pipeline
Sipuleucel-T
Docetaxel
Cabazitaxel
Castrate resistant disease
Tumor Volume
Time (yr)
Hormonal therapy - ADT
RhoVac, 2018
Surgery
Radiation
Monitoring
1st line hormone therapy
2nd line hormone therapy
Immunotherapy
Chemotherapy
Cabazitaxel
Xofigo, Docetaxel
Active surveillance
Watchful waiting
ADT
GnRH agonists
Xtandi
Zytiga, Erleada
Provenge
Selected Pipeline
Erleada+gnRH+
radiation
ProscaVax*
RV001
Xtandi+leuprolide
ProscaVax*
Darolutamide
Xtandi+ADT
Erleada+ADT
DCVAC/Pca*
Non-metastatic Micro-metastasis Formation Metastatic
Castration Sensitive Castration 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 Confirmed Immune 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.
CTA Subm.
Ped. Sci.Adv.
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, 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
Share information
Date of listing
9 March 2016
Price at listing
8.3 SEK
Price (25-Apr-19)
32.4 SEK
Market Cap (25-Apr-19)
308 million SEK
+173%
BioStock Stockholm April 29, 2019

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