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1 Best possible treatment from day 1 January 2019

Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Page 1: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Best possible treatment from day 1

January 2019

Page 2: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Biovica develops and commercializes blood based assays for prognosis and monitoring of

effect of targeted cancer treatments

Our objective is to enable best possible treatment for cancer patients from day one!

Anders RylanderCEO

Page 3: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

• Develops biomarker assays for enabling personalized treatments for better outcome

• Biotech company in early commercial phase

• Listed on First North

• Market Cap ~ SEK 160 m

• Annual turnover of SEK 2.7 m

• Patented technology

3

Biovica in Brief

Page 4: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Why invest in Biovica?

• Beneficial for cancer patients and payers

• Addresses an unmet need for personalized treatments within metastatic cancer

• Large market potential of SEK 6 billion for metastatic breast cancer area in US & Europe

• Strong scientific collaborations and evidence

• Early commercial phase, next milestone FDA application 2019

More info: http://biovica.com/investor-relations/analytiker/

Page 5: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

• Measures cell proliferation

• Implemented on standard platform

• Strong competitive position

5

The product DiviTum®

Page 6: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

DiviTum® a blood based biomarker assay

• Blood based

• Monitor and predict treatment response in cancer therapy

• ELISA – standardized platform

• CE-marked

• Patented method and kit

6

Page 7: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

DiviTum® provides early response to whether or not the patient's cancer treatment is effective

7

DiviTum®

Imagediagnostics

Months

DiviTum® measures cell proliferation rate for faster evaluation of cancer treatment effects

References: See http://biovica.com/technology/publications/

Page 8: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

DiviTum® - strong position in regards to competing / complementary technologies

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Imaging• Standard method for treatment evaluation• Requires 3-4 months follow up time• Example: PET/CT, MRI

Biopsies• Tumor samples collected through a needle• Invasive, not suitable for treatment monitoring• Example: Ki-67 (proliferation marker)

Blood based markers• Requires only blood sample – convenient for treatment monitoring• No marker established as golden standard in breast cancer• Example: CA 15-3 (breast cancer)

Page 9: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

• First application – metastatic breast cancer (MBC)

• Potential of SEK 6 billion/year in US and Europe alone (MBC)

• Long term potential – standard marker for cancer treatment evaluation

9

Unmet need and market

Page 10: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

There’s an unmet need for biomarkers for individualized cancer treatments

• Many treatment options

• Efficacy evaluation

• Treatment resistance

• Cost issues

• Time consuming diagnostics

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Page 11: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Cost for cancer treatments exceeds USD 100 billion!

0

20

40

60

80

100

120

2013 2014 2015 2016 2017

Oncology Therapeutics (BUSD)

Oncology treatment cost

Source: IQVIA Oncology cost report 2018

0

100

200

300

400

500

600

700

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Oncology Development Pipeline (# of new compounds)

Targeted Cytotoxics Hormonals Radiotherapies

≥ 90% of new treatments are targeted or hormonals – Biovica focus area

Page 12: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

Biovica focuses primarily on metastatic breast cancer

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Breast cancer

Lung cancer

GI-cancer

Prostate cancerOthers

* ) B a s e d o n G l o b o c a n 2 0 1 8 - d at a

• 450 000 patients with metastatic breast cancer in US and Europe

• Market potential SEK 6 billion/year (US & Europe)

• Additional potential: Research market, other metastatic cancers, local cancer, CDx, etc

Page 13: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

• 16 articles, peer reviewed and published in oncology journals

• Results within major oncology areas (Breast, Lung, Gastro Intestinal, Blood malignancies)

• Ongoing program within breast cancer with world leading cancer institutes

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Strong Clinical Study Results for DiviTum®

Page 14: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

DiviTum® - Strong evidence within breast cancer

TEX Metastatic Breast Cancer, Chemo therapy, 287 patEarly Breast Cancer, 161 pat

BRCA80 pat

Breast Cancer Targeted Therapy US, 48 pat

Metastatic BC, 2nd lineHormonal, 244 pat

Metastatic Breast Cancer, Hormonal treatment, 31 pat

Metastatic Beast Cancer, hormonal, targeted, chemo,

142 pat

ScreeningHigh Risk

Early Breast CancerStage I-II

Locally Advanced diseaseStage III

Metastatic diseaseStage IV

PublishedPresented References: See http://biovica.com/technology/publications/

Page 15: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

Study Stage #Pat Results

BRCA High risk 80 DiviTum able to predict which high-risk-patients (BRCA-positive) that would develop cancer.

BC early I,II 161 DiviTum able to predict risk for recurrence within 5 years.

TEX III, IV 287 DiviTum prognostic for progression and survival. Better than CA 15-3 (golden standard marker breast cancer).

Wash-U II, III 48 DiviTum able to assess changes caused by targeted treatment , 2 weeks after treatment start. Correlated to biopsy proliferation marker.

Pilot Prato IV 31 DiviTum able to identify patients responding to hormonal treatment both before and after one month of treatment.

Lund IV 142 DiviTum able to identify patients responding to 3 types of treatments both before and during treatment.

EFECT IV 244 DiviTum able to identify patients responding to hormonal treatment (2nd

line) both before and after one month of treatment.

7 studies All stages n=993

DiviTum® summary of results from published breast cancer studies, all with statistically significant results

15References: See http://biovica.com/technology/publications/

Page 16: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

Study Stage #Pat Endpoints Status

PYTHIA IV 120 TK-activity for targeted drug response 2019

PREDIX III 200 TK for targeted drug response and survival 2020

FELINE III 120 TK for targeted drug response and correlation to other biomarkers 2019

City of Hope, LA IV 18 Pilot two targeted drugs, response 2019

University of Pennsylvania IV 28 Pilot chemo & targeted drug, response 2019

Johns Hopkins IV 100 Biomarker for targeted drug resistance 2020

6 studies III-IV n=586

Ongoing metastatic breast cancer study program in collaboration with world-leading institutes

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Page 17: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

• Early commercial phase

• 4 main work flows

• Clinical development

• Product development

• Regulatory approval

• Market access

• Next milestone: FDA application

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Road to market

Page 18: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

Biovica go-to market plan

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2013 2015 2017 2019 2021

1st MBC 1st targeted MBC MBC Regulatory & Demand

Targeted Lung & GI Pilot

DiviTum CE

CE

DiviTum FDA

FDA Pre-sub Supp.#1 Supp.#2

FDA

Sales research market

Reimbursement

Commercial partnerships

ClinDev

Prod Dev

Reg. Dev

Mar-ketAcc.

Page 19: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

• Experience of taking biomarker assays and oncology products to market

• Experience of FDA and reimbursement processes

• Committed, a majority of key people are Biovica shareholders

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Team

Page 20: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Experienced management teamAnders RylanderCEOHoldings: 3 575 640 A-shares and 360 956 B-shares

Cecilia DrivingCFOHoldings: 9 000 B-shares and 40 000 warrants

Karin Mattsson, Ph.DR&D DirectorHoldings: 1 000 B-shares and 40 000 warrants

Mattias BergqvistClinical Dev. DirectorHoldings: 106 560 B-shares and 20 000 warrants

Wing Cheng, Ph.DMarket Access & QA DirectorHoldings: 2 500 B-sharesand 20 000 warrants

Adam GermunderOperations DirectorHoldings: 3 600 B-shares and20 000 warrants

Pontus NobreusBusiness Dev. DirectorHoldings: 6 000 B-shares20 000 warrants

Page 21: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Board of Directors

Jarl Ulf JungneliusBoard MemberHoldings: 0

Göran BrorssonChairmanHoldings: 73 245 A-shares,116 000 B-shares, 3 000 warrants

Jesper SöderqvistBoard MemberHoldings: 41 085 A-shares,32 700 B-shares, 3 000 warrants

Maria HolmlundBoard MemberHoldings: 9 750 B-shares

Anders RylanderBoard MemberHoldings: 3 575 640 A-shares and 360 956 B-shares

Page 22: Biovica develops and commercializes blood based assays for ... · Breast Cancer Targeted Therapy US, 48 pat. Metastatic BC, 2 nd line. Hormonal, 244 pat. Metastatic Breast Cancer,

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Best possible treatment from day 1

January 2019