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Precision Therapy for Cancer Patients
October 2019
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DISCLAIMER
This presentation contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uuncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Further, certain forward-looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation. Oncology Venture does not undertake any obligation to update or revise forward looking statements in this presentation nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
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• Founded in 2004 in Denmark and publicly traded on NASDAQ First North (Stockholm).
• Robust Pipeline of 7 novel anti-cancer drugs that address significant cancer markets.
• Best-in-class DRP® platform creates drug-specific, predictive diagnostics to:
• Help select & treat the most likely responder patients for each of our pipeline drugs.
• Accelerate clinical development of each of our programs.
• Strong intellectual property position with over 30 patents/applications in key world markets, covering DRP® diagnostics for more than 75 different cancer drugs.
• Experienced new management and drug development team.
• Currently seeking SEK 100 million investment to advance our promising pipeline with DRP through near-term, value creating milestones from a new, focused strategy.
Oncology Venture Company Snapshot
“We are building a personalized medicine company developing new therapeutics for unmet needs in
the treatment of human cancers through use of our world-class predictive diagnostics platform”.
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A New, Experienced Management Team
30+ years of commercial industry experience focused in oncology, including former CEO roles at Apexian Pharmaceuticals, Raphael Pharmaceuticals (formerly Cornerstone Pharmaceuticals), and Senior Vice President and President, Commercial Operations (North America) for Mallinckrodt Pharmaceuticals, leading the company listing on NYSE. Earlier in his career, he held senior leadership positions at General Electric, Johnson & Johnson, Eli Lilly & Company and Bristol Myers Squibb.
Dr. Steen KnudsenChief Scientific Officer, Founder
Founder of MPI and the inventor of the Drug Response Predictor (DRP®) technology. As a Professor of Systems Biology, Steen he has extensive expertise in mathematics, bioinformatics, biotechnology, and systems biology.
Henrik MoltkeChief Financial Officer 30+ years of experience in the life sciences industry serving on executive teams, including numerous
CFO roles. He was a Co-Founder of NeuroSearch A/S, has raised more than 2 billion Danish Krone in investment for life science companies, and has participated in more than 20 drug license deals.
Steve R. CarchediChief Executive Officer
Dr. Marie FoeghChief Medical Officer
25+ years of commercial leadership experience in women’s health. Throughout her career, she has successfully developed and achieved regulatory approval of more than ten novel drug indications, and has strong experience working with the FDA , EMEA and consumer advocacy groups.
20+ years of experience in business development, licensing, and alliance/partnership management within the oncology sector with an emphasis on precision medicine and companion Dx. He was responsible for identifying and acquiring 5 of our current oncology pipeline assets, including Dovitinib (Novartis) and 2X-121 (Eisai), and is a Co-Founder of 2X Oncology, Inc., our first U.S. spinout.
James G. CullemSenior Vice President, Corporate Development
Thomas JensenChief Technology Officer
Amongst Thomas’ accolades are his inventions of Molecular Biological Guidelines combined with techniques for high quality reproducible RNA extraction and downstream processing. This allows for high resolution analysis of cancer patient’s biopsies. His inventions are an important foundation of the DRP® - Drug Response Prediction platform
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Lead Indication Phase 1/2 Phase 2 Phase 3 Pre-NDA
DNA damaging agentHR Metastatic Prostate Cancer
Doxorubicin in GSH-linked Liposome enabling BBB penetration
Metastatic Breast Cancer
FAS Ligand (ImmunoOncology)
Multiple Myeloma
Pan-Tyrosine KinaseInhibitor
Renal Cell Carcinoma
Cisplatin in phospholipase A2 modified liposome
Ovarian Cancer
Metastatic Breast Cancer
Our Oncology Pipeline
Microtubulin inhibitor Metastatic BreastCancer (neoadjuvant)
PARP & Tankyrase inhibitor
• Each program will be developed with a DRP® diagnostic to select and treat patients likely to benefit from treatment.
EU only US approved
Dovitinib
®
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Precision Therapy for Cancer Patients Requires Predictive Diagnostics to Select Likely Responders to a Given Drug
The Problem: Current cancer drug development and patient outcomes are plagued by:
• High Toxicity, high failure rates, low response rates, and high costs.
• An outdated model of treating all patients instead of selecting and treating only theright patients.
• Lack of suitable, validated, predictive diagnostics for each drug.
P e r s o n a l i z e d M e d i c i n e
Classical drug development:Treat them all
Oncology Venture approach:Treat only the susceptible
Low average patient benefit High average patient benefit
G O A L
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A First-in-Class Diagnostic Platform that Models Human Tumor Biology
• The DRP® Platform creates uniquediagnostics that can predict whether a cancerpatient will respond to a particular drug.
• A bioinformatic technology based ongene expression & systems biologyanalysis.
• Uses cancer cell line testing data as an“input” to yield a drug responsesignature.
• Refined by passing through a “filter”based on 3,000+ human clinical biopsysamples to eliminate background “noise”.
• Each DRP® diagnostic is drug-specific.
What is DRP® ?
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How We Create a Drug-Specific DRP®
In vitro
TRANSCRIPT-OMICS
HUMAN
SYSTEMSBIOLOGY
In vitro
Drug Response
DATA
Multi
Gene
DRP
DRUG
BLIND
CLINICAL
VALIDATION
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“Systems biology” is used to analyze all genes(~25,000) expressed in a cancer cell/tumor,without bias towards current knowledge ofrelevant drug targets or pathways.
From cancer cell line drug testing data as an “input”,our DRP® engine applies the system biology analysisand a “filter” of human clinical trial response data, toyield a 50 to 400 gene DRP® for that specific drug.
Cancer is Complex The Tumor Tells us What is Important
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Key Competitive Advantages of our DRP® TechnologyCurrent, competitive predictive diagnostics are inadequate due to:
• Low success rates- not predictive (variable)
• Limited market- Reliance on single biomarkers and known drug target(s)
• Failure to account for the complexity of cancer biology
• No clinical validation
• No specific drug response benefit
• Not exclusive- Limited Intellectual Property
• Examples: Foundation Medicine, Ventana, DAKO, Myriad Genetics.
DRP® BENEFITS:
• High success rates- predictive of patient responders.
• Effective across broad drug types (targeted kinase inhibitors, epigenetic inhibitors, chemotherapeutics, DNA repair inhibitors).
• Highly validated in more cancer clinical trials than any other competing predictive diagnostic technology.
• Specific drug response benefit.
• DRP® 30+ global drug patents in 75 Drugs with 20 yrs of market exclusivity.
Historical Knowledge-Driven Approach
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Prospective Validation of DRP® in Phase 2 Trial of in mBC
DRP score
0%
100%
Top
Middle
Bottom
No benefit expected:
Excludedfrom trial
33%
33%
33%
Interim data (July 2019): median TTP 7 week (in middle 33%) vs. 19 weeks (in top 33%)
DRP® Selected Patients Show a Substantially Improved Therapeutic Benefit
®
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DRP® Platform has Been Highly Validated in Over 35 Clinical Trials
Breast, Ovarian, LungCisplatin/LiPlaCis NSCLC metastatic Breast
Weak
CC<0.1 or P>0.05
Fulvestrant neoadjuvant Breast metastatic Breast
Evidence Level Level III: Retrospective Level II: Prospective
with archival samples
Level I: Prospective
or confirmatory
Epirubicine neoadjuvant Breast metastatic Breast
Belinostat AML
Colon5-FU Colon
Exemestane metastatic Breast
2X-121 PARPi Solid tumors
BreastIxabepilone
Clinical Impact LegendStrong
CC>0.4 or HR<0.5
Moderate
CC<0.4 or HR>0.5
A strong clinical impact means a 3-5 fold increase in ORR or TTP between predicted sensitive and predicted resistant.
A moderate clinical impact means a doubling of ORR or TTP. Compared to the unselected population, this may
represent a 50% increase in ORR or TTP.
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Our DRP® Platform is Robust, but has limitations
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Validation failures can result from lack of statistical power and/or the age or unavailability of biopsies
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NSCLCTarceva
Weak
CC<0.1 or P>0.05
Sorafenib
Evidence Level Level III: Retrospective Level II: Prospective
with archival samples
Level I: Prospective
or confirmatory
Cetuximab
Bortezomib Multiple Myeloma
Dox+Cyc Breast
Anastrozole Breast
FOLFOX/FOLFIRI
Clinical Impact LegendStrong
CC>0.4 or HR<0.5
Moderate
CC<0.4 or HR>0.5
NSCLC
Colon
Breast
Colon
Paclitaxel neoadjuvant Breast metastatic Breast
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Our Priority Pipeline
Dovitinib
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Dovitinib A Pan-Tyrosine Kinase Inhibitor (TKI)
• Exclusively in-licensed (globally) from Novartis
• Efficacy in Phase 3 trial in Renal Cell Carcinoma (RCC) and in Phase 2 trials in 4 other cancers
• Mechanism-of-Action: Small molecule, targeted inhibitor of FGFR, VEGFR, and other RTKs
• GMP & FDA approved Drug manufacturing is completed- clinical drug supply available.
• Dovitinib DRP® is validated in 5 different cancers.• RCC, GIST, liver, metastatic breast, and endometrial
• Clear Regulatory Approval Pathway- Pre-NDA meeting (U.S. FDA) for “non-inferiority” vs. Sorafenib in RCC targeted for 2020.
• Subsequent NDA filing for RCC with Dovitinib DRP®
• Large market potential with high unmet market need: Global RCC therapeutics market projected to grow to $6.3B by 2022. Annual sales of Nexavar® = $715 M in 2018.
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Our Validated Dovitinib DRP® Identifies Responsive Patients
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PR SD PD
020
40
60
80
100
Dovitinib 2302 RCC trial
Clinical response
DR
P p
red
icte
d d
ovi
tinib
sensi
tivity
(N
CI 5
dose
)
PR SD PD
020
40
60
80
100
CC=−0.27, P=0.011 one sided
Response rate above DRP® cutoff of 50: 23%Response rate below DRP® cutoff of 50: 6%
Dovitinib DRP® correctly predicts response to this drug in biopsies from the Novartis phase 3 RCC trial.
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• Exclusively in-licensed (Europe) from R-PHARM U.S.
• Approved in the U.S. for mBC patients.
• Mechanism-of-Action: small molecule targeted inhibitor of microtubules (cell cytoskeleton components crucial to cell division and stability)
• GMP & FDA approved Drug manufacturing is completed- clinical drug supply available.
• IXEMPRA® DRP® is validated in metastatic breast cancer.
• Clear Clinical Development Path -Phase 2 trial front-line, neoadjuvant therapy in newly diagnosed breast cancer.
• Enrollment of Phase 2 trials targeted for 2020.
• Large market potential with high unmet market need: Global breast cancer therapeutics market projected to grow to $25Billion by 2024. Market potential for IXEMPRA® as front-line neoadjuvant therapy in newly-diagnosed beast cancer,
(Ixabepilone) - An Commercially Approved Tubulin Inhibitor
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Our Validated DRP® Identifies Responsive Patients
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Response rate above DRP® cutoff of 50: 24%Response rate below DRP® cutoff of 50: 3%(in ER+ patient population)
IXEMPRA® DRP® correctly predicts response to this drug in published data from biopsies from the Bristol-Myers Squibb phase 3 mBC trial.
DRP® predicts pCR (P=0.0004)
N=138 (ixabepilone arm)
Ixabepilone DRP® data in metastatic breast cancer patients that obtained pathological complete remission (pCR) (Green) and patients that did not obtain pCR (Red) – We find the patients that benefit and this is KEY to success
pC
R
No_
pC
R
020
40
60
80
10
0
Ixabepilone arm
Response
Pre
dic
ted I
xabe
pilo
ne
sensitiv
ity
pC
R
No_
pC
R
020
40
60
80
10
0
<
18
• Exclusively in-licensed (globally) from Eisai.
• Efficacy in Phase 1 trial, including ovarian and pancreatic cancer
• Multi Target Mechanism-of-Action: First in class small molecule targeted inhibitor of DNA damage repair enzymes (PARP)1 and telomerase maintenance enzymes (Tankyrase).
• Multi-targeted inhibitor PARP 1/2 and Tankyrase 1/2
• Limited drug resistance - Lack of transport by P-glycoprotein potentially overcomes resistance to PARP inhibitors
• GMP & FDA approved Drug manufacturing is completed- clinical drug supply available.
• 2X-121 DRP® is validated.
• Clear Clinical Development Pathway- Phase 2 trials ongoing in ovarian cancer (Dana-Farber Cancer Institute, Boston, MA USA).
• Completion of Phase 2 trials targeted for 2021.
• Broad Combination Therapy- As mono-agent or combination with DNA damaging agents with immuno-oncology drugs
• Large market potential with high unmet market need: Global PARP market projected to reach $9Billion by 2027 use in ovarian cancer.
A Dual PARP and Tankyrase Inhibitor- 121
1) PARP = Poly ADP-Ribose Polymerase, a critical cellular enzyme for repair of certain type of DNA strand breaks.
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Our Validated DRP® Identifies Responsive Patients
All responders (2 ovarian and 1 pancreatic) identified above DRP® cutoff of 50.No responders below DRP® cutoff of 50.
2X-121 DRP® predicts response to this drug in biopsies from the Eisai phase 1 trial.
PR SD PD
020
40
60
80
100
Results of E7449 Phase I Trial
Clinical response
DR
P p
redic
ted
E7449 s
ensitiv
ity (
ad
juste
d for
dose
50−
800m
g)
PR SD PD
020
40
60
80
100
CC=0.42, P=0.07
Plummer et al, ASCO 2018, manuscript submitted to J. Clinical Oncology.
<
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- PARP Competitive Landscape
Product Owner StageResponse biomarker
Resistance (PgP
mediated )
Toxicity(Myelotox)
Multi-targeted (PARP/Tankyrase)
PARP trapping
BBB penetration
Strong maintenance opportunity
olaparib AstraZeneca Approved BRCA Yes Yes No Yes No Yes
niraparib Tesaro/GSK Approved BRCA/HRD Yes Yes No Yes No Yes
veliparib AbbVie Phase 3 BRCA Yes Yes No No No No
rucaparibClovis Oncology
Approved BRCA Yes Yes No Yes No Yes
talazoparib Pfizer Approved BRCA No Yes No Yes No Yes
2X-121 OV Phase 2 DRP® No No Yes Yes Yes Yes
“…. the identification of reliable biomarkers will be critical for the success of this targeted agent” a
a) Lars M. Wagner, Division of Pediatric Hematology/Oncology, University of Kentucky, Lexington, KY, USA, in “Profile of veliparib and its potential in the treatment of solid tumors.” Onco Targets Ther. 2015; 8: 1931–1939. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4524591
Value Proposition: Oncology Venture PARP inhibitor (2X-121) with exclusive DRP® is a first-in-class, multi-targeted drug (Tankyrase & PARP inhibition) with improved efficacy, low toxicity profile, and low drug resistance resulting in improved patient outcomes.
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Strategic Horizons For Growth (Value Creation Events)
Targeting Large Unmet Needs in Terms of Patient Pool
Advance Priority Programs (Dovitinib, IXEMPRA®, 2X-121)
through key DRP validating Clinical Trials
Focused Shareholder Value Creation Points
via DRP®
(Accelerated Path to Approval)
Registration Studies
(Strategic Partnership)& Approvals for
IXEMPRA®
2X-121
2020-21 2025 & Beyond
Business Plan
Step 2
Step 3
Dovitinib Approval & Registration with DRP®
Initiation of Pivotal/Phase 3 Development for
IXEMPRA®2X-121
Step 1
2022-24
DRP® Development/Strategic Partnerships (Big Pharma, Small
Biotech)
PRP® Development
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An Advisory Board Of World Class Key Opinion Leaders
Dr. Dan Von Hoff, MDFounder
Daniel D. Von Hoff, M.D., F.A.C.P. FASCO, FAACR is Professor of Medicine at the Mayo Clinic and Chief Development Officer at TD2
Dr. Von Hoff has published more than 675 papers, 140 book chapters and over 1170 abstracts. He received the 2010 David A. Karnofsky Memorial Award from ASCO for his outstanding contributions to cancer research leading to significant improvement in patient care
Dr. Mansoor Raza Mirza, MD
Dr Mirza is presently Chief Oncologist at the Dept. of Oncology, Rigshospitalet, Copenhagen University Hospital and Medical Director of the Nordic Society of Gynaecologic Oncology-Clinical Trial Unit (NSGO-CTU). He is also Vice-Chairman of the Danish Society of Gynaecologic Oncology
His key academic goals are to promote clinical research, international trial collaboration and education. He has broad experience in clinical protocol development, trial conduct and clinical trial regulations
Dr. Ursula A Matulonis, MD
Ursula A. Matulonis, MD is Chief, Division of Gynecologic Oncology at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School
Dr. Matulonis serves on the National Comprehensive Cancer Network Ovarian Cancer Recommendation and Guideline Committee for both ovarian cancer and for the treatment of anemia, the Gynecologic Oncology Group Quality of Life Committee, a member of The Cancer Genome Atlas Project (TCGA) Endometrial Analysis Working Group
Dr. Joyce A. O’Shaughnessy, MD Joyce A. O’Shaughnessy, MD, is a breast cancer researcher and practitioner
in Texas Oncology, P.A. She specializes in medical oncology with board certification in both internal medicine as well as medical oncology.
She is chair of Breast Cancer Research and the Celebrating Women Chair in Breast Cancer at Baylor-Sammons Cancer Center. She is chair, The US Oncology Network, and is a member of the Scientific Advisory Board for the US Oncology Research Network.
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Financial Overview
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Use of Proceeds
Advancing Priority Projects to Drive Shareholder Value
• Accelerating development of prioritized clinical programs and further commercialization of DRP® and PRP® platform technologies.
• Fulfilment of ongoing operational contracts, agreements and commitments.
• Company operational expenses, including administration, patent portfolio maintenance, and regulatory applications with the FDA, EMEA, and other authorities.
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What are we Doing Differently?Focusing on Selected Programs, Streamlined Organization, and Financial Controls
• A revised new company strategy.
• Focused portfolio priorities on commercialization.
• Instituting robust financial controls.
• Reduced operational cost
• Reallocation of resources focus on clinical programs
• Budget established for each program
• Develop revised new organizational structure.
• 32% headcount reduction.
• New organizational culture and communication plans for driving shareholder value.
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Overview:
• Rights issue of SEK 100 million to existing shareholders to fund the commercial goals and new, focused program strategy.
• Underwritten by external guarantors.
Terms in Brief:
• Each shareholder will have the right to subscribe for 5 new shares for every 7 existing shares held.
• Subscription is done in the form of a “Unit”, consisting of 1 share and 1 warrant.
• Subscription price of SEK 2,00 per Unit.
• The warrant has a strike price of SEK 6,00 and a tenure of 24 months. The warrant has several exercise periods during its 24 months tenure and if all warrants are exercised it will bring an additional SEK 300 million to the company.
• Subscription between 31 October, 2019 and 14 November, 2019.
• Full information and details of the offering is included in the Prospectus, available at www.oncologyventure.com
Rights Issue for the Focused Commercial Strategy
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Summary of Investment Opportunity
• FOCUSED, PHASE 2/3 ONCOLOGY PIPELINE
• 3 clinical stage, novel therapeutics that have shown prior clinical efficacy. Potential for near term approval (U.S.) for one of these assets.
• FIRST TO MARKET DRP® PLATFORM
• Highly-validated DRP® technology to selectively enroll & treat highest likely responder patients to planned Phase II and III trials.
• EFFICIENT DEVELOPMENT MODEL
• Highly efficient use of capital and rapid achievement of success milestones.
• Low program cost from targeted enrollment clinical trial design & use of existing infrastructure.
• EXPERIENCED TEAM
• Expertise in predictive diagnostics, personalized medicine, and oncology drug development.
• RETURN-ON-INVESTMENT
• Advance our promising pipeline through near-term value creating milestones.
NEW, focused strategy to drive Shareholder Value
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Key Contacts
FOR MORE INFORMATION
Website: https//www.oncologyventure.com
Facebook: https://www.facebook.com/oncologyventure/ LinkedIn: https://www.linkedin.com/company/oncology-venture/Twitter: https://twitter.com/OncologyVenture
Henrik MoltkeChief Financial Officer
+45 53 63 96 37
Steve R. CarchediChief Executive Officer
+1 (908) 720-1786