against resistant cancer listed - onxeo · in addition, certain of the industry and market data...
TRANSCRIPT
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LISTED EURONEXT │ Paris NASDAQ │ Copenhagen
EPA: ONXEO
TODAY’S SCIENCE TARGETING TUMOR
DNA FUNCTIONS
TOMORROW’S NEW HOPE AGAINST RESISTANT CANCER
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IMPORTANT: You must read the following before continuing. In accessing this document, you agree to be bound by the following terms and conditions.
This document has been prepared by Onxeo SA (together with its subsidiaries, the "Group") and is for information purposes only. The content of this document is provisional and for information purposes only and is notto be construed as providing investment advice. The information, statements and opinions contained in this document (the “Information”) are provided as of the date of this document only and may be subject tosignificant changes at any time without notice. Neither the Group, nor its advisors, nor any other person is under any obligation to update the Information. Subject to applicable law, none of the Company or its advisorsaccepts any responsibility whatsoever and makes no representation or warranty, express or implied, as to the fairness, accuracy, completeness or correctness of the Information. The Information has not been subject toindependent verification and is qualified in its entirety by the business, financial and other information that the Group is required to publish in accordance with the rules, regulations and practices applicable to companieslisted on Euronext Paris, including in particular the risk factors in the Company’s Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.17-0423 onApril 24, 2017, in any other periodic report and in any other press release, which are available free of charge on the websites of the Group (www.onxeo.com) and/or the AMF (www.amf-france.org).
This document contains information on the use of the Group's products and its competitive position. Some of the Information is from third parties. While this third party information has been obtained from sourcesbelieved to be reliable, there is no guarantee of the accuracy or completeness of such data. In addition, certain of the industry and market data comes from the Group's own internal research and estimates based on theknowledge and experience of the Group's management. While the Group believes that such research and estimates are reasonable and reliable, they, and their underlying methodology and assumptions, have not beenverified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, undue reliance should not be placed on any of the industry, market or competitive position datacontained in the Information.
The Information is not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident of, or located in, any locality, state, country or other jurisdiction where such distribution or usewould be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The Information does not constitute or form part of, and should not be construed as an offer or thesolicitation of an offer to subscribe for or purchase of any securities. No public offering of securities may be conducted in France prior to the delivery by the French Financial Markets Authority of a visa on a prospectusthat complies with the provisions of Directive 2003/71/CE as amended. This document is for information purposes only and does not constitute an offering document or an offer of securities to the public in the UnitedKingdom to which section 85 of the Financial Services and Markets Act 2000 of the United Kingdom applies. Securities may not be offered or sold in the United States absent registration under the US Securities Act of1933, as amended, or an exemption from registration thereunder.
This document contains certain forward-looking statements. All statements in this document other than statements of historical fact are or may be deemed to be forward looking statements. These statements are notguarantees of the Group's future performance. These forward-looking statements relate without limitation to the Group's future prospects, developments, marketing strategy regulatory calendar, clinical milestones,assumptions and hypothesis, clinical development approach and financial requirements and are based on analyses of earnings forecasts and estimates of amounts not yet determinable and other financial and non-financial information. Forward-looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future.Forward-looking statements cannot, under any circumstance, be construed as a guarantee of the Group's future performance as to strategic, regulatory, financial or other matters, and the Group’s actual performance,including its financial position, results and cash flow, as well as the trends in the sector in which the Group operates, may differ materially from those proposed or reflected in the forward-looking statements contained inthis document. Even if the Group’s performance, including its financial position, results, cash-flows and developments in the sector in which the Group operates were to conform to the forward-looking statementscontained in this document, such results or developments cannot be construed as a reliable indication of the Group's future results or developments. The Group expressly declines any obligation to update or to confirmprojections or estimates made by analysts or to make public any correction to any prospective information in order to reflect an event or circumstance that may occur after the date of this document.
Important Information
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April 2020
Developing disruptive therapies in the field of DNA Damage Response (DDR) to address unmet needs in oncology
3
NEXT KEY MILESTONES FUNDEDFinancial visibility to Q3 2020 supports strategic plan to deliver key near-term clinical milestones
STRONG MANAGEMENT & OPERATIONAL TEAMA highly skilled team of 30, with strong translational & clinical expertise, led by experienced management and board of directors with demonstrated track record in product & business development
DIFFERENTIATED SCIENCE IN DNA DAMAGE RESPONSEPlatON™, proprietary chemistry platform of decoy oligonucleotides, generating new compounds
AsiDNA™, lead candidate at clinical stage, a first-in-class decoy agonist showing unique anti-tumoral propertiesOX401, a newly optimized next-gen PARPi*
A WELL-DEFINED BUSINESS MODELCreate value by bringing drug candidates from preclinical stage to proof-of concept in man, the best inflection points to monetize these assets and generate revenues.
LISTED EURONEXT │ Paris NASDAQ │ Copenhagen
EPA: ONXEO
* PARP inhibitors (PARPi) are a leading class of targeted therapies, the first approved and marketed in the field of DDR
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April 2020
Cutting-edge R&D pipeline with unique mechanisms of action in DDR
4
Programs OPTIMIZATION PRECLINICAL PHASE I PHASE Ib PHASE II
platON™ Proprietary Platform of Decoy Oligonucleotides
OX401Next-gen PARPi + STING pathway activation
AsiDNA™ IT + radiotherapy
AsiDNA™ IV
AsiDNA™ IV + chemotherapy
AsiDNA™ IV + PARPi
DRIIV -1b
DRIIV study in solid tumors
GENERATION OF NEW COMPOUNDS TARGETING DNA FUNCTIONS
DN
A D
amag
e
Re
spo
nse
1 IT: intratumoral – IV: intravenous
DRIIM study in metastatic melanoma
Ongoing proof-of concept
DD
R
+ IO
REVocan
Completed or ongoing Legend Planned short-term
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April 2020
Intense development efforts focused on AsiDNA™ and OX401
5
2019
OX401 presented at the European ESMO-TAT Congress
2020 in Paris
Jan Mar
5 abstracts presented at AACR on AsiDNA™
Apr 2020
AsiDNA™ OX401
Sep
Pipeline expansion w/OX401, a next-gen PARPi: no resistance and immune
response activation
Positive interim results from DRIIV-1b study
FPI inDRIIV-1b study of
AsiDNA™ in combination w/chemotherapy
May
Agreement with Gustave Roussy to conduct
REVOCAN, a phase 1b/2 study of AsiDNA™ &
niraparib for treatment of relapsed ovarian cancer
Apr
$6.6m exclusive agreement with Acrotech on
belinostat
New equity line started with Nice & Green – Total
of 12 million warrants
Kepler Cheuvreux initiates coverage w/
“Buy” recommendation
Oct
€495,000 grant as part of the Innov'up
Leader program PIA
Feb
Agreement to settle the remaining actions in the
litigation with SpePharm and SpeBio
Corporate
Jun
Final results of DRIIV-1 study: strong activity via IV route,
optimal dose for combo set at 600mg
May
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April 2020
April 6, 2020: a successful transaction to complete Onxeo’s strategic transition to a DDR focus company
6
Transaction grants full and worldwide rights to all territories ( ex. North America and India, already licensed to Acrotech), IP and know-how on all belinostat forms
License with Pint Pharma for Latin America and contracts with Clinigen and iQone for the Named Patient Program in Europe assigned to Acrotech
All future potential revenues from the belinostat franchise to revert to Acrotech
Reflects Onxeo ability in terms of BD, alliance management and NPP around the world
$6.6m paid by US partner Acrotech Biopharma LLC for exclusive WW rights to belinostat
Financial visibility extended into Q2 2021, beyond key clinical milestones* for AsiDNA™
* Timelines may be affected by Covid-19 pandemic
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April 2020
Consolidated P&L account
7
In € thousands 12/31/2019 12/31/2018
Recurring revenue from licensing agreements 3,455 2,310
Non-recurring revenue from licensing agreements 833 3,817
TOTAL REVENUES 4,289 6,127
Purchases (350) (215)
Personnel expenses (4,808) (5,438)
External expenses (7,857) (8,731)
Taxes and duties (127) (346)
Net depreciation, amortization and provisions (671) (92)
Other current operating expenses (365) 622
OPERATING EXPENSES (14,178) (14,200)
Other current operating income 95 4,546
CURRENT OPERATING INCOME (LOSS) (9,794) (3,527)
Other operating income and expenses (24,543) (12,117)
Share of profit from equity affiliates (39) 5,176
OPERATING LOSS AFTER SHARE OF PROFIT FROM EQUITY AFFILIATES (34,376) (10,468)
Income from cash and cash equivalents 19 15
Gross cost of financial debt (1,037) (601)
Other financial income and expenses (659) (104)
FINANCIAL INCOME (LOSS) (1,677) (691)
Income tax expense 2,324 1,760
- of which deferred taxes 2,330 1,764
CONSOLIDATED NET INCOME (LOSS) (33,728) (9,399)
Good performance of commercialization activities (notably by US partner Acrotech)
Impairment of R&D assets + goodwill €14.9m / depreciation of SpeBio shares €3.7m / provision SpePharm €6m
Cost of bond financing (proportional to royalties received from Acrotech)
Decrease of deferred tax liability due to impairment of R&D assets
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April 2020
Consolidated balance sheet - Assets
8
Assets in € thousands 12/31/2019 12/31/2018
Non-current assets
Intangible assets 23,358 38,573
Tangible assets 109 296
Right-of-use assets 2,718 -
Investments in equity-accounted companies 20 3,701
Other financial fixed assets 141 304
TOTAL NON-CURRENT ASSETS 26,345 42,874
Current assets
Stocks and work in progress 64 47
Accounts receivable and related accounts 991 1,479
Other receivables 4,520 7,597
Cash and Cash equivalent 5,708 11,253
TOTAL CURRENT ASSETS 11,284 20,376
TOTAL ASSETS 37,629 63,250
Impairment of goodwill -€2m and belinostat-related R&D assets -€12.9m
Rights of use relating to leases in the scope of IFRS 16
Depreciation of JV SpeBio shares sold at nominal value in Feb. 2020 within settlement with SpePharm
Reduction of receivables in line with R&D activity
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April 2020
Consolidated balance sheet - Liabilities
9
Liabilities and Shareholders’ Equity in € thousands 12/31/2019 12/31/2018
Shareholders’ equity
Share capital 15,329 13,344
Minus: treasury shares (189) (97)
Share premium 44,924 48,824
Reserves (9,139) (270)
Earnings (33,728) (9,399)
TOTAL EQUITY 17,197 45,402
Non-current liabilities
Deferred tax liabilities 2,330
Provisions 6,821 531
Other financial liabilities 7,412 6,593
TOTAL NON-CURRENT LIABILITIES 14,233 9,455
Current liabilities
Short-term borrowings and financial debts 1,170 450
Trade payables and related accounts 3,672 4,145
Other liabilities 1,358 3,798
TOTAL CURRENT LIABILITIES 6,199 8,393
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 37,629 63,250
Capital increase from the equity line €4.8m
Variation of deferred tax resulting from the €12.9m impairment of assets
Provision of €6m payable to SpePharm before 01/31/24
Loan relating to leases (IFRS 16) +€2m / Repayment of bond financing -€1.1m
Impact of SpeBio/SpePharm €2.8m penalty paid early 2019(netted with the €1.5m current account)
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April 2020
Consolidated cash outlook
10
5 708
(10 111)(2 729)
2 412
4 743 14011 253
0
2 000
4 000
6 000
8 000
10 000
12 000
Cash January 1,2019
Net operatingincome
& expenses
R&D tax credit Capital increase -equity line
Repayment ofloans
Other Cash December31, 2019
€7.3m in cash at March 31, 2020
$6.6m from Acrotech Biopharma
Financial visibility extendedinto Q2 2021
Post Q1 2020 information
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April 2020
AsiDNA™ is a first-in-class therapy for combination designed to address the #1 challenge in oncology: resistance to treatment
11
Decoy Agonist mechanism of action does not induce resistance
Differentiated Decoy Agonist mechanism of action in the clinically-validated field of DNA Damage Response
Long IP (up to 2040)
Clinical-stage assetFavorable safety profile incl. in combination Proof of mechanism / signals of efficacy
Strategic focus on the abrogation of resistance to targeted therapies
Collaborations with top-academic centers(Institut Curie - Gustave Roussy – Oncopole Toulouse…)
REVocan Phase 1b/2 to evaluate the addition of AsiDNA™ on the abrogation resistance to niraparib (to start H1 2020)
Depletes the cells from which resistance to targeted therapy emerges
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April 2020
Our strategic priority: raise AsiDNA™ as the new treatment paradigm to abrogate resistance
12
Preventing resistance – a major challenge for targeted therapies such as PARPis & TKIs - would lead to prolonged efficacy
❶
❷
“Resistance is the biggest challenge in cancer biology” (Paul Workman – ICR)
Strategic objectives Targeted Indications OpportunityApproval /
Full Market Size
Optimal market access (fast, favorable P&R*)
2L with niraparib (PARPi) in ovarian cancer
Short endpoint: PFSExpansion of maintenance treatment and delay new course of platinum
2024$6,7B (1)
1st line treatment in a large WW market
1L with anti-EGFR TKI in EGFRm non-smallcell lung cancer
Target specific population with high risk of progressionAddress 1st line of treatment
2025$16,9B (1)
REVocanCombo w/ PARPi
Combo w/ TKI
* P&R : pricing & reimbursement - (1) GlobalData (8MM)
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April 2020
New preclinical results: AsiDNA™ abrogates acquired resistance to PARP inhibitors (class effect)
13
UWB1.289 (Ovarian cancer model – BRCA1-/-)
0 10 20 30 40 500
4×104
8×104
1.2×105
1.6×105
2×105
Nira
Nira+Asi at D34
Days post treatment
Cell
num
ber
niraparib
Emergence of resistant cells
Cell death
AsiDNA™ leads to niraparib-resistant cells eradication in ovarian cancer model, even if introduced only once resistance emerges (CA 125 increase)
REVocan study (REVersion of resistance in ovarian cancer with AsiDNA™ and niraparib) ) was designed on the basis of these results
D17
D24
D31
D40
D17
D24
D31
D40
0
5
10
15
20
30
60
90
120
150
CA
12
5
(pg/m
l)
Introduction at CA125 increase (REVocan study protocol) Start of AsiDNA™
administration
Start of AsiDNA™ administration
Source: Onxeo, data on file
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April 2020
Results confirmed in in vivo experiments in a triple negative breast cancer model
AsiDNA™ abrogates acquired resistance to PARP inhibitors
14
MDAMB-436 (TNBC HR deficient - PARPi sensitive)
Source: Onxeo, data on file
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April 2020
Non Small Cell Lung Cancer model – anti-EGFR sensitive
AsiDNA™ eradicates cells resistant to anti-EGFR and anti-ALK
New preclinical results: AsiDNA™ prevents resistance to TKI
15
0 3 5 6 7 10 12 13 14 17 21 24 27 34 38 41 46 49 52
-20
0
20
40
60
80
100
120
ErlotinibErlotinib+AsiDNA
Time (days)
Su
rviv
ing
ce
lls (
%)
No surviving cells
Emergence of resistant cells
No surviving cells
Emergence of resistant cells
PC9-3 (NSCLC EGFRmut)
Non Small Cell Lung Cancer model – anti-ALK sensitive
H3122 (NSCLC EML4-ALK)
Source: Onxeo, data on file
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April 2020
Relapsed ovarian cancer: a high unmet medical need
16
2nd line treatment : platinum-based chemotherapy (for patients sensitive to platinum)
2nd line maintenance : PARP inhibitors
Median PFS 9,3 mo in non-BRCA mutated patients (86% of pts)(1) treated with niraparib in 2nd line maintenance ( vs. 21 mo in patients with BRCA mutation)(2)
Development of resistance to PARPi limits duration of response(3)
3rd line with platinum-based CT in sensitive patients, but loss of sensitivity after subsequent relapses leads to lack of therapeutic options
> 128,000 new incident cases in 2018(1)
Potential to extend maintenance / PFS, especially in non-BRCA mutated patients
Potential to maintain sensitivity to platinum for subsequentlines of treatment
Current options
Challenges
Population
US
23,000
Japan
10,000
5 EU
31,000
China
64,000
(1) GlobalData (8MM = 5EU + US + JPN + Urban China) (2) NOVA study (3) Mweempwa A, Wilson MK. Mechanisms of resistance to PARP inhibitors - an evolving challenge in oncology. Cancer Drug Resist2019;2:608-17.
AsiDNA™ opportunity
❶
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April 2020
EGFR-mutant NSCLC : a large worldwide market
17
Anti-EGFR TKIs now used in 1st line as well as in 2nd
line treatment of EGFR-mutant NSCLC
EGFRm NSCLC patients treated with anti-EGFR TKIs will inevitably develop acquired resistance to their treatment(2)
Anti-EGFR TKIs now used as 1st line treatment, which limits further treatment options once resistance emerges
Increasing progression free survival (PFS) and efficacy of 1st line treatment becomes critical
NSCLC = 85% of all lung cancers
920,000 new incident cases in 2020(1)
High occurrence of EGFR mutations in NSCLC (≈20% of Caucasians and ≈50% of Asians) makes this subset a critical population in lung cancer(1)
Potential to prevent resistance to anti-EGFR TKIs in 1st line
Potential to increase PFS / efficacy of 1st line treatment
Current options
Challenges
AsiDNA™ opportunity
Population
US
188,000
Japan
121,000
5 EU
184,000
China
427,000
(1) GlobalData (8MM = 5EU + US + JPN + Urban China).(2) Gao, J., Li, H., Jin, C. et al. Strategies to overcome acquired resistance to EGFR TKI in the treatment of non-small cell lung cancer. Clin Transl Oncol 21, 1287–1301 (2019).
❷
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April 2020
Ready to start REVocan Phase Ib/II study: obtain proof-of-concept of the abrogation of resistance to PARP inhibitors by late 2020/early 2021
18
Patients selection: patients under 2nd line of maintenance with niraparib > 6 months
Inclusion at CA 125 increase (CA 125 : well established predictive biomarker of resistance)
n= up to 26 patients, platinum-sensitive relapsed ovarian cancer
Primary objective: Safety run & CA125 decrease (GCIG criteria)
Secondary objective: Efficacy: PFS (RECIST criteria) - OS
REVocanREVersion of resistance in Ovarian Cancer with AsiDNA™ and Niraparib
FPI expected from H1 2020 => Preliminary data by end 2020/Early 2021 *
PI: Dr. Patricia Pautier (Arcagy Gineco Network)
Clinical collaboration
N = up to 26 pts (6 centers)
* Timelines may be affected by Covid-19 pandemic
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April 2020
Ongoing DRIIV-1b Phase 1b study : Confirm safety and efficacy signals in reference combo by year end
19
AsiDNA™ 600 mg
Cohort 1
carboplatin
AsiDNA™ 600 mg
carboplatin + paclitaxel
Cohort 26 pts
ongoing
+
+
Patients with ≥ 3 prior lines of treatment, progressing at inclusion
Very good tolerance of the combination (no DLT)
Disease stabilized (SD) in 2/3 patients for 5.5 mo. (TNBC 6th L) and 10 mo. (NSCLC 3rd L)
Disease controlled with AsiDNA™ for significantly longer than with any of the prior treatment lines
3 pts
Preliminary data by end 2020 *
* Timelines may be affected by Covid-19 pandemic
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April 2020
Short term key catalysts in 2020/early 2021 with moderate impact of Covid-19 on milestones to date
20
FPI
DRIIV-1b cohort 2
preliminary data
H2 2019 H1 2020 * H2 2020 *
DRIIV-1bcohort 1
prelim. data
* Timelines include first estimation of Covid-19 impacts, which may be further reviewed depending on
Covid-19 pandemic evolution
DRIIV-1b cohort 2
preliminary data
AsiDNA™ +TKI data to support
clinical plan
AsiDNA™ +TKI data to support
clinical plan
Preclinical validation of OX401 profile
Tolerance in combination + first signals of efficacyDRIIV–1bAsiDNA™ +
carboplatin +/-paclitaxel
REVOCANphase 1b/2
AsiDNA™ + niraparib
Clinical Research agreement
Reversion of resistance
Prevention of resistanceAsiDNA™ + TKI
Preclinical proof-of-concept
Next-gen PARPi + activation of immune responseOX401Preclinical
proof-of-mechanism
*
*
REVOCAN First data set
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April 2020
Onxeo: A fruitful year 2019 and ready for the 2020 challenges
21
AsiDNA™: positioned to address resistance, the biggest challenge in oncology
The only decoy agonist in clinical development in the field of DDR
Confirmed activity in man and very favorable safety profile in IV, including in combo
Key readouts from Phase 1b/2 REVOCAN study to validate the ability to abrogate resistance to targeted therapies expected in late 2020/early 21
OX 401: Compelling next candidate designed by capitalizing on company expertise
Cash visibility extended to Q2 2021, bridging our key catalysts
Operations maintained with minimal impact to date from Covid-19 on planned operations and key milestones
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Thank you for your attention!