presentation q3 2016/17 - nuevolution · in this presentation or any obligation to update or revise...
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Nuevolution AB (publ)Presentation Q3 2016/17
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Matters discussed in this presentation may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this presentation are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialise or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The company does not guarantee that the assumptions underlying the forward‐looking statements in this presentation are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this presentation or any obligation to update or revise the statements in this presentation to reflect subsequent events. Undue reliance should not be placed on the forward-looking statements in this document.
The information, opinions and forward-looking statements contained in this communication speak only as at its date and are subject to change without notice. The company does not undertake any obligation to review, update, confirm or to release publicly any revisions to any forward‐looking statements to reflect events that occur or circumstances that arise in relation to the content of this presentation.
FORWARD-LOOKING STATEMENTS
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• Technology update
• Pipeline update
• Business & partnering
• Financials
• IR actitivies
• Company track record and outlook
AGENDA
Major Technology Achievements During Q3
The Engine
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MASSIVE EXPANSION OF THE DRUG DISCOVERY ENGINETechnology update
• World largest screening library• 40 trillion compounds• ~20 million times bigger than
available to Big Pharma• Super potent molecules
identified directly from library during validation
• Library now applied successfully in programs
• Coming up:• Two libraries (10 billion)• Unique properties• Completion in Q4 2016/17
Libraries - new capabilities Screening – new capabilities
• Expanding applicability of tech.• Handling of disease targets
anchored in cell membranes (e.g. GPCRs)
• PNAS article together with Nobel laureate Robert J. Lefkowitz
• On-going:• Expanded collaboration with
Lefkowitz group
Pipeline ProgressPositive Progress in Multiple Programs
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Leading programs Disease Discovery Pre- clinical Phase I Partner
RORγt inhibitor (Dermatology / PsA) Inflammation
RORγt inhibitor (Additional indications) Inflammation
BET BRD inhibitor Inflammation
Cytokine X Inflammation
RORγt agonist Immuno-oncology
GRP78 Oncology
Other programs (Oncology / Immunology / Immuno-oncology) 15+
Research Collaborations:
Oncology / Neuroscience Various
Oncology / Inflammation / InfectiousDiseases Various
Hematological cancers (NSD proteins) Oncology
PIPELINE UPDATEPromising pipeline and partnerships progress in Q3
Results
Results
Results
In vitro PoC
+one program
RORgt inhibitors
INFLAMMATION
Validation of Additional Indications
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In vivo proof-of-concept in IBD of NUE compound• NUE compound (dosed orally) reversed the
increased weight/length ratio dose-dependently • At a 30 mpk dose (oral) on par with
dexamethasone (steroid) and IL-17A antibody (injection)
RORγT INHIBITOR (ADDITIONAL INDICATIONS)First efficacy model of IBD (TNBS) – Efficacy of NUE on par with steroid and IL-17A antibody
Inflammatory Bowel Disease (IBD)
IBD model: TNBS (harsh irritant) induced in mice
Inflammation induced by TNBS causes colon length to decrease and weight to increase
Crohn’s disease & ulcerative colitis• Gastrointestinal inflammation• 1o Abdominal pain, bloody
diarrhea, fewer, weight loss, bowel obstruction
• 2o Anemia, fatigue a.o.• Increased risk of cancer• Significant unmet medical need
Endoscopy of ulcerative colitis
TNBS model
Improvement byNUE (oral dosing)
* Statistically significant vs. diseased
* **
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In vivo proof-of-concept in IBD of NUE compound• NUE compound (dosed orally) reversed the
increased weight/length ratio dose-dependently • At 100 mpk dose (oral) superior to IL-17A
antibody (injection)
RORγT INHIBITOR (ADDITIONAL INDICATIONS)Second efficacy model of IBD (DSS) – Efficacy of NUE superior to IL-17A antibody
Inflammatory Bowel Disease (IBD)
IBD model: DSS (milder irritant) induced in mice
Crohn’s disease & ulcerative colitis• Gastrointestinal inflammation• 1o Abdominal pain, bloody
diarrhea, fewer, weight loss, bowel obstruction
• 2o Anemia, fatigue a.o.• Increased risk of cancer• Significant unmet medical need
Endoscopy of ulcerative colitis
DSS model
Improvement byNUE (oral dosing)
Inflammation induced by DSS causes colon length to decrease and weight to increase
**
*
* Statistically significant vs. diseased
BET BRD inhibitorsINFLAMMATION
In Vivo Proof-of-Concept and Good Safety
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In vivo proof-of-concept in Arthritis model of NUE7770• NUE7770 (oral) reduced arthritis scoring at 30 and 100 mpk (twice daily)• Efficacy on par with IL-17A antibody (injection)
BET BRD INHIBITOREfficacy demonstrated in models of rheumatoid arthritis, Lupus and fibrotic disease
Rheumatoid arthritis
CIA (Collagen Induced Arthritis) model
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In vivo proof-of-concept in Arthritis model of NUE7770• NUE7770 (oral) reduced arthritis scoring at 30 and 100 mpk (twice daily)• Efficacy on par with IL-17A antibody (injection)
BET BRD INHIBITOREfficacy demonstrated in models of rheumatoid arthritis, Lupus and fibrotic disease
1) IPF = Idiopathic Pulmonary Fibrosis 2) Pristane model results reported in Q2 2016/17 report
IPF1
Supports efficacy in fibrotic diseases• Dose-dependent reduction of
hydroxy-proline (collagen biomarker) with NUE7770
• No morphological im-provement obs. in this short duration model
• Next step: Scleroderma
Rheumatoid arthritis
Lupus
• Dose-dependent reduction in antibody titers against dsDNA and ANA at week 10
Pristane model2
Bleomycin model (3-week)
X-ray of IPF
CIA (Collagen Induced Arthritis) model
Image of key organ malfunctions in lupus
Eight-week study of Lupus initiated in Q3 2016/17• Results in Q4 2016/17
Genetic model (MRL-lpr)
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Benign toxicology for NUE7770
• Two-week toxicology study shows benign toxicity profile for NUE7770, a selective BET BRD inhibitor, against the non-selective compound, JQ-1
BET BRD INHIBITORSafety demonstrated
Low cytotoxicity of NUE7770
• Sanger 375 cancer cell line profiling demonstrated low cytotoxicity
• Ongoing: Evaluation of gene expression changes with selective inhibitor NUE7770 vs. non-selective inhibitor
In vitro safety
In vivo safety
PLT↓ ≡ loss in blood platelets, ALT/AST↑ ≡ unwanted increase in liver enzymes
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RORgt agonist
IMMUNO-ONCOLOGY / CANCER
(Immune Stimulation)
In Vitro Proof-of-Concept
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RORγT AGONIST (IMMUNO-ONCOLOGY / CANCER)Promising in vitro results
• Immune cells from the spleen are used to demonstrate ability to boost immune response
• IL17A production by splenocytes stimulated with antigen may be increased by RORγt agonists
• NUE compound increases IL17A production from splenocytes by more than 100% and on par with competitor compound
• NEXT: Provided successful outcome of pharmacokinetic profiling, in vivo PoC in cancer xenograft model will be pursued
In vitro efficacy on mouse splenocytes
Immune stimulationby NUE compound
Partnerships
Positive Progress in Partnerships
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PARTNERSHIPSGood progress in partnerships
• Additional technology access fee of USD 600,000 (MSEK 5.45)
• Good progress in other collaborative programs
Additional technology access feeIn vitro proof-of-concept in two programs
Screening initiated
• 1st program obtained in vitro proof-of-concept• 2nd program also obtained in vitro proof-of-
concept and now transferring to Amgen collaboration
• First screening of the leukemia targets (NSD family) initiated
Progressing according to plan
• Nuevolution and Almirall teams work closely together to progress the program to Phase I clinical studies
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BUSINESS & PARTNERINGJP Morgan and Bio Europe Spring
Busy quarter in Business & Partnering
• Continue to pursue• Risk-sharing/pre-sale collaborations• Out-licensing of lead programs• Platform-based collaborations
• Expanded our pharma and biotech network
• JP Morgan’s healthcare conf. (January) and BioEurope Spring (March) promoted• RORγt inhibitor (indications outside Almirall collaboration)• BET BRD inhibitor• RORγt agonist
receiving encouraging feedback
Maintain our guidance of one further agreement during the next nine months
Strong Cash Position
Continued High Investor Relation Activities
Financials
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FINANCIALS: P&LQ3 revenue mainly from Janssen Biotech; Q3 R&D expenses up led by investments in lead programs
• Q3 revenues: MSEK 1.6 (6.0)• Income from Janssen Biotech
• Additional technology access fee to be recognized in Q4 and onwards
• Minor income from IFD
• Q3 R&D expenses: MSEK 26.2 (21.9)• Reagents, chemicals and CROs• In vivo tests for RORγt and BET inhibitor
programs• Fees for patent applications (RORγt and BET)
• Q3 SG&A expenses: MSEK 5.2 (5.7)
• Q3 pre-tax result: MSEK -29.8 (-21.7)• Q3 tax income of MSEK 1.1 (1.7)
• Danish R&D tax credit in both quarters
• Q3 net result: MSEK -29.0 (-20.9)• Q3 EPS-D of SEK -0.66 (-0.49)
Q3 Q3 Q1-Q3 Q1-Q3
Auditor review (ISRE 2410) 2016/17 2015/16 2016/17 2015/16
MSEK MSEK MSEK MSEK
Revenue 1.6 6.0 114.4 18.2
R&D expenses -26.2 -21.9 -79.1 -64.1
SG&A expenses -5.2 -5.7 -16.9 -29.3
Operating result -29.8 -21.7 18.3 -75.2
Financial income 0.3 0.1 2.7 1.4
Financial expenses -0.6 -1.0 -1.5 -1.8
Result before tax -30.1 -22.6 19.5 -75.5
Tax 1.1 1.7 -17.7 5.2
Net result -29.0 -20.9 1.8 -70.3
EPS, SEK -0.68 -0.49 0.04 -2.05
EPS-D, SEK -0.66 -0.49 0.04 -2.05
Avg. no. of shares outstanding, m 42.858 42.858 42.858 42.858
Avg. no. of shares diluted, m 44.239 42.858 43.146 42.858
(*): This number shows the possible dilution, if any warrants will be exercised. No warrants were exercised during period.
*
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FINANCIALS: BALANCE SHEETWell funded for execution of current business strategy
• Cash & cash equivalents as per 31 March 2017 of MSEK 200.9 (215.7)
• Net cash as per 31 March 2017 of MSEK 196.2 (210.8), after deduction of leasing liabilities of MSEK 4.7 (4.9)
• Janssen Biotech payment (USD 600,000)• 31 March 2017: Receivables• 26 April 2017: Cash
• With net cash of MSEK 196.2, Nuevolution remains well funded for execution of its current business strategy
Auditor review (ISRE 2410) 31 Mar. 2017 31 Mar. 2016 30 June 2016
MSEK MSEK MSEK
ASSETS
Non-current assets 10.6 12.0 14.1
Current receivables, non-interest bearing 18.3 31.0 14.9
Cash and cash equivalents 200.9 215.7 206.0
Total current assets 219.2 246.7 220.9
TOTAL ASSETS 229.8 258.7 235.0
EQUITY AND LIABILITIES
Shareholders' equity 195.9 221.6 198.1
Non-current interest bearing liabilities 3.3 3.7 3.5
Current liabilities, interest bearing 1.4 1.2 1.2
Current liabilities, non-interest bearing 15.7 16.8 19.5
Accrued expenses and deferred income 13.4 15.4 12.7
Total current liabilities 30.5 33.4 33.4
TOTAL EQUITY AND LIABILITIES 229.8 258.7 235.0
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IR ACTIVITIESMeet us
• Analysts covering NUE.ST
• Aktiespararna/Jarl Securities• Remium Nordic
• Redeye
• Økonomisk Ugebrev• Edison
May 22: Investeringsträff, Aktiespararna Stockholm Vasa
May 23: Investor lunch meeting, Redeye, Stockholm
June 12: Småbolagsdagen, Redeye/Aktiespararna, Stockholm
June 13: InvestorDagen, Dansk Aktionærforening, Aarhus
September 12: Rodman & Renshaw 19th Annual Global Investment Conf., NYC
September 17: Aktiedagen, Aktiespararna, Malmoe
September 28: InvestorDagen, Dansk Aktionærforening, Copenhagen
November 27: Store Aktiedagen, Aktiespararna, Gothenburg
Analyst coverage 2017 IR events scheduled
• Nuevolution continues to invest in IR activities to support ambition of uplisting its shares to a main market
Significant Progress Since IPO
More to Come
Track Record
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TRACK RECORDAchievements since IPO in December 2015
IPO Capital raise of MSEK 250
Novartis Drug Discovery payment of MUSD 2
Janssen Additional target collaboration fees of MUSD 1.2
Amgen Risk-sharing agreement – Payments up to MUSD 410 per target
Almirall License agreement on RORγt program – Payments up to MEUR 453
Pipeline Significant progress in several lead programs
Technology World’s largest drug discovery library (40 trillion) & expanded tech. applicability
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• At least one agreement• Program out-licensing agreement, or• Risk-sharing/pre-sale collaboration, or• Platform-based agreement
COMPANY OUTLOOKAnticipated milestones
BUSINESS & PARNERING OBJECTIVES, NEXT 12 MONTHS
RESEARCH & DEVELOPMENT MAIN OBJECTIVES, NEXT 6-12 MONTHS
• Progress on RORgt program towards First-in-Human within Dermatology and/or other Indications
• In vivo PoC and detailed Mechanism-of-Action for bromodomain BET-BD1 selective compounds within: • Lupus / Fibrosis and, • Th17 pathologies like Psoriasis and/or IBD
• In vivo PoC in one or more AMGEN partnered programs
NUEVOLUTIONTRANSFORMING CHALLENGES
INTO MEDICINE