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

Transcript of 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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Slide 2

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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Slide 3

• Technology update

• Pipeline update

• Business & partnering

• Financials

• IR actitivies

• Company track record and outlook

AGENDA

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Major Technology Achievements During Q3

The Engine

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Slide 5

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

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Pipeline ProgressPositive Progress in Multiple Programs

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Slide 7

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

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RORgt inhibitors

INFLAMMATION

Validation of Additional Indications

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Slide 9

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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Slide 10

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

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BET BRD inhibitorsINFLAMMATION

In Vivo Proof-of-Concept and Good Safety

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Slide 12

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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Slide 13

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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Slide 14

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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Slide 15

RORgt agonist

IMMUNO-ONCOLOGY / CANCER

(Immune Stimulation)

In Vitro Proof-of-Concept

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Slide 16

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

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Partnerships

Positive Progress in Partnerships

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Slide 18

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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Slide 19

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

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Strong Cash Position

Continued High Investor Relation Activities

Financials

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Slide 21

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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Slide 22

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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Slide 23

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

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Significant Progress Since IPO

More to Come

Track Record

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Slide 25

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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Slide 26

• 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

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NUEVOLUTIONTRANSFORMING CHALLENGES

INTO MEDICINE