Nuevolution AB (publ) Presentation Q3 2016/17

Transcription

1 Nuevolution AB (publ) Presentation Q3 2016/17

2 FORWARD-LOOKING STATEMENTS 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.

3 AGENDA Slide 3 Technology update Pipeline update Business & partnering Financials IR actitivies Company track record and outlook

4 The Engine Major Technology Achievements During Q3

5 MASSIVE EXPANSION OF THE DRUG DISCOVERY ENGINE Technology update Slide 5 Libraries - new capabilities Screening new capabilities 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 Expanding applicability of tech. Handling of disease targets anchored in cell membranes (e.g. GPCRs) PNAS article together with Nobel laureate Robert J. Lefkowitz Coming up: Two libraries (10 billion) Unique properties Completion in Q4 2016/17 On-going: Expanded collaboration with Lefkowitz group

6 Pipeline Progress Positive Progress in Multiple Programs

7 PIPELINE UPDATE Promising pipeline and partnerships progress in Q3 Slide 7 Leading programs Disease Discovery Pre- clinical Phase I Partner RORγt inhibitor (Dermatology / PsA) Inflammation RORγt inhibitor (Additional indications) Inflammation Results BET BRD inhibitor Inflammation Results Cytokine X Inflammation RORγt agonist Immuno-oncology Results GRP78 Oncology Other programs (Oncology / Immunology / Immuno-oncology) 15+ Research Collaborations: Oncology / Neuroscience Oncology / Inflammation / Infectious Diseases Hematological cancers (NSD proteins) Various Various Oncology In vitro PoC +one program

8 RORgt inhibitors INFLAMMATION Validation of Additional Indications

9 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) Improvement by NUE (oral dosing) * * * Endoscopy of ulcerative colitis Crohn s disease & ulcerative colitis Gastrointestinal inflammation 1 o Abdominal pain, bloody diarrhea, fewer, weight loss, bowel obstruction 2 o Anemia, fatigue a.o. Increased risk of cancer Significant unmet medical need TNBS model 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) Slide 9 * Statistically significant vs. diseased IBD model: TNBS (harsh irritant) induced in mice Inflammation induced by TNBS causes colon length to decrease and weight to increase

10 RORγT INHIBITOR (ADDITIONAL INDICATIONS) Second efficacy model of IBD (DSS) Efficacy of NUE superior to IL-17A antibody Inflammatory Bowel Disease (IBD) Improvement by NUE (oral dosing) * * * Endoscopy of ulcerative colitis Crohn s disease & ulcerative colitis Gastrointestinal inflammation 1 o Abdominal pain, bloody diarrhea, fewer, weight loss, bowel obstruction 2 o Anemia, fatigue a.o. Increased risk of cancer Significant unmet medical need DSS model 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) Slide 10 * Statistically significant vs. diseased IBD model: DSS (milder irritant) induced in mice Inflammation induced by DSS causes colon length to decrease and weight to increase

11 BET BRD inhibitors INFLAMMATION In Vivo Proof-of-Concept and Good Safety

12 BET BRD INHIBITOR Efficacy demonstrated in models of rheumatoid arthritis, Lupus and fibrotic disease Rheumatoid arthritis CIA (Collagen Induced Arthritis) model 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) Slide 12

13 BET BRD INHIBITOR Efficacy demonstrated in models of rheumatoid arthritis, Lupus and fibrotic disease Rheumatoid arthritis IPF 1 Bleomycin model (3-week) X-ray of IPF Supports efficacy in fibrotic diseases Dose-dependent reduction of hydroxy-proline (collagen biomarker) with NUE7770 No morphological improvement obs. in this short duration model Next step: Scleroderma Lupus CIA (Collagen Induced Arthritis) model 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) 1) IPF = Idiopathic Pulmonary Fibrosis 2) Pristane model results reported in Q2 2016/17 report Slide 13 Image of key organ malfunctions in lupus Pristane model 2 Dose-dependent reduction in antibody titers against dsdna and ANA at week 10 Genetic model (MRL-lpr) Eight-week study of Lupus initiated in Q3 2016/17 Results in Q4 2016/17

14 BET BRD INHIBITOR Safety demonstrated In vitro safety 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 vivo safety Benign toxicology for NUE7770 Two-week toxicology study shows benign toxicity profile for NUE7770, a selective BET BRD inhibitor, against the nonselective compound, JQ-1 Slide 14 PLT loss in blood platelets, ALT/AST unwanted increase in liver enzymes

15 Slide 15 RORgt agonist IMMUNO-ONCOLOGY / CANCER (Immune Stimulation) In Vitro Proof-of-Concept

16 RORγT AGONIST (IMMUNO-ONCOLOGY / CANCER) Promising in vitro results Slide 16 In vitro efficacy on mouse splenocytes 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 Immune stimulation by NUE compound

17 Partnerships Positive Progress in Partnerships

18 PARTNERSHIPS Good progress in partnerships Slide 18 Progressing according to plan Nuevolution and Almirall teams work closely together to progress the program to Phase I clinical studies Screening initiated First screening of the leukemia targets (NSD family) initiated In vitro proof-of-concept in two programs 1 st program obtained in vitro proof-of-concept 2 nd program also obtained in vitro proof-ofconcept and now transferring to Amgen collaboration Additional technology access fee Additional technology access fee of USD 600,000 (MSEK 5.45) Good progress in other collaborative programs

19 BUSINESS & PARTNERING JP Morgan and Bio Europe Spring Slide 19 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

20 Financials Strong Cash Position Continued High Investor Relation Activities

21 FINANCIALS: P&L Q3 revenue mainly from Janssen Biotech; Q3 R&D expenses up led by investments in lead programs Slide 21 Q3 Q3 Q1-Q3 Q1-Q3 Auditor review (ISRE 2410) 2016/ / / /16 MSEK MSEK MSEK MSEK Revenue R&D expenses SG&A expenses Operating result Financial income Financial expenses Result before tax Tax Net result 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) EPS, SEK EPS-D, SEK Avg. no. of shares outstanding, m Avg. no. of shares diluted, m * (*): This number shows the possible dilution, if any warrants will be exercised. No warrants were exercised during period. Q3 pre-tax result: MSEK (-21.7) Q3 tax income of MSEK 1.1 (1.7) Danish R&D tax credit in both quarters Q3 net result: MSEK (-20.9) Q3 EPS-D of SEK (-0.49)

22 FINANCIALS: BALANCE SHEET Well funded for execution of current business strategy Slide 22 Auditor review (ISRE 2410) 31 Mar Mar June 2016 MSEK MSEK MSEK ASSETS Non-current assets Current receivables, non-interest bearing Cash and cash equivalents Total current assets TOTAL ASSETS EQUITY AND LIABILITIES Shareholders' equity Cash & cash equivalents as per 31 March 2017 of MSEK (215.7) Net cash as per 31 March 2017 of MSEK (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 Non-current interest bearing liabilities Current liabilities, interest bearing Current liabilities, non-interest bearing Accrued expenses and deferred income Total current liabilities TOTAL EQUITY AND LIABILITIES With net cash of MSEK 196.2, Nuevolution remains well funded for execution of its current business strategy

23 IR ACTIVITIES Meet us Slide 23 Analyst coverage Analysts covering NUE.ST Aktiespararna/Jarl Securities Remium Nordic Redeye Økonomisk Ugebrev Edison 2017 IR events scheduled 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 Nuevolution continues to invest in IR activities to support ambition of uplisting its shares to a main market

24 Track Record Significant Progress Since IPO More to Come

25 TRACK RECORD Achievements since IPO in December 2015 Slide 25 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 Technology Significant progress in several lead programs World s largest drug discovery library (40 trillion) & expanded tech. applicability

26 COMPANY OUTLOOK Anticipated milestones Slide 26 BUSINESS & PARNERING OBJECTIVES, NEXT 12 MONTHS At least one agreement Program out-licensing agreement, or Risk-sharing/pre-sale collaboration, or Platform-based agreement 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

27 NUEVOLUTION TRANSFORMING CHALLENGES INTO MEDICINE