Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen

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Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
Nuevolution AB (publ)
   Presentation Q3 2016/17
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
FORWARD-LOOKING STATEMENTS

          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.

Slide 2
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
AGENDA

          • Technology update

          • Pipeline update

          • Business & partnering

          • Financials

          • IR actitivies

          • Company track record and outlook

Slide 3
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
The Engine
Major Technology Achievements During Q3
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
MASSIVE EXPANSION OF THE DRUG DISCOVERY ENGINE
Technology update

                        Libraries - new capabilities              Screening – new capabilities
                    •    World largest screening library          •   Expanding applicability of tech.
                           •   40 trillion compounds                    •   Handling of disease targets
                           •   ~20 million times bigger than                anchored in cell membranes
                               available to Big Pharma                      (e.g. GPCRs)
                           •   Super potent molecules                   •   PNAS article together with
                               identified directly from library             Nobel laureate Robert J.
                               during validation                            Lefkowitz
                           •   Library now applied successfully
                               in programs

                    •    Coming up:                               •   On-going:
                           •   Two libraries (10 billion)               •   Expanded collaboration with
                           •   Unique properties                            Lefkowitz group
                           •   Completion in Q4 2016/17

Slide 5
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
Pipeline Progress
 Positive Progress in Multiple Programs
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
PIPELINE UPDATE
Promising pipeline and partnerships progress in Q3

      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                          Various                  In vitro PoC
      Oncology / Inflammation / Infectious                                                           +one program
                                                       Various
      Diseases
      Hematological cancers (NSD proteins)            Oncology

Slide 7
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
RORgt inhibitors
          INFLAMMATION

 Validation of Additional Indications
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
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)

                                                                                                                                Crohn’s disease & ulcerative colitis
                                                               Improvement by                                                   • Gastrointestinal inflammation
                                                               NUE (oral dosing)
                                                                                                                                • 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
                                                                                              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)

                                       * 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
Slide 9
Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
RORγT INHIBITOR (ADDITIONAL INDICATIONS)
Second efficacy model of IBD (DSS) – Efficacy of NUE superior to IL-17A antibody

                                                                                                       Inflammatory Bowel Disease (IBD)

                                                                                                                                         Crohn’s disease & ulcerative colitis
                                                                                                                                         • Gastrointestinal inflammation
                                                                               Improvement by
                                                                               NUE (oral dosing)                                         • 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
                                                                                                       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)

                                    * 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
Slide 10
BET BRD inhibitors
             INFLAMMATION

 In Vivo Proof-of-Concept and Good Safety
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
BET BRD INHIBITOR
Efficacy demonstrated in models of rheumatoid arthritis, Lupus and fibrotic disease

           Rheumatoid arthritis                                                                               IPF1

                                                                                                                                      Bleomycin model (3-week)
                                                                                                                                      Supports efficacy in fibrotic
                                                                                                                                      diseases
                                                                                                                                      • Dose-dependent reduction of
                                                                                                                                        hydroxy-proline (collagen
                                                                                                                                        biomarker) with NUE7770
                                                                                                                                      • No morphological im-
                                                                                                                                        provement obs. in this short
                                                                                                              X-ray of IPF              duration model
                                                                                                                                      • Next step: Scleroderma

                                                                                                              Lupus

                                                                                                                                      Pristane model2
                                                                                                                                      • Dose-dependent
                                                                                                                                        reduction in antibody
                                                                                                                                        titers against dsDNA and
                                                                                                                                        ANA at week 10
           CIA (Collagen Induced Arthritis) model
                                                                                                                                      Genetic model (MRL-lpr)
           In vivo proof-of-concept in Arthritis model of NUE7770
              • NUE7770 (oral) reduced arthritis scoring at 30 and 100 mpk (twice daily)                                              Eight-week study of Lupus
              • Efficacy on par with IL-17A antibody (injection)                                                                      initiated in Q3 2016/17
                                                                                                              Image of key organ
                                                                                                              malfunctions in lupus   • Results in Q4 2016/17
           1) IPF = Idiopathic Pulmonary Fibrosis   2) Pristane model results reported in Q2 2016/17 report
Slide 13
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 non-
                           selective compound, JQ-1

                           PLT↓ ≡ loss in blood platelets, ALT/AST↑ ≡ unwanted increase in liver enzymes
Slide 14
RORgt agonist
           IMMUNO-ONCOLOGY / CANCER

               (Immune Stimulation)

              In Vitro Proof-of-Concept

Slide 15
RORγT AGONIST (IMMUNO-ONCOLOGY / CANCER)
Promising in vitro results

                             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

Slide 16
Partnerships
Positive Progress in Partnerships
PARTNERSHIPS
Good progress in partnerships

           Progressing according to plan                      Screening initiated

           • Nuevolution and Almirall teams work closely      • First screening of the leukemia targets (NSD
             together to progress the program to Phase I        family) initiated
             clinical studies

           In vitro proof-of-concept in two programs          Additional technology access fee

           • 1st program obtained in vitro proof-of-concept   • Additional technology access fee of USD
           • 2nd program also obtained in vitro proof-of-       600,000 (MSEK 5.45)
             concept and now transferring to Amgen            • Good progress in other collaborative programs
             collaboration

Slide 18
BUSINESS & PARTNERING
JP 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
Slide 19
Financials
           Strong Cash Position

Continued High Investor Relation Activities
FINANCIALS: P&L
Q3 revenue mainly from Janssen Biotech; Q3 R&D expenses up led by investments in lead programs

                                                                                               Q3             Q3       Q1-Q3       Q1-Q3    •   Q3 revenues: MSEK 1.6 (6.0)
     Auditor review (ISRE 2410)                                                          2016/17       2015/16       2016/17      2015/16
                                                                                                                                                 • Income from Janssen Biotech
                                                                                           MSEK          MSEK          MSEK        MSEK
                                                                                                                                                       • Additional technology access fee to be
     Revenue                                                                                   1.6           6.0        114.4        18.2                recognized in Q4 and onwards
     R&D expenses                                                                            -26.2         -21.9         -79.1      -64.1        • Minor income from IFD
     SG&A expenses                                                                            -5.2          -5.7         -16.9      -29.3
     Operating result                                                                        -29.8         -21.7          18.3      -75.2
                                                                                                                                            •   Q3 R&D expenses: MSEK 26.2 (21.9)
     Financial income                                                                          0.3           0.1           2.7        1.4
     Financial expenses                                                                       -0.6          -1.0          -1.5       -1.8
                                                                                                                                                 • Reagents, chemicals and CROs
     Result before tax                                                                       -30.1         -22.6          19.5      -75.5        • In vivo tests for RORγt and BET inhibitor
     Tax                                                                                       1.1           1.7         -17.7        5.2           programs
     Net result                                                                              -29.0         -20.9           1.8      -70.3        • Fees for patent applications (RORγt and BET)
                                                                                                                                            •   Q3 SG&A expenses: MSEK 5.2 (5.7)
     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   •   Q3 pre-tax result: MSEK -29.8 (-21.7)
     Avg. no. of shares diluted, m *                                                      44.239        42.858         43.146      42.858   •   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)
     (*): This number shows the possible dilution, if any warrants will be exercised. No warrants were exercised during period.
Slide 21
FINANCIALS: BALANCE SHEET
Well funded for execution of current business strategy

     Auditor review (ISRE 2410)                  31 Mar. 2017
                                                       MSEK
                                                                31 Mar. 2016
                                                                      MSEK
                                                                               30 June 2016
                                                                                     MSEK
                                                                                              •   Cash & cash equivalents as per 31 March
                                                                                                  2017 of MSEK 200.9 (215.7)
     ASSETS
     Non-current assets                                  10.6           12.0           14.1
                                                                                              •   Net cash as per 31 March 2017 of
     Current receivables, non-interest bearing          18.3           31.0            14.9       MSEK 196.2 (210.8), after deduction of
     Cash and cash equivalents
     Total current assets
                                                       200.9
                                                       219.2
                                                                      215.7
                                                                      246.7
                                                                                      206.0
                                                                                      220.9
                                                                                                  leasing liabilities of MSEK 4.7 (4.9)

     TOTAL ASSETS                                      229.8          258.7           235.0   •   Janssen Biotech payment (USD 600,000)
                                                                                                    • 31 March 2017: Receivables
     EQUITY AND LIABILITIES                                                                         • 26 April 2017: Cash
     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

       • With net cash of MSEK 196.2, Nuevolution remains well funded for execution of its current business strategy
Slide 22
IR ACTIVITIES
Meet us

       Analyst coverage                             2017 IR events scheduled

       • Analysts covering NUE.ST                  May 22: Investeringsträff, Aktiespararna Stockholm Vasa
           • Aktiespararna/Jarl Securities         May 23: Investor lunch meeting, Redeye, Stockholm
           • Remium Nordic                         June 12: Småbolagsdagen, Redeye/Aktiespararna, Stockholm
           • Redeye                                June 13: InvestorDagen, Dansk Aktionærforening, Aarhus
           • Økonomisk Ugebrev                     September 12: Rodman & Renshaw 19th Annual Global Investment Conf., NYC
           • Edison
                                                   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
Slide 23
Track Record
Significant Progress Since IPO

       More to Come
TRACK RECORD
Achievements 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   √
Slide 25
COMPANY OUTLOOK
Anticipated milestones

           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

Slide 26
NUEVOLUTION
TRANSFORMING CHALLENGES
      INTO MEDICINE
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