Nuevolution AB (publ) - Presentation Q3 2016/17 - Amgen
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Nuevolution AB (publ) Presentation Q3 2016/17
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
AGENDA
• Technology update
• Pipeline update
• Business & partnering
• Financials
• IR actitivies
• Company track record and outlook
Slide 3
The Engine Major Technology Achievements During Q3
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
Pipeline Progress Positive Progress in Multiple Programs
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
RORgt inhibitors
INFLAMMATION
Validation of Additional Indications
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
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 10BET BRD inhibitors
INFLAMMATION
In Vivo Proof-of-Concept and Good SafetyBET 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 12BET 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 13BET 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 14RORgt agonist
IMMUNO-ONCOLOGY / CANCER
(Immune Stimulation)
In Vitro Proof-of-Concept
Slide 15RORγT 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 16Partnerships 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 18BUSINESS & 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 19Financials
Strong Cash Position
Continued High Investor Relation ActivitiesFINANCIALS: 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 21FINANCIALS: 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 22IR 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 23Track Record
Significant Progress Since IPO
More to ComeTRACK 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 25COMPANY 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 26NUEVOLUTION
TRANSFORMING CHALLENGES
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