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BerGenBio — Investor Presentation 2017
Dec 14, 2017
3555_rns_2017-12-14_c8f06c2e-7bda-411d-8777-fcce40db5c63.pdf
Investor Presentation
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First-in-class medicines to treat aggressive cancers
DNB Nordic Healthcare day 2017
14th December 2017 Richard Godfrey, CEO
Disclaimer
Certain statements contained in this presentation constitute forwardlooking statements. Forward-looking statements are statements that are not historical facts and they can be identified by the use of forward-looking terminology, including the words "anticipate", "believe", "intend", "estimate", "expect", "will", "may", "should" and words of similar meaning. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. Accordingly, no assurance is given that such forwardlooking statements will prove to have been correct. They speak only as at the date of the presentation and no representation or warranty, expressed or implied, is made by BerGenBio ASA or its affiliates ("BerGenBio"), or by any of their respective members, directors, officers or employees that any of these forward-looking statements
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Corporate snapshot
Background
Leaders in developing therapeutics
that target AXL, a protein that makes cancers and their environment highly aggressive and which is associated with poorer outcomes across many cancers
Diversified pipeline, lead drug is tested in several indications of high unmet medical need and large market potential
Promising efficacy with sustained treatment benefit and confirmed favourable safety
Companion diagnostic supported by biomarker tests
BGB324
First-in-class highly selective small molecule AXL inhibitor
Broad phase II clinical programme in NSCLC, TNBC, AML/MDS, melanoma
Pipeline
BGB324
AXL antibody
AXL ADC (partnered)
Immunomodulatory small molecules
OSE:BGBIO
Raised NOK400m in IPO on OSE in April '17
NOK1,000m market cap (Dec13th 2017)
Corporate
35 staff
Headquarters and research in Bergen, Norway; Clinical Trial Management in Oxford, UK
BerGenBio is developing AXL inhibitor drugs to treat aggressive cancers
BGB324 Phase II clinical trials AXL inhibition as cornerstone for cancer therapy
Recent highlights from clinical studies:
- BGBC003 Leukaemia
- BGBC004 & BGBIL005 Lung cancer
BGBC003
Relapsed & refractory AML and high risk MDS
Relapsed/refractory AML & MDS – Blood cancer, difficult to treat malignancies, predominantly elderly frail patient population.
8
Clinical Trial data for R/R AML patients from ASH December 2017
| BerGenBio BGB324 19% 37 patients all comers, elderly R/R patients |
|
|---|---|
| et al1 Pratz TAK-659 9% 31 patients investigational FLT-3 and SYK inhibitor |
|
| et al4 Daver FLX925 0% 51 patients Dual FLT3 and CDK4/6 Single agent |
|
| Dawson et al6 GSK525762 11% 46 patients BET inhibitor |
|
| et al5 DiNardo Ivosidenib (AG-120) 258 patients – selected mutant IDH1 (mIDH1) inhibitor 30% for mlDH1 mutation |
|
| Goldberg et al2 24 patients Venetoclax* + hypomethylating agent (HMA) or low dose 28% cytarabine (LDAC) Combination |
|
| Rausch et al3 27 patients Venetoclax + HMA or LDAC 22% |
*Venetoclax + LDAC received breakthrough designation in 1st line AML (July 2017)
9 (1) ASH 2017 abstract 2622 (2) ASH 2017 abstract 1353 (3) ASH 2017 abstract 1356 (4) ASH 2017 abstract 1343 (5) ASH 2017 abstract 725 (6) ASH 2017 abstract 1377
Superior early monotherapy efficacy with favourable safety in R/R AML & high risk MDS reported at ASH 2017
19% Response Rate (CRi + PR)
• 2 CRi
• 5 PRs
An additional 7 patients were stable > 4 months
Well tolerated
Correlation with predictive biomarker candidates
BerGenBio AML blood based biomarkers predict patients benefitting from BGB324 therapy
BGBC003: Phase II trial in AML and MDS – remains ongoing.
BGBC003 Phase II – AML/high risk MDS as monotherapy and in combination with decitabine or azacitidine
BGBC005
NSCLC patients, last line setting BGB324 + chemo (docetaxel)
BGB324 + docetaxel in NSCLC patients (last line setting)
NSCLC Patients Mostly diagnosed at late stage, 70% mortality within 1y
BGBIL005 – patient population
Heavily pre-treated patient population:
- All failed at least 1 line of chemo
- Most received prior immunotherapy without sustained benefit
- Most patients are metastatic
- No more treatment options remain
Best response (CT scan every 6 weeks)
BGBIL005, Patient case # 004: PR on BGB324 + docetaxel after failure on chemo and IO
| Age, ethnicity & sex |
63 year old Caucasian female |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung, lymph, lung metastasis |
| Mutations | None (EGFR wt, ALK negative) |
| Previous lines of therapy |
CARBOPLATIN/PACLITAXEL CARBOPLATIN/PEMETREXED PEMBROLIZUMAB |
| Current status | Ongoing, C5 |
BGBIL005, Patient case # 006: PR on BGB324 + docetaxel after failure on chemo and IO
| Age, ethnicity & sex |
53 year old Asian male |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung, lymph, liver, brain |
| Mutations | None (EGFR wt, ALK negative) |
| Previous lines of therapy |
CISPLATIN/PEMETREXED CISPLATIN VINORELBINE NIVOLUMAB |
| Current status | Ongoing, C5 |
BGBIL005, Patient case # 002: SD on BGB324 + docetaxel after failure on chemo and IO
| Age, ethnicity & sex |
75 year old Caucasian male |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung, lymph |
| Mutations | CAM5.2, MIB-1 |
| Previous lines of therapy |
CARBOPLATIN/PACLITAXEL/BEVACIZUMAB PEMETREXED NIVOLUMAB |
| Current status | Off study, alive |
BGBIL005, Patient case # 005: SD on BGB324 + docetaxel after failure on chemo and IO
| Age, ethnicity & sex |
63 year old Hispanic male |
|---|---|
| Histologic diagnosis | NSCLC |
| Stage | IV |
| Sites | Lung |
| Mutations | None (EGFR wt, ALK negative) |
| Previous lines of therapy |
NIVOLUMAB/IPILIMUMAB NIVOLUMAB CARBOPLATIN/PEMETREXED |
| Current status | Off study, alive |
BGBIL005: Phase I/II trial in NSCLC, BGB324 with docetaxel – remains ongoing.
BGBIL005 Phase I/II – NSCLC (2nd line – progressed/treatment-refractory disease) – Investigator-sponsored study
Sponsor Investigator: Dr David Gerber, UTSW Dallas
"The vast majority of my lung cancer patients progress onto chemotherapy, combining this with BGB324 may significantly improve the performance of the chemo and could lead to meaningful disease modification in some patients."
BGB324 is an AXL inhibitor to target aggressive cancers…
Aggressive cancers
Time after diagnosis (years)
Strong AXL expression correlates with poor survival rate Broad evidence of AXL linked with poor prognosis5
| Astrocytic brain tumors | Melanoma |
|---|---|
| Breast cancer | Mesothelioma |
| Gallbladder cancer | NSCLC |
| GI | Pancreatic cancer |
| • Colon cancer |
Sarcomas |
| • Esophageal cancer |
• Ewing Sarcoma |
| • Gastric cancer |
• Kaposis sarcoma |
| Gynaecological | • Liposarcoma |
| • Ovarian cancer |
• Osteosarcoma |
| • Uterine cancer |
Skin SCC |
| HCC | Thyroid cancer |
| HNC | Urological |
| Haematological | • Bladder cancer |
| • AML |
• Prostate cancer |
| • CLL |
• RCC |
| • CML |
BGB324: selective AXL inhibitor, restores sensitivity to immune cell attack and therapy, prevents spread
BGB324 targets immunosuppression and therapy resistance
Which cancers are we targeting
Most common tumours express high AXL levels
AXL low = Higher survival; AXL high = Poor survival
Low Axl expression2
High Axl expression2
Companion diagnostic in development to identify AXL positive patients
Advancing a broad clinical development pipeline
Targeting cancers with an addressable market of USD 11bn
Most common tumours express high AXL levels
And…it's a simple pill taken once a day
BGB324 ongoing clinical trials Reporting interim response & safety data on a regular basis
Milestones 2017 & 2018
Significant value drivers expected over the next 12 months:
üInterim clinical data from 6 ph2 trials H1'18
üFinal readout from 4 phase 2 trials in H2
üInitiation of AXL antibody BGB149 clinical trials in H2
Key financials
| Key Figures (NOK million) | Q3 2017 | Q3 2016 | YTD2017 | YTD2016 | FY 2016 |
|---|---|---|---|---|---|
| Operating revenues | |||||
| Operating expenses | - 36.6 |
- 16.3 |
- 136.2 |
- 103.5 |
- 131.6 |
| Operating profit (loss) | -36.6 | -16.3 | -136.2 | -103.5 | -131.6 |
| Profit (loss) after tax | -35.4 | -15.4 | -134.6 | -101.9 | -129.8 |
| Basic and diluted earnings (loss) per share (NOK) |
-0.71 | -45.64 | -3.06 | -339.63 | -419.68 |
| Net cash flow in the period | -41.1 | 82.1 | 237.3 | 113.2 | 87.8 |
| Cash position end of period | 399.2 | 187.2 | 399.2 | 187.2 | 161.8 |
• OPEX sequentially increased by 8% in Q317 over Q217 as recruitment to our clinical studies is ramping up
• Robust cash position gives runway to deliver key clinical read outs on our ongoing clinical studies.
Summary and outlook / Investment case
First-in-class AXL inhibitors for aggressive cancers with addressable market in excess of \$11bn
BGB324 in multiple Phase II programmes with interim data readout @ ASCO 2018
Well resourced & experienced organisation to deliver pipeline and milestones
Clear strategy to develop and commercialise assets
Thank you.
For further information please visit www.bergenbio.com
Developing first-in-class Axl inhibitors to treat aggressive cancer