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Zelluna ASA — Investor Presentation 2021
Nov 11, 2021
3779_rns_2021-11-11_4dc27be7-62cf-4f0e-aca2-9e8a0a2dc8a7.pdf
Investor Presentation
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Enabling the Immune System to Fight Cancer
Third Quarter 2021 Presentation 11 November 2021
Carlos de Sousa, CEO Jens Bjørheim, CMO Hans Vassgård Eid, CFO
Important Notice and Disclaimer
This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Ultimovacs' business, financial condition and results of operations. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "programmes", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of Ultimovacs' strategy and its ability to further grow, risks associated with the development and/or approval of Ultimovacs' products candidates, ongoing clinical trials and expected trial results, the ability to commercialise UV1, technology changes and new products in Ultimovacs' potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Ultimovacs disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The reservation is also made that inaccuracies or mistakes may occur in this information given about current status of Ultimovacs or its business. Any reliance on the information is at the risk of the reader, and Ultimovacs disclaims any and all liability in this respect.
Table of Contents
Highlights Q3 2021
Operational Update Q3 2021
Key financials Q3 2021 & Newsflow
Highlights Q3 2021
New Phase II trial in NSCLC – UV1 to be investigated with pembrolizumab
- 138 patients
- Drammen Hospital is the sponsor
- 8-10 sites in Norway
Successful Capital Raise
- A private placement was successfully completed on 26 October 2021
- Gross proceeds of MNOK 270 raised
Further encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma
- 30 patients split on two cohorts
- Data from cohort 1 were presented in June at the ASCO 2021 Annual Meeting.
- Results from cohort 2 were announced on 12 August 2021
- 2-year survival data from cohort 1 were announced on 13 October 2021
- Consistent set of data showing strong initial signals of clinical response and a good safety profile supporting use of UV1 in combination treatments
Fast Track designation confirms our confidence in the therapeutic potential of UV1
Fast Track designation, mandates the FDA to facilitate the development and expedite review of drugs and biologics:
- intended to treat serious or life-threatening conditions and
- that demonstrate the potential to address unmet medical needs
Ultimovacs receives Dual "Fast Track" designation from the FDA, for:
- UV1 as add-on therapy to pembrolizumab for the treatment of unresectable or metastatic melanoma
- UV1 as add-on therapy to ipilimumab for the treatment of unresectable or metastatic melanoma
Through the "Fast Track" designation for UV1, the following benefits are provided by the FDA: Fast Track Benefits
- Facilitates the development and expedites the review of UV1
- Enables early and frequent communication with the FDA to support UV1's development
- Provides eligibility for Accelerated Approval and Priority Review in case certain required criteria are met
- Entitles to a Rolling Review of the Biologic License Application (BLA) by the FDA
UV1
Continued progress in the broad UV1 Phase II program
- INITIUM (154 patients): Ultimovacs sponsored trial in malignant melanoma in which UV1 is combined with nivolumab and ipilimumab.
- 91 patients enrolled as of 10 November 2021 (compared to 68 patients in the previous quarterly report)
- NIPU (118 patients): trial in mesothelioma, UV1 in combination with nivolumab and ipilimumab. Oslo University Hospital is the sponsor of the NIPU study. Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to support the execution of the trial.
- 45 patients enrolled as of 10 November 2021 (compared to 38 patients in the previous quarterly report)
- The DOVACC trial (184 patients): Collaboration study with NSGO-CTU, ENGOT and AstraZeneca in ovarian cancer, UV1 is combined with durvalumab and Olaparib.
- Regulatory approval in place and first site opened, first patient expected during Q4 2021
- FOCUS (75 patients): trial in collaboration with the Immunological Tumor Group at University Medicine Halle, Germany, where UV1 will be given in combination with pembrolizumab in head and neck cancer patients.
- 5 patients enrolled as of 10 November 2021 (compared to none in the previous quarterly report)
Covid-19 impact
- The effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain and dependent on the speed of return to a more normal situation
- Ultimovacs continues to monitor the impact from COVID-19 on its clinical trials and to implement activities to minimize the impact on patient recruitment
- Ultimovacs will update the guidance for INITIUM and our investigator-initiated Phase II trials in our Q4 2021 report
- Enrollment updates will continue to be provided in each quarterly report
TENDU
- Enrollment of the first cohort of three patients was completed in Q2 2021
- In June 2021, the Drug Safety Monitoring Board allowed the dose to be increased to 400 μg for the next three patients in cohort 2
- The first patient in the second cohort was enrolled in September 2021
Table of Contents
Highlights Q3 2021
Operational Update Q3 2021
Key Financials Q3 2021 & Newsflow
UV1 with strong potential to enhance standard of care for NSCLC patients
ABOUT NSCLC
- Among the most common cancer in men and women
- NSCLC represents ~85% of all lung cancers
- Poor prognosis: 5 year survival at ~25%2
1/3 of the total NSCLC population is potentially
eligible for UV1/Pembrolizumab treatment
UV1 as a valuable combination treatment to pembrolizumab in NSCLC
Global NSCLC Market Value
- Checkpoint inhibitors (CPIs) are standard of care for advanced & recurrent NSCLC with a ~56% value share (in US\$)
- Pembrolizumab's1 market share of CPIs in NSCLC is ~ 67% (in US\$)
- UV1 to be combined with best selling CPI in NSCLC
Source: Global Data - Data related to 2020
13 1. Pembrolizumab is indicated as monotherapy treatment for patients with stage IIIB/IIIC or stage IV NSCLC for treatment in the first-line setting in patients with tumor expressing PDL1 above 50% and no EGFR or ALK translocation
LUNGVAC: New phase II trial of UV1 in NSCLC
- LUNGVAC: advanced or metastatic non-small cell lung cancer
- Combination: Pembrolizumab (Keytruda)
- Patients: 138 patients, 8-10 hospitals in Norway
- Milestones: First patient expected enrolment H1 2022
- Topline results expected end of 2024
- Contributors: Sponsored by Drammen Hospital with Odd Terje Brustugun, MD PhD. as principal investigator
Broad Phase II UV1 Pipeline with >650 Patients
| Indication | Clinical trial information | Pre clinical |
Phase I | Phase II | Phase III | Contributors | |
|---|---|---|---|---|---|---|---|
| UV1 | First line metastatic malignant melanoma |
With pembrolizumab 30 patients |
|||||
| First line metastatic malignant melanoma |
With ipilimumab & nivolumab 154 patients |
INITIUM | |||||
| Second line mesothelioma |
With ipilimumab & nivolumab 118 patients |
NIPU | 1 | ||||
| Second line ovarian cancer |
With durvalumab & olaparib 184 patients |
DOVACC | 1 | ||||
| First line head and neck cancer |
With pembrolizumab 75 patients |
FOCUS | Martin-Luther University Halle |
||||
| First line NSCLC | With pembrolizumab 138 patients |
LUNGVAC | DRAMMEN HOSPITAL | ||||
| TET | Prostate cancer | Dose finding trial, monotherapy 9-12 patients |
TENDU |
Note: UV1 Phase II development is supported by good safety profile and signals of clinical efficacy observed in three Phase I trials where 52 patients with prostate cancer, lung cancer or malignant melanoma were included. Patients in these studies have been followed for at least five years.
UV1 Phase 1: Positive 5-Year Safety and Efficacy in Malignant Melanoma
0 5 10 0 10 20 30 40 50 60 70 17 months >60 months 6.7 months 2.9-3.7 months IPI4 study3 Months Months vs historical comparison with monotherapy2 and IPI4 study3 12 months 2.7 months UV1 plus ipilimumab Ipilimumab alone N=12 N=181 N=151 N=12 N=315 N=151 N=181
Median Progression Free Survival
Topline readout of Phase 1 trials at Year 51 vs historical comparison with monotherapy2 and
- Safety profile supports clinical progression
-
Signals of clinical efficacy observed
-
Malignant melanoma: (EudraCT No. 2013-005582-39)
Median Overall Survival Topline readout of Phase 1 trials at Year 51
-
Robert C et al. Lancet Oncol. 2019; 20: 1239-51 (n=181), Larkin J et al. N Engl J Med. 2015 Jul 2;373(1):23-34 (n=315)
-
Historical control for the melanoma study: Aamdal, E. et al (2021) Ipilimumab in a real-world population: A prospective phase IV trial with long-term follow-up. Int. J. Cancer. https://doi.org/10.1002/ijc.33768
IPI4 – ipilimumab mono
Strong response rates vs. historical ipilimumab data
1 Robert C et al. Lancet Oncol. 2019; 20: 1239-51 (n=181), Larkin J et al. N Engl J Med. 2015 Jul 2;373(1):23-34 (n=315) 2 Historical control for the melanoma study: Aamdal, E. et al (2021) Ipilimumab in a real-world population: A prospective phase IV trial with long-term follow-up. Int. J. Cancer. https://doi.org/10.1002/ijc.33768
Encouraging results with good safety and strong signals of efficacy
- Good safety profile supporting use of UV1 in combination treatments
- ‐ Safety of combination similar to PD1 antibody (e.g., pembrolizumab) alone, except injection site reactions
- Consistent set of data showing strong initial signals of clinical response
Strong signals of efficacy
- The Response Rates for the 30 patients in cohort 1 and cohort 2 combined, as measured by iRECIST:
- complete response (CR) 9/30
- partial response (PR) 8/301
- stable disease (SD) 2/301
- progressive disease (PD) 11/30
- Median Progression Free Survival (mPFS):
- Cohort 1: 18.9 months
- Cohort 2: not reached at 12 months
- Cohort 1+2 combined: not reached at 12 months
- Overall Survival (OS):
- Cohort 1 after 12 months: 85%
- Cohort 1 after 24 months: 80%
- Cohort 2 after 12 months: 90%
Objective response rate (ORR) 57%, Complete response rate (CR) 30%
Strong response rates vs. historical pembrolizumab data
UV1 plus pembrolizumab (n=30) Pembrolizumab alone (n=279)
1 Cohort 1 at 18 months, Cohort 2 at 12 months. 2 Data from KEYNOTE-006 (Robert C, 2019). KEYNOTE-006 is the pivotal study referred to in the Keytruda (pembrolizumab) package inserts. Data from Robert C (2019) is a post-hoc non-planned analysis. UV1/pembrolizumab phase I/II trial measured by iRECIST KEYNOTE-006 was measured by RECIST 1.1.
Encouraging OS & mPFS vs. historical pembrolizumab data
Median Progression Free Survival
UV1 + pembrolizumab:
- Cohort 1: 18.9 months
- Cohort 2: not reached at 12
- Cohort 1+2 combined: not reached at 12 months
1 Keytruda package inserts and Robert C, Ribas A, Schachter J, et al. Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study. Lancet Oncol. 2019;20(9):1239-1251. doi:10.1016/S1470-2045(19)30388-2
Next Steps for UV1 in Advanced Malignant Melanoma – INITIUM Phase II trial
- INITIUM Phase II combination trial with nivolumab and ipilimumab in malignant melanoma ongoing
- Enrollment ongoing since June 2020
- 154 patients in 38 sites in 4 countries (US, UK, Belgium and Norway)
- 91 patients enrolled as of 10 November 2021 (Q3 2021 reporting)
- Topline results expected H2 2022
NIPU & DOVACC Phase II Trials
NIPU: Malignant pleural mesothelioma
- Combination: nivolumab, ipilimumab
- Contributors: Oslo University Hospital (sponsor); BMS
- Patients: 118 from 6 sites: Norway, Sweden, DK, Spain, Australia
- Enrollment ongoing since June 2020
- 45 patients enrolled as of 10 November 2021 (Q3 2021 reporting)
- Milestones: Topline results expected H2 2022
DOVACC: Ovarian cancer
- Combination: olaparib, durvalumab
- Contributors : NSGO/ENGOT, Astra Zeneca
- Patients: 184 from >40 sites in ~10 European countries
- Milestones: FPFV expected Q4 2021 Topline results expected 2023
FOCUS and LUNGVAC Phase II Trials
FOCUS: Head and neck squamous cell carcinoma
- Combination: pembrolizumab
- Contributors : Sponsored by Halle University Hospital network
- Patients: 75 from 10 sites in Germany
- First patient enrolled August 2021
- 5 patients enrolled as of 10 November 2021 (Q3 2021 reporting)
- Milestones: Topline results expected 2023
LUNGVAC: Advanced or metastatic NSCLC
- Combination: pembrolizumab
- Contributors: Sponsored by Drammen Hospital with Odd Terje Brustugun, MD PhD. as principal investigator
- Patients: 138 patients, 8-10 hospitals in Norway
- First patient expected to be enrolled in H1 2022
- Milestones: Topline results expected end of 2024
TET Technology Platform and the TENDU Phase I Trial
• The TET technology platform:
- ‐ allows for a beneficial safety profile and simplified administration since the antigens and adjuvant are part of the same molecule
- ‐ ADJUVANT technology: tetanus antigens are built into TENDU to potentiate the vaccine, these are targeted by antibodies that already exist in our body, as a result of childhood vaccination programs in the U.S. and Europe
- The TENDU trial investigates a prostate cancer specific vaccine based on the TET technology
- ‐ Conducted at Oslo University Hospital
- ‐ 9 patients will be enrolled
- ‐ This Phase I trial will provide valuable information on safety and immune activation toward the further development of new vaccine solutions based on the TET technology
- ‐ Enrollment of the first cohort of three patients was completed in Q2 2021
- ‐ In June, the Drug Safety Monitoring Board allowed the dose to be increased to 400 μg for the next three patients in cohort 2
- ‐ First patient in second cohort enrolled in September 2021
Table of Contents
Highlights Q3 2021
Operational Update Q3 2021
Key Financials Q3 2021 & Newsflow
Private Placement in October 2021
- On 26 October 2021, Ultimovacs successfully carried out a private placement of 2,160,000 new shares at a subscription price of NOK 125 per share, raising gross proceeds of NOK 270 million
- More than 100 investors took part in the private placement
- The net proceeds of the private placement will be used for:
- (i) financing of the LUNGVAC Phase II trial evaluating UV1 in non-small cell lung cancer,
- (ii) bringing the UV1 platform into Phase III readiness,
- (iii) further development of the Tetanus-Epitope-Targeting ("TET") technology platform, and
- (iv) general corporate purposes
- Following the Private Placement, the Company has a share capital of NOK 3,422,176.10 divided into 34,221,761 shares, each with a par value of NOK 0.10
| Key financials per Q3-2021 - Ultimovacs Group | ||||||
|---|---|---|---|---|---|---|
| NOK (000) | Q3-20 | Q3-210 | YTD200 | YTD21 | FY20 | Payroll expenses |
| Total revenues | - | - | - | - | - | ▪ Higher cost in Q3-21 than the same period in |
| Payroll and payroll related expenses | 13 115 | 23 314 | 36 327 | 50 031 | 50 989 | 2020 due to: |
| External R&D and IPR expenses (incl. grants) | 15 307 | 16 031 | 53 334 | 52 631 | 60 870 | ▪ share-option costs (MNOK 12 higher), a |
| Other operating expenses (incl. depreciation) | 2 695 | 3 171 | 8 897 | 10 241 | 12 287 | non-cash item |
| Total operating expenses | 31 116 | 42 517 | 98 558 | 112 903 | 124 146 | |
| Operating profit (loss) | 0 -31 1160 |
-42 517 | -98 558 | -112 903 | -124 146 | period compared to Q3-20 |
| Net financial items | 3910 | -791 | 2 587 | -668 | 3 594 | External R&D and IPR expenses |
| Profit (loss) before tax | -30 725 | -43 308 | -95 971 | -113 570 | -120 552 | ▪ R&D costs approximately at the same level as |
| Net increase/(decrease) in cash and cash eq. | 0 -29 186 |
-32 880 | 54 582 | -90 751 | 42 058 | the previous year. Amounts are shown net of grants, which are higher in the 2021 periods. |
| Cash and cash equivalents at end of period | 453 523 | 347 804 | 453 523 | 347 804 | 440 925 | Other operating expenses |
| Number of FTEs at end of period | 1 9 |
2 1 |
1 9 |
2 1 |
1 9 |
|
| ▪ Slight increase from the previous year |
||||||
| Net cash of MNOK 348 at the end of Q3 2021 (prior to the October 2021 capital raise) |
Comments:
Payroll expenses
- Higher cost in Q3-21 than the same period in 2020 due to:
- share-option costs (MNOK 12 higher), a non-cash item
- two additional full-time employees in this period compared to Q3-20
External R&D and IPR expenses
▪ R&D costs approximately at the same level as the previous year. Amounts are shown net of grants, which are higher in the 2021 periods.
Other operating expenses
Net cash of MNOK 348 at the end of Q3 2021
Key financials – operating cash flow
* Q4-20 are adjusted (increased) by MNOK 5 to exclude the receival of public grants from Skattefunn. No other adjustments made.
Comments:
- The negative operating cashflow in Q3-21 is approximately at the same level as in the previous quarters in 2021.
- A further increase in negative operating cashflow related to R&D should be expected going forward with the initiation of new phase II trials (DOVACC and LUNGVAC), increased patient recruitment in ongoing trials and other R&D costs
Key financials – quarterly overview
Key financials per Q3-2021 - Ultimovacs Group
| NOK (000) | Q1-20 | Q2-20 | Q3-20 | Q4-20 | Q1-21 | Q2-21 | Q3-21 |
|---|---|---|---|---|---|---|---|
| Total revenues | - | - | - | - | - | - | |
| Payroll and payroll related expenses | 10 015 | 13 197 | 13 115 | 14 662 | 12 203 | 14 514 | 23 314 |
| External R&D and IPR expenses (incl. grants) | 19 938 | 15 307 | 7 537 | 16 012 | 20 588 | 16 031 | |
| Other operating expenses (incl. depreciation) | 3 048 | 2 695 | 3 390 | 3 000 | 4 069 | 3 171 | |
| Total operating expenses | 36 183 | 31 116 | 25 588 | 31 215 | 39 171 | 42 517 | |
| Operating profit (loss) | -31 259 | -36 183 | -31 116 | -25 588 | -31 215 | -39 171 | -42 517 |
| Net financial items | 1 274 | 391 | 1 007 | -2 582 | 2 706 | -791 | |
| Profit (loss) before tax | -34 909 | -30 725 | -24 582 | -33 798 | -36 465 | -43 308 | |
| Net increase/(decrease) in cash and cash eq.uivalents | -31 479 | 115 247 | -29 186 | -12 524 | -28 213 | -29 657 | -32 880 |
| Cash and cash equivalents at end of period | 483 159 | 453 523 | 440 925 | 409 288 | 381 799 | 347 804 | |
| Number of FTEs at end of period | 1 9 |
1 9 |
1 9 |
2 1 |
2 1 |
2 1 |
Expected News Flow and Milestones
Key Takeaways from the Q3 2021 Report
- New Phase II trial in NSCLC a further extension of the broad UV1 Phase II program
- 5 indications, different combinations, >650 patients at close to 100 hospitals in appr. 15 countries
- Further strengthening of the encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma
- Dual Fast Track designation confirms our confidence in the therapeutic potential of UV1
- Updated guidance for read-out of the Phase II trials will be given in the Q4 2021 report
- The development of the TET platform continues no safety issues in the TENDU trial so far, next dosing level initiated
- Successful capital raise of MNOK 270 in October 2021
Enabling the Immune System to Fight Cancer
For questions
Carlos de Sousa, CEO [email protected] +47 908 92507
Hans Vassgård Eid, CFO [email protected] +47 482 48632