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Zelluna ASA — Investor Presentation 2021
Aug 20, 2021
3779_rns_2021-08-20_b6456eb0-8958-4934-8dcf-ec5426e258a5.pdf
Investor Presentation
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Enabling the Immune System to Fight Cancer
Second Quarter 2021 Presentation 20 August 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 Q2 2021
Operational Update Q2 2021
Key financials Q2 2021 & Newsflow
Highlights Q2 2021
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
- Consistent set of data showing strong initial signals of clinical response and a good safety profile supporting use of UV1 in combination treatments

Highlights Q2 2021 (cont.)
The broad UV1 Phase II program is progressing well
- INITIUM (154 patients): Ultimovacs sponsored trial in malignant melanoma in which UV1 is combined with nivolumab and ipilimumab.
- 68 patients enrolled as of 19 August 2021 (compared to 40 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.
- 38 patients enrolled as of 19 August 2021 (compared to 29 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, first patient expected during Q3 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.
- First patient enrolled.

Highlights Q2 2021 (cont.)
TENDU
• Enrollment of the first cohort of three patients treated with the lowest dose is completed. In June 2021, having found no safety concerns in the first cohort, the Drug Safety Monitoring Board allowed the dose to be increased to 400 μg for the next patient in cohort 2.
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.
- The Company continues to monitor the situation and to implement activities to minimize the impact on patient recruitment.
- Appr. 100 patients recruited in total during the past 12 months

Table of Contents
Highlights Q2 2021
Operational Update Q2 2021
Key Financials Q2 2021 & Newsflow
Supports Broad Phase II UV1 Pipeline in >500 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 | * | ||||
| Second line ovarian cancer |
With durvalumab & olaparib 184 patients |
DOVACC | * | ||||
| First line head and neck cancer |
With pembrolizumab 75 patients |
FOCUS | Martin-Luther University Halle |
||||
| TET | Prostate cancer | Dose finding trials, 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 1 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.
*Supply agreements with BMS and AZ

Phase I UV1 + pembrolizumab in Malignant Melanoma
- Encouraging Results with Good Safety and Strong Signals of Efficacy

Phase I Trial Design Key results announced during Q2 2021: Cohort 1 at 18 months (ASCO), Cohort 2 at 12 months
- 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

Phase I UV1 + pembrolizumab in Malignant Melanoma
- Strong Signals of Efficacy
• The Response Rates for the 30 patients in cohort 1 and cohort 2 combined, as measured by iRECIST:
Objective response rate (ORR) 57%,
Complete response rate (CR) 30%
- complete response (CR) 9/30
- partial response (PR) 8*/30
- stable disease (SD) 2*/30
- 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 2 after 12 months: 90%
- Cohort 1+2 combined after 12 months: 87%
- Cohort 1 after 18 months: 80%
* Recently, the response for one patient in cohort 1 was reclassified from partial response to stable disease.

Phase I UV1 + pembrolizumab in Malignant Melanoma
- 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.
Phase I UV1 + pembrolizumab in Malignant Melanoma - Encouraging OS & mPFS vs. Historical pembrolizumab Data

Median Progression Free Survival
UV1 + pembrolizumab:
- Cohort 1: 18.9 months
- Cohort 2: not reached at 12 months
- Cohort 1+2 combined: not reached at 12 months
Pembrolizumab:
• 5.5-11.6 months1
UV1 plus pembrolizumab (n=30) Pembrolizumab alone (n=279)

1Data 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. For overall survival, the 75% comparison is a visual reading from Keynote 006 Kaplan Meyer graph at 12 months.
INITIUM and NIPU Ongoing Phase II Trials
INITIUM
- Randomized Phase II trial in 1st line treatment of patients with metastatic malignant melanoma
- Ultimovacs sponsored study
- 154 patients in 40 sites in Norway, Belgium, UK and USA
- FPFV in June 2020
- Topline results expected H2 2022
- 68 patients enrolled as of 19 August 2021 (vs. 40 in Q1 2021)
NIPU
- Randomized Phase II trial in 2nd line malignant pleural mesothelioma
- Sponsored by Oslo University Hospital in collaboration with BMS
- 118 patients in 6 sites in Norway, Sweden, Denmark, Spain and Australia
- FPFV in June 2020
- Topline results expected H2 2022
- 38 patients enrolled as of 19 August 2021 (vs. 29 in Q1 2021)

FPFV = First patient first visit, LPFV=Last patient first visit, PFS = progression-free survival,
OS = overall survival, ORR = overall response rate, DOR = duration of response
DOVACC and FOCUS Phase II Trials initiating Patient Enrollment
DOVACC
- Randomized Phase II second maintenance trial in BRCA negative ovarian cancer patients
- Sponsored by NSGO/ENGOT in collaboration with Astra Zeneca
- 184 patients in >40 sites in approximately 10 European countries
- Regulatory approval in place. FPFV expected Q3 2021.
- Topline results expected 2023
FOCUS
- Randomized phase II trial in patients with recurrent or metastatic PDL1 positive head and neck cancer
- Sponsored by Halle University Hospital network
- 75 patients in 10 sites in Germany
- First patient enrolled in August 2021
- Topline results expected 2023

FPFV = First patient first visit, LPFV=Last patient first visit, PFS = progression-free survival,
OS = overall survival, ORR = overall response rate, DOR = duration of response
The TENDU Phase I Trial
- This trial investigates a prostate cancer specific vaccine based on the TET technology
- The TENDU trial is conducted at Oslo University Hospital
- 9-12 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 is completed.
- In June, having found no safety concerns in the first cohort, the Drug Safety Monitoring Board allowed the dose to be increased to 400 μg for the next three patients in cohort 2.
- Next patient is expected to be enrolled in Q3 2021.


Table of Contents
Highlights Q2 2021
Operational Update Q2 2021
Key Financials Q2 2021 & Newsflow
Key Financials
| Key financials per Q2-2021 - Ultimovacs Group | Comments: | |||||
|---|---|---|---|---|---|---|
| NOK (000) | Q2-20 | Q2-210 | YTD200 | YTD21 | FY20 | Payroll expenses |
| Total revenues | - | - 0 |
- | - | - | ▪ Higher cost in YTD21/Q2-21 than same periods in 2020 |
| Payroll and payroll related expenses | 13 197 | 14 514 | 23 212 | 26 716 | 50 989 | due to: |
| External R&D and IPR expenses (incl. grants) | 19 938 | 20 588 | 38 027 | 36 600 | 60 870 | ▪ higher share-option costs |
| Other operating expenses (incl. depreciation) | 3 048 | 4 069 | 6 203 | 7 070 | 12 287 | ▪ two additional full-time employees in this period |
| Total operating expenses | 36 183 | 39 171 | 67 442 | 70 386 | 124 146 | compared to YTD20/Q2-20. |
| Operating profit (loss) | -36 183 | -39 171 | -67 4420 | -70 3860 | -124 146 | External R&D and IPR expenses |
| Net financial items | 1 274 | 2 706 | 2 1960 | 1240 | 3 594 | ▪ R&D cost in YTD21/Q2-21 approximately at same level as |
| Profit (loss) before tax | -34 909 | -36 465 | -65 245 | -70 262 | -120 552 | same periods in 2020, however YTD21 includes grants of MNOK 6.0 vs MNOK 3.0 in YTD20. |
| Net increase/(decrease) in cash and cash eq. | 115 247 | -29 657 | 83 768 | -57 871 | 42 058 | Other operating expenses |
| Cash and cash equivalents at end of period | 483 159 | 381 799 0 |
483 159 | 381 799 | 440 925 | ▪ Approximately at the same level as the previous year |
| Number of FTEs at end of period | 1 9 |
2 1 |
1 9 |
2 1 |
1 9 |
|
| Cashflow / cash and cash equivalents | ||||||
| ▪ MNOK 50 has been converted to EUR (Q1-21) |
||||||
| ▪ In addition, Ultimovacs has entered into EUR currency future contracts of MNOK 100 at a spot rate of NOK 10.18. Planned to be swapped on a monthly basis until the EUR-funds are needed. Currency loss/gains from these contracts booked in 'net financial items' |
Comments:
Payroll expenses
- Higher cost in YTD21/Q2-21 than same periods in 2020 due to:
- higher share-option costs
- two additional full-time employees in this period compared to YTD20/Q2-20.
External R&D and IPR expenses
▪ R&D cost in YTD21/Q2-21 approximately at same level as same periods in 2020, however YTD21 includes grants of MNOK 6.0 vs MNOK 3.0 in YTD20.
Other operating expenses
▪ Approximately at the same level as the previous year
Cashflow / cash and cash equivalents
- MNOK 50 has been converted to EUR (Q1-21)
- In addition, Ultimovacs has entered into EUR currency future contracts of MNOK 100 at a spot rate of NOK 10.18. Planned to be swapped on a monthly basis until the EUR-funds are needed. Currency loss/gains from
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 Q2-21 is around the same level as in previous quarters in 2020/21
- A further increase in the negative operating cashflow related to R&D should be expected in the second half of 2021 with the initiation of the two new phase II trials, increased patient recruitment and other R&D costs

Key Financials – Quarterly Overview
Key financials per Q2-2021 - Ultimovacs Group
| Q1-20 | Q2-20 | Q3-20 | Q4-20 | Q1-21 | Q2-21 |
|---|---|---|---|---|---|
| - | - | - | - | - | - |
| 10 015 | 13 197 | 13 115 | 14 662 | 12 203 | 14 514 |
| 18 089 | 19 938 | 15 307 | 7 537 | 16 012 | 20 588 |
| 3 155 | 3 048 | 2 695 | 3 390 | 3 000 | 4 069 |
| 31 259 | 36 183 | 31 116 | 25 588 | 31 215 | 39 171 |
| -31 259 | -36 183 | -31 116 | -25 588 | -31 215 | -39 171 |
| 922 | 1 274 | 391 | 1 007 | -2 582 | 2 706 |
| -30 337 | -34 909 | -30 725 | -24 582 | -33 798 | -36 465 |
| -31 479 | 115 247 | -29 186 | -12 524 | -28 213 | -29 657 |
| 367 686 | 483 159 | 453 523 | 440 925 | 409 288 | 381 799 |
| 1 9 |
1 9 |
1 9 |
1 9 |
2 1 |
2 1 |

Expected News Flow and Milestones


Key Takeaways From Q2 Report
- Encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma
- The broad UV1 Phase II program is progressing well
- 4 indications, different combinations
- More than 500 patients at more than 90 hospitals in appr. 15 countries
- Patient recruitment proceeding despite the COVID-19 challenge
- The development of the TET platform continues no safety issues related to the first dosing cohort in the TENDU trial, progressing to the next dosing level


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