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Zelluna ASA — Investor Presentation 2021
May 11, 2021
3779_rns_2021-05-11_00531082-af47-4ec6-a5ae-064b6dfd3a75.pdf
Investor Presentation
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Enabling the immune system to fight cancer
First quarter 2021 presentation
11 May 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 Q1 2021
Operational update Q1 2021
Key financials Q1 2021 & Newsflow
Highlights Q1 2021
UV1 Phase II program extended to four trials – more than 500 patients to be enrolled
- INITIUM (154 patients): Ultimovacs sponsored trial in malignant melanoma in which UV1 is combined with nivolumab and ipilimumab.
- 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.
- The DOVACC trial (new in Q1 2021):
- Collaboration study with NSGO-CTU, ENGOT and AstraZeneca
- Ovarian cancer
- UV1, durvalumab and Olaparib
- 184 patients
- 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.

Highlights Q1 2021 (cont.)
Ongoing patient recruitment in the INITIUM, NIPU and TENDU trials
- INITIUM: 40 out of 154 patients enrolled (24 enrolled as of Q4 2020 reporting)
- NIPU: 29 out of 118 patients enrolled (18 enrolled as of Q4 2020 reporting)
- TENDU: the first cohort of three patients has been enrolled
Covid-19 impact
- The Company continues to implement activities to minimize the impact on patient recruitment.
- 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 normal situation.

Highlights Q1 2021 (cont.)
Poster presentation at ASCO
• An abstract on the Company's Phase I trial evaluating its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab in patients with metastatic malignant melanoma has been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting to be held virtually on 4-8 June, 2021.

Table of contents
Highlights Q1 2021
Operational update Q1 2021
Key financials Q1 2021 & Newsflow
Broad Development Pipeline: more than 500 patients in Phase II
| Indication | Clinical trial information | Preclinical | Phase I |
Phase II |
Phase III |
Partner/Collaboration | |
|---|---|---|---|---|---|---|---|
| UV1 | Prostate cancer | Conducted at OUS, 22 patients. Completed in 2015 | Oslo University Hospital | ||||
| Non-small cell lung cancer (NSCLC) |
Conducted at OUS, 18 patients. Completed in 2016 | Oslo University Hospital | |||||
| Metastatic malignant melanoma |
Conducted at OUS, 12 patients. UV1 in combination with Ipilimumab. Completed in 2016 |
Oslo University Hospital | |||||
| Metastatic malignant melanoma |
First line phase I trial with combination UV1/pembrolizumab). 30 patients, enrolment completed in Aug-20 |
||||||
| Metastatic malignant melanoma |
INITIUM: Phase II proof of concept trial (first line metastatic malignant melanoma with triple combination ipilimumab/nivolumab/UV1) 154 patients |
||||||
| Mesothelioma | NIPU: Phase II proof of concept trial (second line mesothelioma with triple combination ipilimumab/nivolumab/UV1) 118 patients |
Bristol Myers Squibb and Oslo University Hospital (OUS) |
|||||
| Ovarian cancer | DOVACC: Phase II proof of concept trial (randomized, second line maintenance in ovarian cancer with combination durvalumab/Olaparib/UV1) 184 patients |
AstraZeneca and NSGO/ENGOT | |||||
| Head and Neck cancer | FOCUS: Phase II proof of concept trial (first line head and neck cancer with combination pembrolizumab/UV1) 75 patients |
University Medicine Halle (Saale) / Martin-Luther-University |
|||||
| TET | Prostate cancer | TENDU: phase I study to assess the safety of the TET platform |
|||||
| Various | First-in-class cancer vaccine solutions based on the TET platform technology |


INITIUM and NIPU are 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
- 40 patients enrolled as of 10 May 2021 (vs. 24 after Q4 2020)
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
- 29 patients enrolled as of 10 May 2021 (vs. 18 after Q4 2020)

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 are Phase II trials soon to be started
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
- FPFV around mid-year 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
- FPFV around mid-year 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 TET-platform and the TENDU trial
The TET-platform (Tetanus-Epitope Targeting)
- Next-generation vaccine technology expanding Ultimovacs' product pipeline
- Promising approach to strengthen and increase T cell responses against cancer-specific peptides by combining antigens and the vaccine adjuvant in the same molecule
- Expected beneficial safety profile and simplified administration
- The platform generates new, first-in-class cancer vaccine candidates that harness the preexisting antibody response against tetanus resulting from standard tetanus vaccination
- These vaccine candidates can be tailored to many types of cancer

The TET-platform and the TENDU trial (cont,)
- This trial will investigate a prostate cancer specific vaccine based on the TET technology
- The main objective is to assess the safety of the TET technology
- The TENDU trial will be conducted at Oslo University Hospital, and 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
- The first cohort of three patients was enrolled in Q1 2021


Table of contents
Highlights Q1 2021
Operational update Q1 2021
Key financials Q1 2021 & Newsflow
Key financials
Key financials per Q1-2021 - Ultimovacs Group
| NOK (000) | Q1-20 | Q1-210 | FY20 |
|---|---|---|---|
| Total revenues | - | - 0 |
- |
| Payroll and payroll related expenses | 10 015 | 12 203 | 50 989 |
| External R&D and IPR expenses (incl. grants) | 18 089 | 16 012 | 60 870 |
| Other operating expenses (incl. depreciation) | 3 155 | 3 000 | 12 287 |
| Total operating expenses | 31 259 | 31 215 | 124 146 |
| Operating profit (loss) | -31 259 | -31 2150 | -124 146 |
| Net financial items | 922 | -2 5820 | 3 594 |
| Profit (loss) before tax | -30 337 | -33 798 | -120 552 |
| Net increase/(decrease) in cash and cash eq. | -31 479 | -28 176 | 42 058 |
| Cash and cash equivalents at end of period | 367 686 0 |
409 288 0 |
440 925 |
| Number of FTEs at end of period | 2 1 |
1 9 |
Comments:
Payroll expenses
- Higher cost in Q1-21 than same period in 2020 due to:
- higher share-option costs this quarter
- two additional full-time employees in this period compared to Q1-20.
External R&D and IPR expenses
▪ R&D costs at same level Q1-21 and Q1-20 (Q1-21 includes MNOK 2.2. in grants vs. 0 in Q1-20)
Other operating expenses
▪ Approximately at the same level as the previous year
Cashflow / cash and cash equivalents
- MNOK 50 has been converted to EUR
- 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. → MNOK 1.6 in currency loss from these contracts in Q1-21
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 Q1-21 is at the same level as in previous quarters in 2020
- A further increase in operating cashflow related to R&D should be expected in 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 Q1-2021 - Ultimovacs Group
| NOK (000) |
Q1-20 | Q2-20 | Q3-20 | Q4-20 | Q1-21 |
|---|---|---|---|---|---|
| Total revenues |
- | - | - | - | - |
| Payroll and payroll related expenses |
10 015 |
13 197 |
13 115 |
14 662 |
12 203 |
| External R&D and IPR (incl . grants) expenses |
18 089 |
19 938 |
15 307 |
7 537 |
16 012 |
| Other operating (incl depreciation) expenses |
3 155 |
3 048 |
2 695 |
3 390 |
3 000 |
| Total operating expenses |
36 183 |
31 116 |
25 588 |
31 215 |
|
| profit (loss) Operating |
-31 259 |
-36 183 |
-31 116 |
-25 588 |
-31 215 |
| financial items Net |
922 | 1 274 |
391 | 1 007 |
-2 582 |
| Profit (loss) before tax |
-30 337 |
-34 909 |
-30 725 |
-24 582 |
-33 798 |
| increase/(decrease) in cash and cash eq.uivalents Net |
-31 479 |
115 247 |
-29 186 |
-12 524 |
-28 176 |
| Cash and cash equivalents end of period at |
367 686 |
483 159 |
453 523 |
440 925 |
409 288 |
| Number of end of period FTEs at |
1 9 |
1 9 |
1 9 |
1 9 |
2 1 |

Recent and expected newsflow 2020-2021


Event calendar
19 May 2021 at 23.00 CEST: ASCO Release of abstract 20 May 2021 at 10.00 CEST: Ultimovacs webcast presenting the data 20 May 2021 at 19:25 CEST: Presentation at the Sachs Immuno-Oncology Forum 20 May 2021 at 14:00 CEST: Participation in the RADIUM podcast 25 May 2021 at 16:00 CEST: Presentation at ABGSC Life Science Summit Seminar 26–27 May 2021: Presentation at BioStock Investor Summit 4 June 2021 at 15.00 CET: ASCO Release of Poster presentation

Key take-aways from Q1 report
- UV1 Phase II program extended to four trials more than 500 patients to be enrolled
- Patient recruitment in the INITIUM and NIPU trials is proceeding despite COVID-19 challenge
- Poster presentation at the 2021 ASCO Annual meeting: ASCO has accepted an abstract from the Phase I trial investigating the combination of UV1 and pembrolizumab in metastatic malignant melanoma
- The TET platform moved into clinical evaluation, with the treatment of the first patient in Phase I TENDU study investigating prostate cancer-specific therapeutic vaccine. The first cohort of three patients has been enrolled as per the reporting date.



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