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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

www.ultimovacs.com