Zelluna ASA — Earnings Release 2022

Nov 10, 2022

Ultimovacs ASA Reports Third Quarter 2022 Financial Results and Provides General Business Update

Ultimovacs ASA Reports Third Quarter 2022 Financial Results and Provides General Business Update

Oslo, November 10, 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical

stage leader in immune stimulatory vaccines for cancer, announces its third

quarter 2022 results today.

Third Quarter 2022 Highlights:

* Ultimovacs is getting close to key value inflection points: Readouts from

the first two UV1 phase II studies in combination with checkpoint

inhibitors, INITIUM and NIPU, are expected during the first half of 2023

* Good patient enrollment continues across Ultimovacs' phase II program,

including the recruitment of the first patients in LUNGVAC, the fifth

randomized phase II clinical trial with UV1 in combination with checkpoint

inhibitors

* New data from our phase I study UV1-103 in malignant melanoma, with the

combination of UV1 and pembrolizumab, showed an encouraging 71% overall

survival rate after three years in cohort 1, on top of the good safety and

33% complete response rate data previously announced for all 30 patients in

the study

* 'Hard-to-treat patients' appear to have much to gain as multiple biomarker

analyses of the biological samples from the UV1-103 study support the

promising efficacy signals

* Financially, Ultimovacs' shareholder base and funding remain strong, with an

expected financial runway until first half of 2024 based on current

programs.

Carlos de Sousa, CEO of Ultimovacs, says:

"Ultimovacs made strong progress in the third quarter of 2022, building towards

the topline readouts from the first two phase II trials of UV1 in combination

with checkpoint inhibitors, INITIUM and NIPU. The company announced very

positive three-year overall survival rate of 71% from its ongoing U.S.-based

phase I trial of UV1 in metastatic malignant melanoma, backed by biomarker data

from the same trial indicating that UV1 may level the odds for patients with

hard-to-treat tumors. We also announced that the first patient had been

randomized in LUNGVAC, the' fifth comparative phase II clinical trial, in lung

cancer.

The new data and clinical progress data reinforce our confidence that the broad

applicability of UV1 in combination with anti-PD1 checkpoint inhibitors in real-

world settings can provide a transformative role in treating solid tumors. Our

progress is built on strong financial foundations, with an expected cash runway

into H1 2024, beyond key value inflection points for the company."

Third Quarter 2022 Summary and Recent Business, Clinical and Research Progress

* On 5 October 2022, Ultimovacs announced positive three-year results of 71%

overall survival rate in Cohort 1 of the UV1-103 trial in metastatic

malignant melanoma. (post period event)

* On 18 October 2022, Ultimovacs ASA announced multiple biomarker analyses

data from the phase I UV1-103 malignant melanoma trial. The analyses of

biological samples from the UV1-103 study support the promising efficacy

signals, including enhanced efficacy in 'hard-to-treat patients' (post

period event)

* On 25 October 2022, Ultimovacs announced that the first patient had been

randomized in the phase II LUNGVAC Trial. (post period event)

* On 22 August 2022, Ultimovacs received a Notice of Allowance from the United

States Patent and Trademarks Office (USPTO) concerning its US patent

application covering methods for eliciting a T cell immune response with the

UV1 universal cancer vaccine.

Clinical Trials Enrollment Update

* INITIUM trial (malignant melanoma): Recruitment was completed in June 2022

with a total of 156 patients. Enrollment has started in the single arm

supplementary study.

* NIPU trial (mesothelioma):  108 out of 118 patients have been enrolled to

date, up from 92 as of the previous quarterly report.

* FOCUS trial (head and neck cancer): 41 out of 75 patients have been enrolled

to date, up from 27 as of the previous quarterly report.

* DOVACC trial (ovarian cancer): 7 out of 184 patients have been enrolled to

date, up from 6 as of the previous quarterly report.

* LUNGVAC trial (non-small cell lung cancer): The first out of 138 patients

was enrolled in October 2022, and a total of 3 patients have been enrolled

to date.

* TENDU trial (prostate cancer): 10 out of 12 patients have been enrolled to

date, up from 9 as of the previous quarterly report.

Scientific Publications and Presentations

* On 18 October 2022, trial investigator Yousef Zakharia presented clinical

endpoint and biomarker data from patients in the UV1-103 Phase I trial, in

an oral presentation entitled "Clinical Activity of Combined Telomerase

Vaccination and Pembrolizumab in Unresectable Melanoma" given at the 19th

International Conference of the Society for Melanoma Research (SMR). (post

period event)

* On 12 September 2022, Ultimovacs announced the publication of data from its

Phase I melanoma trial in Journal of Translational Medicine.

Third Quarter 2022 Financial Results

* Total operating expenses amounted to MNOK 44.1 in Q3-22, and MNOK 111.4 YTD.

Total loss was MNOK 38.3 for the period and MNOK 97.3 YTD.

* Net negative cash flow from operations was MNOK 32.3 in Q3-22, and net

decrease in cash and cash equivalents, not including currency effects, was

MNOK 29.7 during Q3-22. Cash and cash equivalents amounted to MNOK 469.1 as

per 30 September 2022

The quarterly report and presentation will be published at 08:00 CET and will be

publicly available at the Ultimovacs webpage. The presentation by the company's

management team can be followed as a live webcast

(https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20221110_5) at 14:00

CET. The presentation will be held in English and questions can be submitted

throughout the event. The presentation is scheduled to conclude at 14:55 CET.

For further information, please see www.ultimovacs.com or contact:

Carlos de Sousa, CEO

Email: carlos.desousa@ultimovacs.com

Phone: +47 908 92507

Anne Worsøe, Head of IR & Communication

Email: anne.worsoe@ultimovacs.com

Phone: +47 90686815

Mary-Ann Chang, LifeSci Advisors

Email: mchang@lifesciadvisors.com

Phone: +44 7483 284 853

About Ultimovacs

Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to

treat a broad range of cancers. Ultimovacs' lead universal cancer vaccine

candidate UV1 targets human telomerase (hTERT), present in 85-90% of cancers in

all stages of tumor growth. By directing the immune system to hTERT antigens,

UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade

and increase anti-tumor responses. With a broad phase II program in five cancer

indications enrolling more than 650 patients, Ultimovacs aims to clinically

demonstrate UV1's impact in multiple cancer types, in combination with other

immunotherapies, for patients with unmet needs. Ultimovacs' second technology

approach, based on the proprietary Tetanus-Epitope-Targeting (TET) platform,

combines tumor-specific peptides and adjuvant in the same molecule and entered

Phase I studies in 2021.

This information is considered to be inside information pursuant to the EU

Market Abuse Regulation and is subject to the disclosure requirements pursuant

to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Joachim Midttun, Finance

Manager at Ultimovacs ASA, on November 10, 2022 at 08:00CET.