Oslo, 22 August 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage
biotechnology leader in novel immunotherapeutic cancer vaccines, announces its
second quarter 2023 results today.
"In the first half of this year, Ultimovacs has further advanced the broad
evaluation of our therapeutic cancer vaccine UV1 across key indications. Our
UV1-103 study in the U.S. continues to demonstrate encouraging and lasting
patient survival, a direct measure of clinical benefit in cancer trials. In
addition, we recently reached an important milestone with three randomized Phase
II studies fully enrolled in different cancer indications. We are eagerly
awaiting the forthcoming data these trials will provide, helping us better
comprehend UV1's potential and the benefits it can provide in the clinical
outcomes for the patients," said Carlos de Sousa, CEO of Ultimovacs. "The data
from these randomized Phase II studies, expected within the Company's current
financial runway, will guide us on the path towards bringing UV1 to the market
and making a positive impact on the lives of cancer patients."
Second Quarter 2023 Highlights:
* In April, Ultimovacs revised the readout timeline for INITIUM due to slower
patient disease progression than anticipated. All patients have been
monitored for over 12 months. Patient follow-up continues until 70 confirmed
cases of cancer progression have been reached, which is still outstanding.
The updated readout is now expected in the first half of 2024, with the
extended period bearing minor cost implications for the Company. Assuming
continued slow progression in the number of events, Ultimovacs will explore
alternative approaches for data readout acceptable to regulatory
authorities.
* In June, Ultimovacs reported topline results from the UV1 Phase II NIPU
study. While the primary Progression Free Survival (PFS) endpoint was not
met in the independent central review, a significant positive PFS outcome
was measured in the on-site analyses at all five study centers in Australia,
Spain, Denmark, Sweden, and Norway. Furthermore, an encouraging trend in
Overall Survival (OS) benefit was observed in the UV1 arm compared to the
control arm. Detailed data and updated results will be presented at an
international medical conference during this fall.
* In August, the Company announced enrollment completion of 75 patients with
head and neck cancer for the UV1 Phase II FOCUS study. The topline readout,
including PFS and OS, will be disclosed after 12 months minimum follow up,
expected in second half 2024.
* In total, more than 300 cancer patients have now received treatment with UV1
in Phase I and Phase II trials. To date, no safety concerns have been
reported with the use of UV1.
* Ultimovacs has further solidified its patent estate receiving an Intention
to Grant from the European patent office in April, and a Decision to Grant
from the Japanese patent office in July, for the protection of UV1 cancer
vaccine-checkpoint inhibitor combinations until at least 2037. These patents
will be the European and Japanese counterpart of the US patent which was
granted in August 2022.
* In June, the clinical and biomarker analyses of the UV1-103 Phase I trial
was published in Clinical Cancer Research, a renowned peer-reviewed journal
by the American Association for Cancer Research.
* In June, Ultimovacs' Chief Scientific Officer Gustav Gaudernack was awarded
the Norwegian Tech Awards' Honorary Prize as an outstanding pioneer in the
fight against cancer.
* Ultimovacs continues to expect that the current cash resources will support
operations until mid-2024, based on current programs. The extension of the
timeline for the INITIUM topline readout has limited financial impact for
the Company.
Clinical trial enrollment updates
UV1 Phase II Program:
* INITIUM (malignant melanoma): Enrollment of 156 patients completed in
JulyJune 2022. Topline readout expected in H1 2024.
* NIPU (metastatic pleural mesothelioma): Enrollment of 118 patients was
completed in January 2023. Topline readout was announced in Q2 2023.
Detailed and updated data expected Q4 2023.
* FOCUS (head and neck cancer): Enrollment of 75 patients completed in August
2023. Topline readout expected H2 2024.
* DOVACC (ovarian cancer): 37 out of 184 patients have been enrolled to date,
up from 24 as of the previous quarterly report. Topline readout expected in
H2 2024.
* LUNGVAC (non-small cell lung cancer): 11 out of 138 patients have been
enrolled to date, up from 7 as of the previous quarterly report. Topline
readout expected H2 2025.
TENDU Phase I trial (prostate cancer) based on the TET technology platform:
Enrollment of 12 patients was completed in mid-December 2022. Readout expected
H2 2023.
Financial update
* Ultimovacs expects that the current cash resources will support operations
to H2 2024, based on current programs and plans, i.e., through the reporting
of overall survival data in NIPU and the topline readouts in INITIUM and
FOCUS. The revised time for INITIUM topline readout has minor cost
implications for Ultimovacs.
* Total operating expenses amounted to MNOK 50.6 in Q2 2023, and MNOK 101.4
YTD. Total loss was MNOK 43.4 for the period and MNOK 77.5 YTD.
* Net negative cash flow from operations was MNOK 71.0 in Q2 2023, and net
decrease in cash and cash equivalents, not including currency effects, was
MNOK 68.1 during Q2 2023. Cash and cash equivalents amounted to MNOK 344.1
as per 30 June 2023.
The quarterly report and presentation will be published at 08:00 CEST on 22
August 2023 and will be publicly available on the Ultimovacs website. The
presentation by the Company's management can be followed as a live webcast
(https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20230822_2) at 14:00
CEST today, 22 August 2023. Questions can be submitted throughout the event. The
webcast is scheduled to conclude at 14:55 CEST.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632
Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86815
About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines with broad applicability. Ultimovacs' lead cancer vaccine
candidate, UV1 is directed against human telomerase (hTERT), an antigen that is
present in 85-90% of cancers in all stages of tumor growth. A broad clinical
program, with Phase II trials in five cancer indications enrolling more than
670 patients, aims to demonstrate UV1's impact in combination with other
immunotherapies in multiple cancer types expressing telomerase and where
patients have unmet medical needs. UV1 is universal, off-the-shelf and easy to
use, and is a patented technology owned by Ultimovacs.
In addition, Ultimovacs' adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific antigens and
adjuvant in the same molecule and is in Phase I clinical development.
This information is subject of 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 August 22 2023 at 08:00 CET.