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First Quarter 2023 Highlights
- Ultimovacs is well prepared for the data readout from the first two
randomized UV1 Phase II studies in malignant melanoma (INITIUM) and
metastatic pleural mesothelioma (NIPU).
- Data from the INITIUM study were previously expected during the first half
of 2023, based on historical timelines for the disease progression and
standard of care treatment. In April, Ultimovacs announced that it is taking
longer than anticipated for the 156 patients in the INITIUM trial to
experience disease progression. This is positive for the patients and
guidance for readout was extended to the second half of 2023 from first
half.
- Enrollment of 118 patients in the NIPU trial was completed in January 2023.
Topline data continues to be expected during the first half of 2023.
- Enrollment in the randomized Phase II study in head and neck cancer (FOCUS)
is on track and has reached 80%, with 61 out of 75 the patients recruited.
- Ultimovacs received from the European Patent Office a Notice of Intention to
Grant a patent on UV1 in combination with checkpoint inhibitors, a
counterpart to the U.S. patent granted last year.
- Ultimovacs continues to expect that the current cash resources will support
operations until mid-2024, based on current programs. The extension of
timeline for INITIUM topline readout has limited financial impact for
Ultimovacs.
Carlos de Sousa, CEO of Ultimovacs, says:
“In the first quarter of 2023, Ultimovacs made overall good progress with our
ambitious Phase II clinical program to assess the universal cancer vaccine UV1
in a broad range of indications. Patients participating in the INITIUM study in
malignant melanoma are taking longer than anticipated to experience disease
progression when comparing with historical data. Although we have not yet
received the trial data, we are optimistic and encouraged by this positive
development for the patients. We now expect to announce the topline results from
INITIUM in the second half of 2023. The NIPU trial in metastatic pleural
mesothelioma completed enrollment in January this year, and we continue to
expect results in this first half of 2023. Enrollment in the FOCUS study in head
and neck cancer is on track, and we expect results in first half of next year.
With three sets of data from randomized, comparative Phase II trials expected
within a year, we are looking forward to an exciting time ahead as these data
will provide important direction on the best path forward towards regulatory
approval.”
Update on UV1 Phase II Clinical Development Program
- INITIUM (malignant melanoma): Enrollment was completed in July 2022 with a
total of 156 patients. Readout expected H2 2023.
- NIPU (metastatic pleural mesothelioma): Enrollment was completed in January
2023 with a total of 118 patients. Readout expected H1 2023.
- FOCUS (head and neck cancer): 61 out of 75 patients have been enrolled to
date, up from 50 as of the previous quarterly report. Readout expected H1
2024.
- DOVACC (ovarian cancer): 24 out of 184 patients have been enrolled to date,
up from 17 as of the previous quarterly report. Readout expected H2 2024.
- LUNGVAC (non-small cell lung cancer): 7 out of 138 patients have been
enrolled to date, up from 2 as of the previous quarterly report. 3 patients
treated with pembrolizumab prior to the change in reimbursement, will be
maintained as a separate sub-group in the trial. Readout expected H2 2025.
First Quarter 2023 Financial Results
- Total operating expenses amounted to MNOK 50.8 in Q1 2023, and total loss
was MNOK 34.1 for the period.
- Net negative cash flow from operations was MNOK 36.6 in Q1 2023, and net
decrease in cash and cash equivalents, not including currency effects, was
MNOK 34.0. Cash and cash equivalents amounted to MNOK 405.5 as per 31 March
2023.
The quarterly report and presentation will be published at 08:00 CET on 10 May
2023 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/20230510_8) at 14:00
CET today, 10 May 2023. 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
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 which 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 peptides 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 May 10, 2023 at 08:00 CET.
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