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Beskrivning

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IndustriBioteknik
Ultimovacs är ett norskt läkemedelsbolag. Bolagets affärsinriktning är att utveckla immunoterapier mot diverse cancertillstånd. Forskning och utveckling utgår ifrån egenbaserad teknologisk plattform, där produkterna huvudsakligen vidareutvecklas som vaccin. Störst närvaro återfinns inom Europa och Nordamerika. Bolaget grundades under 2011 och har sitt huvudkontor i Oslo, Norge.
2020-02-14 08:00:00
Oslo, 14 February 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a
pharmaceutical company developing novel immunotherapies against cancer,
announces its fourth quarter 2019 results today. A presentation by the company's
management team will take place today in meeting room Nyland at Thon Hotel Vika
Atrium (Munkedamsveien 45, 0250 Oslo) at 09:00 CET.

The presentation can be followed as a live webcast (access through link
https://channel.royalcast.com/webcast/hegnarmedia/20200214_10/) which will also
be available on our website. It will be possible to post questions during the
presentation through the webcast.

Highlights for the fourth quarter of 2019:

o The process of starting up the randomized phase II trial in malignant melanoma
(named INITIUM) is progressing according to plan towards inclusion of the first
patient in Q1-20. The trial will include 154 patients.

o UV1 will be investigated in a randomized, multi-center phase II trial in
mesothelioma (named NIPU), sponsored by Oslo University Hospital and supported
by Ultimovacs and Bristol-Myers Squibb. The trial is expected to commence in
Q1-20 and will include a total of 118 patients.

o The initiation of the NIPU trial implies that UV1 will be tested in two large
randomized phase II trials in different cancer types with a total of 272
patients. This represents a major step forward for Ultimovacs and the
development of UV1. Being engaged in two such trials in parallel will enhance
the opportunities for successful clinical results and support that UV1 may be
broadly applicable across cancer types.

o In the US based phase I trial in malignant melanoma, in which UV1 is given in
combination with a PD-1 checkpoint inhibitor, all 20 of the initially planned
patients have been successfully included (cohort 1 – safety pembrolizumab/UV1).
No unexpected safety issues related to UV1 have been observed to date. In this
study, a group of 10 patients (cohort 2 – dose finding GM-CSF) will be added in
order to investigate an increased dosage of the adjuvant GM-CSF. In this second
cohort, three of the ten patients have been included to date and Ultimovacs
expects that the remaining patients will be fully enrolled during 2020. This
trial gives supporting data for future filing applications. The progress of this
trial does not dictate timelines for the randomized phase II trials.

o Ultimovacs has obtained data on overall survival after 4 years in the
metastatic malignant melanoma cancer trial. In this completed phase I/IIa trial,
UV1 was given in combination with ipilimumab. The trial was conducted at the
Oslo University Hospital. Treatment was generally well-tolerated. Immune
responses towards the UV1 peptides occurred very early and 10/11 (91%) of
evaluable patients showed an immune response. With 4 years of follow-up, one
patient obtained a complete tumor response and three patients obtained a partial
response, resulting in an objective response rate of 44% based on 9 evaluable
patients. The median progression free survival (mPFS) was 6.7 months. Overall
survival after 4 years was 50%. Although this study did not have a direct
comparator arm, the results compare favorably to the ipilimumab monotherapy
phase IV study at the Oslo University Hospital (the ‘IPI4 study’). The hospital
enrolled 69 patients in the IPI4 study, with the same investigators, during the
same time period and with similar inclusion criteria as Ultimovacs’ phase I
study. The IPI4 study had a 4-year overall survival of 27.5%, which is
consistent with survival data in the major historical ipilimumab studies. 

o On 7 February 2020, the abstract “A Phase I/IIa Clinical Trial Investigating
the Therapeutic Cancer Vaccine UV1 in Combination with Ipilimumab in Patients
with Malignant Melanoma: 4-year Survival Update” was presented during a poster
session at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium in Florida.

o Total operating expenses for the period amounted to MNOK 27.8, total operating
loss was MNOK 25.4, negative cash flow from operations was MNOK 13.3 and net
decrease in cash and cash equivalents was MNOK 12.4. Total cash and cash
equivalents per 31 December 2019 amounted to MNOK 399.6.  

o As presented in a separate stock exchange announcement on 13 February 2020,
Ultimovacs has appointed Carlos de Sousa as new Chief Executive Officer. Mr. de
Sousa will join Ultimovacs as new CEO on 1 June 2020. Until then, Øyvind
Kongstun Arnesen will continue in his position as CEO.

The report and presentation are also available on the company website. 



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

Øyvind Kongstun Arnesen, CEO
oeyvind.arnesen@ultimovacs.com, +47 469 33 810

Hans Vassgård Eid, CFO
hans.eid@ultimovacs.com, +47 469 19 822