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Ultimovacs ASA - Contemplated private placement

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE’S REPUBLIC OF CHINA, SOUTH AFRICA, NEW ZEALAND, JAPAN OR THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL

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Ultimovacs ASA - Contemplated private placement

With reference to the stock exchange notice dated 27 May 2020 – “Ultimovacs ASA Announces Collaboration with Big Pharma Company and Leading European Oncology Clinical Trial Group to Evaluate UV1 in a Third Phase II Clinical Trial”, Ultimovacs ASA (“Ultimovacs” or the “Company”) contemplates a private placement of NOK 160 million (the “Private Placement”) by issuing new shares (the “Offer Shares”). The total number of Offer Shares to be issued will depend on the final offer price and size to be determined following a bookbuilding process, within the current authorisation granted by the Annual General Meeting on 23 April 2020 (the “Authorisation”). ABG Sundal Collier and DNB Markets, a part of DNB Bank ASA are acting as joint bookrunners (the “Joint Bookrunners”) in connection with the Private Placement.

The net proceeds of the Private Placement will secure Ultimovacs’ funding of its part of the expected project costs in the new randomized phase II trial and further strengthen the overall clinical development program of Ultimovacs as well as general corporate purposes.

Gjelsten Holding AS, Canica AS, Watrium AS, Radiumhospitalets Forskningsstiftelse, Langøya Invest AS, Helene Sundt AS and CGS Holding AS (the “Underwriters”) and Prieta AS have pre-committed shares corresponding to a total subscription amount of at least NOK 43.7 million and the Underwriters have in addition underwritten NOK 36.3 million (in total at least NOK 80 million).

The Private Placement will be directed towards Norwegian and international institutional investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. The Private Placement is fully covered on pre-commitments and indications received during a market sounding process earlier today. As a result, from the time of this release only existing shareholders in the Company can expect to be allocated shares in the Private Placement.

The subscription price and allocation of shares in the Private Placement will be determined through an accelerated bookbuilding process. The bookbuilding period commences today at 16:30 CET and will close at 08:00 CET on 28 May 2020. The bookbuilding may, at the discretion of the Company and the Joint Bookrunners, close earlier or later and may be cancelled at any time and consequently, the Company may refrain from completing the Private Placement. The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before the opening of trading on the Oslo Stock Exchange tomorrow, 28 May 2020. Completion of the Private Placement is subject to final approval by the Company’s Board of Directors (the “Board”).

The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of EUR 100,000, provided that the Company may, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to applicable regulations, including the Norwegian Securities Trading Act and ancillary regulations, are available.

Notification of allotment and payment instructions is expected to be issued to the applicants on or about 28 May 2020 through a notification to be issued by the Joint Bookrunners. The allocation will be determined at the end of the bookbuilding period and final allocation will be made at the Board of Directors’ sole discretion.

The Offer Shares allocated in the Private Placement are expected to be settled through a delivery versus payment transaction by delivery of existing and unencumbered shares in the Company that are already listed on Oslo Børs, pursuant to a share lending agreement between the Company, Gjelsten Holding AS and the Joint Bookrunners. The Offer Shares will thus be tradable from allocation. The Joint Bookrunners will settle the share loan with a corresponding number of new shares in the Company to be issued by the Board pursuant to the Authorisation.

The Company has agreed with the Joint Bookrunners to a lock-up on future share issuances for a period of 180 days from the settlement date for the Private Placement, subject to customary exceptions. The Company’s Board, members of the executive management and the board represented shareholders have all agreed with the Managers to a lock-up on existing shareholdings for a period of 180 days from the settlement date for the Private Placement, subject to customary exceptions.

The Board of Directors has considered the Private Placement in light of the equal treatment obligations under the Norwegian Securities Trading Act and Oslo Børs’ Circular no. 2/2014, and is of the opinion that the proposed Private Placement is in compliance with these requirements. The Board is of the view that it will be in the common interest of the Company and its shareholders to raise equity through a private placement, in view of the current market conditions and the growth opportunities currently available to the Company. A private placement enables the Company to raise capital in an efficient manner, and the Private Placement is structured to ensure that a market based subscription price is achieved.

For additional information, please contact:

Øyvind Kongstun Arnesen, CEO, oeyvind.arnesen@ultimovacs.com, +47 469 33810

Hans Vassgård Eid, CFO, hans.eid@ultimovacs.com, +47 482 48632

Important Notices

This announcement is not and does not form a part of any offer to sell, or a solicitation of an offer to purchase, any securities of the Company. The distribution of this announcement and other information may be restricted by law in certain jurisdictions. Copies of this announcement are not being made and may not be distributed or sent into any jurisdiction in which such distribution would be unlawful or would require registration or other measures. Persons into whose possession this announcement or such other information should come are required to inform themselves about and to observe any such restrictions.

The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any part of the offering or their securities in the United States or to conduct a public offering of securities in the United States. Any sale in the United States of the securities mentioned in this announcement will be made solely to “qualified institutional buyers” as defined in Rule 144A under the Securities Act.

In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State. The expression “Prospectus Regulation” means Regulation 2017/1129 as amended together with any applicable implementing measures in any Member State.

This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This communication must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only for relevant persons and will be engaged in only with relevant persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “strategy”, “intends”, “estimate”, “will”, “may”, “continue”, “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control.

Actual events may differ significantly from any anticipated development due to a number of factors, including without limitation, changes in investment levels and need for the Company’s services, changes in the general economic, political and market conditions in the markets in which the Company operate, the Company’s ability to attract, retain and motivate qualified personnel, changes in the Company’s ability to engage in commercially acceptable acquisitions and strategic investments, and changes in laws and regulation and the potential impact of legal proceedings and actions. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not provide any guarantees that the assumptions underlying the forward-looking statements in this announcement are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this announcement or any obligation to update or revise the statements in this announcement to reflect subsequent events. You should not place undue reliance on the forward-looking statements in this document.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

Neither of the Joint Bookrunners nor any of their respective affiliates makes any representation as to the accuracy or completeness of this announcement and none of them accepts any responsibility for the contents of this announcement or any matters referred to herein.

This announcement is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgment. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy any securities or a recommendation to buy or sell any securities in the Company. Neither the Joint Bookrunners nor any of their respective affiliates accepts any liability arising from the use of this announcement.

This information is subject of the disclosure requirements of section 5-12 of the Norwegian Securities Trading Act.

Kilde

[Funcomi10kr]

Ultimovacs leverer virkelig, de største eierne garanterer for 50% av emisjonen og vi er på lag med nok et big pharma selskap, gleder meg til fortsettelsen!

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Ultimovacs ASA - Private placement of new shares successfully placed

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE’S REPUBLIC OF CHINA, SOUTH AFRICA, NEW ZEALAND, JAPAN OR THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL

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Ultimovacs ASA - Private placement of new shares successfully placed

Oslo, Norway, 28 May 2020

Reference is made to the stock exchange announcement by Ultimovacs ASA (OSE: ULTIMO) ("Ultimovacs” or the “Company”) on 27 May 2020 regarding the contemplated private placement of new shares (the “Offer Shares”) of NOK 160 million (the “Private Placement”). The Company hereby announces that it has allocated 4,113,111 new shares in the Private Placement at a subscription price of NOK 38.90 per share, raising gross proceeds of NOK 160 million. ABG Sundal Collier and DNB Markets, a part of DNB Bank ASA are acting as joint bookrunners (the “Joint Bookrunners”) in connection with the Private Placement.

The net proceeds of the Private Placement will secure Ultimovacs’ funding of its part of the expected project costs in the new randomized phase II trial and further strengthen the overall clinical development program of Ultimovacs as well as general corporate purposes.

Notification of allotment of the Offer Shares including settlement instructions will be sent to the applicants through a notification from the Joint Bookrunners on 28 May 2020.

Offer Shares will be settled with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between the Company, Gjelsten Holding AS and DNB Markets in order to facilitate delivery of listed shares to investors on a delivery versus payment basis. The Offer Shares will thus be tradable from allocation. DNB Markets will settle the share loan with a corresponding number of new shares in the Company to be issued by the Board of Directors pursuant to the authorization granted at the Company’s annual general meeting on 23 April 2020.

Following registration of the new share capital pertaining to the Private Placement, the Company will have a share capital of NOK 3,197,351.10 divided into 31,973,511 shares, each with a par value of NOK 0.10.

The Board of Directors has considered the Private Placement in light of the equal treatment obligations under the Norwegian Securities Trading Act and Oslo Børs’ Circular no. 2/2014, and is of the opinion that the Private Placement is in compliance with these requirements. The Board of Directors is of the view that it is in the common interest of the Company and its shareholders to raise equity through a private placement, in view of the current market conditions and the growth opportunities currently available to the Company. A private placement enables the Company to raise capital in an efficient manner, and the Private Placement is structured to ensure that a market based subscription price is achieved.

The following primary insiders were allocated Offer Shares in the Private Placement:

Gjelsten Holding AS, represented on the board by Henrik Schüssler, has been allocated 424,267 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 6,171,866 shares, corresponding to 19.3% of the total number of shares and votes in the Company (passing below the 20% disclosure threshold).

CGS Holding AS, represented on the board by Leiv Askvig, has been allocated 100,000 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 882,132 shares, corresponding to 2.8% of the total number of shares and votes in the Company.

Helene Sundt AS, represented on the board by Leiv Askvig, has been allocated 100,000 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 882,132 shares, corresponding to 2.8% of the total number of shares and votes in the Company.

Sundt AS, represented on the board by Leiv Askvig, has been allocated 75,000 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 692,150 shares, corresponding to 2.2% of the total number of shares and votes in the Company.

Watrium AS, represented on the board by Kristin Louise Abrahamsen Wilhelmsen, has been allocated 119,650 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 1,740,575 shares, corresponding to 5.4% of the total number of shares and votes in the Company.

Board member Leiv Askvig, through Basen Kapital AS, has been allocated 12,000 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 91,500 shares, corresponding to 0.3% of the total number of shares and votes in the Company.

Board member Ketil Fjerdingen, through Langøya Invest AS, has been allocated 115,681 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 1,342,006 shares, corresponding to 4.2% of the total number of shares and votes in the Company.

Radiumhospitalets Forskningsstiftelse, represented on the board by Jónas Einarsson and Eva Dugstad, has been allocated 103,038 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 1,498,913 shares, corresponding to 4.7% of the total number of shares and votes in the Company (passing below the 5% disclosure threshold).

Finance Manager and primary insider Joachim Midttun has been allocated 6,800 Offer Shares in the Private Placement, and will following delivery of such Offer Shares hold an aggregate of 10,000 shares, corresponding to 0.0% of the total number of shares and votes in the Company.

For additional information, please contact:

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

Hans Vassgård Eid, CFO hans.eid@ultimovacs.com, +47 482 48 632

Important Notices

This announcement is not and does not form a part of any offer to sell, or a solicitation of an offer to purchase, any securities of the Company. The distribution of this announcement and other information may be restricted by law in certain jurisdictions. Copies of this announcement are not being made and may not be distributed or sent into any jurisdiction in which such distribution would be unlawful or would require registration or other measures. Persons into whose possession this announcement or such other information should come are required to inform themselves about and to observe any such restrictions.

The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any part of the offering or their securities in the United States or to conduct a public offering of securities in the United States. Any sale in the United States of the securities mentioned in this announcement will be made solely to “qualified institutional buyers” as defined in Rule 144A under the Securities Act.

In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State. The expression “Prospectus Regulation” means Regulation 2017/1129 as amended together with any applicable implementing measures in any Member State.

This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This communication must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only for relevant persons and will be engaged in only with relevant persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “strategy”, “intends”, “estimate”, “will”, “may”, “continue”, “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control.

Actual events may differ significantly from any anticipated development due to a number of factors, including without limitation, changes in investment levels and need for the Company’s services, changes in the general economic, political and market conditions in the markets in which the Company operate, the Company’s ability to attract, retain and motivate qualified personnel, changes in the Company’s ability to engage in commercially acceptable acquisitions and strategic investments, and changes in laws and regulation and the potential impact of legal proceedings and actions. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not provide any guarantees that the assumptions underlying the forward-looking statements in this announcement are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this announcement or any obligation to update or revise the statements in this announcement to reflect subsequent events. You should not place undue reliance on the forward-looking statements in this document.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

Neither of the Joint Bookrunners nor any of their respective affiliates makes any representation as to the accuracy or completeness of this announcement and none of them accepts any responsibility for the contents of this announcement or any matters referred to herein.

This announcement is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgment. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy any securities or a recommendation to buy or sell any securities in the Company. Neither the Joint Bookrunners nor any of their respective affiliates accepts any liability arising from the use of this announcement.

This information is subject of the disclosure requirements of section 5-12 of the Norwegian Securities Trading Act.

Kilde

[Tekspert]

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

1. @polygon (134 likes)

Da er INITIUM på Clinicaltrials også!

2. @Neladner (88 likes)

Ultimovacs småprat (ULTIMO)

Det at jeg ikke kan svare betyr ikke at jeg ikke setter pris på engasjementet. Jeg er imponert over hvor mye du og andre har skjønt uten å ha faglig bakgrunn. I tiden framover skal jeg bidra til å heve nivået ytterligere, det er mye lettere når jeg ikke har ansvaret for kommunikasjonen fra ett enkelt selskap.

3. @Fornybar (60 likes)

Ultimovacs småprat (ULTIMO)

Så for å oppsummere:

Resten av topp 10:

4. @Investor (22 likes)

5. @Otard (13 likes)

6. @Funcomi10kr (11 likes)

7. @Boykie (10 likes)

8. @Senior (9 likes)

9. @Bra_Britt (6 likes)

10. @Dormancy (5 likes)

Gratulerer!

[Savepig]

Ultimovacs småprat (ULTIMO)

Tenkte å komme med en kommentar på siste nyhet fra Ultimovacs, og det passer godt i dag, for styreleder i Ultimovacs hevder i alle fall det jeg har sagt for en stund siden, og det er at selv om ikke tidligere CEO Kongstun har i nærheten av lovet noe, så er det en helt reell mulighet at det fint kan være mulig å få en godkjennelse basert på en, og nå etter hvert kanskje flere av disse RP2Ts (randomised phase 2 trials).

Jonas Einarsson i dagens Radium Podcast:

"Selskapet har som kjent gjort de første fase 1/2 studiene, hvor vi hadde spennende resultater, men selvfølgelig ikke noe vi kan ha noe statistikk på, men med tydelige tegn på klinisk effekt.
Og så var da planen videre å teste dette ut i ordentlige randomiserte studie, til å begynne med, for det var den første studien i malignt melanom, som da selskapet selv er hovedsponsor for, og har full kontroll på hele studien. Det må vi ha, en sånn en randomsert. Det er den såkalte INITIUM-studien, som er i ferd med å starte opp i USA og Europa, og ikke minst her på Radiumhospitalet hvor vi håper at den første pasienten skaø komme inn relativt raskt, det jobbes med det. Studien er jo åpen.
Og så lanserte vi denne NIPU-studien, som er i mesotheliom, som også er en kombinasjonsstudie og også en randomisert studie.
Da har vi 2 forskjellige indikasjoner der, og så kommer nå da den tredje, som også er en randomisert studie, og en relativt stor fase 2 studie i en ny indikasjon, så da har vi altså da gående et program med 3 randomsierte studier med mer enn 400 pasienter.

Og håpet er da at resultatene av disse 3 studiene skal bli så bra at vi kan file eller få en eller annen form for godkjenning på de."

Synes også Ultimovacs får mye “bang for the bucks”, og synes den investoren som sa i følge Kongstun “Low on hype, high on content” treffer spikeren på hodet.
Og det virker jo som BP også tenker i de baner, som faktisk bidrar med betydelige innsatsfaktorer i disse studiene.

Har ennå ikke klart å snuble meg inn i Ultimovacs, tross at det er pt er en av mine 3 favoritter på OSE, etter PCIB og PHO. Men det er vel snart på tide.

Har vel også hevdet at Photocure er et selskap med svært liten risiko, og flott oppside som alle bør ha i porteføljen sin, men synes Ultimovacs begynner å ligne på et selskap flere biotekinvestorer bør ha “i bunn av porteføljen sin”.
Begrunnelsen er at kapitaliseringen virker solid, og disse 3 studiene vil putre og gå i jevn fart fremover, slik at det er liten sannsynlighet for plutselige ubehagelige (kurs)overraskelser, samtidig som det kan komme hyggelige meldinger, og stadig høyere nivåer i årene fremover.

Ad det samme, så bet jeg meg merke i flere kliniske forsøk som har et godt samspill med hverandre, godt antall pasienter, ok finansiering, randomisering og sikte på registrering.

Det er et fint sett med avkrysningsbokser som smekker på plass der.

[TekBot]

Ultimovacs ASA – New share capital registered

Oslo, Norway, 5 June 2020

Reference is made to the stock exchange announcement published by Ultimovacs ASA (the “Company”) on 28 May 2020 regarding the successful placing of a private placement with gross proceeds of approximately NOK 160 million (the “Private Placement”).
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The share capital increase related to Private Placement has been registered with the Norwegian Register of Business Enterprises. Following such registration, the share capital of the Company is NOK 3,197,351.10, divided into 31,973,511 shares, each with a par value of NOK 0.10.

This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

For further information, please visit 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

Kilde

[TekBot]

Ultimovacs ASA Announces First Patient Enrolled in the NIPU Phase II Clinical Trial Testing UV1 Against Mesothelioma

Oslo, 15 June 2020: Ultimovacs ASA (“Ultimovacs” or “Company”, ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, announced today that the first patient has been enrolled in the Phase II NIPU trial evaluating its lead product, UV1, as part of a combination treatment regimen against advanced malignant pleural mesothelioma (MPM), a rare lung cancer. The current clinical development timeline for UV1 in this indication remains in line with past guidance.

The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, will be investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in 118 patients with advanced malignant pleural mesothelioma. Oslo University Hospital (OUS) is the trial sponsor and first site to open. OUS is partnered with Ultimovacs and the global pharmaceutical leader, Bristol-Myers Squibb, which will provide ipilimumab and nivolumab for this study. OUS is in the process of activating the remaining sites in this trial.
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Jens Bjørheim, Chief Medical Officer at Ultimovacs ASA commented:
“Advanced malignant pleural mesothelioma is an indication that still has a high unmet medical need. As such, the collaboration group with OUS and Bristol-Myers Squibb enables Ultimovacs to evaluate UV1 in a difficult-to-treat type of cancer in which we believe it could add benefit and work synergistically with checkpoint inhibitors. The continued enrollment in the NIPU trial remains an important part of our extensive Phase II clinical program in which we are planning to include more than 400 patients in three studies. Our hope is to provide an improved therapeutic option to patients suffering from a disease in which median overall survival is one year.”

Carlos de Sousa, Chief Executive Officer at Ultimovacs ASA added:
“The initiation of the NIPU trial follows the recent announcement of the entry into a collaboration with a big pharma and a leading European oncology clinical trial group as well as the successful completion of an oversubscribed private placement which fully finances the current UV1 clinical development program. The dosing of the first patient in our Phase II INITIUM trial in metastatic malignant melanoma is also expected soon. We are grateful for the support from our collaborator group that provides significant value to the program and enables the testing of UV1 in an underserved indication. Our goal is to continue to apply this type of collaboration model to the ongoing evaluation of UV1 in the future and ideally, deliver the full value of immunotherapy to patients in need.”

About NIPU
The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in mesothelioma. Oslo University Hospital (OUS) is the sponsor of the NIPU study. Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. A total of 118 patients will be included in the NIPU study. Half of the patients will be treated with the combination of UV1, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at six national hospital centers specialized in treating mesothelioma in four countries (Norway, Sweden, Denmark and Australia). The study sites are planned to be Oslo University Hospital in Norway, Karolinska University Hospital and Skåne University Hospital Lund in Sweden, Copenhagen University Hospital and Aalborg University Hospital in Denmark and University of Western Australia in Perth, Australia.

The objective of the study is to induce a clinically meaningful progression-free survival benefit in patients with advanced malignant pleural mesothelioma after progression on first-line standard platinum doublet chemotherapy. The primary endpoint of the trial is progression-free survival. Planned readout of topline results is expected in the second half of 2022.

Advanced malignant pleural mesothelioma is a rare malignant tumor originating from the cells lining the mesothelial surface in the lungs. It is the most common type of mesothelioma and is a disease with a high unmet medical need with a median overall survival of approximately 1 year. It is a serious form of thoracic cancer that is diagnosed in more than 30,000 and kills over 25,000 people per year.

About UV1 and the Phase II Clinical Trials
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen, telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immuno-oncology drugs which require an ongoing T cell response for their mode of action. To date, UV1 has been tested in four clinical trials in a total of 78 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

In addition to the NIPU trial described above, UV1 will be tested in two other randomized Phase II trials:
• The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma. Patients will be given UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor). The trial will be run in the US and Europe (including Norway). A total of 154 patients will be enrolled in the INITIUM study. 77 of the patients will be treated with nivolumab and ipilimumab, whereas the other 77 patients will receive nivolumab, ipilimumab and UV1. The primary endpoint of the study is progression-free survival. Planned readout of topline results is expected in the second half of 2022.
• A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.

The Phase II clinical program builds on three completed studies and one ongoing Phase I clinical trial. The Phase II trials will evaluate UV1 in three different indications in more than 400 patients and in collaboration with two big pharma companies. These trials are all fully financed. The ongoing and planned clinical trials represent a strong platform for Ultimovacs to advance towards a potential registration of the universal cancer vaccine, UV1.

For further information, please visit 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

Kilde

[Savepig]

Pent!

[Fornybar]

The dosing of the first patient in our Phase II INITIUM trial in metastatic malignant melanoma is also expected soon. We are grateful for the support from our collaborator group that provides significant value to the program and enables the testing of UV1 in an underserved indication. Our goal is to continue to apply this type of collaboration model to the ongoing evaluation of UV1 in the future and ideally, deliver the full value of immunotherapy to patients in need

For investorene er dette veldig relevant.

[Otard]

Og Radforsk har tilfeldigvis fylt opp kontoen med 103000 aksjer på nyeste lista også.
NRK nyheter har også en sak om at immunterapi for lungekreft har gitt mange pasienter et lengre liv og at de får det bedre, men fremdeles er det litt bingo hvem som har nytte av immunterapi. Drammen vil nå igangsette et studie for å prøve å finne ut hvem som kan ha nytte av immunterapi. Litt fritt etter hukommelsen. Det pleier å komme i loop flere ganger nå på morran.

[polygon]

Det er altså bare aksjene de fikk tildelt i emisjonen for to uker siden. Og av en eller annen grunn ble overført lenge etter alle de andre.

[polygon]

Vi satser på UV1 som standard behandling sammen med sjekkpunkthemmere i samtlige indikasjoner, ja

[Fornybar]

@Neladner @forsk Hvorfor blir aktører som Folketrygdfondet invitert med på emisjonene deres når det første de gjør er å kaste ut aksjene til shortaktører. De fungerer jo som en fyrlykt for tørste shortfond som vil manipulere lille Oslo Børs.

Det gjør at selskapet må levere 100% for å ikke få kursen gruset, og aksjonærverdiene ødelagt. Kanskje tilogmed evnen til å hente penger i fremtiden.

Kan vanskelig tro at å legge opp til storstilt shorting av utviklingsselskaper med laaaange, kapitalkrevende løp er en god idé.

Det må da finnes andre penger å få tak i, om emisjonene er så overtegnet som det fremstilles.

[polygon]

det første de gjør er å kaste ut aksjene til shortaktører.

Ja, det lukter jo veldig utlån av de 50K de har gått ned med siden emisjonen.

Har man prøvd noe så enkelt som å snakke med dem?

[Fornybar]

Ja, de låner som prinsipp ut aksjer for å få meravkastning. At kursen går ad undas er ikke så nøye, for de får jo renteinntekter.

[polygon]

Ja, og hvor mange tuselapper tjener de pa. på å låne ut 50K aksjer i ultimo? Forsvinnende få!

Men når det er sagt, så tror jeg disse aksjene uansett bare blir stående på en meglerkonto, og ikke faktisk blir lånt videre og solgt. …slik som ting ser ut nå i hvert fall…

[Fornybar]

Det skal sies at dette kun er negativt dersom selskapet ikke leverer på guiding og det blir kurspress nedover. Leverer de som forespeilet - og det virker de jo å gjøre - vil de jo sannsynligvis måtte dekke inn til langt høyere kurser enn de solgte på.

[Rahl]

“meravkastning” er faen meg relativt ass…

[TekBot]

Ultimovacs ASA Announces First Patient Dosed in the Phase II INITIUM Trial in Metastatic Malignant Melanoma

Oslo, 15 June 2020: Ultimovacs ASA (“Ultimovacs” or “Company”, ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, announced today that the first patient has been dosed in the global, randomized Phase II INITIUM clinical trial testing Ultimovacs’ lead candidate, UV1, in combination with ipilimumab and nivolumab in 154 patients with metastatic malignant melanoma. The first patient was dosed at the Oslo University Hospital (OUS) which is the first site to open in this trial. Topline results are anticipated to be announced in the second half of 2022.

Jens Bjørheim, Chief Medical Officer at Ultimovacs ASA commented:
…

Vis børsmeldingen

“As our Company-sponsored Phase II trial, INITIUM represents an important focus for our UV1 clinical development program. The first patient dosed marks the achievement of an important milestone for the Company in our lead indication, metastatic malignant melanoma, in which patients often do not have a long-lasting response to current treatments. As a Phase II proof of concept study, the INITIUM trial has the potential for regulatory submission based on supportive trial results. We look forward to the continued enrollment in the INITIUM trial as it is an important part of our extensive Phase II clinical program in which we are planning to include more than 400 patients in three studies.”

Carlos de Sousa, Chief Executive Officer at Ultimovacs ASA added:
“The dosing of the first patient in the INITIUM trial today coincides with the dosing of the first patient in the other Phase II clinical trial, NIPU, which will test UV1 in patients with advanced malignant pleural mesothelioma. These important milestones follow our recent announcement of entry into a collaboration with a big pharma company and European oncology clinical trial group to evaluate UV1 in another oncological indication. Subsequently, the Company also successfully completed an oversubscribed private placement, which fully finances the current UV1 clinical development program. It is exciting to join Ultimovacs at this particularly dynamic time and I look forward to supporting the Company as it explores the potential of its universal cancer vaccine in patients with difficult to treat cancers.”

Ultimovacs is in the process of activating more than 35 sites globally for the INITIUM trial. Additional hospitals in Norway, other European countries as well as the United States will be opened for patient inclusion throughout the second and third quarters of 2020.

About INITIUM
The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma. Patients will be given UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor). The trial will be run in the US and Europe (including Norway). A total of 154 patients will be enrolled in the INITIUM study. 77 of the patients will be treated with nivolumab and ipilimumab, whereas the other 77 patients will receive nivolumab, ipilimumab and UV1. The primary endpoint of the study is progression-free survival. Planned readout of topline results is expected in the second half of 2022.

About UV1 and the Phase II Clinical Trials
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen, telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immuno-oncology drugs which require an ongoing T cell response for their mode of action. To date, UV1 has been tested in four clinical trials in a total of 78 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

In addition to the INITIUM trial described above, UV1 will be tested in two other randomized Phase II trials:
• The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in mesothelioma. Oslo University Hospital (OUS) is the sponsor of the NIPU study. Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. A total of 118 patients will be included in the NIPU study. Half of the patients will be treated with the combination of UV1, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at six national hospital centers specialized in treating mesothelioma in four countries (Norway, Sweden, Denmark and Australia). Planned readout of the primary endpoint progression-free survival is H2-2022.
• A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.

The Phase II clinical program builds on three completed studies and one ongoing Phase I clinical trial. The Phase II trials will evaluate UV1 in three different indications in more than 400 patients and in collaboration with two big pharma companies. These trials are all fully financed. The ongoing and planned clinical trials represent a strong platform for Ultimovacs to advance towards a potential registration of the universal cancer vaccine, UV1.

For further information, please visit 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

Kilde