GlobeNewswire by notified

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

Share

Oslo, August 19, 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announces its second quarter 2022 results today. The presentation by the company's management team can be followed as a live webcast at 09:00 CET and will be made available on the website. It will be possible to post questions during the presentation through the webcast.

Highlights of Second Quarter 2022 and Recent Business, Clinical and Research Progress

  • On 30 June 2022, Ultimovacs completed the planned recruitment of 154 patients in the INITIUM trial. Two additional patients were enrolled in July 2022, bringing the final number of patients enrolled to 156. Consistent with INITIUM’s event-driven design, topline progression-free survival results will be disclosed after progression of cancer or death has been observed in a total of 70 patients.
  • On 20 June 2022, Ultimovacs announced positive 2-year overall survival data in UV1-103, the ongoing phase I clinical study of the cancer vaccine UV1 in combination with pembrolizumab for the treatment of malignant melanoma. Across all 30 patients in the study, the 24-month overall survival rate was 73%. Patients will continue to be followed for long-term survival.
  • On 22 April 2022, Ultimovacs received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) concerning its US patent application on the use of vaccine-checkpoint inhibitor combinations to treat cancer (also reported in the Q1-2022 report).

Clinical TrialsEnrollment Update

  • INITIUM trial: Recruitment has been completed. In total 156 patients have been enrolled – 154 patients as originally planned, plus two additional patients.
  • NIPU trial: 92 out of 118 patients have been enrolled to date, up from 78 as of the previous quarterly report.
  • FOCUS trial: 27 out of 75 patients have been enrolled to date, up from 18 as of the previous quarterly report.
  • DOVACC trial: 6 out of 184 patients have been enrolled to date, up from 4 as of the previous quarterly report. The administrative and regulatory processes of initiating the trial in more than 40 hospitals in approximately 10 countries have taken longer than expected. Until recently, only one site was actively recruiting; more hospitals are now ready to initiate patient enrollment.
  • LUNGVAC trial: All preparations for recruitment of 138 patients have been completed. The first patient is expected to be enrolled in Q3 2022.
  • TENDU trial: 9 patients have been enrolled to date, up from 8 as of the previous quarterly report. The three main dosing cohorts are fully enrolled, and no safety concerns or dose-limiting toxicities have been observed. Up to three additional patients will be added at the highest dose level of 960 mcg.

Scientific Publications and Presentations

  • On 25 May 2022, Ultimovacs announced the publication of long-term follow-up data on UV1 in the Journal for ImmunoTherapy of Cancer (JITC).
  • On 10 May 2022, Ultimovacs gave a poster presentation at the Cancer Immunotherapy (CIMT) annual meeting in Mainz, Germany. The poster presentation covered results from long-term follow-up data from the use of the UV1 vaccine in three phase I/IIa clinical trials.


Second Quarter 2022 Financial Results

  • Total operating expenses amounted to MNOK 35.4 in Q2-22, and MNOK 67.3 YTD. Total loss was MNOK 22.4 for the period and MNOK 59.0 YTD.
  • Net negative cash flow from operations was MNOK 33.0 in Q2-22, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 31.8 during Q2-22. Cash and cash equivalents amounted to MNOK 486.3 as per 30 June 2022.
  • On 21 April 2022, a total of 480,000 options to buy shares in the Company were distributed amongst the employees. The number of options granted corresponds to 1.40% of the outstanding number of shares in the Company. Following the award of the new share options, a total of 2,313,585 share options have been granted, corresponding to 6.76% of the outstanding number of shares in the Company. (also reported in the Q1-2022 report)

Carlos de Sousa, CEO of Ultimovacs, says:

“Ultimovacs is approaching a potential major clinical transition with the continuing progress during the first half of 2022 of the Company’s extensive Phase II program centered on its universal cancer vaccine, UV1.

During the past quarter, we completed recruitment of patients to the INITIUM trial of UV1 in malignant melanoma and exceeded 75% of our recruitment target for the NIPU clinical trial of UV1 in mesothelioma. We anticipate topline progression-free survival data from both of these event-driven, comparative trials in the first half of 2023. Our second technology base, the TET platform combining adjuvant and vaccine in one molecule, has also performed well, progressing smoothly through Phase I studies in patients with relapsed, resected prostate cancer. The three main dosing cohorts are fully enrolled, and no safety concerns or dose-limiting toxicities have been observed. Up to three additional patients will be added at the highest dose level of 960 mcg.

Ultimovacs continues to share clinical updates with the international research and clinical community validating our scientific approach. During the past quarter the Company has presented the results of a 7.5-year follow-up study with UV1 in three different cancers; malignant melanoma, non-small cell lung cancer and prostate cancer, showing long-lasting, UV1-specific immune responses that are associated with longer survival, and synergistic effects in combination with a range of checkpoint inhibitors.

Our strong finances provide a cash runway into H1 2024 that will take Ultimovacs well beyond the expected readouts of the INITIUM and NIPU phase II trials in H1 2023. We anticipate a stimulating and eventful second half of 2022,” Carlos de Sousa concludes.

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. 

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
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86 815

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com 
Phone: +44 7483 284 853 

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 August 19,2022 at 08:00 CET.

Attachments

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Mohawk Industries, Inc. Invites You to Join the Third Quarter 2022 Earnings Conference Call5.10.2022 22:01:23 CEST | Press release

CALHOUN, Ga., Oct. 05, 2022 (GLOBE NEWSWIRE) -- In conjunction with Mohawk Industries, Inc. (NYSE: MHK) Third Quarter 2022 earnings release on Thursday October 27, 2022, you are invited to listen to the conference call that will be broadcast live on Friday October 28, 2022 at 11:00 am ET. What:Mohawk Industries, Inc. 3rd Quarter 2022 Earnings CallWhen:October 28, 202211:00 am ETWhere:www.mohawkind.comSelect Investor InformationHow:Live over the Internet – Simply log on to the web at the address above orRegister for the conference call at https://dpregister.com/sreg/10171853/f4b0080751Live Conference Call:Dial 1-833-630-1962 (US/Canada)Dial 1-412-317-1843 (Int’l) Mohawk Industries is the leading global flooring manufacturer that creates products to enhance residential and commercial spaces around the world. Mohawk’s vertically integrated manufacturing and distribution processes provide competitive advantages in the production of carpet, rugs, ceramic tile, laminate, wood, stone and viny

REPURCHASE OF SHARES5.10.2022 20:00:00 CEST | Press release

REPURCHASE OF SHARES Amsterdam, the Netherlands - Flow Traders N.V. (“Flow Traders”) (Euronext: FLOW) has repurchased 54,950of its own shares in the period from 29September 2022 up to and including 5October 2022 at an average price of €19.28. This is in accordance with the share buyback programme announced on 22 July 2022. The consideration of this purchase was €1.1 million. The total number of shares purchased under this programme to date is 337,152 shares at an average price of €19.43 for a total consideration of €6.6 million. 3,127,247 shares were held in treasury as at 5 October 2022. Contact Details Flow Traders N.V. Jonathan Berger / Investor Relations Officer Phone: +31 20 7996799 Email: investor.relations@flowtraders.com About Flow Traders Flow Traders is a leading global financial technology-enabled liquidity provider in financial products, historically specialized in Exchange Traded Products (ETPs), now expanding into other asset classes. Flow Traders ensures the provision of

Dovre's Suvic Oy has signed a contract for the foundation construction of two new wind farms5.10.2022 17:00:00 CEST | Press release

Dovre Group Plc Press release October 5, 2022 at 6 pm Dovre's Suvic Oy has signed a contract for the foundation construction of two new wind farms Suvic has signed a design and construction agreement for constructing the foundations for two new wind farms in Ostrobothnia in the municipality of Ii. The new wind farms will be called Isokangas and Palokangas. The design work will start by the end of 2022 and the construction work will commence in the spring of 2023. The owner of the project is Exilion Tuuli, which is an investment company owned by Elo, The State Pension Fund of Finland and Veritas. Isokangas and Palokangas will together have 17 windmills with a total capacity of 100 MW. "We are very happy to start cooperation with a new Finnish customer Exilion Oy", states Suvic Oy's CEO and Chairman of the Board Mr. Ville Vesanen. Additional information: Suvic Oy Ville Vesanen CEO Tel. +358 44 328 9928 vve@suvic.fi, www.suvic.fi Suvic Oy is a Finnish construction company founded in 2017

Evaxion welcomes Per Norlén as new CEO.5.10.2022 14:32:40 CEST | Press release

COPENHAGEN, Denmark, Oct. 05, 2022 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, announces that its new Chief Executive Officer (CEO) Per Norlén has joined the company on October 3rd. Dr. Norlén is a board-certified physician and associate professor with more than 20 years in the biotech sector, of which the last decade has been in executive leadership roles. He brings a wealth of experience from being CEO of listed drug development companies. He has a proven business development track record, including major out-licensing deals with biotech and Pharma. “Evaxion has emerged from being an under-the-radar start-up to becoming a clinical stage biotech company leading the development of tailored cancer immunotherapies, individually designed for each patient. I am convinced that Evaxion is on to something extremely important that holds the potential to

UPM inaugurates its new deep sea pulp terminal in the Port of Montevideo5.10.2022 14:00:00 CEST | Press release

(UPM, Helsinki, 5 October 2022 at 15:00 EEST) – UPM inaugurates today its new pulp terminal in the port of Montevideo, Uruguay. This investment of approximately USD 280 million is a fundamental part of UPM’s USD 3.47 billion growth investment in Uruguay that includes a state-of-the-art pulp mill in Paso de los Toros, new eucalyptus tree nursery as well as local community investments in Paso de los Toros. “This is a significant milestone in our growth project in Uruguay. The new pulp terminal with direct connections from the new pulp mill and to the global markets plays a key role in the growth and competitiveness of UPM’s pulp business,” says UPM President and CEO JussiPesonen. “The public infrastructure investments to the deep sea port and railway improve the competitiveness of all export sectors in Uruguay.” The new pulp terminal is located in the newly developed deep sea port in Montevideo, and it will have a direct rail connection to the new UPM Paso de los Toros mill. In the futur