Erik Kinnman, CEO of Vivesto

SIGNIFICANT EVENTS DURING THE THIRD QUARTER

• In August, Vivesto announced that the enrollment of patients in the Docetaxel micellar advanced prostate cancer Phase 1b study with the Swiss Group for Clinical Cancer Research (SAKK) was terminated early, and that Docetaxel micellar showed good tolerability at doses considered standard for conventional docetaxel formulations, as well as signs of clinical activity.
• On September 15, Vivesto's shares were delisted from the Frankfurt Stock Exchange ("FSE"). The delisting from the FSE does not affect the listing of the company's shares on Nasdaq Stockholm.
  

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

• In October announced that the Board of Directors has decided to focus the company's resources on the Cantrixil and Paccal Vet development programs, as well as on a number of measures aimed at reducing costs in the company. All further development related to the XR-18 technology platform within Vivesto, and all operations in the company's laboratories in Uppsala will be discontinued. The plan enables the delivery of a number of important milestones and secures the company's financial position and continued operations until the end of 2026.

THIRD QUARTER: JULY 1, 2023 – SEPTEMBER 30, 2023

• Consolidated net sales amounted to TSEK 0 (1,015)
• Operating profit/loss was TSEK -16,565 (-71,318)
• Net profit/loss after tax amounted to TSEK -15,784 (-71,682)
• Earnings per share amounted to SEK -0.03 (-0.14)

THE PERIOD: JANUARY 1, 2023 – SEPTEMBER 30, 2023

• Consolidated net sales amounted to TSEK 0 (1,015)
• Operating profit/loss was TSEK -66,943 (–133,970)
• Net profit/loss after tax amounted to TSEK -64,385 (–136,653)
• Earnings per share amounted to SEK -0.12 kr (-0.28)

CEO REVIEW
The hard work during the first half of the year continued in the third quarter as Vivesto set its foundation as an oncology-focused research and development company with the potential to take a leading position within specific areas where we can make a difference. Following the strategic review and steps to streamline the company to reduce costs this year, the Vivesto Board of Directors decided after the end of the third quarter to focus the company’s resources on the Cantrixil and Paccal Vet development programs.
Vivesto took additional steps aimed at reducing costs in the company, including discontinuing all further development related to the XR-18 technology platform and closing the company’s laboratories in Uppsala. I regret that this closure means staff reductions, but it needs to happen for us to move forward with this new focus.
This new strategic direction to become a pure development company with a focus on early-stage oncology projects where there is a clear need for more effective drugs is expected to reduce costs by more than SEK 35 million on an annual basis and enables Vivesto to deliver several important milestones and secure the company’s financial position and continued operations until the end of 2026. Targeting our investments toward the Cantrixil and Paccal Vet programs increases our ability to achieve success in our clinical development and enhance long-term value for our stakeholders.
Vivesto’s animal business Paccal Vet is a great opportunity. There is a tremendous unmet medical need for improved veterinary drugs. There are more than 180 million dogs in the U.S. and in Europe, and owners are increasingly spending more to care for their pets, including $39.6 billion on vet care and product sales in 2022 in the U.S., according to the American Pet Products Association.
The Paccal Vet clinical development program is progressing according to plan. During the summer of 2023, Vivesto had a successful pre-submission meeting with the US FDA's Center for Veterinary Medicine regarding the development of Paccal Vet. Preparations for our clinical pilot study to investigate the effect of Paccal Vet in dogs are ongoing and we expect all necessary activities for the start of patient recruitment to be in place by the end of 2023.
To maximize the commercial potential of the cancer program Cantrixil, we decided to target our development resources to bladder cancer and blood cancer, both of which are indications clearly in need of additional solutions and with significant commercial potential. We have had positive results from the pre-clinical tests and, based on those, we will decide on the continued development plan for Cantrixil. Additional important results are expected early next year.
Earlier in the year, the American pharmaceutical company Elevar Therapeutics said it intended to transfer the rights and obligations of the cancer drug Apealea to a third Party. Vivesto has had a global partnership with Elevar since 2020, but Apealea was only launched in Germany by Elevar’s partner Inceptua. Development in the rest of the world and sales in Europe have gone slower than expected so we view this as an opportunity to find a better partner. Vivesto is negotiating a termination agreement with Elevar. Activities with aimed at identifying potential new partners have been initiated and discussions with several potential partners are ongoing.
Vivesto’s updated focus is an opportunity for the company. The streamlined development plan, combined with significantly lower cash burn rate, provide the possibility to build long-term value and anchor the company as an early-stage oncology development company. Thanks for following Vivesto.

Erik Kinnman, CEO of Vivesto

The report is available on the company’s website: https://www.vivesto.com/en/financial-reports-and-presentations/

For more information: 
Erik Kinnman, Chief Executive Officer
Phone: +46 018-50 54 40
E-mail: IR@vivesto.com


About Vivesto AB
Vivesto is a research and development company that develops new treatment options for patients suffering from hard-to-treat cancer. The company develops projects with the potential to offer new treatment options for cancer patients with high medical needs. Vivesto has the capacity and expertise to develop drugs from early preclinical development to clinical phase. Late clinical-phase and commercial development is intended to take place through partnerships with other pharmaceutical companies.
Vivesto’s most advanced program Apealea® (paclitaxel micellar) has been granted market approval in the EU as a treatment for adult patients suffering from the first relapse of platinum sensitive epithelial ovarian cancer, or primary peritoneal cancer or fallopian tube cancer. In addition, Vivesto is developing the cancer programs Cantrixil and Docetaxel micellar, and the veterinary oncology program Paccal Vet (paclitaxel micellar) which is being developed for the treatment of malignant melanoma and hemangiosarcoma in dogs.
Vivesto’s shares are traded on Nasdaq Stockholm (ticker: VIVE). Visit www.vivesto.com for more information about Vivesto.