SIGNIFICANT EVENTS DURING THE SECOND QUARTER
- In June, Vivesto announced that the company had a successful and encouraging pre-submission conference (PSC) with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) regarding development of Paccal Vet. A pilot study in dogs with hemangiosarcoma and malignant melanoma is planned to start for in the second half of 2023.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
- In August, Vivesto announced early termination of patient enrollment in the Docetaxel micellar advanced prostate cancer Phase 1b study with the Swiss Group for Clinical Cancer Research (SAKK). The study closed its accrual after enrollment of 11 of the planned 18 patients, since Vivesto believes that the data generated will be sufficient ahead of switching into development with a new formulation based on its improved XR-18 micelle technology platform.
SECOND QUARTER: APRIL 1, 2023- JUNE 30, 2023
- Consolidated net sales amounted to TSEK 0 (0)
- Operating profit/loss was TSEK -28,842 (-36,323)
- Net profit/loss after tax amounted to TSEK -28,172 (-38,514)
- Earnings per share amounted to SEK -0.05 (-0.07)
THE PERIOD: JANUARY 1, 2023 - JUNE 30, 2023
- Consolidated net sales amounted to TSEK 0 (0)
- Operating profit/loss was TSEK -50,378 (-62,652)
- Net profit/loss after tax amounted to TSEK -48,601 (-64,971)
- Earnings per share amounted to SEK -0.09 kr (-0.13)
CEO REVIEW
An intensive first half year is behind us, and also my first half year as CEO of Vivesto. The period has comprised a thorough review of the entire business and all assets, resulting in a strategic plan going forward and the implementation of cost-cutting measures decreasing the company's burn rate significantly. An internal reorganization has streamlined the organization and strengthened our focus on research and development, and on business development activities. Vivesto now has a fit for purpose organization capable of taking primarily cancer projects from early preclinical phase to clinical proof-of-concept. There is a clear path forward to grow the business and to expand the project portfolio, using existing organization and technology platforms or via external opportunities in line with our strategy. I can now confidently say Vivesto has the foundation for cementing its position as an oncology-focused research and development company, with the potential to take a leading position within specific areas.
There is a great unmet medical need for better treatments and more effective veterinary oncology drugs, making Paccal Vet an extremely interesting asset for Vivesto. In the beginning of June, the company had a successful and encouraging pre-submission meeting with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM). FDA supports our plans to evaluate Paccal Vet in a clinical study in dogs with hemangiosarcoma and malignant melanoma, and confirmed the study design and data points. The positive interactions with FDA strengthen our beliefs in Paccal Vet and the strategy laid out. A pilot study is planned to start in the second half of 2023 in the US, or both the US and Europe, which is to be followed by a pivotal study.
As we announced earlier this year, American pharmaceutical company Elevar Therapeutics announced its intention to transfer the rights and obligations of the cancer drug Apealea to a third party. Vivesto has had a global strategic partnership with Elevar since 2020 and so far, Apealea has been market-launched in Germany by Elevar's partner Inceptua. Development and sales in Europe have gone slower than expected, so we see this as an opportunity to find a more suitable partner. Vivesto is looking for a new partner, either on a regional or global basis, to take on Apealea's future sales and development.
Our plan to expand the indication areas for Cantrixil to increase the future market potential continues as we target both bladder and blood cancer, both indications with high unmet medical needs and significant commercial potential. We are eager to see results from preclinical in vitro efficacy studies in both indications during the fall.
We were also pleased to see that Docetaxel micellar can be administrated without prior premedication with steroids. The recruitment in the open-label, multicenter, single-stage Phase 1b study with the study's sponsor, the Swiss Group for Clinical Cancer Research (SAKK), was ended recently after enrollment of 11 of the planned 18 patients. Throughout the study the drug has been possible to give without high-dose cortisone pre-medication. Only paclitaxel expected serious adverse events have been observed in the study. Final data will available after the last patients have finished their treatments, whereafter the results will be analyzed during 2024. Patients treated with other existing formulations of docetaxel require steroid administration to avoid certain serious adverse events related to the current formulations with solvent. The administration of steroids can lead to marked bone fragility, exacerbated by cancer metastases in the bone, or steroid-related metabolic issues. Vivesto has progressed in the development of its XR-18 drug delivery platform and intends to use this next-generation improved technology in future development of Docetaxel micellar.
Vivesto sees the company's next generation drug delivery platform XR-18 playing a significant future role with molecules too large to properly dissolve in patients. The XR-18 program has advanced, developed improved properties and is being explored in in vitro studies with several API combinations. We have several XR-18 molecules that look promising and are exploring the best path forward. As part of our increased business development efforts we are considering how to best leverage potential value in the XR-18 platform. We will come back with more information when appropriate.
I am confident there is significant value yet to be unlocked at Vivesto. We clearly need to find a resolution for Apealea, but I am impressed by the assets Vivesto has internally. We now have a clearer path forward with Paccal Vet and we hope to see promising data from Cantrixil in bladder and blood cancer. Moreover, it was encouraging to see the preliminary observations in the Docetaxel micellar study with SAKK. Finally, our goal is to ensure we leverage our XR-18 platform in internal development projects forward and in parallel evaluate ways to leverage its potential.
With a R&D focused strategy, a track record of advancing clinical projects to reach the market, and a fit for purpose team to get the job done, we have the right conditions to make Vivesto a leading oncology focused research and 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 difficult-to-treat cancer. The company has a portfolio of projects with the potential of offering cancer patients with unmet medical needs new treatment alternatives. Vivesto has a track-record of developing drugs from the preclinical stage, through clinical development to regulatory approval. 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. Other clinical development programs include Cantrixil for late-stage ovarian cancer, and Docetaxel micellar, in development for advanced prostate cancer. Moreover, the company is developing Paccal Vet (paclitaxel micellar) for malignant melanoma and hemangiosarcoma in dogs. Vivesto has developed proprietary drug delivery technologies designed to improve solubility of various active pharmaceutical ingredients.
Vivesto's shares are traded on Nasdaq Stockholm (ticker: VIVE). Visit www.vivesto.com for more information about Vivesto.
This information is information that Vivesto AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2023-08-24 08:00 CEST.
