• In November Erik Kinnman was appointed as CEO and he took up his position on January 23, 2023.
• In November Vivesto’s acting CEO Christer Nordstedt resigned from his position in order to assume a new role outside of the company.
  

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

• In January Vivesto announced Inceptua’s decision to withdraw the market authorization application for Apealea® in Switzerland.
  

FOURTH QUARTER: OCTOBER 1 – DECEMBER 31, 2022

• Consolidated net sales amounted to TSEK 0 (9,639)
• Operating profit/loss was TSEK -31,038 (-2,068)
• Net profit/loss after tax amounted to TSEK -30,025 (-2,849)
• Earnings per share amounted to SEK -0.06 (-0.01)

FINANCIAL YEAR: JANUARY 1 – DECEMBER 31, 2022

• Consolidated net sales amounted to TSEK 1,015 (26,192)
• Operating profit/loss was TSEK -165,008 (-133,396)
• Net profit/loss after tax amounted to TSEK -166,678 (-132,722)
• Earnings per share amounted to SEK -0.34 (-0.30)
• Short-term investments, cash and cash equivalents amounted to TSEK 142,513 (97,269)
• Equity/assets ratio was 94% (92%)
  

CEO REVIEW
I joined Vivesto only just a few weeks ago, but I can already see that the company has a lot of potential.

Over the coming weeks and months, I will work closely with the Vivesto team and Board to map out a plan for driving this company forward and develop Vivesto into a leading specialty pharmaceutical company focused on the development of new therapeutic options for cancer patients with great medical needs.

The life science sector has struggled over the past years with the Covid pandemic and general market volatility slowing development plans and rattling confidence. Continuing to evolve Vivesto in the oncology space will take time, but we have a healthy cash position, the expertise, and the right platform technology to be a success. I am excited to think about what lies ahead for Vivesto.

As Christer mentioned last quarter, Vivesto’s formulation technology is important to the company’s future. To best leverage this asset, the company is identifying various substances, with patent protection, or without patent protection, so-called generic substances, which could be used with our technology and offer patients critical treatment benefits. As new molecules have grown larger and more difficult to dissolve, our XR-18 formulation technology can play an important role for many molecules that cannot be used today, because they are too large or don’t dissolve properly. This is an opportunity for Vivesto to work with other pharma companies and strengthen our position. We will certainly keep the market informed of our progress.

Vivesto’s current development projects and products are the foundation of Vivesto. Clinical plans are constantly evaluated to find out if it is possible to make small tweaks in study setup or design to improve the chances of success or shorten the time to market approval. Evaluating substances within other indications to broaden the target group and increase the future market potential is another way to add value to the existing portfolio. Vivesto is working on both of these strategies for our clinical cancer program Cantrixil and hope to strengthen the value of the project.

A lot of focus has been on Apealea. Our partner Elevar licenced the drug several years ago and chose Inceptua to manage the market launch in Europe. So far, Apealea has been released in Germany and is on its way to be launched in the UK. We are in contact with Elevar to follow the launch activities and how sales develop in Germany, and to track the launch plans in additional European markets. We do not have any sales figures yet, but we will update the market when possible.

The investigator-initiated phase 1b study evaluating Docetaxel micellar in patients with metastatic prostate cancer, conducted in Switzerland by the Swiss Group for Clinical Cancer Research (SAKK), is still enrolling patients. More than half of the number of patients have been recruited and we expect all patients to be included in the second half of 2023 and to be able to present results in 2024.

We are continuing to evaluate an opportunity with the veterinary oncology drug candidate Paccal Vet, our formulation of paclitaxel for the treatment of cancer in dogs. Many people brought pets into their lives over the past years, especially dogs, and people are becoming more aware of the significance of pet care. Available pet veterinary drugs are not always developed to be used in pets and could be associated with side effects and lack of effect. Thus, there is a big medical need for better treatments and for more effective veterinary oncology drugs specifically developed to treat cancer in dogs. Paclitaxel is currently not available in veterinary medicine as no currently available formulations are tolerated by dogs.

We consequently believe that Paccal Vet could serve a significant unmet need and are evaluating a clinical trial with a possible start in 2023. Considering the medical need and market opportunity, we are reviewing the possibilities of continuing development in veterinary medicine and, if appropriate, may prepare for further studies in selected oncology indications.

Over the past year, the company has worked hard to reduce its cost base, which has led to significant reductions in personnel and operational costs. As part of our efforts to focus our business and achieve good cost efficiency, we have implemented some organizational changes in addition to the significant cost savings already achieved.

I look forward to learning more about Vivesto’s opportunities and getting a better feeling for where we stand and a clear vision for where we are heading. We have an experienced team in place, a portfolio of products in development, a unique technology platform, and opportunities to expand our portfolio on which to build value for the future.

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 specialty pharmaceutical company focused on the development of new therapeutic options for patients suffering from hard-to-treat cancers. It has a growing pipeline of clinical-stage assets targeting late-stage cancers. Apealea® (paclitaxel micellar) is being made available to ovarian cancer patients through a partnership with Elevar Therapeutics, Inc. Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. Vivesto’s shares are traded on Nasdaq Stockholm (VIVE). To find out more about Vivesto please visit www.vivesto.com.