Interim report for the period January 1, 2022 – September 30, 2022

• In July Christer Nordstedt was appointed acting CEO.
• In July Vivesto announced that the company has decided to wind down its activities in Russia following the Russian invasion of Ukraine, ongoing hostilities and international sanctions. The wind down of Vivesto’s activities in Russia means that a write down of SEK 44.6 million is carried out during the third quarter of 2022, equal to the net book value of the capitalized development costs for Paclical® after amortization as of June 30, 2022.
• In August, Vivesto’s and Elevar’s partner Inceptua began the commercial launch of Apealea® in Germany.

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

• In November Vivesto announced that the acting CEO Christer Nordstedt had resigned from his position in order to assume a new role outside of the company. Christer Nordstedt will remain as senior advisor to Vivesto on a consultancy basis within R&D.

THIRD QUARTER: JULY 1, 2022 – SEPTEMBER 30, 2022

• Consolidated net sales amounted to TSEK 1,015 (11,920)
• Operating profit/loss was TSEK 71,318 (-29,572)
• Write-down of development costs attributable to Russia TSEK -44,624 (0)
• Operating profit/loss adjusted for write-down of development costs attributable to Russia

TSEK -26,694 (-29,572), a decrease of SEK 2,878

• Net profit/loss after tax amounted to TSEK -71,682 (-30,987)
• Earnings per share amounted to SEK -0.14 (-0.07)

THE PERIOD: JANUARY 1, 2022 – SEPTEMBER 30, 2022

• Consolidated net sales amounted to TSEK 1,015 (16,553)
• Operating profit/loss was TSEK -133,970 (-126,579)
• Write-down of development costs attributable to Russia TSEK -44,624 (0)
• Operating profit/loss adjusted for write-down of development costs attributable to Russia TSEK -89,346 (-126 579), a decrease of SEK 37,233
• Net profit/loss after tax amounted to TSEK -136,653 (-129,873)
• Earnings per share amounted to SEK -0.28 (-0.29)
• Short-term investments, cash and cash equivalents amounted to TSEK 164,241 (149,677)
• Equity/assets ratio was 95% (80%)

ACTING CEO REVIEW

Immediately after I took over as acting CEO at Vivesto in July, I began a thorough review of the entire business. All of Vivesto’s assets and projects have been reviewed and evaluated from both a scientific and financial perspective. Our work is currently focused on three main areas: to further strengthen the research portfolio, to increase the value of existing projects and technology platforms, and to further trim our costs in order to be able to use a greater part of our resources to build and run our research portfolio.
After the initial review, it is clear that, just as previously assumed, our formulation technology should be able to be used with significantly more drugs than just paclitaxel. As part of the work to strengthen Vivesto’s research portfolio, we have identified a number of different substances, with patent protection, or without patent protection, so-called generic substances, which could be formulated with our technology and offer patients important treatment benefits.
Within modern pharmaceutical chemistry, a strong trend has been seen for several years towards new molecules becoming larger and more difficult to dissolve than before. These molecules often have higher specificity and effect, that is, they are more effective than previous generations of drug substances. In addition, they often address a new category of targets previously unknown to science, or previously not considered possible to develop into useful drugs. I am convinced that Vivesto’s formulation technology can be valuable for numerous molecules that today cannot be used due to lack of solubility, including molecules with remaining patent protection. We will therefore systematically, with the help of artificial intelligence, neural networks and other applicable technology, search for such opportunities with the aim of establishing collaborations with other pharma companies. In this way, we could grow our portfolio with more value-generating projects and strengthen Vivesto’s position as a drug developer.
Our existing development projects and products form the basis of Vivesto, and we work intensively to increase the value of existing assets. There are several ways to increase the value of a project/molecule. The clinical plan is reviewed continuously with the aim of finding out whether it is possible to make minor changes in study setup or study design to strengthen the chances of success or shorten the time to market-approved drug. Another way is to evaluate the substance within other indications in order to broaden the target group and increase the future market potential. We are currently working on both of these strategies for our clinical cancer program Cantrixil and hope to strengthen the value of the project in this way.
Another high-priority area for Vivesto is to build a larger and stronger IP portfolio around our proprietary formulation technology. It was therefore very satisfying that we in September were able to submit a patent application for the XR-18 to the Swedish Patent and Registration Office.
As previously announced, our market-approved product Apealea was launched in Germany in August this year. The launch took place through our partner Elevar and its European partner Inceptua. This is an important milestone as it is the first time that Apealea has been launched commercially in a larger market. We are in close contact with Elevar to follow how sales develop in Germany and how the launch plans progress in other markets. We cannot provide any sales figures at this time, but we hope to be able to do so during the first half of 2023.
In addition, we can also report that 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), continues to enroll patients. More than half of the patients are included and according to SAKK’s assessment the recruitment can be completed during the next year. Results are expected in 2024.
Vivesto has previously received a conditional approval in the USA for the veterinary drug Paccal Vet, our formulation of paclitaxel for the treatment of cancer in dogs. For strategic reasons, the process was not completed, and the drug was therefore withdrawn from the market. The market for companion animals is now facing rapid growth, while there are currently very few approved drugs for cancer in dogs. With a solid research foundation and significant in-house expertise in the field, we are reviewing the possibilities of continuing development in veterinary medicine and, if deemed appropriate, preparing for further studies in selected indications.
During the roughly four months I have been acting CEO at Vivesto, I have gained a very good insight into the company’s operations. I am impressed by the development work that is being carried out and I see significant potential in both the company’s assets and its dedicated employees. The role as acting CEO has always been intended to be of a temporary nature and at the end of November I will move on to a new position outside of the company. I now look forward to continuing to contribute to Vivesto’s development as a senior advisor within R&D on a consulting basis.

Christer Nordstedt, acting CEO of Vivesto

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

Invitation to presentation of Vivesto’s Q3 report
Vivesto will hold a conference call and an online presentation of the Q3 report on November 17, 2022, at 10.00 am CET. The call will be hosted by Acting CEO Christer Nordstedt and Acting CFO Robert Maiorana. The presentation will be in English and followed by a question-and-answer session. The conference call will be broadcast live on the web via the link:
https://ir.financialhearings.com/vivesto-q3-2022

Telephone number for the conference call is:
SE: +46856642707
UK: +443333009268
US: +16467224902

For more information:
Christer Nordstedt MD PhD, Acting 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.