SIGNIFICANT EVENTS DURING THE SECOND QUARTER
- In April Daniel Tesfa was appointed Chief Medical Officer.
- In April Vivesto signed an agreement with leading US CRO Visikol Inc. to evaluate anti-cancer drug formulations using, among other things, its proprietary drug delivery platforms.
- In May the Annual General Meeting resolved on re-election of Hege Hellström and Peter Zonabend as well as new election of Pål Ryfors and Roger Tell as members of the Board of Directors. Anders Härfstrand, Andrea Buscaglia and Birgit Stattin Norinder had declined re-election. Peter Zonabend was elected as Chairman of the Board.
- In June Vivesto announced that the Board of Directors of the company had agreed with the company’s CEO, Francois Martelet, to mutually terminate his employment as of 21 July 2022.
- In June Robert Maiorana was appointed acting CFO, with effect from July 1, 2022.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
- In August, Vivesto’s and Elevar’s partner Inceptua began the commercial launch of Apealea® in Germany.
- 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 July Christer Nordstedt was appointed acting CEO. Christer Nordstedt will hold the position until the recruitment of a permanent CEO is completed.
SECOND QUARTER: APRIL 1, 2022 – JUNE 30, 2022
- Consolidated net sales amounted to TSEK 0 (4,596)
- Operating profit/loss was TSEK -36,323 (-56,165)
- Net profit/loss after tax amounted to TSEK -38,514 (-57,677)
- Earnings per share amounted to SEK -0.07 (-0.12)
THE PERIOD: JANUARY 1, 2022 – JUNE 30, 2022
- Consolidated net sales amounted to TSEK 0 (4,633)
- Operating profit/loss was TSEK -62,652 (-97,007)
- Net profit/loss after tax amounted to TSEK -64,971 (-98,886)
- Earnings per share amounted to SEK -0.13 (-0.22)
- Short-term investments, cash and cash equivalents amounted to TSEK 188,828 (176,302)
- Equity/assets ratio was 95% (77%)
It is an honor to have taken up the role of acting CEO here at Vivesto in mid-July. As a Doctor and scientist I am proud and glad to be leading a company that is focused on developing medicines for hard-to-treat cancers where there remains such a high unmet medical need. My first few weeks in the role have been highly engaging and I’ve really enjoyed getting to know the Vivesto team and doing a deep dive into each of our development programs. As acting CEO I aim to lead Vivesto to the best of my ability until a permanent replacement is appointed. The last quarter has been a time of change for Vivesto with new recruits and appointments among the senior leadership team.
Daniel Tesfa M.D. Ph.D., our new Chief Medical Officer joined the business in early July and he is responsible for leading the clinical development of our oncology programs. Daniel brings extensive experience in clinical development and precision oncology, most recently, from Swedish biopharmaceutical company SOBI (Swedish Orphan Biovitrum AB), where he led clinical development. Daniel has already made a positive impact and is working very closely with our Chief Scientific Officer, Reinhard Koenig, M.D. PH.D. Robert Maiorana was appointed to the role of acting Chief Financial Officer from 1 July. Robert has worked at Vivesto since the second half of 2020 and as Finance Manager since March 2021 and is thus well familiar with the business and the company. The search for a permanent Chief Financial Officer is ongoing.
The financial markets for listed biotech companies have been challenging during last quarter with increasing concerns about the impact of rising inflation and the resulting cost to business. Geopolitical tensions have also added to business uncertainty. In early July, Vivesto announced that, like most other companies, we have decided to wind down operations in Russia as a result of Russia’s invasion of Ukraine. This meant that distribution activities for Paclical® (Apealea®) in Russia and the Commonwealth of Independent States (CIS) have been paused until further notice. The challenging macroeconomic environment and geopolitical tensions in eastern Europe are beyond Vivesto’s control, but today we are in a resilient position as we are well capitalized following the rights issue earlier this year and we hold no debt.
We remain focused on adding value by developing new cancer medicines and and new treatment options. Preparations for the next clinical study of Cantrixil for metastatic ovarian cancer are ongoing. Docetaxel micellar is being evaluated in a Phase I investigator-initiated trial in metastatic prostate cancer instigated by the Swiss Group for Clinical Cancer Research (SAKK). Recruitment is progressing steadily and we look forward to the completion.
We have been in regular contact with our global strategic partner Elevar over the last quarter. Inceptua, Elevar’s distribution partner in Europe, continues to work on the launch of Apealea. In August, Inceptua announced the launch of Apealea in Germany. This is an important milestone as Germany is the first major global market where Apealea has been commercially launched. In the UK Inceptua is interacting with National Health Service (NHS) to secure reimbursement for Apealea. Until now Inceptua has secured a maximum list price for Apealea allowing private market access to the drug. The launches in Europe are out of our direct control and we continue to give our full support to Elevar and Inceptua to maximize the chances of success when the launch of Apealea proceeds on a country-by-country basis over the next couple of years.
In April we announced that we had signed a research agreement with Visikol Inc., a prominent U.S. contract research services provider, for Visikol to evaluate, among other things, the cellular effects of new and existing anti-cancer drug formulations developed using Vivesto’s XR-17™ and XR-18 technologies. This will allow us to select promising developmental drug candidates and further expand our current and future oncology pipeline focused on hard-to-treat and late-stage cancers. I look forward to sharing more information with you in due course when it is appropriate to do so.
Many thanks for your continued support.
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 Q2 report
Vivesto will hold a conference call and an online presentation of the Q2 report on August 25, 2022, at 10.00 am CEST. 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:
Telephone number for the conference call is:
SE: +46 8 505 163 86
UK: +44 20 319 84884
US: +1 412 317 6300
Pin code: 7523069#
For more information:
Christer Nordstedt MD PhD, Acting Chief Executive Officer
Phone: +46 018-50 54 40
Consilium Strategic Communications (For Vivesto)
Phone: +44 (0)20 3709 5700
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.