SIGNIFICANT EVENTS DURING THE FIRST QUARTER
- Continued focus of the operations towards research and development, including a reduction in staff and overall improvement in cost control, has contributed to lower expense base.
- In March,
Vivesto announced that a clinical efficacy study with the veterinary oncology drug candidate Paccal Vet is planned to start in the second half of 2023. - In March,
Vivesto was informed that Elevar is discontinuing its efforts to develop and commercialize Apealea and instead seeks to transfer its rights to a third party. Considering the uncertainty regarding the launch activities of Apealea,Vivesto decided to write down balance sheet items amounting in total to MSEK 190 in the annual report as perDecember 2022 . - In January,
Vivesto announced Inceptua’s decision to withdraw market authorization application for Apealea® inSwitzerland .
FIRST QUARTER:
- Consolidated net sales amounted to TSEK 0 (0)
- Operating profit/loss was TSEK -21,537 (-26,329)
- Net profit/loss after tax amounted to TSEK -20,429 (-26,457)
- Earnings per share amounted to
SEK -0.04 (-0.06)
CEO REVIEW
With just over four months behind me as CEO, I have gained a good insight into the business and gotten to know the team at
As a result of our review, we decided to intensify our investment in veterinary oncology. There is a great unmet medical need for better treatments and more effective veterinary oncology drugs. This is especially true in the treatment of cancer in dogs, where drugs developed for humans through so-called off-label use are widely used. Since today's human medicines are not designed for use in pets, they are often associated with side effects and lack of efficacy. It is clearly demonstrated in current paclitaxel formulations which, due to the fact that they contain the solvent cremophor or human albumin, are not tolerated by dogs and therefore are excluded as a treatment option despite paclitaxel being a well-documented and effective cytostatic drug. The market for veterinary medicines in general is growing as the number of pets grows, and especially the number of dogs. At the same time, we are becoming increasingly aware of the importance of caring for our pets and more willing to pay for adequate medical care and medicines.
Based on the great medical need and the commercial potential we see in the field, we have decided to initiate clinical development of the veterinary oncology drug candidate Paccal Vet. In a first step, we plan to start a clinical efficacy study with Paccal Vet in dogs in the cancer indications hemangiosarcoma and malignant melanoma during the second half of the year. Both are indications where there are currently no approved chemotherapy treatments available. Positive safety and efficacy data are already available for the use of Paccal Vet in dogs. A pre-submission meeting with the FDA is planned to discuss the continued clinical development path for Paccal Vet and we await feedback from that meeting in early summer.
In March, American pharmaceutical company Elevar Therapeutics announced its intention to transfer the rights and obligations of the cancer drug Apealea to a third party.
An important part of the review has been to evaluate the company's existing development projects to find out if it is possible to increase the chances of success, shorten the time to market approval or increase the future market potential. As a result of this work, we intend to expand the indication area for the Cantrixil cancer program to also include bladder cancer and blood cancer, both indications with high unmet medical needs and significant commercial potential. I look forward to coming back with more information when we have a more detailed development plan in place.
Patient recruitment in the investigator-initiated Phase 1b study evaluating Docetaxel micellar in patients with metastatic prostate cancer continues and more than half of the planned patients have been included. However, recruitment is somewhat slower than expected and we are therefore evaluating together with the study's sponsor, the
In addition to our clinical projects, we are actively working to develop the next generation drug delivery technology XR-18, a technology that may play an important role for many molecules that today cannot be used because they are too large or do not dissolve properly. XR-18 works in the same way as
To streamline the organization and reduce our running costs, we are now reorganizing
Overall, after my first months as CEO, I see significant potential in
Our work continues with a clear ambition – to develop
Thank you for your continued support.
The report is available on the company’s website: https://www.vivesto.com/en/financial-reports-and-presentations/
For more information:
Phone: +46 018-50 54 40
E-mail: IR@vivesto.com
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