Announcement • 6h
Vivesto AB Reports Positive Results From Intravenous Cantrixil Pharmacokinetic And Toxicology Study Vivesto AB reported positive results from its exploratory pharmacokinetic (PK) and toxicology study with Cantrixil. The study is the first conducted with Cantrixil administrated intravenously (i.v.) in a larger animal species (dog). The data support continued development of Cantrixil toward a Phase I clinical trial in acute myeloid leukemia (AML) in humans, and a pilot study in dogs with cancer. The study results demonstrate that i.v. Cantrixil was well tolerated at all dose levels, with no adverse findings, no cardiovascular effects, and no signs of local irritation or toxicity at the injection site. Pharmacokinetic parameters, including blood concentration levels and half-life, were consistent with expectations and complement prior preclinical data. In the PK/toxicology study, four dogs received increasing i.v. doses of Cantrixil in three rounds at 2, 5 and 10 mg/kg. The study design and day 7 assessments support the intended once-weekly dosing frequency for both humans and dogs. Cantrixil was well tolerated by all dogs, with no adverse or toxicologically relevant findings. No cardiovascular adverse effects were reported, a particularly important finding as cardiovascular toxicity is a known and often dose-limiting risk for cytotoxic agents. Furthermore, there were no local signs of irritation or toxicity at the injection site. Hematological and clinical biochemistry parameters, which were analyzed before treatment start and 7 days after each treatment administration, a common timepoint for assessing cytotoxic agents, showed no alterations. The pharmacokinetic parameters of Cantrixil, including blood concentration levels, were in line with previous observations from the in vivo study performed in a mouse model of AML earlier last year. Drug half-life was as expected, confirming that the i.v. formulation performs as intended and is consistent with existing preclinical documentation. Together with previous findings, these new results support the continued advancement of Cantrixil toward a Phase I clinical trial in AML in humans, in parallel with continued CMC development to produce clinical trial material. As previously announced, Vivesto is also developing Cantrixil for dogs with cancer, building on its anti-cancer mechanism of action and synergies with the company’s existing veterinary oncology program. New Risk • Feb 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 106% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (106% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr44m net loss in 2 years). Market cap is less than US$100m (kr96.0m market cap, or US$10.7m). New Risk • Feb 03
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 106% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (106% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr44m net loss in 2 years). Market cap is less than US$100m (kr98.4m market cap, or US$11.0m). 
