Just over a month ago, Lundbased Rhovac reported topline results from the phase IIb study with the drug candidate onilcamotide, where they did not see the hoped-for effect. After taking a closer look at the results, the company has given another update and presented some possible ways forward. BioStock contacted RhoVac’s CEO Anders Månsson to find out more.
Lund-based RhoVac is developing the drug candidate onilcamotide, a treatment for prostate cancer aimed at preventing or limiting the development of metastatic prostate cancer in patients who have undergone surgery or radiation therapy. After reporting topline results from the recent phase IIb study, the company was able to conclude that the candidate did not have the expected effect compared to placebo.
You can learn more about the topline results here.
Since then, RhoVac has looked closer at the study results to see if there is any subgroup of patients who might be helped by the treatment. So far, the further analysis has not yielded any results that indicate that this would be the case. In an update made on Thursday, the company announced that it has so far not seen anything in the results that justifies further studies with the candidate.
However, the analysis will be continued and will look especially at efficacy related to different immune types, so-called HLA types. According to RhoVac, this type of data will be available for analysis in July.
Exploring the options
At the same time, the board is working on a plan for RhoVac’s next move. One path that is being investigated is the possibility of a so-called reverse merger. If no such solution is found and the continued result analysis of does not yield anything that justifies further studies, the alternative will probably be a solvent liquidation of the company. The company will then repay all debts and realise its assets, after which the remainder of the cash balance is paid to the shareholders.
RhoVac aims to provide further updates on which option will be relevant by the end of July. The company then plans to conduct an extraordinary general meeting no later than September to decide on the way forward.
Regardless of which of the options becomes reality, RhoVac will work towards an accelerated repayment of the convertibles issued at the beginning of the year. The convertibles run until April 11, 2023, with an annual interest rate of 10 per cent. The aim is to be able to make a first payment as early as the end of the summer. You can read about the convertible here.
In light of the disappointing topline results, RhoVac has chosen to reduce the company’s operations as much as possible while the analysis continues. The company has stopped the follow-up of the BRaVac study and also terminated its agreement with the contract research company that handled the study. The workforce and consultants have been reduced, which means, among other things, that the company’s head of research Steffen Wad Jorgensen has been dismissed.
BioStock contacted RhoVac’s CEO Anders Månsson to find out more.
The analysis of the BRaVac results continues and you will look more specifically at so-called HLA types. Can you tell us a little bit more about what this means and what it is you hope to find in that analysis?
– We have analysed the data now available but currently we are not finding a subgroup that, in our opinion, justifies risk and costs in new studies. The hope now is primarily to find a connection between efficacy and immune type, so-called HLA type. We will only have access to this data in July, so we will have to come back with answers to that question later this summer.
You state in your update that you are exploring the possibility of a merger with another company. Are there any concrete conversations about it today?
– We have had discussions with several companies. I cannot say anything more about where we stand today, we will have to get back to you if and when we have something concrete to consider.
When it comes to the convertible loan, you aim to make a first payment by the summer. When do you aim to have repaid the entire loan?
– In order to repay the entire loan, we need to realise the tax credit for 2021, which will be paid out in November 2022, and to receive the last payment from Horizon 2020, which is due around the end of the year. But we are investigating the conditions for a larger partial refund already this summer. We also want to minimise the interest costs for the loan, and also for the sake of convertible holders, we want to repay it as soon as possible.
Is there any risk that you will be unable to repay the loan in full?
– We make the assessment that we are solvent, and we will also earn a tax credit during the year that will be paid out in 2023.
If there were to be a liquidation of the company, what does such a process look like and how long does it take?
– It means that a liquidator takes over the operation and responsibility of the company with a focus on realising the value of the remaining assets after repayment of liabilities and paying back the net proceeds to shareholders. It may take a 9-10 months according to estimate.