“We’re on our way.” This is how Pila Pharma CEO Dorte X. Gram starts the 2021 year end report that was released last week. During the first half of the year as a public company, the focus has been on building the high-quality team that will drive the development of the drug candidate XEN-D0501, hopefully all the way to market. In connection with the newly released report, BioStock has contacted Gram to get her view of the past year.
The foundation for what is Pila Pharma today was laid during Dorte X Gram’s time at Novo Nordisk, where she researched the possible role of the TRPV1 receptor in type 2 diabetes. The theory behind the research is that TRPV1 indirectly inhibits the body’s insulin regulation and glucose tolerance and thus plays an important role in the development of the disease. Along the way, there have been clear signs that they are on to something, as the TRPV1 inhibitor XEN-D0501 has been shown to give diabetics an improved insulin release during a one-month trial treatment.
Preparing toxicology studies
The next big goal in the project is to test the candidate in a phase IIb study, which is expected to start in 2023. In preparation for that study, several activities are currently underway, as BioStock has previously reported. A three-month toxicology study will be conducted, and study materials will be produced in collaboration with the British manufacturing partner Almac Sciences.
Pila Pharma recently announced that it has succeeded in improving the synthesis of XEN-D0501 and to collect more active pharmaceutical ingredient (API) from the starting material than it has managed before. According to the company, this is an important part of the development that paves the way for a more cost-effective future production of the XEN-D0501, which includes, among other things, the upcoming batch of the XEN-D0501 API.
Targets high quality research
Of course, Pila Pharma’s CEO Dorte X Gram also wants to pave the way for continued success in the drug development, where the emphasis is put on creating an experienced development organization that can ensure high quality. The company recently recruited Novo Nordisk veteran Susanne Rugh, who has helped bring three of the Danish pharmaceutical giant’s top sellers to market.
A Head of Toxicology was hired in the fourth quarter. This person will lead the work on the toxicology study, which will start as soon as API production is fully completed.
Reviewing autumn funding round
The increased activity in the company is also shown in the financial statement of the report, where operating profit for the full year 2021 amounted to just under -9.3 MSEK, compared to approximately -3.4 MSEK for the corresponding period last year. Cash and cash equivalents in the company amounted to approximately 28.2 MSEK at the end of 2021 and the equity/assets ratio was 95 per cent.
Regarding the company’s financing, we note that the share price at the time of writing is a bit below the level of 10 SEK that applies to subscription of new shares in the form of TO1 series warrant exercise, which has a subscription period right before the summer. In the report, the company writes that it has paid attention to this, and that it intends to resolve the financing of the continued development in another way, should the warrant not be resolved as originally intended.
Gram herself has made sure to take advantage of the recent stock market turbulence and this week bought just under 19,000 shares at a price of 5.40 SEK. She thus follows up on the purchase she made at the end of last year when she bought about 32,000 shares at a price of 6.50 SEK.
BioStock has contacted Gram for comment on the past year and the activities that await the company next.
In addition to the important development work, in 2021 you have focused a lot on building the organisation that we see today. Looking back on 2021, and looking at where you stand as a company today, what are your thoughts?
– In 2021, we were a smaller team that focused on the IPO process. When that was set in motion we started the heavy development activities around our drug candidate, such as the manufacturing of new tablets and APIs.
– Since the IPO, we have focused on building a virtual organisation with highly competent employees, either on a consultancy basis or through collaborations with talented contract research organisations. In fact, at the time of writing, I am on a tour of the UK to meet the virtual team here. I have chosen to keep the proportion of internal employees at a low level in order to be flexible and be able to spend the money on what is most important at the moment.
You have previously mentioned that it is important that the research Pila Pharma conducts is of high quality. Could you go a little deeper into what you think characterises high-quality research?
– Before going public, we were in an exploratory phase where we wanted to find out if XEN-D0501 had an effect on diabetics, and we found evidence of this in a smaller study. Now the time has come to walk the regulatory path toward the market. So, it is important that we have a competent organisation with experienced employees who know where we are going and how to get there, so that the results we get are of the highest quality, since everything will be included in in a registration application. That I crucial for big pharma and thus also for us going forward.
Your next important developmental activity before the phase IIb study is a three-month toxicology study. Since you have already conducted a one-month toxicology study with good results, how would you assess the likelihood that you will see good results even in the three-month study?
– Yes, Bayer, who originally developed our development candidate, did one-month preclinical studies with good safety results. We are currently discussing the design of our upcoming three-month studies and we believe that there is no reason to expect a worse result during the longer study.
– But you cannot know for sure, and since it’s a regulatory requirement to conduct these three-month studies before we can start a three-month study in humans, we prepare ourselves as carefully as possible.
You start your report with “we’re on the move,” so it sounds like you expect to accomplish a lot during the year. What do you hope to look back on in a year’s time to summarise 2022?
– By the end of 2022, we would like to have started and completed preclinical studies to ensure that these results can be included in the application for clinical trials that we plan to submit around the turn of the year.
– Then the plan is to prepare the clinical study in detail and raise more money to fund the operational phase of the clinical study – preparing study material for each patient, starting up clinics and starting the recruitment and treatment of patients in 2023.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.