The foundation of what is today Pila Pharma was submitted Dorte X Grams time on Novo Nordisk, where she conducted research on TRPV1-receptor's possible role 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. During the journey, there have been clear indications that they are on to something, where the TRPV1 inhibitor XEN-D0501 has been shown to give diabetics improved insulin release when treated for a month.
Preparing for toxicology studies
The next major goal in the project is to test the candidate in a phase IIb study, which is aimed to be launched in 2023. In preparation for that study, several activities are currently underway, such as BioStock reported A three-month toxicological study will be conducted and study materials will be produced in collaboration with the British manufacturing partner Almac Sciences.
Here, Pila Pharma recently announced that it has successfully improved the synthesis of XEN-D0501, thereby extracting more active ingredient (API) from the starting material than previously possible. According to the company, this is an important part of the development that paves the way for a more cost-effective future manufacturing of XEN-D0501, which includes, among other things, the upcoming batch of XEN-D0501-API.
Want to ensure high quality in research
Something that Pila Pharma's CEO Dorte X. Gram also wants to pave the way for is of course continued success in development work. The emphasis here is on creating a strong and experienced development organization that can ensure high quality in development work. In that spirit, the company recently brought on board Novo Nordisk veteran Susanne Rugh, who has been involved in bringing three of the Danish pharmaceutical giant's bestsellers to market.
During the fourth quarter, a Head of Toxicology has also been hired, who will lead the work on the toxic study, which will begin as soon as API manufacturing is fully completed.
Reviewing the autumn funding round
The increased activity in the company is also reflected in the financial statements' income statement, where the operating profit for the full year 2021 was just under SEK -9,3 million, compared to approximately SEK -3,4 million for the corresponding period last year. The company's liquid assets amounted to approximately SEK 2021 million at the end of 28,2 and the equity/assets ratio was 95 percent.
Regarding the company's financing, we can note that the share price at the time of writing is slightly below the level of 10 kronor that applies to subscription of new shares in the TO1 series warrant that has been exercised before summer. The company writes in the report that it has noted this and that it intends to solve the financing of the continued development in another way, if the warrant is not exercised as originally intended.
Comments from the CEO
Gram herself has made sure to take advantage of the recent stock market turbulence and bought just under 19 shares this week at a price of SEK 000. She is thus following up on the purchase she made at the end of last year when she bought approximately 5,40 shares at a price of SEK 32.
BioStock has contacted Gram to get a comment on the past year and the activities that await the company next.
Pila Pharma
In addition to the important development work, you have focused a lot on building the organization that we see before us today in 2021. What are your thoughts when you look back on 2021 and how do you see where you stand as a company today?
– In 2021, we were a smaller team focused on the listing process. Once that was underway, we started the heavy development activities around our study aid, such as manufacturing new tablets and API.
– Since the listing, we have focused on building a virtual organization with highly skilled employees, either on a consultancy basis or through collaborations with skilled contract research organizations. 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 elaborate a little on what you think characterizes high-quality research?
– Before we went public, we were in an exploratory phase where we first wanted to find out if XEN-D0501 had an effect on diabetics and we received indications of this in a smaller study. Now it is the regulatory path to the market that matters. Then it is important that we have a competent organization with experienced employees who know where we are going and how to get there, so that the results we get along the way are of the highest quality, as everything will eventually be included in a registration application. This is crucial for the large pharmaceutical companies and therefore also for us on the way forward.
Your next important development activity before the Phase IIb study is a three-month toxicology study. Given that you have already conducted a month-long toxicology study with good results, how would you assess the likelihood that you will see good results in the three-month study as well?
– Yes, Bayer, who originally developed our development candidate, conducted preclinical studies with good safety results during one month of dosing. 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 don't know, and since it is a regulatory requirement to conduct these three-month studies before we can start a three-month study in humans, we are preparing as carefully as possible.
You start your CEO message with “we are on track”, so it sounds like you expect to accomplish a lot during the year. What do you hope to look back on in a year when it’s time to summarize 2022?
– By the end of 2022, we would like to have our API manufacturing completed and both started and completed our preclinical studies so that these results can be included in the application for clinical trial authorization that we plan to submit around the turn of the year.
– Then the plan is to prepare the clinical study in detail and to do so, raise more money to finance the operational phase of the clinical study. This means preparing study funds for each patient, starting up clinics and starting to recruit and treat patients in 2023.