Solna-based Xspray Pharma has developed a technology to produce stable amorphous drugs. The technology is being used to develop improved versions of already established protein kinase inhibitors (PKIs), a type of drug used to treat cancer.
Today, there are approximately 80 PKIs used in the treatment of various types of cancer – a market that in the USA alone amounts to approximately 33 billion USD each year. The majority of the products are based on crystalline forms of the active substance. However, these forms are difficult to dissolve, which means that the absorption in the body can vary greatly, especially if the patient also needs medication for stomach ulcers, which is common. High absorption increases the risk of side effects, while too low absorption can lead to a lack of treatment effect.
Aiming for bestsellers
In comparison, Xspray's amorphous products are more readily soluble, which circumvents the absorption problem. Another advantage worth mentioning in this context is that the patent portfolios protecting the PKIs often focus on crystalline forms of the active substance, which gives Xspray the opportunity to quickly get to market once the main patent has expired.
The company's lead candidate Dasynoc is a biobetter of BMS bestseller Sprycel (dasatinib), a drug that sold for almost USD 2023 billion in 2. Dasynoc is designed for the treatment of chronic myeloid leukemia and acute lymphoblastic leukemia, and Xspray is currently preparing for a US market launch in collaboration with commercialization partner Eversana.
The company is currently responding to questions from the FDA in a Complete Response Letter. The plan is to submit a supplemental application for marketing approval before the end of the year, with the goal of launching in the first half of 2025.
In addition to Dasynoc, the portfolio also consists of biobetter candidates XS003-nilotinib, XS008-axitinib and XS025-cabozantinibFor XS003-nilotinib, which is a biobetter on Novartis Tasigna, registration studies in healthy volunteers are underway and the company expects to submit an application for market approval in the first half of 2025. Next steps for XS008-axitinib and XS025-cabozantinib are formulation development.
New capital drives further development and launch
To finance the launch and development of the remaining portfolio, Xspray is now raising capital totaling SEK 235 million. Of this, SEK 135 million consists of a rights issue that is fully covered by subscription commitments, letters of intent and guarantees.
In addition, a loan of SEK 100 million is also being taken out from Fenja Capital II and BundleIn connection with this, the lenders will also receive 1 warrants, which give the right to subscribe for a corresponding number of new shares at SEK 150 per share until November 000, 50. Thereafter, the subscription price of the warrants will be increased to SEK 6 per share until November 2025, 60.
Q&A with the CEO
BioStock has contacted Xspray's CEO By Andersson to learn more about development, launch and capital raising.
We've touched on the overall benefits of your technology. Looking specifically at your lead candidate Dasynoc, how will patients benefit compared to using Sprycel?
– The competitor on the market was groundbreaking when it arrived, but unfortunately still has serious safety and efficacy risks. Our patented way of formulating tablets provides more even absorption and concentration of the drug in the body, and absorption is less pH-sensitive.
– We estimate that 30 – 50 percent of patients treated with PKIs for chronic myeloid leukemia or acute lymphoblastic leukemia are also medicated with acid-inhibiting drugs, despite the fact that it negatively affects the absorption of Sprycel. For these patients, Dasynoc can offer a clear patient benefit by making the treatment effective with stable absorption, even with concomitant treatment of peptic ulcers.
What does the competitive situation look like and how do you stand out in the target market for Dasynoc?
– Currently, only Sprycel is marketed, although there are a couple of approved generic products. Compared to Sprycel, Dasynoc has a clear improvement profile based on our patented technology that we are the only ones with. We will have the best product on the market for a long time and we know from surveys that a large majority of doctors say they would rather prescribe an improved product like ours.
Your upcoming application is the second addition in the process to obtain market approval in the US. How confident are you that this will provide a final answer from the authority?
– There are a number of reasons why we believe in a positive outcome this time. We had a meeting with the FDA last fall that was positive and constructive, so after that we feel very confident that we are now meeting the information needs of the FDA. The issues regarding product labeling are resolved, we meet the FDA's safety limit for solution levels by a good margin and the FDA has previously accepted the inspection-related responses regarding the manufacturing facility in Italy.
Given a positive response from the FDA, what do the subsequent launch plans look like?
– Under the leadership of our own US sales manager and with our partner Eversana, preparations for the planned launch of Dasynoc continue. We are well prepared for FDA approval, which we hope for in the first or second quarter of next year. Eversana gives us exclusive access to a dedicated marketing and sales team across the US, who already have established contacts with the physicians, insurance companies and other payers we serve.
Looking at the portfolio as a whole, you highlight that the technology makes future projects develop faster. Can you explain in more detail how it works and what it means for you?
– By approving Dasynoc, we have proven that we have a technology that is safe, and thus the regulatory process for future products will be both faster and simpler. The authority will then already have answers to many questions and the processing will be less complex. Marketing and sales will also be able to benefit from the work that is now being done for the launch of Dasynoc, through established contacts and the establishment of knowledge about our technology and its benefits.
Several major owners have increased their holdings during the year and are now also participating with subscription commitments and guarantees in your issue. What significance does this have for Xspray?
– With this financing, we will be able to prepare and execute the planned launch of Dasynoc. Our shareholders' support and belief in our commercialization plan is very strong and of course it means an incredible amount to our ability to execute it.
How will you prioritize the use of the cash you receive?
– The financing will primarily be used for the launch of Dasynoc, but we will also be able to continue investing in the development of our other promising product candidates. Among other things, we will be able to conduct the registration studies required to complete an application to the FDA for our next product candidate XS003 nilotinib.
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This material has been prepared for marketing purposes and is not and should not be considered to constitute a prospectus under applicable laws and regulations. The full terms and conditions of the rights issue and further information about the company have been set out in a prospects which has been announced and published on the above-mentioned company's website.