April-June 2025, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -44,885 thousand (-53,620)
- Earnings per share before dilution amounted to SEK -2.35 (-1.64)
- Cash flow from operating activities amounted to SEK -44,111 thousand (-64,181)
- Cash flow from investing activities amounted to SEK -6,132 thousand (-8,738)
January-June 2025, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -87,206 thousand (-121,401)
- Earnings per share before dilution amounted to SEK -2.35 (-3.79)
- Cash flow from operating activities amounted to SEK -110,440 thousand (-119,492)
- Cash flow from investing activities amounted to SEK -20,833 thousand (-13,887)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
- In April, Xspray Pharma announced that it had re-submitted its application for market approval for Dasynoc® to the US Food and Drug Administration (FDA).
- The Annual General Meeting held on May 13, 2025 resolved to re-elect Anders Ekblom (Chairman), Anders Bladh, Christine Lind, Robert Molander and Carl-Johan Spak as members of the Board of Directors and to elect Markus Haeberlein and Anne Prener as new members of the Board of Directors. The Annual General Meeting also resolved to adopt a long-term incentive program for employees (LTIP 2025).
- The FDA set the PDUFA date of October 7, 2025 for the re-submitted New Drug Application (NDA) for Dasynoc®. The PDUFA date is the FDA's deadline for communicating its decision on the company's application. Xspray Pharma is now continuing to prepare for the US launch of Dasynoc® with the aim that it can begin as soon as possible if market approval is received in October.
- In June, Xspray Pharma announced that the FDA had conducted a successful Pre-Approval Inspection (PAI) of the company's manufacturing lines, located at a contract manufacturing partner. The inspection occurred in connection to the FDA making a general GMP-inspection of the entire production facility.
Significant events after the reporting period
- In July, Xspray Pharma announced that the company had completed the population pharmacokinetic (PopPK) modeling that confirmed bioequivalence between XS003 and the reference drug Tasigna®. Bioequivalence with XS003 was achieved at less than half the dose compared with Tasigna®. Accordingly, all regulatory documentation has been completed for submitting a 505(b)(2) NDA for the XS003 product candidate.
- In August, Xspray Pharma entered into a license agreement with Handa Therapeutics granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of Handa's dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa's net proceeds. The agreement also ensures that Xspray's planned launch of Dasynoc® can be done without being affected by regulatory hurdles in the US that can be associated with Handa's market approval.
- After the period, the company announced that the Board had decided to carry out a rights issue of shares of approximately SEK 130 million, with preferential rights for the company's existing owners. The rights issue can be increased by up to SEK 20 million through an over-allotment option. Furthermore, the Board decided to extend and increase an existing loan with an additional SEK 25 million, where the new maturity has been set to March 2027, and the Board also decided to issue warrants to the lenders.
Dear shareholders
Step by step over the past quarter, we continued to work toward the commercialization of our product portfolio. We are now approaching the launch of our first product - Dasynoc®, our improved version of a well-established drug for the treatment of leukemia (CML and ALL). Dasynoc® will provide significant benefits to the treatment outcomes of leukemia patients and their quality of life in the form of lower dosage requirements, lower variability in absorption, and the ability to be co-medicated with all commonly used gastric acid suppressants. After the period, we reached an important milestone when we entered into the company's first out-licensing agreement with Handa Therapeutics. The agreement gives us royalty income on a new dasatinib product that Handa plans to launch, while our own dasatinib product candidate Dasynoc® can be launched without regulatory hurdles that can be associated with Handa's product.
During the quarter, we received two milestone announcements from the FDA - firstly the PDUFA date of October 7, 2025, when we can expect a decision on our application for market approval of Dasynoc®, and secondly the inspection of the company's production line, which had a positive result with no comments. It is also gratifying that we are continuing to make progress on our other product candidates and we will very shortly be submitting a 505(b)(2) NDA to the FDA for market approval of our second product candidate, XS003 - an improved version of the leukemia drug Tasigna®.
Capital procurement
Today, we announced the next step in our financing plan, a solution that aims to secure our financing needs for the upcoming product launch and commercialization of Dasynoc® as well as continued development of other product candidates in our portfolio. The Board thereby decided to carry out a capital raise, consisting of a rights issue of shares of SEK 130 million with preferential rights for existing shareholders. We also have an oversubscription option entailing that the issue can be expanded by SEK 20 million if oversubscribed. We are delighted to have received subscription undertakings and an intention to subscribe for shares amounting to approximately SEK 89 million.
We have also extended and expanded our loan financing. The existing loan of SEK 100 million was increased to SEK 125 million and has a prolonged maturity extending to March 2027. In combination, this means that we have a financing plan and funds in place to enable the successful launch of the company's products. We hope that as we go to market with our products, we can gradually create positive operational cash flows to support the continued development and growth of the operations.
Important license agreement with Handa Therapeutics
After the period, we entered into a licensing agreement with Handa Therapeutics that gives Handa a non-exclusive license to some of Xspray's patents. The license enables Handa to commercialize a dasatinib product in the US market and at a later stage in selected Asian markets. According to the agreement, Xspray will receive a royalty of up to double-digit on Handa's net revenue.
Handa's dasatinib product has the same dose strengths as the original drug Sprycel®, but with some similarities to our own product candidate Dasynoc®. Handa's launch could help increase physicians' knowledge of the pH-related limitations of crystalline dasatinib. Xspray can benefit from this increased knowledge once Dasynoc® is approved. At launch, we believe that Dasynoc® will be "best-in-class" with pH-independent absorption, high precision and lower dose strength, and have compatibility with all proton-pump inhibitors. This means a strong improvement profile with potentially significant clinical benefits for patients.
Our strong patent protection is the basis for us now receiving up to double-digit royalties on Handa's net income. The agreement also ensures that the launch of Dasynoc® can be carried out without the impact of existing or any future regulatory exclusivity related to Handa's dasatinib product.
This is the first out-licensing of patents from Xspray's broad patent portfolio and represents a validation of the quality and value of our patent portfolio. We will primarily continue to develop our own, improved PKI drugs based on proven substances, but we will also evaluate potential licensing agreements on a case-by-case basis.
Preparations ahead of the launch of Dasynoc®
The company has enhanced its in-house expertise in a variety of ways ahead of the forthcoming commercialization. The Board was strengthened at the most recent Annual General Meeting through the election of Markus Haeberlein, Ph.D., who has almost three decades of experience in research and development in the life science industry, and Anne Prener, M.D., Ph.D., who has more than 25 years of leadership experience in life science companies. Both directors bring expertise, a valuable network and solid experience of successful drug launches in the US market.
We also continued to pursue market preparation activities during the quarter together with our commercial partner EVERSANA to create a basis for a rapid and successful launch. The partnership with EVERSANA grants us exclusive access to a dedicated US-wide marketing and sales organization. The team consists of skilled experts with years of documented experience in selling PKI drugs to the specific physicians, insurance companies, and other paying customers we are targeting. We will be able to leverage the infrastructure we are now building up when we bring future products to market.
Application for market approval of XS003
We also continue to make progress on other products in our portfolio. We will shortly be submitting a 505(b)(2) NDA to the FDA for the product candidate XS003, an amorphous version of nilotinib for the treatment of chronic myeloid leukemia.
Prior to submitting an 505(b)(2) NDA, we have carried out population pharmacokinetic modeling for XS003. The analysis confirmed the improved properties of XS003 and bioequivalence with the reference drug Tasigna®, at less than half the dose. Clinical data also showed that XS003 has improved food interaction and a more predictable dose response, which can facilitate precise dose adjustments in clinical practice. This is undeniable confirmation of the strength of XS003.
An exciting time lies ahead, and I am looking forward to keeping you updated throughout our journey.
Per Andersson, CEO
Xspray Pharma
For further information, please contact:
Jacob Nyberg, IR
Xspray Pharma AB (publ)
Tel: + 46 (0) 70 767 08 83
E-mail: ir@xspray.com
About Xspray Pharma
Xspray Pharma AB (publ) is a pharmaceutical company with several product candidates in clinical development utilizing its innovative, patented HyNap technology platform to create improved versions of marketed protein kinase inhibitors (PKI), the largest oncology market segment, often with high drug prices. The company's goal is to become the market leader in improved PKI's for cancer treatment. Xspray Pharma's lead drug candidate, Dasynoc®, is currently undergoing FDA review. It is an amorphous form of dasatinib, demonstrating bioequivalence at a 30% lower dose due to a better solubility profile. Its compatibility with proton pump inhibitors (PPIs), which are often co-prescribed to patients with CML and ALL, is a significant advantage. Xspray Pharma is building a robust product portfolio, including XS003-nilotinib (an optimized version of Tasigna®) and XS008-axitinib (an optimized version of Inlyta®) and XS025-cabozantinib (an optimized version of Cabometyx®).
The Xspray Pharma AB-share is trading at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).
www.xspraypharma.com.
This information is information that Xspray Pharma AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-08-15 08:00 CEST.
