New Risk • Jun 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 23% per year over the past 5 years. Revenue is less than US$1m (kr2.5m revenue, or US$261k). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (28% increase in shares outstanding). Market cap is less than US$100m (€77.9m market cap, or US$89.9m). New Risk • Jun 05
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €77.3m (US$89.2m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 23% per year over the past 5 years. Revenue is less than US$1m (kr2.5m revenue, or US$261k). Minor Risks Shareholders have been diluted in the past year (28% increase in shares outstanding). Market cap is less than US$100m (€77.3m market cap, or US$89.2m). Announcement • Jun 05
Xspray Pharma Receives Complete Response Letter From FDA For Nilopki Xspray Pharma has announced that the FDA is currently unable to approve the New Drug Application for Nilopki. Xspray Pharma is now analysing the response in detail and intends, together with its partners, to address the agency’s comments as soon as possible. Nilopki is an improved formulation of nilotinib for the treatment of chronic myeloid leukaemia (CML). In a Complete Response Letter (CRL) to Xspray Pharma, the FDA has raised three issues: a requirement for dose correspondence with Tasigna, a request for additional manufacturing data at commercial scale, and GMP observations at the contract manufacturer that need to be addressed. Xspray Pharma’s overall strategy and pipeline remain unchanged. The company has a further product candidate under FDA review, Dasynoc, an improved formulation of dasatinib for the treatment of CML and ALL, with a PDUFA date of 25 August 2026. Flerie’s holding in Xspray Pharma amounts to 17%. Chronic myeloid leukemia (CML) is a blood cancer that is a chronic, manageable disease thanks to tyrosine kinase inhibitors (TKIs). An estimated 300,000 people are living with CML in Europe and the United States, and globally the prevalence is estimated to potentially reach up to 10 million. Despite the efficacy of existing TKI therapies, challenges around tolerability and adherence remain, creating a significant market opportunity for improved formulations with lower development risk and shorter time to market. New Risk • May 12
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 28% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 23% per year over the past 5 years. Revenue is less than US$1m (kr2.5m revenue, or US$265k). Minor Risk Shareholders have been diluted in the past year (28% increase in shares outstanding). New Risk • Apr 29
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 28% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 27% per year over the past 5 years. Revenue is less than US$1m (kr2.5m revenue, or US$265k). Minor Risk Shareholders have been diluted in the past year (28% increase in shares outstanding). Announcement • Apr 23
Xspray Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 83.48468 million. Xspray Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 83.48468 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,174,234
Price\Range: SEK 20
Transaction Features: Rights Offering Announcement • Mar 25
Xspray Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 83.48468 million. Xspray Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 83.48468 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,174,234
Price\Range: SEK 20
Transaction Features: Rights Offering New Risk • Feb 19
New major risk - Revenue and earnings growth Earnings have declined by 31% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr260m free cash flow). Earnings have declined by 31% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Share price has been volatile over the past 3 months (9.2% average weekly change). Announcement • Oct 11
Xspray Pharma AB (publ), Annual General Meeting, May 12, 2026 Xspray Pharma AB (publ), Annual General Meeting, May 12, 2026. Announcement • Sep 12
Xspray Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 129.984715 million. Xspray Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 129.984715 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 3,713,849
Price\Range: SEK 35
Transaction Features: Rights Offering Announcement • Aug 20
Xspray Pharma Submits Xs003 to the Fda - the Company's Second Product Candidate from the Hynap Platform Xspray Pharma has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®?. XS003 demonstrates the lowest documented food interaction within the nilinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003's improved food interaction profile, the warning about three hours of fasting, currently included in the reference product's so-called boxed warning, is not expected to apply to XS003. This may simplify treatment and improve adherence. XS003 is an improved formulation of nilotinib (Tasigna®?) and developed using the company's proprietary HyNap™? technology. Data from registration studies demonstrate bioequivalence with the Reference product, despite XS003 being administered at less than half the dose of the reference product. In addition, the studies confirm clearly improved dose linearity, which may provide physicians with better predictability when adjusting doses, and thereby a greater ability to achieve improved treatment outcomes. The uptake of XS003 is only slightly affected when taken with food, while the reference product is significantly affected as reflected in their label (28% vs. 82%). This may indicate improved control and a lower risk of side effects when taken with food. Xspray expects the FDA to initiate its review within 60 days, with a regulatory decision anticipated approximately eight months thereafter. Announcement • Aug 16
Xspray Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 129.984715 million. Xspray Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 129.984715 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 3,713,849
Price\Range: SEK 35
Transaction Features: Rights Offering Announcement • Jul 12
Xspray Pharma AB (publ) Completes the Population Pharmacokinetic Modeling for the Product Candidate XS003 New Drug Application Xspray Pharma has now completed the population pharmacokinetic (PopPK) modeling that constitutes key regulatory documentation ahead of submitting a New Drug Application (NDA) for the product candidate XS003. The analysis confirms bioequivalence with the reference drug Tasigna®?, at less than half the dose - a strong indication marking a potential paradigm shift in the treatment of CML with nilotinib. The analysis is based on modeling and simulation of data from a comparative study in healthy volunteers. The developed PopPK model, which simulates repeated dosing until steady state is reached, shows a strong correlation with observed concentrations - supporting its regulatory relevance. The results confirm formal bioequivalence between XS003 and Tasigna in terms of systemic exposure (AUC and Cmax) - despite the XS003 dose being less than half that of the reference drug. In addition, a clinical study has shown that XS003 has significantly improved food interaction and a more predictable dose response, which can facilitate precise dose adjustments in clinical practice. Previously communicated data showed that bioavailability increased by only 28% with food intake - compared to up to 82% for Tasigna. This absorption stability with food intake may reduce the risk of concentration-dependent side effects, such as abnormal heart rhythm (QTc prolongation), particularly in real-world settings where strict fasting can be difficult to maintain. With these results, XS003 will be the company's second product candidate submitted for FDA approval following Dasynoc, both based on the HyNap™? technology: An innovative amorphous formulation technique that has shown potential to improve absorption for a range of products including protein kinase inhibitors. Announcement • Jun 30
Xspray Pharma AB (publ) Passes FDA Pre-Approval Inspection Xspray Pharma AB (publ) announced that the U.S. Food and Drug Administration (FDA) has conducted a successful Pre-Approval Inspection (PAI) of the company's manufacturing lines, located at a contract manufacturing partner. The inspection confirms that production of the product candidate Dasynoc is fully compliant with current Good Manufacturing Practice (cGMP) standards, marking a key regulatory milestone. Xspray continues to prepare for the commercial launch of Dasynoc-an improved formulation of dasatinib designed to deliver more predictable and consistent exposure, developed for patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The proprietary HyNap™? platform is central to these improvements and enables future expansion into additional oncology indications. Announcement • Apr 08
Xspray Pharma AB (publ) Re-Submits its FDA Application Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc®?, the company's lead product candidate, an amorphous dasatinib for the treatment of leukemia. The application procedure thus runs according to the most recently communicated plan. Within 2-4 weeks, the FDA is expected to announce a new PDUFA date, i.e. the date they intend to decide on the application. Xspray Pharma has submitted its response to the CRL (Complete Response Letter) that the company received from the FDA in July 2024. The CRL addressed the company's NDA application for market approval in the US of the product candidate Dasynoc, an amorphous Dasatinib drug for the treatment of CML (chronic myeloid leukemia) and ALL (acute lymphoblastic leukemia). The response will now be reviewed by the FDA, which can apply two different processing times - two or six months from the re-submission date. The submission of the updated FDA application follows the plan communicated in January of this year. Xspray Pharma reiterates the assessment that the company has sufficient funding to take Dasynoc to approval, regardless of whether the FDA's review takes two or six months from the Re-submission. Announcement • Jan 21
Xspray Pharma AB (publ) Reports Strong Interim Data for Product Candidate XS003 - Confirms Plan to Apply for Market Approval in First Half 2025 Xspray Pharma AB (publ) presented interim data from a food interaction study with the nilotinib product candidate (XS003). The results confirm the benefits of the company's patented HyNap™ technology platform and its ability to deliver significant benefits for patients compared to existing PKI drugs. Key findings from interim data: Food interaction and safety: Xspray's amorphous formulation of nilotinib has shown a marked improvement over all currently approved nilotinib products. It eliminates problems with food interaction, a common limitation of the crystalline version. The study shows that bioavailability remains stable and consistent, regardless of food intake. These results confirm that Xspray's product may offer an improved safety profile – outperforming the existing approved products, improving patients' quality of life and reducing the risk of serious side effects. Innovative technology platform and patent protection: Xspray Pharma is a pioneer in the development of amorphous PKI products and has built a strong patent portfolio around its HyNap™ technology. This offers unique properties that mean clear patient benefits compared to existing nilotinib products. The current study results together with the product candidate's strong patent protection provide unique competitive advantages that enable Xspray Pharma to take considerable market shares regardless of when the original product’s patent protection expires. In previous studies, Xspray's nilotinib product candidate has shown matching bioavailability with Tasigna at more than 50% lower dose. Xspray Pharma is now completing the remaining studies for the nilotinib product candidate and still plans to submit the New Drug Application (NDA) to the FDA in the first half of 2025. New Risk • Jan 11
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €94.6m (US$96.9m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (€94.6m market cap, or US$96.9m). Board Change • Jan 03
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 3 experienced directors. 3 highly experienced directors. Independent Director Robert Molander was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Dec 02
Xspray Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 135.04904 million. Xspray Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 135.04904 million.
Security Name: Oridnary Shares
Security Type: Common Stock
Securities Offered: 3,376,226
Price\Range: SEK 40
Transaction Features: Rights Offering Announcement • Nov 07
Xspray Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 135.04904 million. Xspray Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 135.04904 million.
Security Name: Oridnary Shares
Security Type: Common Stock
Securities Offered: 3,376,226
Price\Range: SEK 40
Transaction Features: Rights Offering Announcement • Oct 22
Xspray Pharma AB (publ), Annual General Meeting, May 13, 2025 Xspray Pharma AB (publ), Annual General Meeting, May 13, 2025. Announcement • Oct 21
Xspray Pharma AB's Nomination Committee for the Annual General Meeting 2025 Xspray Pharma AB announced the Nomination Committee’s composition for the Annual General Meeting, May 13, 2025. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on 21 May 2024, consists of: Thomas Eldered, appointed by Flerie AB, Chairman of the Nomination Committee, Johan Gyllenswärd, appointed by Ribbskottet AB, Mattias Klintemar, appointed by The Foundation for Baltic and East European Studies, Johan Wadell, appointed by AP2, Anders Ekblom, Chairman of the Board of Directors, Xspray Pharma AB The Nomination Committee shall, before the Annual General Meeting on May 13, 2025, prepare proposals for the election of Chairman and other members of the Board of Directors, the election of Chairman of the Annual Meeting, election of auditors, the determination of fees and matters pertaining thereto. Board Change • Oct 16
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Robert Molander was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Sep 19
Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission Xspray Pharma AB (publ) announced significant progress following a productive meeting with the U.S. Food and Drug Administration (FDA). The company plans to resubmit its New Drug Application (NDA) for Dasynoc in Fourth Quarter 2024, incorporating feedback from the Complete Response Letter (CRL) issued by FDA in July 2024. If the FDA sets a two-month review period upon resubmission, the launch of Dasynoc could be expected as early as First Quarter 2025. The FDA recommends adjustments to Dasynoc's tablet strengths to reduce the risk of medication errors. Although these changes are minor (within normal variability), the FDA has requested new batches to be produced before submission. Xspray Pharma has already initiated production of these batches. The company will also provide further clarification on the manufacturing process to ensure full alignment with the FDA’s requirements. Upon resubmission, Xspray Pharma expects the FDA to assign a new Prescription Drug User Fee Act (PDUFA) date, with a final decision anticipated within two or six months of the resubmission, depending on the review timeline set by the FDA. New Risk • Aug 09
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr259m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr259m free cash flow). Shares are highly illiquid. Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (49% increase in shares outstanding). Recent Insider Transactions • Jul 31
Director recently bought €409k worth of stock On the 29th of July, Anders Bladh bought around 105k shares on-market at roughly €3.90 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €1.2m more in shares than they have sold in the last 12 months. Board Change • Jul 29
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Robert Molander was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Jul 10
Xspray Pharma Ab's Xs003 Study Shows Matching Bioavailability to Tasigna At More Than A 50% Lower Dose Xspray Pharma AB announced new clinical data from its XS003 registration study program. XS003 is an amorphous, non-crystalline formulation of nilotinib designed to overcome significant limitations of currently marketed crystalline formulations. In the announced study, XS003 demonstrates matching bioavailability to Tasigna, with a 50% reduced dose. XS003 is designed to reduce food interactions for nilotinib, that currently complicate prescribing and adherence to existing therapies which may increase the risk of sudden death caused by prolongation of the QTc interval, for which Tasigna carries a boxed warning. Crystalline PKI formulations often lead to a substantial portion of the drug being unabsorbed and excreted, ending up in the sewage system. The results show that the XS003 amorphous formulation of nilotinib uses less than 50% of the active ingredient compared to crystalline forms. Thus, there is significantly less excess material available for overdosing, potentially making it a safer drug. Board Change • Jun 10
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Robert Molander was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 24
Xspray Pharma AB (publ) Announces to Present Data At ASCO Highlighting Frequent Decideication of PPIs with TKIs in CML-Patients and Greater Than Expected Positive Effects on the Bioavailability of Crystalline Dasatinib Xspray Pharma AB (publ) announced the online publication of its abstract titled "Frequency of comedyication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability" for presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 3rd, 2024 at 9-12 AM, Poster nr. 120. While Tyrosine Kinase Inhibitors (TKI), including dasatinib, have profoundly improved clinical outcomes in patients with chronic myeloid leukemia (CML), the bioavailability and systematic exposure of the crystalline formulation of dasatinib is reduced by comedication with acid reducing agents which may affect the clinical response and comedication with proton pump inhibitors, such as omeprazole, should be avoided. The collaborative analysis with Uppsala University and the Karolinska Institute and University Hospital demonstrates that 54% of CML patients identified in the Swedish CML-register were prescribed at least one PPI and 34% of TKI-treated patients were comedicated with a PPI. Of those prescribed a PPI, 66% of the prescriptions were by a different healthcare provider. Further, the presentation provides new information on the bioavailability of crystalline dasatinib when comedicated with a PPI, demonstrating a substantially higher than previously reported impact of PPIs on the bioavailability of crystaline dasatinib, with Cmax and AUC24 being reduced by 96% and 88% respectively. Announcement • Mar 28
Xspray Pharma AB (publ) to Report Fiscal Year 2024 Results on Feb 12, 2025 Xspray Pharma AB (publ) announced that they will report fiscal year 2024 results on Feb 12, 2025 Announcement • Feb 13
FDA Accepts Xpray Pharma's NDA-Resubmission for Dasynoc® - PDUFA The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma's New Drug Application (NDA) for Dasynoc®, following a Complete Response Letter (CRL) where additional information was requested. The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024. This is the FDA's deadline for completing the approval process, marking a significant milestone for Dasynoc®, Xspray's innovative protein kinase inhibitor (PKI) product candidate for CML treatment. With the PDUFA date set to 31st of July, Xspray Pharma continues to strategically plan for the commercial launch of Dasynoc® on September 1, 2024. These dates align with the company's comprehensive preparation following the patent litigation settlement with Bristol Myers Squibb (BMS), paving the way for Dasynoc® to become a new option for chronic myeloid leukemia (CML) treatment pending FDA approval. Dasynoc®, an optimized version of dasatinib, highlights Xspray Pharma's dedication to advancing cancer treatment through innovative drug formulations. The product candidate has the potential to become a best-in-class product with a strong patent position for amorphous dasatinib products with improved properties for patients with CML. As the PDUFA date approaches, the company remains focused on its goal to improve the lives of those affected by CML with this novel therapy. Announcement • Nov 22
Xspray Pharma Ab's Xs003 Achieves Superior Bioavailability Milestone, Matching TASIGNA At Reduced Dosage Xspray Pharma AB announced that XS003, its amorphous, non-crystalline formulation of nilotinib, has demonstrated bioavailability within the 80-125% range to TASIGNA following oral administration with significantly lower dose. This is the second of three announced amorphous PKIs under development by Xspray using the HyNap platform to address critical limitations with currently marketed crystalline formulations. XS003 demonstrated the results in a comparative bioavailability study involving healthy volunteers. It is Xspray's second product candidate developed using the HyNap technology. XS003 is being developed under the regulatory 505(b)(2) NDA process, which streamlines the approval process, and XS003 is expected to be submitted to the FDA for approval in the second half of 2024. In 2020, XS003 received orphan drug status by the FDA for the treatment of CML. Worldwide sales for TASIGNA approached $2.0 billion in 2022. Announcement • Nov 10
Xspray Pharma AB Through HyNap™ technology Announces Results from Drug Interaction Studies Xspray Pharma AB through its proprietary HyNap™ technology, announced the results from drug interaction studies demonstrating that DASYNOC’s (DASYNOC CO-PPI Study) uptake into blood following oral dosing is not altered by the concomitant administration of omeprazole, a commonly prescribed PPI, while a significant reduction in the uptake of SPRYCEL (SPRYCEL CO-PPI Study) was observed with the use of omeprazole. Xspray has demonstrated that in the DASYNOC CO-PPI Study, DASYNOC’s uptake into blood was not affected 10 hours after taking omeprazole (107 % of intended AUC0-24h and 86% of intended Cmax). However, in the SPRYCEL CO-PPI Study, the uptake of SPRYCEL was significantly reduced 10 hours after taking omeprazole (only 12% of the intended AUC0-24h and 4% of the intended Cmax). Previous studies supporting the approval of SPRYCEL demonstrated that administration of a single 100 mg dose of SPRYCEL, 22 hours following a 40 mg dose of omeprazole, reduced the mean AUC of dasatinib to 57% and the mean Cmax to 58% of the intended values without PPI. Despite labeled avoidance of coadministration of SPRYCEL with PPIs2, PPIs are used concomitantly in nearly half of all CML patients taking TKIs.1 The SPRYCEL CO-PPI Study data show that subjects received only 12% of the intended dasatinib dosage. This may potentially increase their risk of disease progression and death1. SPRYCEL was approved in 2006 by the FDA and is the market leading branded product that revolutionized the treatment of CML. However, the crystalline formulation of dasatinib in SPRYCEL results in a low, pH-sensitive, and highly variable intestinal absorption that may jeopardize the optimal and anticipated therapeutic response.3–6 In contrast, DASYNOC’s amorphous, non-crystalline, formulation results in higher solubility, improved dissolution and pH independent bioavailability allowing patients to receive the full benefits of dasatinib therapy. Announcement • Sep 16
Xspray Pharma Appoints Edward P. Jordan as Chief Commercial Officer Xspray Pharma announced the appointment of Edward P. Jordan as chief commercial officer. Mr. Jordan will lead the US product launch and commercialization of DasynocTM with an anticipated launch in September 2024, subject to FDA approval. Assuming his new role effective September 15, Mr. Jordan transitions from his recent position as Chief Commercial Officer at Humanigen Inc. In this pivotal role, Mr. Jordan will team up with Xspray Pharma's US commercialization partner, Eversana. Together, they'll prepare for the successful commercialization of DasynocTM where he will leverage a solid history of collaborating with Eversana. Mr. Jordan's will also helm the commercial introduction of other products in Xspray Pharma's pipeline, capitalizing on the company's patented amorphous technology platform while building the US infrastructure. Announcement • Sep 12
Xspray Pharma and Bristol Myers Squibb Reach Settlement on Dasynoc Patent Litigation, Paving Way for Early Market Launch Xspray Pharma announced a resolution to its patent litigation with Bristol Myers Squibb (BMS) concerning its product, DasynocTM. The settlement clears all pending claims, paving the way for Xspray to introduce DasynocTM to the market on September 1, 2024, pending final FDA approval. The launch may occur earlier under certain circumstances. The contested patents and their associated regulatory exclusivities expire on September 28, 2026. The parties will proceed to file a dismissal with the United States District Court for the District of New Jersey, eliminating the need for any additional litigation on this matter. Announcement • Aug 03
Xspray Pharma AB (publ) to Report Q4, 2023 Results on Feb 14, 2024 Xspray Pharma AB (publ) announced that they will report Q4, 2023 results on Feb 14, 2024 Announcement • Jul 12
Xspray Pharma AB (publ) Receives Request for Additional Information Concerning Dasynoc from FDA Xspray Pharma AB (publ) announced an update on recent developments regarding the company's first product, Dasynoc, currently under review by the United States Food & Drug Administration. The company has received a Complete Response Letter whereby the FDA request additional information particularly regarding additional information to doctors and users related to Dasynoc dosinga and a third-party manufacturing facility. At the same time, the CRL accepted critical aspects of the application as it did not identify any deficiencies with the stability or clinical data submitted to the FDA to date. On July 10, Xspray Pharma received a Complete Response Letter (‘CRL’) relating to its Dasynoc New Drug Application (‘NDA’) for all six strengths (15 mg, 36 mg, 50 mg, 57 mg, 70 mg, and 100 mg) under review by FDA. In the CRL, the agency noted that the agency received Xspray's amendment filed on January 10, 2023, which was a complete response to FDA's prior action letter issued September 1, 2022. In the CRL, the FDA accepted Xspray's proposed product name, Dasynoc, and did not identify any deficiencies with the stability or clinical data submitted in support of the NDA to date. The FDA, however, did request that Xspray provide additional information to doctors and users to avoid confusion about the proper dosing of Dasynoc. Patient safety is always a primary concern for Xspray, which developed Dasynoc to have no interference when used with PPIs. Whereas, the label for Bristol-Myers Squibbs's Sprycel® instructs that Sprycel® should not be administered with H2 antagonists or proton pump inhibitors. Xspray will compile the requested information to mitigate any risk of dosing confusion. In light of this, the FDA's review of the Dasynoc label remains ongoing. The CRL also informed Xspray that the inspection and review of a third-party manufacturing facility is ongoing, and the CRL also requested that Xspray provide additional information in support of its NDA. Xspray will promptly compile all the information requested by FDA. Recent Insider Transactions • Dec 02
Director recently bought €240k worth of stock On the 30th of November, Anders Bladh bought around 50k shares on-market at roughly €4.79 per share. This transaction increased Anders' direct individual holding by 31x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €249k more in shares than they have sold in the last 12 months. Announcement • Dec 01
Xspray Pharma AB (publ)'s Drug Candidate Xs004 Granted Orphan Drug Designation in the US for the Treatment of Acute Lymphoblastic Leukemia Xspray Pharma AB (publ) has received a decision from the US Food and Drug Administration granting drug candidate XS004 (dasatinib) Orphan Drug Designation for the treatment of acute lymphoblastic leukemia. The FDA decision is based on the potential that XS004 may be clinically superior to other drugs already approved for the same indication. Xspray Pharma's product candidate may provide a major contribution to patient treatment due to the gastric pH-resistant qualities of the formulation and the significant frequency of concomitant use of acid-reducing agents in the ALL population. In June of this year, the FDA granted orphan drug designation status for XS004 (dasatinib) for the treatment of chronic myeloid leukemia (CML). XS004 is Xspray Pharma's first product candidate currently undergoing FDA review for market approval. The FDA grants orphan drug designation status to potential new drug candidates intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Breakeven Date Change • Nov 16
Forecast to breakeven in 2024 The analyst covering Xspray Pharma expects the company to break even for the first time. New forecast suggests the company will make a profit of kr596.0m in 2024. Average annual earnings growth of 124% is required to achieve expected profit on schedule. Breakeven Date Change • Jun 17
Forecast to breakeven in 2024 The analyst covering Xspray Pharma expects the company to break even for the first time. New forecast suggests the company will make a profit of kr596.0m in 2024. Average annual earnings growth of 98% is required to achieve expected profit on schedule.