Aankondiging • Jul 23
Hyloris Pharmaceuticals SA to Report Fiscal Year 2026 Results on Apr 30, 2027 Hyloris Pharmaceuticals SA announced that they will report fiscal year 2026 results on Apr 30, 2027 Board Change • May 20
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Melanie Mestdagt was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • May 11
Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026 Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026, at 14:00 Romance Standard Time. Aankondiging • Apr 23
Hyloris Pharmaceuticals SA to Report Fiscal Year 2026 Results on Mar 25, 2027 Hyloris Pharmaceuticals SA announced that they will report fiscal year 2026 results on Mar 25, 2027 New Risk • Jan 03
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 7.9% 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 Risk Less than 1 year of cash runway based on free cash flow trend (-€7.4m free cash flow). Minor Risk Share price has been volatile over the past 3 months (7.9% average weekly change). Board Change • Dec 30
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Melanie Mestdagt was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • May 13
Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 10, 2025 Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 10, 2025, at 14:00 Romance Standard Time. Board Change • Dec 30
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Vincent Dessel was the last independent director to join the board, commencing their role in 2024. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Oct 22
First half 2024 earnings released: €0.12 loss per share (vs €0.20 loss in 1H 2023) First half 2024 results: €0.12 loss per share (improved from €0.20 loss in 1H 2023). Revenue: €4.64m (up 143% from 1H 2023). Net loss: €3.49m (loss narrowed 38% from 1H 2023). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Aankondiging • Oct 07
Hyloris Pharmaceuticals SA to Report Fiscal Year 2024 Results on Mar 20, 2025 Hyloris Pharmaceuticals SA announced that they will report fiscal year 2024 results on Mar 20, 2025 Aankondiging • Oct 05
Hyloris Pharmaceuticals SA to Report Fiscal Year 2024 Final Results on Apr 30, 2025 Hyloris Pharmaceuticals SA announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Apr 30, 2025 Breakeven Date Change • Sep 16
No longer forecast to breakeven The 2 analysts covering Hyloris Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €1.20m in 2026. New consensus forecast suggests the company will make a loss of €16.2m in 2026. New Risk • Sep 16
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Shares are highly illiquid. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Revenue is less than US$5m (€4.2m revenue, or US$4.7m). Board Change • Aug 21
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. 3 independent directors (5 non-independent directors). Independent Director Chris Buyse was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Aankondiging • Mar 21
Hyloris Pharmaceuticals SA to Report First Half, 2024 Results on Sep 05, 2024 Hyloris Pharmaceuticals SA announced that they will report first half, 2024 results on Sep 05, 2024 Reported Earnings • Mar 14
Full year 2023 earnings released Full year 2023 results: Net loss: €15.8m (loss widened 46% from FY 2022). Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Aankondiging • Feb 15
Hyloris Pharmaceuticals SA Enrolls First Patient in Phase 3 Clinical Trial for Its Proprietary Mouth Rinse to Control Incidences of Bleeding Related to Dental Procedures Hyloris Pharmaceuticals SA announced that the first patient has been enrolled in a pivotal Phase 3 clinical trial for Tranexamic Acid Oral Rinse. Hyloris' product candidate is a new treatment for use in patients on anti-coagulant therapies (blood thinners) undergoing dental procedures with a risk of excessive bleeding. It is an oral solution containing the locally-acting antifibrinolytic agent tranexamic acid. Positive data in a Phase 1 pharmacokinetic (PK) trial in healthy subjects suggested the treatment was well tolerated under varied conditions with no serious adverse events following tooth extraction, while effectively controlling procedural bleeding without delaying clot formation. Hyloris' proprietary reformulated oral rinse was developed for use in minor surgical procedures with complications/bleedings. The formulation can be used by dental care professionals for patients on anti-coagULant therapies who benefit from the opportunity to continue their anti-coagulant treatments when scheduled for dental procedures. By addressing the unique challenges faced by individuals on blood thinners, this oral care solution seeks to enhance the overall dental experience and improve the oral health of these patients. Tranexamic acid is an antifibrinolytic agents that has been used for decades to reduce or prevent postoperative bleeding in patients with bleeding problems. The drug is currently approved for intravenous administration (CYKLOKAPRON®? IV) in the U.S. for reduction or prevention of bleeding in patients having a high risk of intra and post-operative haemorrhage (during general and oral surgery, such as tooth extractions) due to a bleeding disorder such as haemophilia (as indicated). The drug is also approved in the U.S. as an oral tablet (LYSTEDA®?) for cyclic heavy menstrual bleeding. Aankondiging • Jan 30
Hyloris Pharmaceuticals SA Announces Positive Results for the Phase 2 Trial of Miconazole Domiphen-Bromide (MCZ-DB) in Patients with Acute Vulvovaginal Candidiasis Hyloris Pharmaceuticals SA announced positive results for the phase 2 trial of Miconazole Domiphen-Bromide (MCZ-DB) in patients with acute vulvovaginal candidiasis. The phase 2 trial of MCZ-DB was a 12-week, randomized, double-blind, active-controlled, dose finding trial evaluating the safety and efficacy of two doses of MCZ-DB (MCZ 2% combined with 0.14% or 0.29% of DB) administered once per day for 7 days in patients with acute vulvovaginal candidiasis. The study has been conducted in Belgium with a total of 102 patients enrolled. Efficacy was evaluated by assessing the clinical outcome and mycological outcome to the treatment. A positive clinical outcome is a resolution of VVC signs and symptoms whereas the mycological outcome is determined by a vaginal swab indicating the absence of Candida species yeast. Top line results are summarized: At day 29, day 57 and day 85, the low dose (MCZ and 0.14% of DB) demonstrated superior efficacy compared to the active control (MCZ). At day 15, both doses administered demonstrated positive safety and tolerability without significant superiority over the active control. MCZ-DB was well tolerated in both dose cohorts, with no reported serious adverse events. Following the treatments, there was no indication of systemic exposure to Domiphen Bromide. Breakeven Date Change • Oct 25
Forecast breakeven date moved forward to 2024 The 2 analysts covering Hyloris Pharmaceuticals previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 13% to 2023. The company is expected to make a profit of €1.05m in 2024. Average annual earnings growth of 116% is required to achieve expected profit on schedule. Aankondiging • Oct 18
Hyloris Pharmaceuticals SA Announces U.S. FDA Approval of Maxigesic® IV Hyloris Pharmaceuticals SA announced Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary. The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates. An exclusive license and distribution agreement for the U.S., was already signed between Hyloris’ partner AFT Pharmaceuticals (“AFT”) and Hikma Pharmaceuticals (“Hikma”). Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties and milestone payments, received by AFT. Distribution of Maxigesic® IV in U.S. hospitals should start in early 2024. Following first U.S. sales, Hyloris will be entitled to a milestone payment of USD 2,1 million. In addition, the payment of USD 1,5 million (approximately EUR 1,4 million) relating to existing trade receivables is expected. development of chronic opioid use after surgery is one of the most common post-operative complications2 with particularly devastating consequences. In the U.S., prevalence of new chronic opioid use after surgical procedures was estimated close to 6%3. In the past 2 decades, prescription opioid usage in the U.S. contributed to over 600,000 deaths related to opioid overdoses, with the annual death toll rising tenfold between 1999 and 2021 (80,000 deaths in 2021). Nearly 17,000 deaths involved prescription opioids in 20214.Patients requiring medical attention related to opioid abuse account for around $11 billion of added costs to the U.S. healthcare system annually, or 1% of all hospital costs5. Breakeven Date Change • Jul 26
Forecast breakeven date pushed back to 2025 The analyst covering Hyloris Pharmaceuticals previously expected the company to break even in 2024. New forecast suggests losses will reduce by 9.6% per year to 2024. The company is expected to make a profit of €8.00m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule. Reported Earnings • Mar 17
Full year 2022 earnings released Full year 2022 results: Net loss: €10.8m (loss narrowed 7.0% from FY 2021). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Aankondiging • Jan 20
Hyloris Pharmaceuticals SA Expands Its Pipeline with A Product Candidate for A Mineral Deficiency in the Blood (Hypophosphatemia) Hyloris Pharmaceuticals SA announced it has in-licensed a product candidate targeting hypophosphatemia. This serious condition causes patients to have a low level of phosphorous in the blood. While mild hypophosphatemia is common and many patients are asymptomatic, severe hypophosphatemia can be life-threatening and requires medical treatment. The condition can result in different health challenges, including muscle and bone weakness, respiratory or heart failure, seizures or coma. Deficiency of this vital mineral is always linked to an underlying condition, such as diabetes, anorexia, use of diuretics or alcohol abuse. About Hypophosphatemia: Treatment protocols for patients deficient in phosphate are well-established and have proven useful in other situations of bone mineral imbalance. Oral administration is the preferred way of treating hypophosphatemia, although in most countries no approved drugs exist. Currently, physicians mostly rely on compounded drugs which have, by definition, not been submitted for regulatory scrutiny regarding safety, efficacy, and quality. The company will seek advice and approval from regulators by making use of the rich body of clinical data that has emerged from established clinical practice. With a primary on safety of the product, the company intends to conduct a streamlined development program to achieve market access in Europe, targeting regulatory approval in European countries as from 2026. Global rights of the ongoing development have been licensed-in from Dutch company, QliniQ, who maintains the rights to commercialize the product candidate in its home country, and a selected number of Middle Eastern and developing countries. Aankondiging • Sep 01
Hyloris Pharmaceuticals SA to Report Fiscal Year 2022 Results on Mar 16, 2023 Hyloris Pharmaceuticals SA announced that they will report fiscal year 2022 results on Mar 16, 2023 Breakeven Date Change • May 04
Forecast to breakeven in 2024 The 2 analysts covering Hyloris Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €7.00m in 2024. Average annual earnings growth of 72% is required to achieve expected profit on schedule. 
