# Hyloris

> We add value to pharma through the smart, innovative use of existing medicines — addressing unmet patient needs worldwide.

Source: https://hyloris.com/ (product portfolio last updated 2026-10-13).
Always refer to the most recent investor documents for financial figures and forward-looking statements.

## Our Product Portfolio

Since our inception, we have significantly strengthened our capabilities and skills, expanding our focus towards complex, reformulated and repurposed patented products, thereby moving further up the value chain. By applying our know-how and technological innovations to existing pharmaceuticals, we have built a broad proprietary portfolio of value-added product candidates.

Our pipeline spans 30+ products and product candidates — 25 of which are value-added — and is organized around 3 Strategic Focus Groups for Growth: Mavericks, Core Drivers and Promising Seeds.

The portfolio currently includes 4 commercialized products which deliver royalties income and are widely brought to the market thanks to an impressive number of partnerships (Maxigesic® IV, Sotalol IV, Podofilox Gel, Tranexamic Acid IV RTU), 25+ products in development of which 2 pending filings (Atomoxetine and Valacyclovir powder for suspension). Most of our cardiovascular candidates are intended for commercialization through third party sales force, targeting cardiovascular specialists and hospitals in the U.S., while we are also pursuing value-added candidates in other high-value markets beyond the cardiovascular space.

Page: https://hyloris.com/product-portfolio/

## Mavericks

High-potential products backed by clinical evidence and significant commercial potential

### HY-094 (NCE)

- Status: In development
- Therapeutic area: Iron deficiency
- Indication: Iron Deficiency Anemia
- Target market: WW
- Route of administration: Injection
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-094.pdf

HY-094 is a next-generation intravenous (IV) iron product candidate and new chemical entity (NCE) for the treatment of iron deficiency anemia in adults. It is designed to address limitations of existing IV iron therapies with the potential to provide effective iron replenishment and improved tolerability. HY-094 is being co-developed with AFT Pharmaceuticals for global commercialization.

**Stage:** HY-094 has completed Phase 2b development and is advancing toward Phase 3 clinical trials.

**Indication details:** For the treatment of iron deficiency anemia in adults.

**Benefit:** HY-094 is designed to deliver effective iron replacement with the potential for single-infusion administration, with a favorable tolerability profile.

**IP rights / exclusivity:** Proprietary IP (exclusive global human-use license secured).

### Milrinone ER (Repurposing)

- Status: In development
- Therapeutic area: Cardiovascular
- Indication: Late-stage HF with LVAD
- Target market: WW
- Route of administration: Oral solid
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Milrinone-ER.pdf

Milrinone ER is designed to provide strengthening of heart contraction in a proprietary extended release (ER) oral formulation tailored for long-term use. By providing steady-state exposure in a convenient twice-daily oral dosage form, Milrinone ER has the potential to support a shift toward a more stable, practical, and autonomous long-term treatment approach for patients who currently have limited approved options. This differentiated profile may help reduce key treatment burden barriers that restrict chronic management in this setting.

**Stage:** Ongoing human Phase 1 PK studies.

**Indication details:** For the treatment of right heart failure (RHF) in patients with a left ventricular assist device (LVAD).

**Benefit:** Milrinone ER is designed to lead to a stable and controlled milrinone effect and has the potential to become the first available oral medication to improve strength of heart function in late-stage heart failure patients. This product is planned to be eligible and convenient for long-term oral therapy and reduce reliance on existing regimens of chronic intravenous pharmacotherapy with all its downsides regarding cost, complexity and safety.

**IP rights / exclusivity:** Priority patent application filed in 2025.  Expiry when granted: 2046.

This application covers the composition under development.

FDA Orphan Drug Designation.

LVAD-associated RHF indication.

### Miconazole DB (NCE)

- Status: In development
- Therapeutic area: Infectious diseases
- Indication: rVVC/BV
- Target market: WW
- Route of administration: Topical
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Miconazole-DB.pdf

Dual-action vaginal cream combining miconazole, a standard-of-care fungistatic, with domiphen bromide (DB) to address both yeast and bacterial infections. The program is initially focused on Vulvovaginal Candidiasis (VVC), with subsequent expansion into bacterial vaginosis (BV). By delivering treatment directly to the vaginal mucosa, the product is designed to improve outcomes in patients with persistent, mixed or difficult-to-diagnose infections.

**Stage:** Dose-finding Phase 2 study in VVC completed.

Preparations are underway for an exploratory clinical trial to assess potential efficacy against bacterial strains, including Gardnerella.

**Indication details:** Treatment of vulvovaginal candidiasis (VVC) and bacterial vaginosis (BV).

**Benefit:** The dual-action candidate combines miconazole’s antifungal activity with domiphen bromide’s antiseptic properties, promoting eradication of both Candida and bacterial pathogens. This differentiated mechanism may help address an important driver of recurrence.

**IP rights / exclusivity:** Intellectual property protection through 2038, 2044 and 2045.

### Suramin IV (NCE)

- Status: In development
- Therapeutic area: Tropical diseases
- Indication: Human African Trypanosomiasis
- Target market: U.S.
- Route of administration: Injection
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Suramin-IV.pdf

Suramin IV is being developed for Human African Trypanosomiasis (HAT). Because HAT is included on the FDA's list of tropical diseases eligible for a Priority Review Voucher, approval in this indication could potentially qualify the program for a Priority Review Voucher, subject to applicable FDA requirements. 

The HAT program may also serve as a strategic bridge toward Autism Spectrum Disorder (ASD) as a potential follow-on indication.

**Stage:** Suramin IV for HAT is currently in Phase 3 development.

A Phase 2 study on ASD has been completed.

**Indication details:** Suramin IV is being developed for the treatment of Trypanosoma brucei rhodesiense, the acute and rapidly progressing form of Human African Trypanosomiasis.

HAT is a neglected tropical disease, and this specific disease is included on the FDA list of tropical diseases for which a Priority Review Voucher (PRV) may be granted.

Following HAT, ASD could be pursued as an additional indication.

**Benefit:** Suramin IV is a standardized intravenous formulation of the long-established standard of care for rhodesiense HAT. Although suramin has been used globally for decades and is recognized by the WHO and CDC, it has never been FDA-approved for any indication in the U.S. By formalizing the regulatory path for this life-saving therapy, the program aims to become the first FDA-approved suramin product in the U.S. while also creating a PRV opportunity.

**IP rights / exclusivity:** FDA Orphan Drug Designation.

HAT indication.

### Alenura™ (Repurposing)

- Status: In development
- Therapeutic area: Urology
- Indication: IC / Painful Bladder Syndrome
- Target market: WW
- Route of administration: Instillation
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_ALENURA.pdf

IC/BPS is a chronic and debilitating bladder pain condition marked by recurring discomfort, pelvic pain, and acute symptom flares. Alenura™ is a ready-to-use intravesical therapy for adults with IC/BPS acute pain flares, combining alkalinized lidocaine with the potential to provide immediate local pain relief and heparin to help support and protect the bladder lining.

**Stage:** Currently in Phase 2 clinical development, including a 4-arm study comparing Alenura™ with its individual components and placebo.

The Independent Data Monitoring Committee (IDMC) recommended continuation of the trial following interim analysis.

Additional studies are ongoing to support an End-of-Phase 2 meeting in H2 2026.

**Indication details:** For adults with pain associated with IC/BPS, a condition causing recurring discomfort or pain in the bladder and surrounding pelvic region, believed to result from dysfunction of the inner bladder wall’s glycosaminoglycan layer.

**Benefit:** A ready-to-use intravesical therapy designed to provide rapid pain relief while also supporting the bladder’s protective lining, with the potential to deliver both immediate and sustained symptom control during acute IC/BPS flares.

**IP rights / exclusivity:** Multiple patents and patent applications (max expiry 2038).

## Core Drivers

Catalyst products building a strong recurring revenue base in the near term

### Maxigesic® IV (Reformulation)

- Status: Commercial product
- Therapeutic area: Non-opioid analgesic
- Indication: Post-operative pain
- Target market: WW
- Route of administration: IV
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Maxigesic-IV.pdf

Maxigesic® IV is a differentiated proprietary intravenous fixed-dose combination of 1,000 mg of paracetamol and 300 mg of ibuprofen, developed to provide effective, opioid-sparing treatment for acute pain in hospital settings. By combining two well-established analgesics in a single IV formulation, it is positioned to address an important unmet need in postoperative pain management within a large global market. The product is partnered worldwide with AFT Pharmaceuticals (excluding Australia and New Zealand).

**Stage:** Licensed in more than 100 countries, approved in over 50 countries, and marketed in more than 30 countries.In the U.S., the product is commercialized by Hikma under the registered trade name Combogesic® IV.

**Indication details:** U.S.: Short-term treatment of mild to moderate pain, or moderate to severe pain as an adjunct to opioids, as well as fever, when intravenous administration is clinically justified.

EU: Short-term symptomatic treatment of acute moderate pain and reduction of fever when intravenous administration is clinically necessary or when other routes of administration are not suitable.

**Benefit:** Faster, superior pain relief compared to either drug alone, offering an effective non-opioid alternative to reduce opioid use in hospital post-operative pain management.

**IP rights / exclusivity:** Range of patents covering formulations, uses, and methods of manufacturing, including an aqueous paracetamol and ibuprofen IV formulation

(U.S. expiry: July 2035 – Aug 2036) and an improved manufacturing method for paracetamol-based aqueous solutions (U.S. expiry: June 2039).

### Sotalol IV (Reformulation)

- Status: Commercial product
- Therapeutic area: Cardiovascular
- Indication: Atrial fibrillation
- Target market: U.S.
- Route of administration: IV
- Commercialised by:  (AltaThera)
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Sotalol-IV.pdf

Sotalol IV is an intravenous formulation of an established antiarrhythmic developed to enable the safe and efficient initiation of sotalol therapy in patients with atrial fibrillation or ventricular arrhythmias.

**Stage:** FDA-approved and commercialized in the U.S. by AltaThera.

**Indication details:** Sotalol IV is indicated for the treatment of documented, life-threatening ventricular arrhythmias, including sustained ventricular tachycardia.

It is also indicated to help maintain normal sinus rhythm by delaying recurrence of atrial fibrillation or atrial flutter in highly symptomatic patients who are already in sinus rhythm.

In addition, it may provide a useful intravenous option for patients who are temporarily unable to take oral sotalol.

**Benefit:** Sotalol IV is designed to shorten hospital initiation time, reduce overall healthcare resource utilization, and improve treatment efficiency for patients starting sotalol therapy.

IV loading may reduce hospitalization to as little as one day in appropriate patients, while also allowing more controlled management of drug exposure and clinical monitoring.

**IP rights / exclusivity:** Protected by formulation patents, including ready-to-use intravenous composition patents, with protection currently referenced through 2034.

### Podofilox Gel (Generic)

- Status: Commercial product
- Therapeutic area: Infectious diseases
- Indication: Ext. genital/perianal warts
- Target market: U.S.
- Route of administration: Topical
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Podofilox-Gel.pdf

Podofilox gel is the first generic equivalent to Condylox® gel in the U.S., developed for the treatment of external genital and perianal warts. 

The product is a 0.5% podofilox topical gel administered twice daily for 3 consecutive days, followed by a 4-day treatment break, for up to 4 weeks.

**Stage:** FDA approved, commercially available in the U.S.; launched by Padagis in December 2023.

**Indication details:** For adult patients, for the topical treatment of external genital and perianal warts caused by certain types of human papillomavirus (HPV).

**Benefit:** Provides an effective and convenient topical, non-invasive treatment option for external genital and perianal warts, offering patients a well-established alternative to more invasive procedures.

**IP rights / exclusivity:** Granted patent in Belgium covering an improved manufacturing process.

### Tranexamic Acid RTU (Generic)

- Status: Commercial product
- Therapeutic area: Bleeding
- Target market: WW
- Route of administration: Oral Mouth Rinse
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Tranexamic-Acid-RTU-.pdf

Ready-to-use intravenous formulation of tranexamic acid designed to simplify current practice by reducing or eliminating the need for reconstitution and dilution prior to administration. Unlike concentrated products that usually require preparation by qualified medical professionals, the RTU formulation enables immediate administration. This provides a convenient and practical option for use in surgical procedures and other clinical settings where reduced preparation time, lower handling complexity, and improved workflow efficiency are important advantages.

**Stage:** In June 2025, Hyloris’ exclusive U.S. partner received FDA approval of its Abbreviated New Drug Application (ANDA) for an intravenous, ready-to-use (RTU) formulation of tranexamic acid, supplied as 10 mg/mL in 100 mL vials. The U.S. launch is planned for the first half of 2026. In Europe, the product is being developed under a value-added medicine approach, reflecting its meaningful practical and clinical advantages versus concentrated reference medicinal products, and is under registration in several countries.

**Indication details:** In patients with hemophilia, for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

In practice it is mostly used for prevention and treatment of excessive bleeding.

**Benefit:** A ready-to-use intravenous formulation that eliminates the need for reconstitution, offering a convenient, time-saving alternative that may streamline treatment and improve patient outcomes.

**IP rights / exclusivity:** Granted U.S. (expiry 2 Dec 2039) and BE (expiry 17 June 2039) patents; Ready-to-Use Tranexamic Acid intravenous solution.

### TXA Oromucosal Solution (XTRAZA®) (Repurposing)

- Status: In development
- Therapeutic area: Dentistry
- Indication: Bleeding
- Target market: EU
- Route of administration: Oral Mouth Rinse
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_TXA-Oromucosal-Solution-XTRAZA.pdf

Proprietary, locally acting tranexamic acid oral rinse designed for dental procedures in patients taking anticoagulants (blood thinners), providing a standardized, non-systemic solution to help control local bleeding immediately following dental surgery.

**Stage:** The IDMC (independent data monitoring committee) recommendation was to continue with the initial sample size of 280 patients, with no safety concerns observed. However, Hyloris decided to discontinue the study and further US development.

Based on its clinical operations experience, the observed recruitment rate and the total trial cost per patient, Hyloris concluded that continued development would not achieve its target internal rate of return.

Scope of this product is reduced to EU.

**Indication details:** Prevention and treatment of excessive bleeding in patients on anticoagulant therapy undergoing dental procedures.

**Benefit:** Convenient oral rinse that helps control bleeding in patients taking blood thinners, offering a practical, localized alternative to systemic treatment approaches and supporting easier use in dental practice.

**IP rights / exclusivity:** U.S. patents granted and pending; current expected expiry in 2039.

### Metolazone IV (Reformulation)

- Status: In development
- Therapeutic area: Cardiovascular
- Indication: Congestive Heart Failure
- Target market: WW
- Route of administration: IV
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Metolazone-IV.pdf

Metolazone IV is being developed as the first injectable formulation of metolazone, designed for hospital use in patients with acute decompensated heart failure 

and severe fluid overload. It is designed to enable immediate drug delivery and more predictable dosing when oral absorption is impaired or oral administration is not feasible.

**Stage:** Registration batches have been initiated, and clinical completion is anticipated in 2026.

**Indication details:** For the treatment of salt and water retention, including oedema associated with congestive heart failure and renal disorders such as nephrotic syndrome or reduced kidney function.

**Benefit:** The IV formulation is expected to provide faster onset of action, enable concomitant administration with IV furosemide (the first-line standard of care), and improve treatment reliability in patients with gastrointestinal oedema, nausea, or inability to take oral medication.

It may also support better in-hospital dosing control in acutely ill patients.

**IP rights / exclusivity:** Patents and pending patent applications in the U.S. and selected countries, including protection for a lyophilized metolazone formulation for parenteral administration;

Expiry 2044, subject to grant and jurisdiction.

### Valacyclovir Oral Suspension (Reformulation)

- Status: In development
- Therapeutic area: Infectious diseases
- Indication: Viral infection
- Target market: U.S., major European markets, Canada, Mexico, Australia, China, South Korea and the GCC countries
- Route of administration: Oral Liquid
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Valacyclovir-Oral-Suspension.pdf

Valacyclovir powder for suspension is a differentiated formulation of a well-established antiviral designed for patients who have difficulty swallowing tablets. 

It aims to improve access, dosing accuracy, and adherence across pediatric, geriatric, and immunocompromised populations through a more practical oral presentation.

**Stage:** Hyloris has submitted an NDA to the U.S. FDA.  A Complete Response Letter was received following manufacturing-site observations identified during an FDA inspection at the CDMO responsible for the product. No product-specific deficiencies were raised. Hyloris is evaluating next steps with the current CDMO, which is addressing the FDA observations, as well as alternative manufacturing solutions; this may shift launch timing into 2027.

**Indication details:** Valacyclovir is indicated for herpes virus infections. Adult patients label uses include cold sores, initial and recurrent genital herpes, suppressive therapy and reduction of transmission of genital herpes, and shingles. 

Pediatric patient label uses include cold sores and chickenpox.

**Benefit:** Currently, valacyclovir is available in oral solid form. This oral liquid formulation is designed to support treatment of infections such as shingles and chickenpox, particularly in patients who cannot easily swallow solid dosage forms. With taste-masking technology and room-temperature stability, it offers a more patient-friendly alternative to tablets and extemporaneously compounded suspensions, with the potential to improve convenience, dosing precision, and adherence.

**IP rights / exclusivity:** Proprietary formulation protected by U.S. patents with expiries in 2035 and 2036, and pending patent applications in key markets with expiry expected in 2045.

### Atomoxetine Oral Liquid (Reformulation)

- Status: In development
- Therapeutic area: Mental- and behaviour
- Indication: ADHD
- Target market: WW
- Route of administration: Oral Liquid
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Atomoxetine-Oral-Liquid.pdf

Atomoxetine Oral Liquid is a reformulated, easy-to-dose version of the established atomoxetine capsule therapy for ADHD, designed for patients who struggle to swallow capsules. In addition, it enables precise weight-based and flexible dosing and improved palatability, addressing important compliance, acceptability and other administration challenges in pediatric patients or other patient subpopulations with issues swallowing oral solid capsules.

**Stage:** Following successful completion of the U.S. clinical trial in summer 2025, the NDA was filed with the U.S. FDA in early 2026 by Hyloris' commercial partner Rosemont Pharmaceuticals. In addition, patient participation in a supporting clinical trial for Europe was completed in Q1 2026 and may support future filings in additional territories once results become available.

**Indication details:** Primarily indicated for the treatment of ADHD, especially in patients who benefit from flexible dose titration and an oral liquid presentation.

**Benefit:** This taste-masked oral liquid enables precise weight-based dosing and easier titration, supporting adherence and tolerability, particularly in children and adolescents who may not reliably take capsule formulations.

**IP rights / exclusivity:** Multiple patents and pending applications provide potential protection through 2044, including claims covering the oral liquid formulation.

### Ondansetron ER (Reformulation)

- Status: In development
- Therapeutic area: Nausea
- Indication: Nausea & vomiting (Chemotherapy)
- Target market: WW ex. U.S. MX and CA
- Route of administration: Tablet
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Ondansetron-ER.pdf

Ondansetron ER is a once-daily extended-release oral formulation of ondansetron designed to combine rapid onset with sustained 24-hour antiemetic control. By integrating immediate-release and extended-release components in a single oral formulation, it is intended to provide more consistent symptom control during chemotherapy, radiotherapy, and post-operative recovery.

**Stage:** Late-stage development.

**Indication details:** For the relief of nausea and vomiting associated with chemotherapy (CINV), radiotherapy (RINV), and post-operative recovery.

**Benefit:** The formulation combines immediate-release and extended-release delivery to support both rapid symptom control and prolonged antiemetic coverage, with the potential to improve convenience, adherence, and overall treatment experience.

**IP rights / exclusivity:** Confidential.

### Dofetilide IV (Reformulation)

- Status: In development
- Therapeutic area: Cardiovascular
- Indication: Atrial Fibrillation
- Target market: U.S.
- Route of administration: IV
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Dofetilide-IV.pdf

Dofetilide IV is a differentiated intravenous formulation of Dofetilide developed to provide a faster, more controllable alternative to the currently available oral-only route. It is intended to support the restoration and maintenance of normal heart rhythm in patients with atrial fibrillation and atrial flutter, while improving the practicality of treatment initiation in the hospital setting.

**Stage:** The pivotal clinical trial has been completed successfully, and U.S. regulatory submission is expected in Q2 2026.

A meeting with the FDA held in February 2026 confirmed the proposed regulatory strategy.

**Indication details:** Dofetilide IV is intended for the same core indications as oral dofetilide, with added utility for: IV loading to achieve therapeutic concentrations more efficiently, potentially reducing hospital stay associated with initiation, re-titration or re-initiation of therapy, facilitating IV-to-oral transition.

**Benefit:** Initiation of oral dofetilide currently requires three or more days of in-hospital monitoring. Dofetilide IV has the potential to reduce this to one day, lowering resource utilization and improving treatment efficiency. Intravenous administration may also allow more controlled management of exposure and safety, including immediate interruption of dosing if QTc prolongation or other adverse effects occur.

**IP rights / exclusivity:** Granted patents with expiry dates between 2039 and 2043, with additional pending applications, including protection relating to one-day loading approaches,

aqueous IV dofetilide compositions, and additional uses supporting the dosing and treatment advantages of the IV formulation.

### Phosphate Oral Liquid (Reformulation)

- Status: In development
- Therapeutic area: Electrolyte and mineral disorders
- Indication: Hypo Phosphatemia
- Target market: WW
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Phosphate-Oral-Liquid.pdf

HY-088 is a proprietary oral liquid phosphate product designed to improve the treatment of hypophosphatemia through a standardized ready-to-use formulation. Its liquid presentation is intended to support easier administration, more consistent dosing, and better patient usability than compounded or non-standard alternatives.

**Stage:** Registration batches have been successfully completed, and the first European regulatory filing is planned for late H1 2026.

**Indication details:** For the treatment of hypophosphatemia, a condition characterized by abnormally low phosphate levels in the blood.

Hypophosphatemia may arise in a range of clinical settings, including congenital disorders, malabsorption, or treatment-related causes.

**Benefit:** HY-088 is designed to provide accurate, consistent phosphate dosing in a convenient oral liquid format, offering a safer and easier-to-administer alternative to compounded or less standardized treatments, with the potential to improve both patient compliance and treatment reliability.

**IP rights / exclusivity:** Pending patent applications in selected countries, with expiry expected in 2045 and 2046.

### Pantoprazole IV RTU (Reformulation)

- Status: In development
- Therapeutic area: GI
- Indication: GERD and EE
- Target market: WW
- Route of administration: Injection
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Pantoprazole-IV-RTU.pdf

It’s a differentiated, ready-to-use IV pantoprazole product designed to replace current lyophilized formulations that require reconstitution and often dilution before administration. The directly injectable formulation is intended to reduce preparation burden and workload, while improving speed, convenience, and consistency of hospital administration.

**Stage:** Currently in reformulation development, with manufacturing batches and supporting clinical activities in preparation.

Hyloris is targeting to launch as of 2028.

**Indication details:** For the intravenous treatment of acid-related disorders where IV administration is clinically appropriate including gastroesophageal reflux disease (GERD) in patients with a history of erosive esophagitis and pathological hypersecretory conditions such as Zollinger-Ellison syndrome.

**Benefit:** The ready-to-use IV formulation is designed to reduce preparation steps, shorten administration time, and minimize handling complexity versus lyophilized products, with the potential to improve efficiency, reduce error risk and generate cost savings for healthcare providers.

**IP rights / exclusivity:** Pending U.S. and international patent applications covering liquid, storage-stable, directly injectable pantoprazole formulations, their uses and manufacturing methods.

Expected expiry: 2045.

### HY-074 (Reformulation)

- Status: In development
- Therapeutic area: Cardiovascular
- Indication: Acute Coronary Syndrome
- Target market: WW
- Route of administration: IV
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-074.pdf

HY-074 is a novel intravenous formulation of a widely used oral antiplatelet therapy, developed for use in acute coronary syndrome (ACS). It is intended to provide a practical IV alternative in emergency settings where rapid treatment initiation is important and oral administration may be less suitable.

**Stage:** Registration batches have been produced by the selected CMO, and a pivotal clinical trial is planned for 2026.

Additional potential indications outside the cardiovascular field are also being explored.

**Indication details:** For use in the management of reinfarction risk in acute coronary syndrome and related emergency cardiovascular settings, including situations where rapid antiplatelet treatment is needed and oral administration may not be optimal.

**Benefit:** HY-074 is designed to provide faster onset of antiplatelet activity, greater dosing control, and more practical administration in acute care settings, particularly for patients who are nauseous, unconscious, or otherwise unable to take oral medication.

**IP rights / exclusivity:** Patent applications filed, with maximum expected expiry in 2043–2044.

### Aspirin IV (Reformulation)

- Status: In development
- Therapeutic area: Cardiovascular
- Indication: Acute Coronary Syndrome
- Target market: WW
- Route of administration: IV
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Aspirin-IV.pdf

Aspirin IV is an intravenous formulation of acetylsalicylic acid designed to provide rapid and reliable antiplatelet activity in acute coronary syndrome (ACS), where early platelet inhibition is clinically important.

**Stage:** Late-stage development, with the pivotal study completed successfully. No serious adverse events were reported, and IV aspirin delivered an equivalent pharmacological response with a faster onset of action than oral aspirin. A meeting with the U.S. FDA confirmed alignment on the proposed regulatory pathway and resolved the remaining key items ahead of the planned submission in 2026.

**Indication details:** For adults, to decrease the risk of morbidity and mortality associated with emergency cardiac events, including acute myocardial infarction (AMI) and ischemic stroke.

**Benefit:** Aspirin™ is a cornerstone of long-term thrombosis management. In acute settings such as ACS, the IV route delivers immediate antiplatelet effect with faster onset than oral aspirin, and eliminates the intrasubject and inter-subject variability of oral administration that has been consistently documented in the literature.

**IP rights / exclusivity:** Multiple U.S. patents on aspirin compositions; expiry 2038-2039. Patents and pending patent applications in selected countries.

### Fusidic Acid (Generic)

- Status: In development
- Therapeutic area: Infectious diseases
- Target market: Canada
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_Fusidic-Acid-.pdf

Generic equivalent to Fucidin® cream, a topical antibiotic cream containing 2% fusidic acid (20 mg/g), used for the treatment of bacterial skin infections, including primary and secondary infections. Typically applied to the affected area 3 to 4 times daily for 7 to 14 days.

**Stage:** Regulatory submission in Canada expected in 2026.

**Indication details:** Treatment of bacterial skin infections such as impetigo, erythrasma, and infected skin cuts and burns.

**Benefit:** High-barrier generic formulation intended to provide a reliable topical alternative to the reference product, while meeting the quality, stability, and performance requirements for regulatory approval in Canada.

**IP rights / exclusivity:** No specific IP or regulatory exclusivity currently assumed.

## Promising Seeds

Early-stage products pending clinical validation

### HY-083 (NCE)

- Status: In development
- Therapeutic area: Respiratory
- Indication: Idiopathic Rhinitis
- Target market: WW
- Route of administration: Nasal spray
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-083.pdf

Potential first-in-class proprietary intranasal spray based on a TRPV1 agonist mechanism, designed to address the underlying sensory nerve dysregulation associated with idiopathic rhinitis. The product aims to provide sustained symptom relief by modulating overactive nasal sensory pathways that may contribute to persistent congestion, rhinorrhea, and sneezing. Existing symptomatic treatments provide limited or incomplete relief in this patient population.

**Stage:** The program has progressed to the selection of promising new chemical entity (NCE) candidates.

Multiple compounds have been synthesized, several of which have demonstrated strong potency in specialized laboratory assays.

**Indication details:** Idiopathic rhinitis is a form of chronic rhinitis without a clearly identifiable allergic, infectious, or other causal trigger. It is associated with overactivity of nasal sensory pathways, including TRPV1-mediated mechanisms in the nasal mucosa, which may contribute to symptoms such as nasal obstruction, rhinorrhea, and sneezing.

**Benefit:** Potential first-in-class proprietary therapy targeting TRPV1 receptors in the nasal mucosa, with the aim of improving nasal function and reducing key symptoms of idiopathic rhinitis, including congestion, rhinorrhea, and sneezing.

**IP rights / exclusivity:** Confidential. Hyloris is pursuing a dual-track development strategy involving new chemical entity candidates, which could support NCE-based patent protection if successful.

### HY-095 (Reformulation)

- Status: In development
- Therapeutic area: GI
- Indication: Equine Gastric Ulcer Syndrome
- Target market: WW
- Route of administration: Injection
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-095.pdf

Novel long-acting injectable (LAI) proton pump inhibitor (PPI) designed to provide a more reliable and weight-adjusted alternative to daily oral paste therapy for horses with Equine Gastric Ulcer Syndrome (EGUS). The product aims to reduce absorption variability, improve treatment adherence, and offer a differentiated profile versus the current standard of care.

**Stage:** Initial prototype testing in horses was completed in 2025. Further prototype testing is planned for 2026 to build on these early findings and support continued evaluation and advancement of the program.

**Indication details:** Treatment of Equine Gastric Ulcer Syndrome (EGUS).

**Benefit:** Long-acting, weight-adjusted injectable formulation with the potential to provide reliable and sustained drug delivery, reduce reliance on daily oral dosing, improve adherence, and potentially shorten treatment duration compared with daily oral therapies.

**IP rights / exclusivity:** Confidential.

### HY-098 (Repurposing)

- Status: In development
- Therapeutic area: Rare Diseases
- Indication: Rare, inherited skin disorder
- Target market: WW
- Route of administration: Topical
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-098.pdf

Topical repurposing program using a well-established active substance in a localized formulation for the treatment of a rare inherited inflammatory skin disorder. The product is designed to improve local efficacy and tolerability while limiting systemic exposure.

**Stage:** An exploratory clinical trial may start in 2026 to evaluate initial safety and efficacy.

The active substance has been used systemically for many years in an unrelated indication and has an established safety profile, supporting a more de-risked development approach.

**Indication details:** For the treatment of a rare inherited inflammatory skin disorder characterized by recurrent flare-ups, painful skin lesions, and chronic inflammation.

**Benefit:** Localized delivery directly to affected skin areas may provide a more effective and better-tolerated treatment approach, with the potential to improve symptom control while reducing systemic exposure.

**IP rights / exclusivity:** U.S. patent application covering the method of treatment and topical composition, with expected expiry in 2044.

Potential to qualify for Orphan Drug Designation.

### HY-089 (Repurposing)

- Status: In development
- Indication: Burning Mouth Syndrome
- Target market: WW
- Route of administration: Local-acting dose
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-089.pdf

Repurposed and reformulated locally acting product designed as a novel, locally acting long-term treatment for Burning Mouth Syndrome (BMS). It is intended to deliver a proven active ingredient directly to the affected oral tissue, offering a targeted alternative to systemic therapies.

**Stage:** Two promising pre-prototypes are advancing in development.

The objective is to finalize a differentiated formulation that is eligible for patent protection and can progress into clinical validation.

**Indication details:** Treatment of Burning Mouth Syndrome (BMS).

BMS is a chronic condition characterized by persistent burning sensations in the mouth without an identifiable cause. 

It most commonly affects the tongue, lips, gums, or the entire oral cavity and may be associated with dryness, altered taste, or a metallic sensation.

**Benefit:** This novel, locally acting oral formulation is designed to provide targeted symptom relief and address a significant unmet need in a condition for which

no approved treatments currently exist.

**IP rights / exclusivity:** Confidential.

### HY-086 (PTX-252) (NCE)

- Status: In development
- Therapeutic area: Oncology
- Indication: AML
- Target market: WW
- Route of administration: IV
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-086-PTX-252-.pdf

Differentiated NCE adjunctive therapy designed to enhance standard chemotherapy by modulating the tumor microenvironment. Its chelating mechanism targets toxic metal levels associated with poor outcomes in Acute Myeloid Leukemia (AML) with additional potential in small cell lung cancer (SCLC).

**Stage:** Selected compound in early clinical development, with formulation work completed and Phase 1 preparations underway.

The program has received FDA Orphan Drug Designation in AML.

**Indication details:** Adjunctive therapy to standard-of-care chemotherapy in acute myeloid leukemia (AML), with additional potential in small cell lung cancer (SCLC).

AML is an aggressive hematologic malignancy, while SCLC is a fast-growing neuroendocrine lung cancer; both are associated with high unmet need.

**Benefit:** Potential to improve chemotherapy effectiveness and clinical outcomes by modifying the tumor microenvironment in a way that may enhance response to treatment.

**IP rights / exclusivity:** Patents and pending patent applications.

FDA Orphan Drug Designation in AML.

### HY-106 Methanobactin (NCE)

- Status: In development
- Therapeutic area: Rare Diseases
- Indication: Wilson’s disease
- Target market: Europe and Turkey
- Route of administration: Injection
- Product fiche (PDF): https://hyloris.com/wp-content/uploads/2026/05/Hyloris_Product-fiche_HY-106-Methanobactin-.pdf

Novel copper-selective chelator based on methanobactin, designed to address key limitations of current Wilson’s disease treatments. The candidate demonstrates high copper affinity and a favorable non-clinical safety profile, with low expected toxicity and limited expected tissue accumulation.

**Stage:** First-in-human study planned for 2026 in healthy volunteers.

**Indication details:** Treatment of Wilson’s disease, a rare inherited metabolic disorder characterized by toxic copper accumulation in the body.

Potential future label expansion may include cholestatic liver fibrosis and iron overload.

**Benefit:** Highly copper-selective injectable therapy with the potential for intermittent dosing, possibly weeks apart, rather than daily treatment, based on non-clinical data.

**IP rights / exclusivity:** Patent application on innovative use.

Potential eligibility for Orphan Drug Designation.

## Investor documents

Most recent first.

- [Investor/Company presentation H1 2026](https://hyloris.com/wp-content/uploads/2026/10/Hyloris_COMPANY-PRESENTATION_20260924_FV_H1-2026-Update_Website.pdf)
- [2026 Hyloris Half Year Report](https://hyloris.com/wp-content/uploads/2026/09/HYLORIS-Half-Year-Report-26-EN.pdf) (French version: https://hyloris.com/wp-content/uploads/2026/09/HYLORIS-Half-Year-Report-26-FR.pdf)
- [2026 Ordinary General Meeting Presentation](https://hyloris.com/wp-content/uploads/2026/06/Hyloris_AGM_2026_Slides.pdf)
- [2025 Hyloris Annual Report](https://hyloris.com/wp-content/uploads/2026/04/HYLORIS_RA25_Annual-Report-2025_EN_20260430.pdf) (French version: https://hyloris.com/wp-content/uploads/2026/04/HYLORIS_RA25_Rapport-Annuel-2025_FR_20260430.pdf)
- [2025 Hyloris ESG Report](https://hyloris.com/wp-content/uploads/2026/05/HYLORIS_RA25_ESG-Report-2025_EN_260507.pdf) (French version: https://hyloris.com/wp-content/uploads/2026/05/HYLORIS_RA25_Rapport-ESG-2025_FR_260507.pdf)
- [Investor/Company Presentation 2026 (AR 2025)](https://hyloris.com/wp-content/uploads/2026/05/Hyloris_COMPANY-PRESENTATION_20260401_FV-Website.pdf)
- [Corporate presentation - 25 September 2025](https://hyloris.com/wp-content/uploads/2025/11/Investor-Presentation-Hyloris-September-2025.pdf)
- [2025 Hyloris Half-Year Report](https://hyloris.com/wp-content/uploads/2025/09/2025-06-30-Hyloris-HY-report_EN-final.pdf) (French version: https://hyloris.com/wp-content/uploads/2025/09/2025-06-30-Hyloris-HY-report_FR-final.pdf)
- [2024 Hyloris Annual Report](https://hyloris.com/wp-content/uploads/2025/05/20250502-HYLORIS_AR24_EN_subsequent-to-2025_04_30-publication.pdf) (French version: https://hyloris.com/wp-content/uploads/2025/05/20250506-HYLORIS_RA24_FR-final.pdf)
- [2024 Hyloris Sustainability Report](https://hyloris.com/wp-content/uploads/2025/11/Hyloris-Sustainability-Report-2024.pdf)
- [Corporate presentation - 29 March 2025](https://hyloris.com/wp-content/uploads/2025/03/Corporate-Presentation-Hyloris-March-2025.pdf)
- [Corporate presentation - 21 January 2025](https://hyloris.com/wp-content/uploads/2025/01/Corporate-Presentation-Hyloris-21-January-2025.pdf)
- [2024 Hyloris Half-Year Report](https://hyloris.com/wp-content/uploads/2024/10/20241016-Hyloris-2024-HY-report_EN.pdf) (French version: https://hyloris.com/wp-content/uploads/2024/10/20241016-Hyloris-2024-HY-report_FR.pdf)
- [Corporate presentation - September 2024](https://hyloris.com/wp-content/uploads/2024/09/Corporate-Presentation-Hyloris-25September-2024_final.pdf)
- [2023 Hyloris Annual Report](https://hyloris.com/wp-content/uploads/2024/07/HYLORIS_AR2023_FINAL_EN-1.pdf) (French version: https://hyloris.com/wp-content/uploads/2024/07/HYLORIS_AR2023_FINAL_FR.pdf)
- [Corporate presentation - Half-Year results september 2023](https://hyloris.com/wp-content/uploads/2023/09/Hyloris-H1-23-webcast-deck-1.pdf)
- [2023 Half-Year Report](https://hyloris.com/wp-content/uploads/2023/09/Hyloris-Interim-Report-H1-2023-FINAL-EN.pdf) (French version: https://hyloris.com/wp-content/uploads/2023/09/Hyloris-Interim-Report-H1-2023-FINAL-FR.pdf)
- [2022 Hyloris ESG Report](https://hyloris.com/wp-content/uploads/2023/05/Planche_Hyloris_AnnualReport22_ESG.pdf) (French version: https://hyloris.com/wp-content/uploads/2023/05/Hyloris_RA22_ESG_FR.pdf)

## Financial calendar

- 24 September 2026: 2026 Half-Year Results
- 25 March 2027: 2026 Annual Results
- 30 April 2027: 2026 Annual Report
- 8 June 2027: Annual General Meeting of Shareholders