Heidelberg Pharma AG: Interim Management Statement on the First Nine Months of 2024

• HDP-101 clinical trial in Europe and US continues with adjusted protocol and dose optimization on track; sixth patient cohort dosed at 90 µg/kg and patients are still on treatment
• Sale of a portion of future royalties for TLX250-CDx to HealthCare Royalty
• New clinical data with HDP-101 presented at the International Myeloma Society (IMS) Annual meeting; one patient in complete remission
• Two R&D webinars with Key Opinion Leaders planned for October
• Guidance adjusted

Ladenburg, Germany, 10 October 2024 – Heidelberg Pharma AG (FSE: HPHA) reported today on its operational progress as well as on the Group’s financial figures for the first nine months of fiscal year 2024 (1 December 2023 – 31 August 2024).

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: “Our development activities are on track. The patients in the sixth cohort of our clinical study with HDP-101 are currently still undergoing treatment, and we expect to complete the cohort in the next few weeks.

We are very pleased to have presented new clinical results from the fifth cohort at the renowned International Myeloma Society Annual Meeting. We see a complete remission with a full elimination of tumor cells in one of our heavily pretreated patients. This success confirms the potential of HPD-101 as a treatment option for multiple myeloma patients.

In October, we adjusted the guidance for our financial figures. This is due to significantly lower R&D costs than planned and higher revenue in 2024.”

Important operational developments and achievements

• HDP-101 development program: HDP-101, an Antibody Targeted Amanitin Conjugate directed against the antigen BCMA, is being tested in a Phase I/IIa open-label, multicenter study for the treatment of relapsed or refractory multiple myeloma, a cancer of the bone marrow. The first part of the study is a Phase I dose escalation study to find the safe and optimal dosing of HDP-101 for the Phase IIa portion of the study. The first four patient cohorts and dose levels were completed with no evidence of dose limiting toxicities.

  In the fifth cohort, all patients at a dose of 100 µg/kg HDP-101 experienced a drop in thrombocyte count, which completely normalized after a few days and was clinically unremarkable. To mitigate this transient effect, the clinical team adjusted and optimized the medication regimen. Cohort 6 consists of three arms, with at least three patients enrolled in each arm. In consultation with the clinical investigators, the dose will be 90 µg/kg in order to test these three dosing regimens with as little risk to the patients as possible.

  Patients in Arm A will be treated with a single dose of HDP-101 on day 1 of each 21-day cycle following pre-medication. Arm B will receive a weekly dose of HDP-101, which means that the dose will be split, and patients will be treated proportionally on days 1, 8 and 15 of each cycle. Arm C receives a partial dose of HDP-101 on days 1 and 8 of the first cycle and then a single dose on day 1 of each of the following 21-day cycles. Patients are currently still being treated in the sixth cohort, which is expected to be completed in the next few weeks.
   

• HDP-102 development program: HDP-102 is an ATAC targeting CD37, which is overexpressed on B-cell lymphoma cells. Preclinical studies have shown excellent anti-tumor efficacy in in vivo studies as well as good tolerability. Heidelberg Pharma intends to develop HDP-102 for specific indications of non-Hodgkin lymphoma (NHL).

  All productions steps for HDP-102 have been completed and all necessary preclinical and toxicological studies have been conducted. The data package required for the clinical trial application will be finalized in Q4 of this year. As a first step, the application will be submitted to the regulatory authority in a non-EU European country, followed by a central submission to the EMA.
   

• HDP-201 development program: Since fall 2023, the company has been developing further ADC projects with other payloads. The first candidate of the second platform is HDP-201, an exatecan-based ADC. Exatecan is a topoisomerase I inhibitor that has proven itself in cancer therapy and is used in two already approved ADCs. Its mode of action differs from that of Amanitin, and thus expands the company’s range of active ingredients.

  HDP-201 targets guanylyl cyclase-C (GCC), a receptor that is expressed on the surface of intestinal cells and cancer cells in various gastrointestinal tumors. Preclinical results show that the tolerability and efficacy of HDP-201 is at least comparable to already approved exatecan ADCs.

  Based on extensive preclinical efficacy and tolerability testing, the final development candidate for HDP-201 was selected and the indication determined in recent weeks. HDP-201 is to be developed for the treatment of colorectal cancer.
   

• Agreement concluded on the partial sale of license fees to HealthCare Royalty: In early March 2024, Heidelberg Pharma signed an agreement with HealthCare Royalty, Delaware, USA, (HCRx) for the sale of a portion of future royalties from global sales of TLX250-CDx. Heidelberg Pharma received an upfront payment of USD 25 million and is also entitled to receive up to an additional USD 90 million from the sale of royalties if defined milestones are reached. After HCRx has received a maximum cumulative amount, the royalties will revert to Heidelberg Pharma, and HCRx will receive a low single-digit percentage of Heidelberg Pharma’s royalties.

Update on partner programs outside ATAC technology

• Progress at partner Telix: TLX250-CDx is a radiolabeled form of the antibody girentuximab, which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinoma (ccRCC) and possibly other tumor types. Accumulation of this antibody in tumor tissue can be visualized by positron emission tomography (PET) scans. This could fundamentally change therapy planning for renal cancer patients and avoid potentially unnecessary surgery. The diagnostic agent may also prove suitable for monitoring treatment response, detecting metastases, and diagnosing other kinds of tumors.

  The antibody was developed at Heidelberg Pharma AG up to a first Phase III trial and outlicensed to the Australian company Telix in 2017.

  Telix had successfully completed a second Phase III trial and, based on these positive Phase III results, completed the submission of a rolling New Drug Application in the United States in June 2024. The company announced at the end of July that the FDA had not accepted the application for approval at that time because of a manufacturing issue. Evidence of adequate sterility assurance during filling of the substance must be provided. Telix plans to resubmit the revised application in the fourth quarter of this year. The application for priority review remains unchanged.

Events after the end of the reporting period

• New clinical data on HDP-101 presented at International Myeloma Society Annual Meeting 2024: At the 21st International Myeloma Society (IMS) Annual Meeting held in Rio de Janeiro, Brazil, at the end of September, Professor Marc-Steffen Raab, Head of the Myeloma Center at the University Hospital Heidelberg and clinical investigator of the study, presented new clinical findings from five patient cohorts of the trial with the BCMA-targeting ATAC HDP-101. Clinical data from the fifth cohort demonstrated complete remission in one patient who had been heavily pre-treated. This patient showed an objective improvement (“partial response”) in the 2nd cycle of treatment and complete remission was confirmed after the 11th cycle.
   
• R&D webinars planned: Heidelberg Pharma will host a webinar on 15 October 2024, focusing on the presentation of clinical data from the HDP-101 trial to date. Another webinar, scheduled for 29 October 2024, will go into more detail on the importance of ADCs in cancer therapy. The data presented will be shared by Heidelberg Pharma’s management team and key opinion leaders (KOLs) in the myeloma field. Both events are open to investors, analysts, journalists and other interested parties.

Results of operations, financial position and net assets

The Heidelberg Pharma Group, consisting of Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH reports consolidated figures as at the balance sheet date. The reporting period referred to below relates to the period from 1 December 2023 to 31 August 2024 (9M 2024).

In the first nine months of the 2024 business year, the Group generated sales revenues and income totaling EUR 7.6 million (previous year: EUR 13.9 million) and is in line with the updated planning. The sales revenues included in this figure fell from EUR 6.6 million the previous year to EUR 5.2 million. Other income amounted to EUR 2.4 million and was therefore significantly lower than the previous year’s level of EUR 7.3 million due to the unscheduled sale of the Emergence stake.

Operating expenses, including depreciation, amounted to EUR 22.8 million in the reporting period (previous year: EUR 30.0 million) and are broken down as follows: Cost of sales decreased to EUR 1.5 million (previous year: EUR 3.1 million) and correspond to 7% of total costs. Research and development costs of EUR 15.7 million decreased compared to the same period last year (EUR 22.1 million). In the 2024 financial year, fewer costs have been incurred for the Phase I/IIa trial than originally planned. Some of the projected expenses for this will be incurred in the further course of the study in the next financial year. R&D costs continue to be the largest cost block, accounting for 68% of operating expenses. Administrative costs, which include the costs of holding activities, the stock exchange listing and the executive management board, increased to EUR 4.7 million compared to the same period last year (EUR 3.6 million), which is due to higher personnel costs including stock options issued. Administrative costs account for 21% of operating expenses. Other expenses for business development, marketing and commercial market supply activities, which mainly include personnel and travel expenses, decreased year-on-year to EUR 1.0 million (previous year EUR 1.2 million) and represented 4% of operating expenses.

The financial result, which is mainly made up of interest income on bank balances, amounted to EUR 1.0 million (previous year: EUR 0.5 million). The significant improvement is due to the now complete repayment of the shareholder loan, as well as interest income from a higher investment volume.

The net loss for the first nine months of the financial year decreased to EUR 14.3 million compared to the previous year’s figure of EUR 15.8 million. Despite lower sales revenues, the improvement is mainly due to lower expenses. Earnings per share improved accordingly from EUR -0.34 in the previous year to EUR-0.31 in the reporting period.

Cash amounted to EUR 36.6 million at the end of the third quarter (30 November 2023: EUR 43.3 million; 31 August 2023: EUR 50.7 million). Excluding financing effects (shareholder loans, sale of receivables), Heidelberg Pharma recorded an average cash outflow of EUR 2.6 million per month in the first nine months of the fiscal year (previous year: EUR 2.3 million).

Total assets as of 31 August 2024 amounted to EUR 65.8 million and were therefore below the figure as at the comparative reporting date of 30 November 2023 (EUR 70.4 million). Equity (EUR 35.8 million) also decreased as a result of the loss for the period compared to the end of the 2023 financial year (EUR 49.3 million).

Financial outlook for 2024

The guidance issued in June 2024 for the current financial year was adjusted downwards on the cost side and upwards on the revenue side on 1 October 2024.

For the financial year 2024, the Heidelberg Pharma Group expects sales and other income between EUR 10.0 million and EUR 12.0 million (previously: EUR 9.0 million to EUR 12.0 million). Operating expenses are expected to fall within a range of EUR 30.0 million and EUR 33.0 million (previously: EUR 36.0 million to EUR 40.0 million). In the 2024 financial year, fewer costs have been incurred for the Phase I/IIa trial than originally planned. Some projected expenses for this trial will be incurred in the further course of the study in the next financial year. Based on these adjustments, an operating result (EBIT) between EUR -19.0 million and EUR-22.0 million is expected (previously: EUR -25.5 million to EUR -29.5 million).

For 2024, Heidelberg Pharma anticipates cash requirements of EUR 13.0 million to EUR 16.5 million (previously: EUR 18.0 million to EUR 22.0 million). Monthly cash consumption is expected to range between EUR 1.1 million and EUR 1.4 million per month (previously: EUR 1.5 million and EUR 1.8 million). Based on the existing planning and available funds, the company’s financing remains secured until mid-2025.

Taking into account a further expected payment of USD 75.0 million from HealthCare Royalty following approval of TLX250-CDx, the company anticipates a financial reach until the end of 2026, based on current medium-term planning.

The complete set of figures for the interim financial statements is available at http://www.heidelberg-pharma.com/ “Press & Investors > Announcements and Reports > Financial Reports > Interim announcement of 10 October 2024. A conference call on this interim announcement will not be offered.

Key figures for the Heidelberg Pharma Group

1 The reporting period begins on 1 December and ends on 31 August.
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

About Heidelberg Pharma

Heidelberg Pharma develops novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the high affinity and specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with various toxins, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the mushroom toxin Amanitin in cancer therapies by exploiting the toxin’s biological mechanism of action with its innovative ATAC technology as a new therapeutic modality. It offers the opportunity to not only overcome resistance of cancer cells against therapeutic agents currently used, but also has the ability to eliminate dormant tumor cells. This could lead to significant advances in cancer therapy – even for patients who no longer respond to any other treatment. The most advanced product candidate HDP-101 is an BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

In addition to Amanitin, other payloads are expanding the ADC platform technologies of Heidelberg Pharma to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at http://www.heidelberg-pharma.com/

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

Ad hoc announcement pursuant to Art. 53 LR

Fribourg, 8 October 2024

AEVIS VICTORIA SA (AEVS.SW) – Swiss Medical Network strengthens its presence in Ticino with the acquisition of «Centromedico»

Swiss Medical Network, the operating subsidiary of AEVIS VICTORIA SA dedicated to healthcare, is acquiring PDS Medical SA, which operates 10 group practices in the Canton of Ticino under the brand name «Centromedico» and thus provides a significant proportion of primary medical care for the population of Ticino. PDS Medical SA recorded revenues of approximately CHF 42 million in 2023. The parties have agreed not to disclose the purchase price.

With this acquisition, Swiss Medical Network strengthens its position in the canton of Ticino and lays the foundation for a second integrated care region in Switzerland under the name «Rete Sant’Anna». Based on the model of the Réseau de l’Arc in the Bernese Jura, where Switzerland’s first fully integrated care organization has been operating since 1 January 2024, the VIVA health plan will also be available in Ticino from 1 January 2025. This concept focuses on preventive and comprehensive healthcare for members, as well as close cooperation between outpatient, inpatient and home care services.

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network Holding SA (80%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven luxury hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.

PRESS RELEASE 

Affluent Medical Announces
Participation in Upcoming Scientific Events

Aix-en-Provence, October 8, 2024 – 5:45 p.m. CEST – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME – “Affluent”), a French clinical-stage medical technology company specializing in the international development and industrialization of implantable innovative medical devices, today announced that the company will participate in the following upcoming scientific conferences in the fourth quarter, 2024:

EACTS 2024
38th European Association for Cardio-Thoracic Surgery Annual Meeting
Location: Lisbon, Portugal
Date: 09-12 October 2024
Learn more

ICS 2024
54th International Continence Society Annual Meeting
Location: Madrid, Spain
Date: 23-25 October 2024
Learn more

PCR London Valves
Official Course of the European Association of Percutaneous Cardiovascular Interventions
Location: London, United Kingdom
Date: 24-26 November 2024
Booth: #A2
Learn more

“Affluent Medical is dedicated to pioneering minimally invasive solutions that redefine patient care, enhance lives and address pressing medical needs of more than 600 million individuals worldwide affected with urinary incontinence and mitral insufficiency. In the past year, we have made major steps in the development of our medical devices, notably, our important deal with Edward Lifesciences, the global leader in patient-focused medical innovations for structural heart disease, for our mitral valve technologies, as well as encouraging initial performance results for our artificial sphincter Artus”, explained Sébastien Ladet, CEO of Affluent Medical. “As we progress our programs towards the pivotal and approval stages, we are very much looking forward to meeting with leading experts and companies in their respective fields to discuss latest research, patient needs as well as our programs and partnering opportunities.”

During the events, Affluent will be available to discuss the company’s latest advances in the development of its three innovative medical devices as well as their unique potential:

MITRAL RING KALIOS^TM:

Kalios^TM is the only mitral annuloplasty device that can be simply adjusted percutaneously by a cardiologist to treat both residual or recurrent mitral valve insufficiency, at any time after implantation, repeatedly and with a beating heart, thereby avoiding a repeat open-heart surgery. Affluent Medical believes that Kalios^TM would avoid further intervention for potentially 30% to 40% of patients over a five-year horizon.

Following positive feedback from the FDA in September 2024, Affluent Medical’s objective is to submit a De Novo application with current clinical data at the end of 2025/early 2026, followed by commercial launch, subject to Edwards’ decisions.

MITRAL VALVE EPYGON:

Epygon is the only biomimetic mitral heart valve that mimics the anatomy of the native mitral valve and physiological blood flow, able to be implanted via a transcatheter route. This transcatheter approach avoids an invasive open-heart procedure and associated complications to treat mitral valve insufficiency.

In 2024, the company began a collaboration with Prof. Mohammad Sarraf, MD, interventional cardiologist at the Mayo Clinic in the US, to evaluate the benefits of the biomimetic design of the Epygon valve. This innovative design aims to replicate the anatomy and natural physiology of the native mitral valve to enable patients to recover good cardiac function more quickly.

During the first half of 2024, Affluent Medical accelerated patient evaluations, achieving a fourfold increase in the number of patients included by the end of June 2024 with the goal is to implant up to 10 patients to complete the pilot phase.

URINARY SPHINCTER ARTUS:

Artus is the first artificial urinary sphincter that can be activated by the patient with a simple remote control for the treatment of moderate to severe urinary incontinence. Urinary incontinence is a major public health problem for over 400 million people worldwide without any innovation in the last 40 years, causing patients to suffer a reduced quality of life associated with the psychological disorders related to the disease.

As of mid-September 2024, seven patients had received an implant, representing over half of the planned patients for the pilot phase of the study. The Company plans to implant a total of 10 patients by Q4 2024 and then launch the pivotal phase of the study.

To schedule a meeting during the upcoming conferences, please contact the company at contact@affluentmedical.com.

About Affluent Medical

Affluent Medical is a French medical technologies company, founded by Truffle Capital, that aims to become a global leader in the treatment of structural heart diseases, one of the world’s leading causes of mortality, and urinary incontinence, which currently affects one in four adults.

Affluent Medical develops next-generation implants that are minimally invasive, innovative, adjustable and biomimetic, designed to restore essential physiological functions. The candidate products developed by the Company are all undergoing clinical studies in humans.

Subject to raising the funds necessary to finance its strategy and the positive results of ongoing clinical studies, the Company aims to gradually market its products from 2026, directly or indirectly.

For more information, please visit www.affluentmedical.com

Contacts:

Mainz Biomed Reports Increased Demand for Enhanced ColoAlert, Existing Partners to Transition to New Version

GANZIMMUN Diagnostics to Feature ColoAlert at the 57th Medizinische Woche Baden-Baden
 

BERKELEY, US and MAINZ, Germany – October 8, 2024 – Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today increasing demand from existing and prospective laboratory partners for its enhanced ColoAlert product that has been launched in July 2024 and is currently being commercialized across Europe and in select international markets. This advanced version of the Company’s colorectal cancer (CRC) screening test is set to become the standard offering for all existing partners, reflecting its proven benefits in optimizing screening efficiency and improving user experience.

Widespread Transition to Enhanced ColoAlert

One of the earliest partners to make the transition is GANZIMMUN Diagnostics, one of Germany’s premier laboratories, which licensed the ColoAlert test. GANZIMMUN will fully implement the enhanced version of the innovative DNA biomarker-based screening product by the beginning of next year, taking advantage of the significant improvements in sample processing and usability that have set a new industry benchmark.

Improving Customer Interest

Partners are particularly drawn to the enhanced features, such as the proprietary DNA stabilizing buffer that ensures reliable results despite varying sample volumes, and the streamlined collection devices that simplify at-home testing for users. These innovations have drastically reduced the need for retesting, offering faster turnaround times for patients, with results available in just 2–3 days from sample arrival.

Promotion at Key Medical Event

GANZIMMUN Diagnostics will showcase the enhanced ColoAlert at the 57th Medizinische Woche Baden-Baden, a medical congress in Germany focusing on complementary medicine, which takes place from October 30 to November 3, 2024. This underscores the increasing role of complementary medicine in cancer prevention and early detection. The event will provide an ideal platform to promote Mainz Biomed’s innovative DNA-based CRC screening test to medical professionals, integrative medicine practitioners, and researchers interested in advanced diagnostic solutions.

“We are excited to support GANZIMMUN in introducing the enhanced ColoAlert at such a prestigious event,” stated Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed. “The 57th Medizinische Woche Baden-Baden provides an excellent opportunity to demonstrate the importance of early colorectal cancer detection and how our innovations are making this process more efficient.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About GANZIMMUN Diagnostics

GANZIMMUN Diagnostics is one of the leading laboratories in Europe for preventive and complementary medicine. A multidisciplinary team comprising more than 420 employees processes approximately 5,500 laboratory orders per day under the leadership of the experienced laboratory physician, Dr. med. Patrik Zickgraf. The comprehensive diagnostic service spectrum, which includes over 4,000 laboratory parameters, includes besides the basic analytics a huge amount of innovative tests such as the ColoAlert.

To learn more, visit https://www.ganzimmun.de/en/

About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
 

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Marinomed Biotech AG publishes remarkable results showing alleviation of allergic eye inflammation in patients treated with Tacrolimus eye drops in peer-reviewed journal

• Tacrosolv eye drops, a low-dose, aqueous Marinosolv-enabled formulation of Tacrolimus, are safe and effective in alleviating symptoms of allergic rhinoconjunctivitis
• Data from phase II dose-finding clinical trial have been published in peer-reviewed Clinical Ophthalmology journal
• Tacrosolv offers great potential in treatment of inflammatory diseases of the ocular surface

Korneuburg, Austria, 08. October 2024 – Marinomed Biotech AG (VSE:MARI) has published clinical data from the phase II dose-finding clinical trial evaluating the efficacy of Tacrosolv eye drops in patients with allergic rhinoconjunctivitis in the peer-reviewed “Clinical Ophthalmology” journal. The placebo-controlled allergen challenge trial assessed the efficacy and safety of two different doses of Tacrosolv. The results show that the higher dose of Tacrosolv eye drops (0.005% Tacrolimus) significantly reduced ocular symptoms of allergic conjunctivitis, and surprisingly, also the associated nasal allergy symptoms. Remarkably, these results were achieved with a dose that is 20-fold lower than that of the only Tacrolimus eye drop product currently on the market.

Eva Prieschl-Grassauer, CSO of Marinomed, comments: “Tacrolimus is an immunosuppressive compound widely used to prevent organ rejection after transplantation or for treating inflammatory skin and eye diseases. In ophthalmology, there is currently only one marketed product in Asia in which Tacrolimus is used as a suspension. Due to its very low solubility in water and the associated very low bioavailability in the inflamed tissue, it takes days to weeks for the therapy to take effect. With our Marinosolv solubilization technology, we could significantly increase the solubility of Tacrolimus in a water-based formulation, thereby improving bioavailability, lowering the needed dose, and leading to a faster onset of action. The encouraging results of this clinical study show that Tacrosolv is a safe and effective treatment option for ocular inflammation. Tacrosolv has the potential to benefit a multitude of inflammatory eye diseases, where the currently limited treatment options create unmet medical need.”

In the clinical trial, adults with a history of allergic conjunctivitis were randomized to either Tacrolimus or placebo treatment for 8 days. Allergic symptoms were induced by controlled allergen exposure on day 1 and 8. During exposure, participants recorded ocular, nasal and respiratory allergy symptoms. The primary endpoint was the mean Total Ocular Symptom Score (TOSS) on day 8. Objective ocular safety parameters were assessed before, during and after exposure.

On day 8, ocular symptoms (mainly redness and watery eyes) were reduced in participants receiving Tacrosolv compared to placebo treatment. Surprisingly, nasal symptoms (mainly itching and sneezing) were significantly reduced in participants treated with Tacrosolv already after the first application. This is an outstanding finding, as the only currently marketed eye drop formulation (Talymus® ophthalmic suspension 0.1%, marketed in Asia) contains a 20-fold higher concentration of Tacrolimus. In conclusion, treatment with Tacrosolv at the dose and frequency studied is safe and significantly alleviates symptoms in participants suffering from allergic rhinoconjunctivitis.

About Marinosolv®:

Marinosolv® is an innovative technology platform that enables the solubilization and enhances the bioavailability of small molecules and peptides that are hardly soluble in aqueous formulations. Consequently, new treatments of a multitude of diseases can be envisaged. The use of the Marinosolv® technology can facilitate efficient drug delivery with a low systemic off-target activity. Existing drugs and off-patent active ingredients can be improved and re-patented as part of new formulations using Marinosolv®. Under the brand Solv4U, Marinomed provides Marinosolv® formulation development in technology partnerships for active ingredients at all stages of drug discovery and for lifecycle extension. For more information on Marinosolv® or Solv4U, please visit https://www.solv4u.com. Scientific publications on Marinosolv® can be accessed in the “Immunology” tabs at https://www.marinomed.com/en/news/scientific-publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

For further inquiries contact:

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

Berlin, Germany and Sydney, Australia – 08. October 2024  – Eckert & Ziegler (ISIN DE0005659700, SDAX) and GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company specialising in developing antibody radiopharmaceuticals for solid tumors, today announced a new global clinical supply agreement. Eckert & Ziegler will provide its GMP grade non-carrier added Lutetium-177 chloride (n.c.a. Lu-177) for use in GlyTherix’s clinical trials focused on innovative treatments for aggressive and invasive cancers.

GlyTherix’s radiotherapy approach combines Lu-177 with an antibody targeting Glypican-1, a protein found in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer. GlyTherix plans to use 177Lu-DOTA-Miltuximab® in its planned Australian Phase Ib in early 2025, followed by US Phase II trials in 2026.

Dr. Harald Hasselmann, CEO of Eckert & Ziegler commented, “We are happy to collaborate with GlyTherix in their mission to develop cutting-edge radiopharmaceuticals. Contributing to the success of such innovative treatments in clinical trials and beyond with our high-quality radioisotopes including Lutetium-177 is our distinct goal.”

Dr. Brad Walsh, GlyTherix Chief Executive Officer said, “We are very pleased to partner with Eckert & Ziegler to provide patients with innovative targeted radiotherapy treatments. As GlyTherix advances its clinical trials using the medical radioisotope Lu-177, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality radioisotopes to patients. This agreement with Eckert & Ziegler strengthens our global clinical supply network and underscores our commitment to enhancing our global radiopharmaceutical manufacturing capabilities to meet increase demand”.
 

About Eckert & Ziegler
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.
 

About GlyTherix
GlyTherix Ltd is an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumours. Miltuximab® specifically targets Glypican-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue. The company has a strong proprietary and Intellectual Property position covering both Miltuximab® and the antigen Glypican-1. This provides robust and long-term protection for the commercialization of important new treatments to people with little hope.
GlyTherix has completed a ‘First-in-Human’ trial of 12 patients using Miltuximab® with no drug-related adverse. Miltuximab® will be used in a Phase Ib trial as an antibody theranostic. GlyTherix is interested in partnerships or collaborations with larger biotech and pharmaceutical partners.

Contact
Eckert & Ziegler SE
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Jan Schöpflin, Marketing / Karolin Riehle, Investor Relations
jan.schoepflin@ezag.de / karolin.riehle@ezag.de
Tel.: +49 (0) 30 / 94 10 84-138; www.ezag.com

GlyTherix
Dr Brad Walsh, CEO
+61 413 231 296
Brad.Walsh@glytherix.com

Relief Therapeutics Announces Promising Preliminary Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa

GENEVA (OCT. 8, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced promising preliminary results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition characterized by fragile skin and chronic wounds.

The study was designed to evaluate the effects of RLF-TD011 on microbiome diversity in wounds of patients with dystrophic and junctional EB. Microbiome analysis showed a statistically significant reduction in Staphylococcus aureus and an increase in beneficial bacteria in EB wounds, accompanied by a marked improvement in alpha microbiome diversity. A notable correlation between wound healing, specifically wound size reduction, and Staphylococcus aureus reduction was also observed. Further analyses will be available in the coming weeks.

Culture-based studies have shown that up to 93% of wounds in EB patients are colonized by Staphylococcus species. “Overgrowth of Staphylococcus aureus can lead to infection in our patients with epidermolysis bullosa and inhibits wound healing,” said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University. The presence of these pathogens contributes to chronic inflammation and alterations in the skin microbiome, both of which exacerbate poor wound healing. The preliminary results showing a reduction in Staphylococcus aureus without disrupting the beneficial bacteria are particularly promising, as they highlight the potential of RLF-TD011 to address a critical need for targeted treatments in EB, ultimately improving patient outcomes.

Additional information about this investigator-initiated study is available at ClinicalTrials.gov (NCT05533866).

ABOUT RLF-TD011
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief’s proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in clinical trials¹. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. The U.S. Food and Drug Administration (FDA) granted it orphan drug designation for EB, and Relief plans to seek QIDP designation for extended market exclusivity.

ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus. According to the National Epidermolysis Bullosa Registry, EB affects approximately 19.57 per million live births in the United States. Globally, EB affects about 500,000 people.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

References
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¹ Lacopi E., et al. The Use of a Novel Super-Oxidized Solution on Top of Standard Treatment in the Home Care Management of Postsurgical Lesions of the Diabetic Foot Reduces Reinfections and Shortens Healing Time. Int J Low Extrem Wounds. 2018 Dec; 17(4):268-274.

Strohal R, et al. The management of critically colonized and locally infected leg ulcers with an Acid-Oxidizing Solution: A pilot study. Adv Skin Wound Care 31(4):163-171, 2018.

Ricci E, et al. The management of chronic ulcers with an AcidOxidizing Solution. J Wound Care 25(8):443-50, 2016.

Abivax Congratulates Victor Ambros and Gary Ruvkun on Their Nobel Prize for the Discovery of microRNA and its Role in Post-Transcriptional Gene Regulation

PARIS, France, October 7, 2024, 10:00 p.m. CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, is thrilled to extend heartfelt congratulations to Victor Ambros and Gary Ruvkun for being awarded the Nobel Prize in Physiology or Medicine. Their groundbreaking work in the field of microRNA has significantly advanced our understanding of gene regulation and its implications for human health.

Marc de Garidel, CEO of Abivax, said, “The recognition of Ambros and Ruvkun underscores the importance of microRNA research and its potential to transform therapeutic approaches”. He went on to say “At Abivax, we are proud to be at the forefront of innovative therapies that harness the power of microRNAs. Our lead candidate, obefazimod, which is currently being evaluated in a Phase 3 Trial clinical program for Ulcerative Colitis and a Phase 2B Trial for Crohn’s Disease, acts by enhancing expression of microRNA-124 (miR-124), which stabilizes inflammatory pathways to reduce inflammation in patients with chronic inflammatory conditions.”

Didier Scherrer, Chief Scientific Officer at Abivax, stated, “We look forward to further developing obefazimod and contributing to the evolving landscape of treatments for ulcerative colitis and Crohn’s disease with a new mechanism of action, inspired by the pioneering work of luminaries like Victor Ambros and Gary Ruvkun.”

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with ulcerative colitis (UC) have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. A Phase 2b clinical trial in Crohn’s disease is ongoing, with the first patient enrolled in October 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

Contact:

Patrick Malloy
SVP, Investor Relations, Abivax
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “plan,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Current results are not necessarily indicative of future results. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

aap Implantate AG (“aap” or “Company”) has reached another important milestone in the transition from MDD (Medical Device Directive 93/42/EEC) to MDR (Medical Device Regulation EU 2017/745). In the week from 9 September 2024 to 13 September 2024, the Notified Body mdc medical device certification GmbH audited aap’s quality system according to MDR. The audit was successfully completed. With this important milestone and the first positively audited technical documentation for its Class IIa products in accordance with the MDR, the company is continuing to work with its notified body to ensure a smooth and rapid transition to MDR certification.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily utilises a broad network of distributors in around 25 countries. In the USA, the company utilises a hybrid sales strategy through its subsidiary aap Implants Inc. Sales are conducted both via distribution agents and through partnerships with global orthopaedic companies. The aap Implantate AG share is listed in the General Standard segment of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may be subject to technical rounding differences that do not affect the overall picture.

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore only apply on the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.

Contact:
If you have any questions, please contact:
aap Implantate AG; R. Di Girolamo; Chairman of the Management Board/ CEO; Lorenzweg 5; D-12099 Berlin
Phone: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; e-mail: r.digirolamo@aap.de

Relief Therapeutics Reports Positive Results from RLF-OD032 Proof-of-Concept Clinical Study for Phenylketonuria

GENEVA (OCT. 4, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today reported positive topline results from its proof-of-concept clinical study evaluating RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, for the treatment of phenylketonuria (PKU).

The four-way crossover pilot study compared the pharmacokinetics of Relief’s investigational drug RLF-OD032 with the reference listed drug KUVAN^® powder for oral solution. Topline data showed that RLF-OD032 administered under fed conditions, with or without water intake, achieved peak and total exposure of sapropterin dihydrochloride similar to those achieved by KUVAN^® under fed conditions with water, considering the range required by the FDA for bioequivalence studies.

“The pilot study successfully met its objective and provided valuable data for designing the next stages of our development and regulatory strategy. These results significantly increase the likelihood of meeting regulatory requirements, and we believe RLF-OD032 is well-positioned to achieve bioequivalence versus KUVAN^® in an upcoming pivotal bioequivalence trial,” commented Giorgio Reiner, Chief Scientific Officer of Relief. “The potential for RLF-OD032 to be administered without water, along with its low-volume dosage, illustrates its value as a unique, ready-to-use, and portable solution, offering enhanced convenience and ease of administration for patients managing PKU.”

Relief plans to advance RLF-OD032 into a pivotal bioequivalence trial as part of the 505(b)(2) NDA submission process in the United States and pursuant to the development guidance previously provided by the FDA in a pre-IND meeting.

ABOUT RLF-OD032
RLF-OD032 is an innovative, ready-to-use, portable and highly concentrated formulation of sapropterin dihydrochloride in liquid suspension for oral administration, designed to lower blood phenylalanine levels in adult and pediatric PKU patients. It offers a more patient-friendly solution by significantly reducing the volume of medication required compared to current formulations. This advancement aims to enhance compliance, particularly among pediatric patients, who often struggle with the high volumes associated with existing sapropterin treatments. If approved, RLF-OD032 would be the first and only portable, ready-to-use liquid formulation of sapropterin dihydrochloride.

ABOUT PHENYLKETONURIA
Phenylketonuria (PKU) is a genetic disorder caused by a deficiency of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the consumption of foods containing protein or aspartame. Individuals with PKU lack the ability to metabolize Phe, which is present in many foods. Without treatment, PKU can cause severe neurological and developmental issues. The standard treatment involves a lifelong phenylalanine-restricted diet supplemented with amino acid-based, phenylalanine-free medical foods to prevent protein deficiency and optimize metabolic control. However, this diet is highly restrictive and often creates barriers to social interaction, limiting compliance and increasing the risk of poor disease management. Sapropterin dihydrochloride is the first approved drug for PKU for reducing Phe blood levels and allowing patients to follow a less restrictive diet.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.