Epidermolysis Bullosa, Junctional

Relief Therapeutics Holding SA / Key word(s): Patent Relief Therapeutics Announces European Patent Office Decision to Grant Patent for RLF-TD011 11.02.2025 / 07:00 CET/CEST Relief Therapeutics Announces European Patent Office Decision to Grant Patent for RLF-TD011 Patent Secures Protection for RLF-TD011 in Epidermolysis Bullosa Wound Treatment GENEVA (FEB. 11, 2025) – 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 that the European Patent Office (EPO) has issued a Decision to Grant for its patent application titled “Therapeutic Uses of Oxidizing Hypotonic Acid Solutions.” This patent will protect therapeutic applications of Relief’s proprietary, highly pure hypochlorous acid solutions, including its investigational drug RLF‑TD011 for the treatment of wounds caused by epidermolysis bullosa (EB) in key European countries. The EPO is expected to formally issue the patent on February 26, 2025, under patent number EP 3993811. The patent will remain in effect until 2040, as anticipated by the Notice of Allowance received in October 2024. Corresponding patent applications are under review in other major markets, including the United States and China. RLF-TD011 has previously received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of EB. The Company also intends to seek qualified infectious disease product (QIDP) designation from the FDA. These designations would provide potential incentives such as market exclusivity upon approval. Relief continues to advance the development of its lead program and recently reported positive results from its investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of EB. The Company is currently preparing a pre-IND meeting package for submission to the FDA to finalize the remaining clinical development and regulatory strategy for RLF-TD011. 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 demonstrated efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In an investigator-initiated trial (NCT05533866), RLF-TD011 has also shown promising results in infection control and wound healing in EB patients with the most severe forms of the disease. RLF-TD011 aims to address unmet needs in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. 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, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin’s layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB. 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, which may be identified by words such as "believe," "assume," "expect," "intend," "may," "could," "will," or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise. End of Media Release

Data from Eloxx’s proof-of-concept trial in patients with nonsense mutation Alport Syndrome (NMAS) presented in late-breaking presentation at American Society of Nephrology (ASN) Kidney Week New protein analyses confirm production of both collagen alpha 4 and collagen alpha 5 in patients post treatment with ELX-02 Results justify the need to conduct a larger clinical trial of ELX-02 in NMAS to confirm clinical benefit U.S. Food and Drug Administration (FDA) allows for continued dosing of subjects in Phase 1 trial of ZKN-013 WATERTOWN, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (OTC: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases with nonsense mutations, today provided significant key corporate updates. “The demonstration of both collagen alpha 4 and collagen alpha 5 in patients in our proof-of-concept study of ELX-02 in NMAS patients is an important milestone in the development of this crucial potential therapy. These new results, presented in a late-breaking presentation at ASN Kidney Week, strongly justify the need to conduct a larger trial to confirm these encouraging results in this underserved patient population,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. “Also, the FDA allowing for continued dosing of subjects in the Phase 1 trial for ZKN-013 is a substantial achievement for the program and makes Eloxx eligible for the next milestone payment in the company’s agreement with Almirall, once confirmed by our partner, Almirall.” Additional Alport Syndrome data presented at the ASN Kidney Week In late October, Daniel Gale, Professor of Nephrology at University College London Department of Renal Medicine, presented additional results from Eloxx’s proof-of-concept study in three NMAS patients treated with ELX-02 in a late-breaking presentation at ASN Kidney Week. The presentation was titled: “Small molecule premature termination codon readthrough therapy: a Phase 2 pediatric and adult trial in Nonsense Mutation Alport syndrome” at the ASN Kidney Week conference. “Although this was a small trial of limited duration, the appearance of new Type IV Collagen in the glomerular basement membranes is the first time a missing podocyte protein has been reconstituted in a human and provides evidence that ELX-02 is acting as intended in the kidneys of patients. A longer, controlled study will be needed to quantify the clinical effectiveness of this therapy,” said Professor Gale. New protein immunostaining and mass spectrometry analyses that were presented, confirmed the production of both collagen a4 (IV) and collagen a5 (IV) proteins in NMAS patients treated with ELX-02. Prior to treatment, collagen a4 (IV) and a5 (IV) were absent in the glomerulus in all three patients. Post treatment biopsy of the patient with the largest improvement in Filtration Slit Density showed a 34% increase in collagen a4 (IV) immunostaining intensity and presence of collagen a3/a4/a5 (IV) peptide with a greater than 6-fold increase in collagen a4 and detectable collagen a5 consistent with formation of a functional protein induction. No collagen alpha 5 was detected pre-treatment in this patient. These additional data support ELX-02’s mechanism of protein induction, and the observed morphology change and reduced foot process effacement in all the patients that was previously reported. The results also justify the conduct of a larger clinical trial with longer ELX-02 treatment duration to validate the observed clinical benefit in NMAS patients. The demonstrated readthrough of premature stop codons also suggests ELX-02 has potential in other rare kidney diseases, including autosomal dominant polycystic kidney disease and cystinosis. FDA allows for continued dosing of subjects in Phase 1 trial of ZKN-013 Following successful dosing of the initial subjects, FDA has allowed continued dosing of healthy volunteers for ZKN-013 for the treatment of recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa. Eloxx is awaiting confirmation from Almirall to proceed with the study based on their review of the results and FDA feedback. ZKN-013 has been exclusively licensed to Almirall, S.A. (BME:ALM), who has global rights to develop and commercialize ZKN-013. Under the terms of the license agreement, Eloxx is eligible for additional development, regulatory and sales milestones of up to $470 million as well as tiered royalties on any potential global sales. About Eloxx Pharmaceuticals Eloxx Pharmaceuticals, Inc. is engaged in the science of ribosome modulation, leveraging its innovative TURBO-ZM™ chemistry technology platform in an effort to develop novel Ribosome Modulating Agents (RMAs) and its library of Eukaryotic Ribosome Selective Glycosides (ERSGs). Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in Phase 2 clinical development for the treatment of Alport syndrome in patients with nonsense mutations. For more information, please visit www.eloxxpharma.com. Forward-looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including without limitation, statements regarding the potential future payments and future benefits under the license agreement, achievement of key milestones under the license agreement, the expected timeline for clinical development, the efficacy of the Company’s product candidates ZKN-013 and ELX-02, the Company’s expected and planned communications with and submissions to the FDA and anticipated funding under the bridge loan are forward-looking statements. Forward-looking statements can be identified by the words “aim,” “may,” “will,” “would,” “should,” “expect,” “explore,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on management's current plans, estimates, assumptions and projections based on information currently available to us. Forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and actual results or outcomes may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: the Company’s incurrence of significant losses; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its ability, or its licensees’ ability, to progress any product candidates in preclinical or clinical trials; the uncertainty of clinical trial results and the fact that positive results from preclinical studies are not always indicative of positive clinical results; the scope, rate and progress of the Company’s, and its licensees’ preclinical studies and clinical trials and other research and development activities; the competition for patient enrollment from drug candidates in development; the Company’s ability to obtain the capital necessary to fund its operations; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; the Company’s ability to obtain financing in the future through product licensing, public or private equity or debt financing or otherwise; general business conditions, regulatory environment, competition and market for the Company’s products; and business ability and judgment of personnel, and the availability of qualified personnel and other important factors discussed under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, as any such factors may be updated from time to time in the Company’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the “Financials & Filings” page of the Company’s website at https://investors.eloxxpharma.com/financials-filings. All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, the Company has no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. ContactJohn Woolfordjohn.woolford@westwicke.com 443.213.0506 Source: Eloxx Pharmaceuticals

Relief Therapeutics Announces Positive Final Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa GENEVA (NOV. 11, 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 positive final 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 clinical trial evaluated the effects of RLF-TD011 on microbiome diversity in chronic and acute wounds in EB patients, focusing primarily on the most severe forms of the disease (junctional and dystrophic EB). Effective wound healing is crucial for these patients, as their wounds are vulnerable to colonization or infection by pathogenic microorganisms, which can significantly reduce healing rates, increase the risk of sepsis, and lead to other severe complications. In particular, Staphylococcus aureus frequently colonizes EB wounds, where it contributes to chronic inflammation and disrupts the skin microbiome. The trial successfully met its primary endpoint. After eight weeks of treatment, RLF-TD011 led to a 24% decrease in S. aureus relative abundance (p=0.01), which correlated strongly (rho=0.64) with wound size reduction. Overall, 78% of treated wounds closed during the treatment period. Microbiome analysis further showed that RLF-TD011 treatment led to a marked increase in alpha diversity, with an increase in beneficial bacteria within the wound microbiome, effectively reducing S. aureus without disrupting beneficial bacteria. Improvements in microbiome diversity persisted through a four-week post-treatment observation period, evidencing RLF-TD011’s durability effect on the wound environment without signs of regression or exacerbation. “Epidermolysis bullosa is a devastating blistering skin disease that greatly impairs quality of life, particularly from the pain, itch, and risk of infection associated with open wounds. Evidence of reduction in the load of S. aureus and associated improved wound closure highlights the value of use of an antimicrobial spray during wound care,” said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University in Chicago, U.S. “These findings support the potential of RLF-TD011 to meaningfully advance wound care for patients with epidermolysis bullosa,” commented Giorgio Reiner, chief scientific officer of Relief. “The data demonstrates RLF-TD011’s antimicrobial efficacy, which is critical for infection management in chronic EB wounds, as well as its role in promoting wound healing. This is an important milestone in the development of RLF-TD011 toward regulatory approval. With this data in hand, we plan to consult with the U.S. Food and Drug Administration to finalize our development and regulatory plan.” Additional information about this investigator-initiated trial 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 certain clinical trials on non-EB wounds. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. RLF-TD011 aims to address an unmet need in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. The U.S. Food and Drug Administration granted it orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (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, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin’s layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB. 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.