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GENEVA, SWITZERLAND / ACCESSWIRE / April 3, 2023 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief Therapeutics, or Relief), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases and disorders, today reported its financial results for the full-year ended December 31, 2022 and provided a corporate update. The Relief Therapeutics 2022 Annual Report, including management's discussion and analysis, financial statements and results of operations for the year ending December 31, 2022, is available for download on the company's website. "We made substantial progress in our transformation of Relief Therapeutics into a fully integrated, commercial-stage biopharmaceutical company in 2022, strengthening our intellectual property portfolio with multiple new patents and with the launch of our PKU GOLIKE® line of products in the U.S. in October, and the subsequent launch of the new PKU GOLIKE BARs™ in the U.S. and Europe earlier this year. In late December, we announced the U.S. FDA approval of OLPRUVA™ for the treatment of patients with urea cycle disorders with our collaboration partners at Acer Therapeutics," said Jack Weinstein, chief executive officer of Relief Therapeutics. "We also announced new stability data for RLF-100®, our novel formulation of aviptadil acetate, which has been shown to be shelf-stable at temperatures suitable for shipping and long-term storage. We believe RLF-100 has significant potential clinical and commercial value and intend to pursue development of this product candidate for treatment of several debilitating lung disease indications." "We also built out our U.S. commercial organization and strengthened our management team, while continuing to advance other elements of our diversified pipeline of risk-mitigated product candidates toward significant catalysts," continued Mr. Weinstein. "In 2022 we also launched a new initiative in genetic medicine focused on inherited metabolic disorders, which is being led by Dr. Serene Forte who joined Relief in July. To support this endeavor, we also recently announced the appointment of Dr. Guangping Gao, a pioneer and global thought leader in the field of molecular genetics and viral vector gene therapy, to serve as the chair of our newly established scientific advisory board. Looking ahead to the balance of 2023, we continue to execute on the revised financing and listing strategy we announced in February. We maintain a lean organization, with a strong, experienced leadership team that has the proven ability to execute our disciplined, cost-effective, capital-efficient approach to drug development and deliver growth. We look forward to concluding the remaining steps on our pathway to a dual listing of our ordinary shares on the Nasdaq Stock Market and further advancing our development plans in 2023, and to realizing the full potential of the Relief Therapeutics portfolio for patients and our shareholders," said Mr. Weinstein. 2022 & EARLY 2023 HIGHLIGHTS OLPRUVATM (sodium phenylbutyrate) for oral suspension FDA Approval U.S. Food and Drug Administration approved OLPRUVA™ (sodium phenylbutyrate for oral suspension for the treatment of certain patients living with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS). Collaboration partner Acer Therapeutics (ACER) announced preliminary launch activities in March 2023; with commercial and medical affairs teams in place to support the U.S. launch in Q2 2023 and product availability expected in July 2023. ACER presented UCD survey data at 44th annual meeting of the Society for Inherited Metabolic Disorders (SIMD) in March 2023. The survey data were designed to quantify preferences of healthcare providers who treat patients with UCDs, and results showed taste and odor are the most important attributes influencing overall prescription and patient adherence to UCD treatments. PKU GOLIKE® for the Treatment of Phenylketonuria (PKU) Relief's newly assembled U.S. commercial team and a leading national health services company serving as exclusive distributor initiated the launch of its PKU GOLIKE® line of products in the U.S. in October. The PKU GOLIKE® family of products are next-generation, prolonged-release amino acid medical foods for the dietary management of phenylketonuria (PKU). In early 2023, Relief also launched the newest product in the PKU GOLIKE line, the PKU GOLIKE BAR™ in the U.S. and Europe. The Company presented results of pre-clinical research evaluating the metabolic impact of PKU GOLIKE® on nitrogen balance, muscle strength and glucose at SIMD 2023. Data presented in a poster session summarized acute and long-term metabolic effects of PKU GOLIKE supplementation on the utilization of amino acids and glucose metabolism in a pre-clinical rat model using biomarkers for muscle metabolism, functional muscle performance and a glucose tolerance test. Beneficial effects were observed on amino acid oxidation, muscle metabolism, grip strength and glucose tolerance in healthy rats. RLF-100® (aviptadil acetate) In November, Relief announced six-month stability data for its new proprietary formulation of aviptadil acetate, RLF-100®; high-purity levels were demonstrated at all temperatures tested (refrigerated, room temperature). Results demonstrate novel RLF-100® formulation to be shelf-stable at temperatures suitable for shipping and long-term storage. RLF-100® was granted Orphan Drug designation (ODD) for pulmonary sarcoidosis by the FDA. In December, Relief announced a definitive settlement agreement was reached with its former collaboration partner NeuroRx, Inc. (NRx) to resolve litigation, resulting in transfer to Relief of all assets previously used in the aviptadil development program. RLF-TD011 Patient enrollment was initiated in a proof-of-concept, investigator-initiated clinical trial of RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare, inherited skin disease characterized by widely distributed, painful, chronic wounds that easily become infected, resulting in an elevated risk of sepsis and death. The study (NCT05533866) is currently enrolling up to 17 patients diagnosed with junctional epidermolysis bullosa (JEB) or dystrophic epidermolysis bullosa (DEB) with S. aureus or P. aeruginosa culture-positive wounds at Ann & Robert H. Lurie Children's Hospital of Chicago. Relief received the approval of an independent IRB for an investigator-initiated trial evaluating RLF-TD011 as an adjunctive treatment for cutaneous t-cell lymphoma (CTCL) (NCT05728879); the study will evaluate the effect of RLF-TD011, a patent-protected hypochlorous acid topical spray, on the microbiome of CTCL skin lesions and determine tolerability, symptom improvement and potential for reducing lesion size and skin disease activity. RLF-OD032 for the Treatment of PKU In July, Relief acquired the worldwide commercialization rights (except in the United Kingdom) for a novel dosage form of an already FDA-approved prescription drug for the treatment of PKU from Meta Healthcare Ltd. Relief continues to work on the FDA investigational new drug (IND) application for submission during the second half of 2023 and anticipate filing for U.S. approval through a 505(b)(2) NDA in 2024. Genetic Medicines Initiative In early 2022, Relief Therapeutics launched a genetic medicine initiative with the objective of developing life-altering, potentially curative treatments for patients suffering from for devastating, as-yet-unaddressed, rare monogenetic diseases. Serene Forte, Ph.D., MPH, was welcomed to Relief in July 2022 to lead the genetic medicines initiative as the company pursues efforts to establish a pipeline of genetic medicine programs. Internationally recognized gene therapy expert Guangping Gao, Ph.D. was appointed as the chair of Relief's newly formed scientific advisory board in April 2023. Key Leadership Appointments We expanded our board of directors with the appointment of life science industry veteran Michelle Lock in January 2022. Serene Forte, Ph.D., MPH, joined Relief in July as the senior vice president, head of genetic medicine, to lead Relief's new genetic medicines initiative. Paolo Galfetti was promoted to the role of chief operating officer at RELIEF THERAPEUTICS Holding SA in October 2022, continuing his responsibilities as chief executive officer of APR Applied Pharma Research SA (APR) and as a member of Relief's board of directors. Jack Weinstein, MBA, was promoted as the chief executive officer at Relief, and Jeremy Meinen, CPA, as the Relief's chief financial officer, in December 2022. Business Update In July, Relief's Registration Statement on Form 20-F under the Securities Exchange Act of 1934 became effective, making Relief Therapeutics a publicly reporting company in the U.S. In early 2023, Relief Therapeutics announced that in furtherance of its efforts to listing the Company's shares on the Nasdaq Stock Market, Relief will hold an extraordinary general meeting (EGM) of shareholders asking them to consider and vote on the proposal to consolidate (or reverse split) the company's ordinary shares. The EGM will take place on April 28, 2023 in Geneva. The full details of the proposal and proposed revised Articles of Association are enclosed in the EGM invitation available on the Relief Therapeutics website, where additional information is also provided in a Q&A list. About Relief Therapeutics Relief Therapeutics 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 and disorders. Our portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic™ and TEHCLO™ drug delivery platform technologies and a highly targeted clinical development pipeline consisting of risk-mitigated assets to address rare metabolic disorders, rare skin diseases and rare respiratory diseases. In addition, the company is commercializing several legacy products via licensing and distribution partners. Our mission to provide therapeutic relief to those suffering from rare diseases and disorders is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief Therapeutics' headquarters are located in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Rome. The Company 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, please visit our website at or follow Relief Therapeutics on LinkedIn and Twitter. FOR MEDIA/INVESTOR INQUIRIES CONTACT: RELIEF THERAPEUTICS Holding SA Catherine Day Vice President, IR & Communications contact@relieftherapeutics.com LifeSci Advisors Irina Koffler +1-917-734-7387 ikoffler@lifesciadvisors.com Disclaimer This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors, which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics 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 Therapeutics' filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief Therapeutics. Copies of Relief Therapeutics' filings with the SEC are available on the SEC EDGAR database at . Relief Therapeutics does not undertake any obligation to update the information contained herein, which speaks only as of this date. SOURCE: Relief Therapeutics Holdings AG View source version on accesswire.com:

Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR Applied Pharma Research SA, shares his family's rare story of living with phenylketonuria GENEVA, SWITZERLAND / ACCESSWIRE / February 28, 2023 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief Therapeutics" or the "Company"), a biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with specialty and rare diseases, is pleased to recognize Rare Disease Day 2023 and announce the U.S. availability of the new PKU GOLIKE™ bars, a medical food for the dietary management of phenylketonuria (PKU). "For me, it's not just a job - it's personal. My oldest son Riccardo was born with PKU, a rare, lifelong metabolic disease I had never heard of before his birth. I learned that living with PKU requires a limited diet and very careful management. If left unmanaged, PKU can lead to devastating consequences, such as brain damage. The diagnosis was overwhelming and terrifying at first," said Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR Applied Pharma Research SA. "My son Riccardo inspires me in my work every day. We are proud to introduce the new tropical and red fruit flavored PKU GOLIKE bars today, which were developed by patients and for patients." People living with PKU do not have the ability to metabolize the amino acid phenylalanine (Phe) found in many foods and they require supplementation of amino acid-based foods for special medical purposes (FSMPs) to prevent protein deficiency and optimize metabolic control. Currently available FSMPs lead to poor or suboptimal clinical outcomes and compliance because they are rapidly absorbed and are characterized by an unpleasant odor and aftertaste. Such factors contribute to barriers to social interaction for PKU patients, further limiting FSMP compliance and exposing patients to the risks of poor disease control. "Everyone in the Relief family works hard every day to make a difference in the lives of all patients and families managing rare diseases around the world. We are very grateful to Paolo for sharing his personal story and share his strong commitment to families dealing with PKU," said Jack Weinstein, chief executive officer of Relief Therapeutics. "Our teams have spent the past four years conducting focus groups and qualitative research, working directly with patients, caregivers and healthcare providers to develop the new PKU GOLIKE bars, which really address the needs expressed by patients. We're happy to celebrate this Rare Disease Day by offering a new, unique product on the market." The new PKU GOLIKE Bars were developed with Physiomimic™ technology, the Company's next-generation, prolonged-release amino acid mix, and contain real fruit in tropical and red fruit flavors, from natural ingredients. More flavors of the bars and other forms of PKU GOLIKE are currently in development. The new grab-and-go bars are ready to use and easy to carry. The 5 g protein equivalent per bars have less than 8 mg of Phe per bar and come 20 bars in each box and the 10 g protein equivalent per bars have less than 15 mg of Phe per bar and come with 10 bars in each box. To learn more about Paolo and Riccardo's story, please visit: ABOUT PHENYLKETONURIA (PKU) Phenylketonuria (PKU) is a rare inherited disorder affecting more than 450,000 patients worldwide.[1] PKU is caused by a defect of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of phenylalanine from the consumption of foods containing protein or aspartame. Untreated PKU can result in global developmental delay or severe irreversible intellectual disability, as well as growth failure, hypopigmentation, motor deficits, ataxia and seizures.[2] To avoid these serious consequences, people with PKU must comply with a strict diet that limits intake of phenylalanine from infancy onward. Patients with PKU require supplementation of amino acids formulated as foods for special medical purposes (FSMP) to prevent protein deficiency. ABOUT PKU GOLIKE® PKU GOLIKE® is a phenylalanine-free food intended for special medical purposes (FSMP) for both children and adults. PKU GOLIKE is comprised of a mixture of amino acids in the form of granules and available in convenient packets and medical food bars. Developed with the company's proprietary, patent-protected Physiomimic™ technology platform, PKU GOLIKE® products are the first prolonged-release amino acid FSMPs, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. The special coating also masks the unpleasant taste, odor and aftertaste of the amino acids. PKU GOLIKE® granules are flavorless and can be mixed with many of your favorite foods. PKU GOLIKE® contains all 19 amino acids that people with PKU need to maintain neurological and muscular health and is fortified with 27 essential vitamins and minerals, including ones normally found in protein-rich foods like iron, calcium, and vitamin B12. PKU GOLIKE® products have been commercially available in Europe since 2019 and in the U.S. since October 2022. For more information in the U.S., please visit . Please note this site is intended for U.S. audiences only. For more information in Europe, please visit: ABOUT APR APPLIED PHARMA RESEARCH SA APR Applied Pharma Research SA is a wholly owned subsidiary of Relief Therapeutics acquired in June 2021. ABOUT RELIEF THERAPEUTICS Relief Therapeutics is a Swiss, commercial-stage, biopharmaceutical company focused on the development and commercialization of products in select specialty and rare diseases, including metabolic disorders, pulmonary diseases and connective tissue disorders. Relief Therapeutics' diversified pipeline consists of assets with the potential to effectively address significant unmet medical needs. PKU GOLIKE®, developed with our proprietary Physiomimic™ technology, is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria (PKU). Relief Therapeutics has a collaboration and license agreement with Acer Therapeutics for the worldwide development and commercialization of Olpruva™ (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). Relief Therapeutics continues to develop RLF-100 (aviptadil) for several pulmonary indications. Further, Relief Therapeutics is undertaking the clinical development of RLF-TD011 for the treatment of epidermolysis bullosa, an indication for which the FDA has granted Orphan Drug designation. Relief Therapeutics is also exploring the clinical development of RLF-TD011 for the treatment of cutaneous t-cell lymphomas. Finally, Relief Therapeutics is commercializing several legacy products via licensing and distribution partners. RELIEF THERAPEUTICS Holding SA 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, please visit or follow Relief Therapeutics on LinkedIn and Twitter. FOR MEDIA/INVESTOR INQUIRIES CONTACT: RELIEF THERAPEUTICS Holding SA Catherine Day Vice President, IR & Communications contact@relieftherapeutics.com LifeSci Advisors Irina Koffler +1-917-734-7387 ikoffler@lifesciadvisors.com DISCLAIMER This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the commercialization of PKU GOLIKE® in the United States will be successful, and (ii) those factors described in Relief's reports to the SIX Swiss Exchange and the Securities and Exchange Commission could adversely affect Relief, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at . [1] Hillert A, Anikster Y, Belanger-Quintana A, et al. The Genetic Landscape and Epidemiology of Phenylketonuria. Am J Hum Genet. 2020;107(2):234-250. doi:10.1016/j.ajhg.2020.06.006 [2] Blau N, van Spronsen FJ, Levy HL. Phenylketonuria. Lancet. 2010 Oct 23;376(9750):1417-27. doi: 10.1016/S0140-6736(10)60961-0. PMID: 20971365. Additional features: File: Bar advert File: Riccardo & Paolo Galfetti File: Press release SOURCE: Relief Therapeutics Holdings AG View source version on accesswire.com: