EQS Group-Ad-hoc: RELIEF THERAPEUTICS Holding AG / Key word(s): Half Year Results Relief Reports Half-Year 2021 Results and Provides Corporate Update 24-Sep-2021 / 07:00 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement.

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Relief Reports Half-Year 2021 Results and Provides Corporate Update

Geneva, Switzerland, September 24, 2021 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today reported its results for the half-year ended June 30, 2021 and provided a corporate update.

"While we await the FDA's decision on the Emergency Use Authorization (EUA) for IV RLF-100 (aviptadil), filed by our collaboration partner NeuroRx, Inc. (NeuroRx), we have successfully transformed Relief into a fully-integrated, multi-product, revenue-generating biopharmaceutical company," stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. "A critical component of our success so far this year was the acquisition of APR Applied Pharma Research SA (APR), which expanded and diversified our specialty drug pipeline, added a number of key commercialized products, including the PKU GOLIKE(R) family of products for the treatment of phenylketonuria (PKU), provided a European based commercial infrastructure that we hope to leverage for future product launches, including ACER-001, and offers an internal R&D capability that we plan to use for the development our own products as well as for third-party products on a fee for service basis."

Dr. Selvaraju continued, "Through our collaboration with Acer Therapeutics, we recently filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for ACER-001, a proprietary powder formulation of sodium phenylbutyrate (NaPB), designed to be both taste-masked and immediate release, for the treatment of urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). We look forward to the potential acceptance of the filing for regulatory review, which we expect to receive next month."

"Also important was our recent acquisition of AdVita Lifescience GmbH (AdVita), from which we gained key pending intellectual property that may cover an improved inhaled formulation of RLF-100 (aviptadil), in development for a number of lung diseases, including acute respiratory distress syndrome (ARDS), and checkpoint inhibitor-induced pneumonitis (CIP). In parallel, IV RLF-100 continues to be evaluated as a treatment for severely ill COVID-19 patients, while the inhaled formulation is being tested in two clinical trials, one for patients with critical COVID-19 and another for moderate and severe COVID-19 patients. As we look ahead, and with a firm financial footing in place, we will maintain our commitment to pursuing additional strategic opportunities, both in-license and acquisition related, in order to aggressively expand and diversify our business." Clinical Development Highlights:

RLF-100 (aviptadil), IV . In March 2021, Relief's collaboration partner, NeuroRx, Inc. (NeuroRx) announced top-line 60-day resultsfor the phase 2b/3 trial of RLF-100(TM) for the treatment of patients with critical COVID-19 respiratory failure.These findings formed the basis for NeuroRx's Emergency Use Authorization (EUA) application to the U.S. Food andDrug Administration (FDA). . In April 2021, NeuroRx announced that RLF-100 had been selected for inclusion in TESICO (Therapeutics forSeverely Ill Inpatients with COVID-19), an international, phase 3, multicenter clinical trial being sponsored bythe U.S. National Institutes of Health (NIH). . In June 2021, NRx Pharmaceuticals Inc. (NRx), the parent company of NeuroRx, announced that NeuroRx hadsubmitted its EUA application to the FDA for the use of RLF-100 in the treatment of critically ill COVID-19 inpatients with respiratory failure. NeuroRx also reported that it plans to submit a New Drug Application (NDA) tothe FDA. . In June 2021, NRx announced additional positive results from the RLF-100 U.S. Expanded Access Protocol(EAP). These EAP data were then submitted to the FDA and were characterized by NRx as "real world" evidence insupport of the findings from the phase 2b/3 trial. . In July 2021, NRx reported that it identified a statistically significant effect of RLF-100 in preventingthe sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. The data was collectedas part of the ongoing U.S. phase 2b/3 trial and NeuroRx reported that it had submitted these findings to the FDAas a supplement to the pending EUA application. . In July 2021, NRx announced the successful validation of the commercial formulation of RLF-100 for IVuse, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriatestorage conditions. . In July 2021, NRx announced that the Nation of Georgia's Prime Minister and Minister of Health had issuedan EUA for RLF-100. . In August 2021, NRx provided a safety update on RLF-100 which is being tested in the ACTIV-3 CriticalCare phase 3 study sponsored by the NIH, designed to evaluate RLF-100 and remdesivir in critical COVID-19 patients,as a monotherapy and in combination against placebo. They reported that the study's Data Safety Monitoring Boardfound no new safety concerns in the trial and recommended continued enrollment. . In August 2021, NRx reported a new analysis showing that patients with acute respiratory failure due toCritical COVID-19 who were treated with aviptadil demonstrated improvement in blood oxygen, indicative of improvedlung function, within a day of starting treatment. NRx noted that this analysis appears to support its plan tosubmit an application for Breakthrough Therapy Designation to the FDA and that, if granted, could confer PriorityReview to the aviptadil NDA, when submitted.

RLF-100 (aviptadil), Inhaled . In January 2021, a clinical trial participation agreement for the inclusion of an inhaled formulation ofRLF-100 into the I-SPY COVID-19 clinical trial was signed between NeuroRx and Quantum Leap Healthcare Collaborative(TM) (Quantum Leap) of San Francisco. . In January 2021, Relief and the former shareholders of AdVita signed a binding term sheet for Relief toacquire all shares of AdVita, giving Relief access to all of AdVita's assets including further pending IP rightsthat may cover RLF-100 inhaled formulation specifications for its potential application in the treatment of lungdiseases such as ARDS, pulmonary sarcoidosis and CIP. . In April 2021, Relief and AdVita announced the initiation of an investigator-sponsored, randomized,double-blind, placebo-controlled phase 2 trial evaluating the inhaled formulation of RLF-100 for the prevention ofCOVID-19-related ARDS. . In July 2021, NeuroRx and Quantum Leap began treating patients with inhaled RLF-100 in the I-SPY COVID-19Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically illCOVID-19 patients. . In July 2021, Relief and the former shareholders of AdVita closed a definitive agreement for Relief toacquire all shares of AdVita, under which Relief paid the AdVita shareholders EUR 25 million in Relief commonshares. . In August 2021, Relief received Orphan Drug Designation (ODD) from the FDA for inhaled RLF-100, for thetreatment of sarcoidosis, adding to existing ODD designations for APR-OD031 for phenylketonuria (PKU) and APR-TD011for epidermolysis bullosa (EB). . In September 2021, AdVita received regulatory clearance to commence a phase 2 clinical trial in Germanyto evaluate inhaled aviptadil for the treatment of sarcoidosis.

ACER-001 . In March 2021, Relief signed a Collaboration and License Agreement with Acer Therapeutics, Inc. (Acer)for the worldwide development and commercialization of ACER-001 for the treatment of Urea Cycle Disorders (UCDs)and Maple Syrup Urine Disease. . In May 2021, Acer announced the outcome of its Type B pre-NDA meeting with the FDA for ACER-001, for thetreatment of UCDs. Based on the FDA's feedback, both Relief and Acer noted that the proposed data package wouldlikely be sufficient to support a Q3 2021 NDA submission under the Section 505(b)(2) regulatory pathway. . Subsequently, in August 2021, Relief and Acer announced the submission of the NDA to the FDA for ACER-001for UCDs. Relief anticipates submitting a Marketing Authorization Application for approval of ACER-001 for UCDs inthe European Union before the end of 2021. Pending a positive decision by regulators, management believes thatACER-001 could be launched in both the U.S. and Europe during 2022.

APR Applied Pharma Research SA . In May 2021, Relief and the former shareholders of APR signed a binding term sheet for Relief to acquireall of the outstanding shares of APR, a privately held Swiss pharmaceutical company with over 25 years' experiencein identifying, developing and commercializing known molecules engineered with drug delivery systems in niche andrase diseases on a global basis. The transaction closed in June 2021. . In May 2021, APR initiated a pivotal clinical trial with its novel nasal spray, Sentinox, a Class IIImedical device, in patients with mild COVID-19. . In September 2021, APR expanded its PKU GOLIKE(R) product line with the launch, in Germany and Italy, ofPKU GOLIKE(R) KRUNCH, giving patients a convenient chewable tablet for on-the-go dietary management ofphenylketonuria, a rare, recessive metabolic genetic disorder affecting approximately 350,000 people, globally.Management hopes to announce its plans to market PKU GOLIKE(R) in the U.S. before year end 2021.

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