Relief Therapeutics : 2021 Half-Year Report

HALF-YEAR REPORT

2021

24th September 2021

TABLE OF CONTENTS

• 2021 TO DATE HIGHLIGHTS........................................................................................................................	-3-
• LETTER TO THE SHAREHOLDERS.................................................................................................................	-9-
• PORTFOLIO & PIPELINE............................................................................................................................	-11-
• COMMERCIAL DEVELOPMENT.................................................................................................................	-13-
• CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS............................................................	-14-
• CONSOLIDATED INTERIM BALANCE SHEET......................................................................................	-15-
• CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE LOSS.................................................	-16-
• CONSOLIDATED INTERIM STATEMENT OF CASH FLOW...................................................................	-17-
• CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY.....................................................	-18-
• NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS................................................	-19-

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2021 TO DATE HIGHLIGHTS

RLF-100 (aviptadil)

RLF-100 (aviptadil), IV

In March 2021, Relief's collaboration partner, NeuroRx, Inc. ("NeuroRx"), a wholly owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx"), announced top-line60-day results from its phase 2b/3 clinical trial of intravenous RLF-100 for the treatment of patients with critical COVID-19 respiratory failure. According to NRx, across all patients and sites, RLF- 100TM met the primary endpoint for successful recovery from respiratory failure at days 28 and 60 and also demonstrated a meaningful benefit in survival after controlling for ventilation status and treatment site. However, the clinical trial results did not demonstrate a statistically significant difference on the trial's primary endpoint without adjustment for these pre- specified covariates. These findings formed the basis for NeuroRx's Emergency Use Authorization ("EUA") application to the U.S. Food and Drug Administration ("FDA"). Once Relief has received and analyzed the full data from the phase 2b/3 clinical trial, the Company will decide on the best path forward for the development of RLF-100 in Europe and other territories.

In April 2021, NRx announced that RLF-100 had been selected for inclusion in ACTIV-3b/TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), an international, phase 3, multicenter clinical trial being sponsored by the U.S. National Institutes of Health (NIH), designed to evaluate RLF-100 and remdesivir in critical COVID-19 patients as a monotherapy, and in combination against placebo.

In June 2021, NRx announced that it had submitted an EUA application to the FDA for the use of intravenous RLF-100 in the treatment of critically ill COVID-19 patients with respiratory failure. NRx has further announced it also plans to submit a New Drug Application (NDA) to the FDA.

In June 2021, NRx announced additional positive results from the RLF-100 U.S. Expanded Access Protocol ("EAP"). The EAP included 240 patients in the intensive care unit with critical COVID-19 respiratory failure requiring either invasive or non-invasive mechanical ventilation, or high flow rate oxygen by nasal cannula, who were not eligible for the phase 2b/3 clinical trial. According to NRx, these EAP data were then submitted to the FDA as open label data in support of the pending EUA application.

In July 2021 (post reporting period), NRx reported that it identified a statistically significant effect of RLF-100 in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. According to NRx, the data was collected as part of the ongoing U.S. phase 2b/3 trial and NRx submitted these findings to the FDA as a supplement to the pending EUA application.

In July 2021 (post reporting period), NRx announced it has validated a commercial formulation of RLF-100 for IV use, allowing for high volume manufacture, with an anticipated one year or greater stability (under appropriate storage conditions). NRx also reported that it had achieved a 30 to 50 fold increase in its manufactured lot size of aviptadil.

In July 2021 (post reporting period), NRx announced that the Nation of Georgia's Prime Minister and Minister of Health issued an EUA for intravenous RLF-100 for the treatment of critical COVID-19.

In August 2021 (post reporting period), NRx provided a safety update on RLF-100 from the NIH sponsored ACTIV-3b/TESICO study. According to NRX, the study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrolment.

In September 2021 (post reporting period), Relief has received scientific advice from the Medicines and Healthcare Products Regulatory Agency ("MHRA") in the United Kingdom ("UK") relating to its lead investigational drug, RLF-100 (aviptadil), for the treatment of respiratory deficiency due to severe COVID-19. The guidance, which was provided in the context of a recent meeting that Relief held with the MHRA, included advice on the appropriate pathway for submission of an application for conditional marketing approval ("CMA") for the intravenous formulation of RLF-100, subject to provision of all data from the U.S. phase 2b/3 study conducted by Relief's collaboration partner, NeuroRx. Relief also held discussions with the European Medicines Agency ("EMA") pertaining to the regulatory path forward for RLF-100 in the European Union. Relief has informed EMA that it will proceed with further dialogue with the MHRA once it has compiled critical information related to the study conduct, clinical data and the drug product.

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2021 TO DATE HIGHLIGHTS

RLF-100 (aviptadil), IV (continued)

In September 2021 (post reporting period), Relief reported that NeuroRx continues to refuse, despite repeated demands by Relief requesting this information, to share with Relief the full clinical trial data set, including details on the statistical analysis performed, from its recently completed phase 2b/3 trial, which data and information is required to be provided to Relief by NeuroRx under the Collaboration Agreement. To date, Relief has only received a high-level summary of the clinical study report and has not been provided with, among other information, access to the 53'909 individual case reports, the raw data from the clinical trial, or the data on the multiple statistical analyses performed. NeuroRx has refused to share with Relief any of the correspondence between NeuroRx and the FDA. Further, NeuroRx has refused to allow NeuroRx's contract partners dealing with issues relating to the development of aviptadil to share information with Relief that it requires to develop RLF-100 (aviptadil) in its territories (including the European Union and the United Kingdom). The failure of NeuroRx to provide this information is seriously impairing Relief's ability to develop and execute a clinical and regulatory strategy for RLF-100 (aviptadil) in its territories.

RLF-100 (aviptadil), Inhaled

In January 2021, a clinical trial participation agreement for the inclusion of an inhaled formulation of RLF-100 into the I-SPYCOVID-19 clinical trial was signed between NeuroRx and Quantum Leap Healthcare Collaborative™ ("Quantum Leap") of San Francisco. The I-SPY trial is a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients.

In January 2021, Relief and AdVita LiveScience GmbH ("AdVita") signed a binding term sheet for Relief to acquire all shares of AdVita, giving Relief access to all of AdVita's assets including further pending IP rights that strengthen RLF-100 inhaled formulation IP for its potential application in the treatment of lung diseases such as acute respiratory distress syndrome ("ARDS"), pulmonary sarcoidosis and checkpoint inhibitor-induced pneumonitis ("CIP").

In February 2021, NeuroRx has reported that it is currently conducting a phase 2/3 clinical trial evaluating the use of inhaled RLF-100 in patients with early COVID-19 disease. This clinical trial commenced in January 2021 and NRx has reported that this trial is expected to conclude by October 2021. Relief has the right to fund and participate in this trial, subject to NeuroRx's obligation to provide information sufficient for Relief to make a decision on whether or not to fund and participate this trial. To date, such information has not been provided. NRx has stated that Relief has declined to fund the expenses of this trial and that it has obtained the funding for this trial from other sources. Relief believes that this trial is part of its collaboration with NeuroRx and that until sufficient information is provided so that Relief can make the decision whether or not to fund and participate in this trial, its collaboration agreement with NeuroRx does not allow NeuroRx to bring in another source to directly fund these expenses.

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 of COVID-19-related ARDS.

In July 2021 (post reporting period), NRx and Quantum Leap announced that they had begun treating patients with inhaled RLF-100 in the I-SPYCOVID-19 trial.

In July 2021 (post reporting period), Relief and AdVita closed a definitive agreement for Relief to acquire all the outstanding shares of AdVita for EUR 25 million in Relief common shares. In addition, Relief will pay milestone payments of up to EUR 20 million in cash, contingent on the achievement of milestones related to AdVita's development programs.

In August 2021 (post reporting period), Relief announced that AdVita has been granted Orphan Drug Designation ("ODD") by the FDA for inhaled RLF-100 for the treatment of pulmonary sarcoidosis. This marks the Company's third ODD, adding to existing designations for APR-OD031 for phenylketonuria ("PKU") and APR-TD011 for epidermolysis bullosa ("EB").

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2021 TO DATE HIGHLIGHTS

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 ("UCD") and Maple Syrup Urine Disease ("MSUD"), under which Acer received a total of USD 15 million in cash payments. Relief also committed to pay Acer up to USD 20 million in U.S. development and commercial launch costs for the UCD and MSUD indications, of which USD 10 million has been paid to date. Acer retains development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer's territories 60%:40% in favor of Relief. In addition, Relief has licensed the rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all net revenues received in Relief's territories. Acer may also receive a total of USD 6 million in development milestone payments following the first European marketing approvals for UCD and MSUD.

In May 2021, Acer announced the outcome of its Type B pre-NDA meeting with the FDA for ACER-001 for the treatment of UCD. Based on the FDA's feedback, Relief and Acer noted that the proposed data package would likely be sufficient to support a Q3 2021 NDA submission under the Section 505(b)(2) regulatory pathway.

Subsequently, in August 2021 (post reporting period), Relief and Acer announced the submission of the NDA to the FDA for ACER-001 for UCD. While there can be no assurance, should the FDA approve the NDA, we believe that it could be available commercially in the United States in 2022.

APR Applied Pharma Research SA

In May 2021, Relief and the then shareholders of APR Applied Pharma Research SA ("APR") signed a binding term sheet for Relief to acquire all of the outstanding shares of APR, a privately held Swiss pharmaceutical company with over 25 years' experience in identifying, developing and commercializing known molecules engineered with drug delivery systems in niche and rare disease areas on a global basis.

In May 2021, APR initiated a pivotal clinical trial with its novel nasal spray, SentinoxTM, a Class III medical device approved in Europe, in patients with mild COVID-19. The trial is not designed for registration purposes but to evaluate the efficacy and safety of the product in reducing viral load in the upper airways in recently SARS-Cov-2 infected individuals.

In June 2021, Relief signed and closed a definitive agreement to acquire all outstanding shares of APR. Under the terms of the agreement, APR's shareholders received CHF 21.5 million in cash and CHF 45 million in Relief common registered shares. The sellers are also eligible to receive additional contingent payments in the form of a combination of cash and Relief common registered shares upon achievement of pre-agreed milestones.

In September 2021 (post reporting period), APR expanded its PKU GOLIKE® product line with the launch, in Germany and Italy, of PKU GOLIKE KRUNCH, a convenient chewable tablet for the dietary management of phenylketonuria ("PKU").

Personnel

To match the fast pace at which the Company is developing, Relief has continued to strengthen its management team.

In April 2021, Relief appointed J.J. Scherpbier of Sonsbeek Pharma Consultancy B.V. as manufacturing and supply chain consultant. Mr. Scherpbier is a highly experienced pharmaceutical consultant with more than 25 years of expertise in the areas of regulatory affairs, life cycle management, pharmaceutical development and GMP.

In May 2021, Relief appointed Taneli Jouhikainen, MD, MBA, to the newly created position of Chief Operating Officer, effective June 1, 2021. Dr. Jouhikainen has over 25 years of life sciences experience in pharmaceutical industry leadership, product development and commercialization roles.

In June 2021, the shareholders of Relief appointed Patrice Jean and Paolo Galfetti to the Relief Board of Directors. Mr. Galfetti has become one of Relief's key executives as Chief Executive Officer of APR and President of Relief Europe.

With the acquisition of APR in June 2021, Relief's workforce increased by more than 40 talented professionals to over 50 employees.

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