Relief Provides a Corporate Update and Comments on the Recently Announced DSMB Update on the U.S. National Institutes of Health (NIH) Study of Intravenous Aviptadil in Critical COVID-19 Patients

GENEVA, SWITZERLAND / ACCESSWIRE / May 31, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet needs, today provided a corporate update.

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1) While Relief was disappointed to learn that the ACTIVE-3b/TESICO trial evaluating aviptadil for the treatment of COVID-19 sponsored by the National Institutes of Health (NIH) has been discontinued for futility, Relief remains committed to continuing the development of aviptadil (codenamed RLF-100™) in both inhaled and intravenous formulations for other indications. Relief intends to obtain and review the data from the NIH-sponsored trial in order to better understand the results observed, up to and including the point at which the study was discontinued.

In the meantime, Relief intends to continue to advance the clinical assessment of RLF-100 in the following areas, consistent with its previously stated corporate objectives:

a. Continuation of the European clinical study of inhaled RLF-100 in COVID-19-infected patients (the Leuppi study), which is at an advanced stage of recruitment and slated to report top-line data later this year (subject to enrolment of eligible patients);

b. Initiation of a clinical trial of RLF-100 in early 2023 in patients with sarcoidosis, a chronic, rare and debilitating pulmonary disease for which there are no treatments approved and for which Relief has received Orphan Drug designation from the FDA;

c. Exploration of RLF-100 in checkpoint inhibitor-induced pneumonitis (CIP), an indication in which Relief's wholly owned subsidiary AdVita LifeScience GmbH obtained method-of-use patent protection for aviptadil earlier this year;

d. Testing of RLF-100 in treatment of non-COVID-19-related acute respiratory distress syndrome (ARDS), with a particular focus on infectious ARDS; and

e. Conduction of the European proof-of-concept clinical development of RLF-100 in the treatment of chronic berylliosis, an orphan lung disease for which there are no treatments approved and characterized by severe inflammation of the lungs, coughing, and increasing breathlessness (dyspnea).

Aviptadil remains a molecule with a well-established mechanism of action and widely documented clinical evidence of biological activity, as well as a favorable human safety and tolerability profile established across two decades of clinical evaluation. As such, Relief believes that the drug merits continued assessment across an array of pulmonary conditions, regardless of whether the drug is ever approved for the treatment of COVID-19.