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 - Seite 2

2) Relief intends to continue pursuing cost-effective, capital-efficient drug development with risk-mitigated assets. These currently include the following agents in Relief's pipeline beyond aviptadil:

a. GOLIKE, an optimized, prolonged-release, taste-masked amino acid mix for management of phenylketonuria (PKU) patients;

b. ACER-001, an immediate-release, taste-masked, patent protected formulation of sodium phenylbutyrate (NaPhe) for treatment of urea cycle disorders (UCD) and maple syrup urine disease (MSUD), which is the basis of an active collaboration arrangement with Acer Therapeutics;

c. An as-yet-undisclosed liquid formulation of an existing approved Rx drug for treatment of PKU, which would complement GOLIKE;

d. APR-TD011, a novel spray-based formulation of an acid-oxidizing solution with documented anti-microbial, anti-inflammatory and wound healing-accelerating properties, which Relief intends to develop as a treatment for all forms of epidermolysis bullosa (EB), a rare, debilitating dermatological disorder.

3) Relief has the following near- and medium-term catalysts:

a. Potential regulatory approval of ACER-001 by the FDA for the treatment of UCD (PDUFA date: June 5, 2022);

b. Confirmation of the long-term stability for its novel inhaled and intravenous formulations of RLF-100 by the end of the second quarter of 2022;

c. Effectiveness of its Registration Statement on Form 20-F under the Securities Exchange Act of 1934, which will allow Relief to move forward with its efforts to list its American Depositary Receipts (ADRs) on the NASDAQ stock market;

d. Initiation of a proof-of-concept trial of APR-TD011 in the second half of 2022 in EB patients;

e. Initiation of a clinical trial of aviptadil in sarcoidosis patients in early 2023;

f. The U.S. commercial launch of GOLIKE in the second half of 2022;

g. With our collaboration partner, Acer Therapeutics, a potential launch of ACER-001 in the U.S. in the second half of 2022;

h. Additional patent issuances or allowances covering further intellectual property (IP) claims pertaining to various elements of Relief's pipeline later this year and in 2023; and

i. Advances in the artificial intelligence (AI)-driven collaboration with InveniAI, which may yield additional programs to broaden Relief's pipeline during 2023.

4) Relief is focused on establishing its U.S. commercial operations and initiating market rollout of its lead commercial product, PKU GOLIKE^®, for the treatment of phenylketonuria ("PKU"). PKU GOLIKE^® is a novel, proprietary next-generation prolonged-release amino acid mix for use as a mainstay of PKU therapy and is available in multiple formulations. Relief, through its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), currently markets this product in Europe with its direct sales and marketing infrastructure covering Germany, Italy, Austria and Switzerland and through exclusive third-party distributors in the remaining countries. The initiative to market this product in the U.S. will be led by Relief's Head of U.S. Commercial Operations, Anthony M. Kim, who has a lengthy track record of successful commercialization of drugs aimed at rare and specialty disease indications in the U.S. market. Relief has also hired Christopher Wick as National Sales Director in the U.S. Mr. Wick is leading the buildout of Relief's U.S. field sales force and has a longstanding track record of performance in driving rare disease sales. Relief expects its highly targeted, specialized U.S. field sales force to be fully hired within the next several weeks.