Ad hoc announcement pursuant to Art. 53 LR
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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 FDAs 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®
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.
Ad hoc announcement pursuant to Art. 53 LR
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Clinical Development Highlights:
RLF-100 (aviptadil), IV
In March 2021, Reliefs collaboration partner, NeuroRx, Inc. (NeuroRx) announced top-line 60-day
results for the phase 2b/3 trial of RLF-100 for the treatment of patients with critical COVID-19
respiratory failure. These findings formed the basis for NeuroRxs Emergency Use Authorization
(EUA) application to the U.S. Food and Drug Administration (FDA).
In April 2021, NeuroRx announced that RLF-100 had been selected for inclusion in 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).
In June 2021, NRx Pharmaceuticals Inc. (NRx), the parent company of NeuroRx, announced that
NeuroRx had submitted its EUA application to the FDA for the use of RLF-100 in the treatment of
critically ill COVID-19 in patients with respiratory failure. NeuroRx also reported that it 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). These EAP data were then submitted to the FDA and were characterized by NRx
as real world evidence in support 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 preventing
the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. The
data was collected as part of the ongoing U.S. phase 2b/3 trial and NeuroRx reported that it had
submitted these findings to the FDA as a supplement to the pending EUA application.
In July 2021, NRx announced the successful validation of the 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.
In July 2021, NRx announced that the Nation of Georgia's Prime Minister and Minister of Health
had issued an EUA for RLF-100.
In August 2021, NRx provided a safety update on RLF-100 which is being tested in the ACTIV-3
Critical Care 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 Board found 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 to Critical COVID-19 who were treated with aviptadil demonstrated improvement in blood
oxygen, indicative of improved lung function, within a day of starting treatment. NRx noted that
this analysis appears to support its plan to submit an application for Breakthrough Therapy
Designation to the FDA and that, if granted, could confer Priority Review to the aviptadil NDA,
when submitted.