geht hier was
führen und eine Zulassung in Kürze erfolgen . Dann kommt noch die ADR freigabe
Nasdaq die ermöglicht institutionellen Anlegern die nicht am OTC handeln zu
investieren ! Es bleibt sehr sehr spannend ! :-)
https://clinicaltrials.gov/ct2/show/...viptadil&draw=2&rank=6
wir können nur hoffen das der crash nicht zu heftig wird . NRXP
bis jetzt minus 50% !!! Schade fing gerade wieder gut an ! :-(
https://www.nrxpharma.com/...tical-covid-19-with-respiratory-failure/
Ad hoc announcement pursuant to Art. 53 LR
1
Relief Reports that its U.S. Collaboration Partners Emergency Use Authorization
Request for ZYESAMI®/RLF-100 (aviptadil) for Patients with Critical COVID-19
with Respiratory Failure was Declined by the U.S. Food & Drug Administration
Geneva, Switzerland, November 5, 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, reported today that the parent company of its U.S. collaboration partner,
NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (NRx), has issued a press release announcing that it was
declined Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the use
of IV aviptadil for the treatment of acute respiratory failure due to critical COVID-19. The related NRx press
release can be accessed through the following link.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Reliefs lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed
and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Ad hoc announcement pursuant to Art. 53 LR
2
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its
litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil
will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients
with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and
filings with the SIX, which could cause the actual results, financial condition, performance or achievements
of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding
SA is providing this communication as of this date and does not undertake to update any forward-looking
statements contained herein as a result of new information, future events or otherwise.
Relief Therapeutics Valuation Report
What a Relief!
Battling respiratory and rare disease and now NeuroRx
The integration of APR is progressing well, the AdVita acquisition successfully closed, and ACER-001 in urea cycle disorders has received FDA acceptance of filing with a 5 June 2022 PDUFA date and US patent allowance providing protection until 2036. Unfortunately, the ongoing dispute with NRx and its CEO Dr. Javitt has escalated to a lawsuit. A potential US Emergency Use Authorization grant for RLF-100 IV in COVID-19 induced ARDS in Q4 2021 would be transformational for Relief marking first commercial sales for RLF-100. Funding has been secured well into 2023.
Key catalysts include:
1. Potential US Emergency Use Authorization RLF-100 IV in COVID-19 ARDS (Q4 2021)
2. AVICOVID-2 topline results RLF-100 INHALED in prevention COVID-19 related ARDS (Q4 2021)
3. Filing EU Conditional Marketing Authorization RLF-100 IV in COVID-19 ARDS (H1 2022)
vL Relief Therapeutics Valuation Report
Adobe Acrobat Document 1.8 MB
Download
https://www.valuationlab.com/app/download/...25OCT21.pdf?t=1635155372
Ist nicht unbedingt das Ende, könnte der Boden sein.
Oder auch nicht.
?
Ich mach es wie die Chinesen, 10 Jahre liegen lassen und dann einsammeln.
Ist natürlich schlecht für die bösen Börsianer.
Um spielen zu können braucht es aber die Zulassung.
Ich erwarte nichts mehr, falls es doch noch steigen sollte hab ich auch nichts dagegen.
Schauen wir mal wie es bis Ende Jahr aussieht.
positiv auf den Kurs auswirkt . Die Hoffnung stirbt bekanntlich zuletzt . Covid
knallt uns auch wieder mit voller Kraft um die Ohren und kein Ende in sicht .
Weiterhin zuversichtlich . Mal schauen was der Austausch im Management
bringt ! Allen noch eine entspannte Woche , passt auf euch auf und bleibt
gesund !!! :-)
Ad hoc announcement pursuant to Art. 53 LR
1
Relief Therapeutics Announces Transitions in Commercial Organization to
Implement Next Phase of Corporate Development
Anthony M. Kim Appointed Senior Vice President and Head of U.S. Commercial Operations
Seasoned Biotech Executive Brings Vast U.S. Commercial Launch Experience to Relief
European and United Kingdom Commercial Operations Transitioned to Paolo Galfetti, President of
Relief Europe
Chris Stijnen to Depart Relief
Geneva, Switzerland, November 9, 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, announced today the appointment, effective December 1, 2021, of
Anthony M. Kim as Senior Vice President and Head of U.S. Commercial Operations. The company also
reported that Chris Stijnen, Chief Commercial Officer since 2020, will be leaving to pursue other
opportunities effective November 30, 2021. His duties regarding EU and UK commercial operations will
be assumed by Paolo Galfetti, President of Relief Europe, and the commercial team at Reliefs subsidiary,
APR Applied Pharma Research SA (APR).
Our collaboration with Acer Therapeutics and strategic acquisitions of APR and AdVita Lifescience GmbH,
all completed in 2021, have allowed us to significantly expand our intellectual property position and
pipeline, while bringing, in-house, a number of already marketed products, such as APRs flagship PKU
GOLIKE®, for the treatment of phenylketonuria, stated Raghuram Selvaraju, Ph.D., Chairman of the Board
of Directors of Relief. Anthonys appointment is a direct acknowledgement of our growing corporate
needs, our commitment to our-long term growth, and our plans to expand availability of our product
candidates in the U.S. including PKU GOLIKE®. Anthony will also be a key part of Reliefs plan to optimize
the commercial success of ACER-001 in collaboration with our partner Acer Therapeutics. As a proven
commercial leader with extensive launch experience gained during his tenures at Novocure, Alexion
Pharmaceuticals, Inc. and Genentech, Anthony is an invaluable addition and we are delighted to welcome
him to the Relief team.
Dr. Selvaraju added, I would also like to acknowledge Chris Stijnens extensive contributions during his
time with the company. His efforts over the past year have been instrumental in helping to drive our
strategy and identify key opportunities for growth. We wish him all the best in his future endeavors.
Ad hoc announcement pursuant to Art. 53 LR
2
I am excited and honored to be joining Relief, and to help further their mission of developing innovative
therapies for areas of great unmet medical need, stated Mr. Kim. I share the companys vision for
improving the lives of patients living with acute and rare medical conditions. I look forward to building
Reliefs presence in the U.S., and to living the values of the organization with integrity, sensitivity, and
humility each day.
Prior to joining Relief, for the past three years, Mr. Kim was Vice President, Global Commercial
Development at Novocure, where he led a 21-person team in the planning and U.S. marketing execution
for that companys Optune® and Optune Lua, FDA-approved, therapeutic devices that deliver
alternating electrical fields to treat patients with Glioblastoma Multiforme and Mesothelioma.
From 2017 to 2018, he was Executive Director of Marketing at Ignyta (subsequently acquired by Roche),
during which time he led the development of the commercial launch plan for entrectinib, an oral,
oncologic agent in pan-tumor clinical trials for patients with neurotrophic tyrosine receptor kinase (NTRK)
and ROS1 fusion-positive disease. From 2012 to 2017, Mr. Kim held positions of increasing responsibility
at Alexion Pharmaceuticals, Inc., most recently serving as Director, Head of U.S. Marketing,
Hypophosphatasia, where he managed the U.S. marketing efforts for the launch of Strensiq, a novel, first-
in-class enzyme replacement therapy for the treatment of hypophosphatasia, a rare inherited metabolic
bone disorder. Earlier, from 2004 to 2012, Mr. Kim held various positions at Genentech, including Product
Manager, Herceptin Marketing and Divisional Sales Manager, Rituxan Hematology.
Mr. Kim received his Bachelor of Arts Degree from Harvard University and a Master of Business
Administration from The Wharton School.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Reliefs drug candidate, RLF-100 (aviptadil), a
synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the
treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in
March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed
and development-stage programs.
Ad hoc announcement pursuant to Art. 53 LR
1
Relief Provides Corporate Update and Outlines Plans to Advance its Diversified
Portfolio of Pipeline Candidates, Including RLF-100 (Aviptadil)
Geneva, Switzerland, November 11, 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 provided a corporate update detailing, among other matters, its
ongoing clinical development and regulatory activities, as well as its plans to accelerate the maturation of
its pipeline.
RLF-100TM
Relief remains committed to the development of RLF-100 (aviptadil) for the treatment of respiratory
complications of COVID-19 infection. A clinical program remains under way in Europe for inhalation-based
administration, while the ACTIVE-3b/TESICO study sponsored by the U.S. National Institutes of Health
(NIH) assessing the intravenous formulation and the I-SPY trial sponsored by Quantum Leap testing the
inhaled formulation also remain ongoing. Further, the parent company of Reliefs U.S. collaboration
partner has publicly reported that they are continuing to conduct an investigational study of inhaled
aviptadil in the U.S. as well. In addition, Relief continues to pursue aviptadil for the treatment of
pulmonary sarcoidosis, and authorization to commence a phase 2 randomized, double-blinded, placebo-
controlled clinical trial in this indication was recently granted by the German medical regulatory
authorities. In August 2021, Relief announced the receipt of U.S. Orphan Drug Designation for the use of
aviptadil in treatment of sarcoidosis. Relief also intends to explore the clinical utility of aviptadil in acute
respiratory distress syndrome (ARDS) unrelated to COVID-19 infection, as well as in other pulmonary
disorders, including chronic beryllium disease (berylliosis) and checkpoint inhibitor-induced
pneumonitis (CIP), in which AdVita has filed pending patent claims. Finally, Relief is also working to
optimize the formulation of aviptadil.
As previously reported, in October 2021 Relief filed a lawsuit against NeuroRx, Inc. ("NeuroRx") and its
Chief Executive Officer, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement
between Relief and NeuroRx relating to the development and commercialization of RLF-100 (aviptadil).
The complaint alleges, among other breaches of the Collaboration Agreement, that NeuroRx has failed to
provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating
IV RLF-100 (aviptadil) for the treatment of acute respiratory failure due to COVID-19 (which data and
information are required to be provided to Relief by NeuroRx under the Collaboration Agreement) and
has failed to allow Relief to have input into NeuroRx's U.S. development program. Without doubt, Relief
Ad hoc announcement pursuant to Art. 53 LR
2
was disappointed that Emergency Use Authorization for aviptadil in the United States was denied.
However, this decision by FDA does not affect Relief's commitment to the further development of this
drug.
U.S. Commercial Initiatives
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, including the innovative new PKU GOLIKE® KRUNCH tablets. Relief,
through its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), currently markets this
product in Europe. 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. Mr. Kim will be responsible for
spearheading the creation of Reliefs U.S. commercial infrastructure and helping to optimize the
introduction of the GOLIKE® product line.
Relief is also working closely with its collaboration partner Acer Therapeutics on the preparations for a
potential launch of ACER-001, a proprietary, taste-masked formulation of sodium phenylbutyrate for the
treatment of Urea Cycle Disorders (UCDs). ACER-001 is the subject of a New Drug Application (NDA)
that has been accepted for review by the United States Food and Drug Administration (FDA) with a
Prescription Drug User Fee Act (PDUFA) approval decision action date of June 5, 2022. Additionally, Relief
is preparing to submit a Marketing Authorization Application (MAA) for ACER-001 to European and U.K.
regulatory agencies, which is expected to be filed during the first half of 2022. Moreover, Relief intends
to assess ACER-001 in a clinical program for Maple Syrup Urine Disease (MSUD) during 2022. Relief and
Acer also continue to explore strategic options to advance the optimization of ACER-001s commercial
value in territories beyond the U.S., U.K. and Europe.
Other Initiatives
Relief intends to advance APR-TD011, a novel, proprietary, spray-based formulation of a hypotonic acid-
oxidizing solution with established wound healing and anti-microbial properties, for epidermolysis bullosa
(EB), a billion-dollar annual target market according to Knowledge Sourcing Intelligence. Relief believes
that APR-TD011 could prove a transformative solution for EB patients, who suffer from debilitating pain
due to large, chronic, constantly blistering skin wounds. APR-TD011 also inhibits the NF-kB pro-
inflammatory pathway and by inactivating matrix metalloproteases, known to mediate wound
Ad hoc announcement pursuant to Art. 53 LR
3
inflammation. Relief believes that APR-TD011 could improve the quality of life of EB patients by
accelerating wound healing and reducing the itching and pain linked to infections and inflammation.
Relief also possesses an array of other assets. These include SENTINOX, a novel nasal spray solution for
upper airway infections with viral pathogens including the SARS-CoV-2 virus, the causal agent of COVID-
19; Nexodyn AOS, an acid-oxidizing solution for treatment of chronic wounds (including foot ulcers); and
the PHYSIOMIMIC platform-enabled amino acid-based product candidates for an array of rare metabolic
disorders. Positive interim clinical data showing accelerated clearance of upper airway viral infection was
recently reported for SENTINOX in a randomized, placebo-controlled clinical trial. SENTINOX was certified
in Europe on February 16, 2021 as a Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1).
Capital Resources
Relief currently has CHF45 million in cash, and, based on current financial current projections and available
cash, expects that it has sufficient resources to fund operations into late 2023, assuming timely approval
of ACER-001. Relief also expects that with a successful launch of ACER-001 and the potential expansion of
its GOLIKE® franchise into the United States, Relief could achieve positive operating cash flow status
during 2024. This could also be positively affected if Relief is successful in obtaining an approval to market
RLF-100.
Finally, in early November, Relief took the first step to establish a Level 1 American Depositary Receipt
(ADR) program in the United States by filing a registration statement on Form F-6 with the U.S. Securities
and Exchange Commission. It is expected that Relief's ADRs will begin trading in the over-the-counter
(OTC) market at some point after its registration statement becomes effective. Relief's ADR program will
complement its existing primary listing on the SIX Swiss Exchange. JPMorgan Chase Bank, N.A. has been
appointed as the depositary bank for the Level 1 ADR program. This filing is the first step in a process
through which Relief hopes to transition its ADR program from a Level 1 ADR program to a Level 2 or a
Level 3 ADR program, with the ultimate goal of listing its ADRs on the NASDAQ Stock Market during the
first half of 2022.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Reliefs lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
Ad hoc announcement pursuant to Art. 53 LR
4
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed
and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA can obtain
approval to market RLF-100 (aviptadil) and the effect on its efforts in that regard of the pending lawsuit
against NeuroRx and its CEO, (ii) whether ACER-001 will be approved for commercialization in the U.S.
and successfully commercialized if approved, (iii) whether PKU GOLIKE® can be successfully marketed in
the U.S., (iv) whether RELIEF THERAPEUTICS Holding SA has sufficient cash resources to fund its operations
into late 2023 and whether RELIEF THERAPEUTICS Holding SA can become cash flow positive by 2024, (v)
whether RELIEF THERAPEUTICS Holding SA will be able to transition its ADR program from a Level 1
program to a Level 2 or a Level 3 program and up list its ADRs to the NASDAQ Stock Market, and (vi) those
risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could
cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS
Holding SA to be materially different from any future results, performance or achievements expressed or
implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this
communication as of this date and does not undertake to update any forward-looking statements
contained herein as a result of new information, future events or otherwise.
https://www.gov.uk/guidance/innovative-licensing-and-access-pathway
....und das Ende der pharmahörigen FDA !
Ad hoc announcement pursuant to Art. 53 LR
1
Relief Reports that its U.S. Collaboration Partner has Announced it has Received
a U.S. Food and Drug Administration Review of Aviptadil Manufacturing
Information
Geneva, Switzerland, November 12, 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, reported today that the parent company of its U.S. collaboration partner,
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (NRx), has issued a press release announcing receipt of the
U.S. Food and Drug Administrations (FDA) response to NRxs October 8, 2021 submission of updated
manufacturing information for aviptadil. According to the press release, the FDA review allows for high
volume production of aviptadil. The press release also reports that the shelf life of aviptadil has been
extended from 62 days to 150 days. The related NRx press release can be accessed through the following
link.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Reliefs lead drug candidate, RLF-100
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed
and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
Ad hoc announcement pursuant to Art. 53 LR
2
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K.,
or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed
in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual
results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be
materially different from any future results, performance or achievements expressed or implied by such
forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this
date and does not undertake to update any forward-looking statements contained herein as a result of
new information, future events or otherwise.
https://trialsearch.who.int/
Wir sind immer noch hier und unser ACTIV3b rekrutiert immer noch.
vieleicht ein Zock wert ? :-)
(AWP) Der Pharmakonzern Roch hat nach enttäuschenden Studien-Ergebnissen die Zusammenarbeit mit dem US-Unternehmen Atea beendet. Nach einer gründlichen Analyse der derzeitigen Covid-19-Behandlungslandschaft habe man die schwierige Entscheidung getroffen, die Partnerschaft mit Atea für das AT-527-Programm zu beenden, um sich auf andere COVID-19-Aktivitäten zu konzentrieren, heisst es in einer Stellungnahme von Roche (ROG 369.15 +0.04%), die AWP vorliegt.
Mit Beendigung der Partnerschaft werden die Rechte und Lizenzen, die Atea Roche im Rahmen der strategischen Zusammenarbeit gewährt hat, an Atea zurückgegeben. Diese Entscheidung kommt, nachdem Atea vor etwa einem Monat mit dem Hoffnungsträger AT-527, der sogenannten Corona-Pille, in einer Phase-II-Studie die gesteckten Ziele nicht erreicht hatte.
Wie Roche weiter mitteilte, will der Konzern die Entwicklung anderer Covid-19-Behandlungs- und Diagnoseoptionen fortsetzen. Dazu zählen etwa die Antikörperkombination Ronapreve (Casirivimab und Imdevimab), die Roche in Zusammenarbeit mit Regeneron betreibt, sowie Actemra/RoActemra (Tocilizumab) von Roche selbst.
Atea wiederum teilte mit, das laufende klinische Phase-III-Studienprogramm MORNINGSKY mit AT-527 weiter voranzutreiben.
Ad hoc announcement pursuant to Art. 53 LR
1
Relief Therapeutics Launches Level 1 ADR Program in the United States
Geneva, Switzerland, November 18, 2021 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(Relief), announced today that its Form F-6 registration statement has become effective, and that Relief
has launched its Level 1 American Depositary Receipt ("ADR") program in the United States (U.S.). It is
expected that Relief's ADRs will begin trading on the over-the-counter ("OTC") market today, November
18, 2021, under the trading symbol ("RLFTY"). Relief's ADR program will complement its existing primary
listing of ordinary shares on the SIX Swiss Exchange ("SIX"). J.P. Morgan has been appointed as the
depositary bank for the Level 1 ADR program.
An ADR is a negotiable receipt, resembling a stock certificate, that is issued by a U.S. depositary bank
appointed by a company to evidence one or more American Depositary Shares ("ADSs"). In the case of
Relief's ADRs, each ADS will represent one hundred and fifty (150) of Relief's ordinary shares. ADRs allow
U.S. investors to buy shares in foreign companies without the need for cross-border or cross-currency
transactions. They are priced in U.S. dollars and can be traded like shares of U.S.-based companies listed
on the OTC market.
Under the program, the owners and holders of ADSs will have the same rights to dividends and distributions
and voting powers as the holders of Relief's ordinary shares subject, however, to enforcement procedures
provided in the deposit agreement entered into by and among Relief, J.P. Morgan, as the depositary, and
the owners and holders of ADSs.
The establishment of the program by Relief is not a new offering of securities, and the ADRs will be based
on the Relief ordinary shares currently in issue. Therefore, Relief will receive no proceeds from the
establishment of the program. However, Relief's goal is to take the necessary steps in the future to
transition from a Level 1 ADR program to a Level 2 or a Level 3 ADR program, with the ultimate goal of
listing its ADRs on the Nasdaq Stock Market during the first half of 2022. There can be no assurance that
Relief will be successful in those efforts.
Instructions for converting Relief ordinary shares into ADRs are posted on Relief's website at
https://www.relieftherapeutics.com/investor-relations or CLICK HERE.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Reliefs drug candidate, RLF-100 (aviptadil), a
synthetic form of Vasoactive Intestinal Peptide ("VIP"), is in late-stage clinical testing in the U.S. for the
treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in
March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
Ad hoc announcement pursuant to Art. 53 LR
2
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed
and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether a market will develop for Relief's ADRs, (ii) whether,
if Relief's ADRs are traded in the U.S., they will become eligible to be listed on the NASDAQ Stock Market,
and the timing of any such listing, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's
press releases and filings with the SIX, which could cause the actual results, financial condition,
performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any
future results, performance or achievements expressed or implied by such forward-looking statements.
RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake
to update any forward-looking statements contained herein as a result of new information, future events
or otherwise.
Ad-hoc-Mitteilung gemäss Art. 53 LR
1
Relief Therapeutics lanciert Level 1 ADR-Programm in den Vereinigten Staaten
Genf, Schweiz, 18. November 2021 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
("Relief"), gab heute bekannt, dass seine Registrierungserklärung nach Form F-6 wirksam geworden ist und dass Relief
sein Level 1 American Depositary Receipt ("ADR") Programm in den Vereinigten Staaten ("U.S.") gestartet hat. Es wird erwartet
Es wird erwartet, dass die ADRs von Relief ab heute, dem 18. November 2021, im Freiverkehr ("OTC"-Markt)
18. November 2021, unter dem Handelssymbol ("RLFTY"). Das ADR-Programm von Relief wird die bestehende Primärnotierung
Notierung von Stammaktien an der SIX Swiss Exchange ("SIX") ergänzen. J.P. Morgan wurde als Depotbank für die
Depotbank für das Level 1 ADR-Programm ernannt.
Ein ADR ist ein begebbarer Beleg, der einem Aktienzertifikat ähnelt und von einer US-Depotbank ausgegeben wird
ausgestellt wird, um eine oder mehrere American Depositary Shares ("ADS") zu verbriefen. Im Fall von
ADRs von Relief repräsentiert jedes ADS einhundertfünfzig (150) Stammaktien von Relief. ADRs ermöglichen
US-Investoren den Kauf von Aktien ausländischer Unternehmen ohne die Notwendigkeit grenzüberschreitender oder währungsübergreifender
Transaktionen. Sie werden in US-Dollar gepreist und können wie Aktien von in den USA ansässigen Unternehmen gehandelt werden, die
auf dem OTC-Markt gehandelt werden.
Im Rahmen des Programms haben die Eigentümer und Inhaber von ADSs die gleichen Rechte auf Dividenden und Ausschüttungen
und Stimmrechte wie die Inhaber der Stammaktien von Relief, jedoch vorbehaltlich der Durchsetzungsverfahren
die in der Hinterlegungsvereinbarung zwischen Relief, J.P. Morgan als Hinterlegungsstelle und den
den Eigentümern und Inhabern der ADSs.
Die Einrichtung des Programms durch Relief ist kein neues Angebot von Wertpapieren, und die ADRs werden auf den
auf den derzeit ausgegebenen Relief-Stammaktien basieren. Daher wird Relief keine Erlöse aus dem Programm erhalten.
Erlös aus der Einrichtung des Programms. Es ist jedoch das Ziel von Relief, in Zukunft die notwendigen Schritte zu unternehmen, um
von einem ADR-Programm der Stufe 1 zu einem ADR-Programm der Stufe 2 oder 3 überzugehen, mit dem letztendlichen Ziel der
ADRs in der ersten Hälfte des Jahres 2022 am Nasdaq Stock Market zu notieren. Es kann nicht garantiert werden, dass
Relief bei diesen Bemühungen erfolgreich sein wird.
Anweisungen für die Umwandlung von Relief-Stammaktien in ADRs finden Sie auf der Website von Relief unter
https://www.relieftherapeutics.com/investor-relations oder HIER KLICKEN.
ÜBER RELIEF
Relief konzentriert sich in erster Linie auf Programme im klinischen Stadium, die auf Molekülen basieren, die in der Vergangenheit bereits klinisch getestet
klinischen Erprobung und Anwendung bei menschlichen Patienten oder einer starken wissenschaftlichen Grundlage. Der Arzneimittelkandidat von Relief, RLF-100 (Aviptadil), eine
synthetische Form des vasoaktiven intestinalen Peptids ("VIP"), befindet sich in den USA in der späten Phase der klinischen Prüfung für die
Behandlung von Atemschwäche aufgrund von COVID-19. Im Rahmen seiner Strategie zur Diversifizierung der Pipeline hat Relief im
März 2021 eine Kooperations- und Lizenzvereinbarung mit Acer Therapeutics für die weltweite
weltweite Entwicklung und Vermarktung von ACER-001. ACER-001 ist ein geschmacksmaskierter und sofortiger
Ad-hoc-Mitteilung gemäss Art. 53 LR
2
Pulverformulierung von Natriumphenylbutyrat (NaPB) zur Behandlung von Harnstoffzyklusstörungen
Harnstoffzyklus-Störungen und der Ahornsirup-Urin-Krankheit. Darüber hinaus haben die kürzlich abgeschlossenen Übernahmen von APR
Applied Pharma Research SA und AdVita Lifescience GmbH, bringt Relief eine vielfältige Pipeline von vermarkteten
und Programmen im Entwicklungsstadium.
RELIEF THERAPEUTICS Holding SA ist an der SIX Swiss Exchange unter dem Symbol RLF notiert und in den
OTCQB in den USA unter dem Symbol RLFTF notiert. Weitere Informationen finden Sie unter www.relieftherapeutics.com.
Folgen Sie uns auf LinkedIn.
KONTAKT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Finanzvorstand und Schatzmeister
contact@relieftherapeutics.com
FÜR MEDIEN-/INVESTORENANFRAGEN:
Rx-Kommunikationsgruppe
Michael Müller
+1-917-633-6086
mmiller@rxir.com
Haftungsausschluss: Diese Mitteilung enthält ausdrücklich oder stillschweigend bestimmte zukunftsgerichtete Aussagen
über RELIEF THERAPEUTICS Holding SA. Solche Aussagen beinhalten bestimmte bekannte und unbekannte Risiken,
Ungewissheiten und andere Faktoren, einschließlich (i) ob sich ein Markt für die ADRs von Relief entwickeln wird, (ii) ob,
wenn die ADRs von Relief in den USA gehandelt werden, sie zur Notierung an der NASDAQ-Börse zugelassen werden,
und der Zeitpunkt einer solchen Notierung, und (iii) die Risiken, die in den Pressemitteilungen von RELIEF THERAPEUTICS Holding SA
Pressemitteilungen und Einreichungen bei der SIX beschriebenen Risiken, die dazu führen könnten, dass die tatsächlichen Ergebnisse, die Finanzlage,
von RELIEF THERAPEUTICS Holding SA wesentlich von den in der Zukunft
zukünftigen Ergebnissen, Leistungen oder Errungenschaften, die in solchen zukunftsgerichteten Aussagen ausgedrückt oder impliziert werden, erheblich abweichen.
RELIEF THERAPEUTICS H
Übersetzt mit www.DeepL.com/Translator (kostenlose Version)
Ad hoc announcement pursuant to Art. 53 LR
1
Relief Therapeutics and InveniAI Sign a Strategic Collaboration Agreement to
Identify New Product Development Opportunities using Artificial Intelligence
Geneva, Switzerland, November 24, 2021 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF,
RLFTY) (Relief), announced today that it has signed a collaboration agreement (the Collaboration)
with InveniAI LLC (InveniAI), a U.S. based company that has pioneered the application of artificial
intelligence and machine learning across biopharma and other industries, in order to identify promising
drug candidates to treat rare and specialty diseases.
Under the terms of the Collaboration, InveniAI will use its proprietary platform for the identification of
potential pharmaceutical product opportunities using its Pharma Big Data Innovation Lab (Platform),
consisting of (i) its proprietary AlphaMeld® platform, a cloud-based Artificial Intelligence (AI) platform
that utilizes proprietary machine learning and deep learning based neural networks to identify product
opportunities in therapeutic areas, (ii) its cross-functional teams at its Integrated Center of Excellence,
and (iii) domain expertise, to generate novel pharmaceutical opportunities and the related development
pathway for the development of such concepts.
In the Collaboration, it is expected that InveniAI will utilize its Platform to navigate the volume of data for
all regulatory agency approved drugs and their associated active ingredients (Active Pharmaceutical
Ingredient (API)) to identify potential rare and specialty disease indications for development and
commercialization by Relief (Product Concepts). InveniAI will seek to prioritize top Product Concepts,
associated diseases, scientific packages and evidence to support the potential drug development
opportunities by Relief. Relief anticipates InveniAIs Platform will complement its wholly owned subsidiary
APR Applied Pharma Research SAs existing capabilities in research and development and drug
reformulation. Based on product leads developed by InveniAI, Relief hopes to develop proprietary
versions of existing drugs, and to protect those drugs with long-lived intellectual property and defensible
patent claims.
Under the terms of the Collaboration, Relief will pay InveniAI an initial up-front fee, success milestones
and commercialization royalties for the full development program. Additional financial details were not
disclosed.
We believe that the addition of InveniAIs AI-powered capabilities will meaningfully complement our
existing drug development efforts. AI is becoming an increasingly important tool in identifying and
screening new drug projects and Relief intends to fully leverage this promising technology, stated
Raghuram (Ram) Selvaraju, Chairman of Relief. In partnering with InveniAI, we are accessing decades
worth of expertise which has already led to successful drug re-innovation (e.g., vilazodone for treatment
of depression and dexmedetomidine for treatment of agitation) and a proven platform that has been the
basis of multiple partnerships with established companies. We believe that our work with InveniAI could
generate multiple promising additions to our pipeline that may represent capital-efficient, cost-effective
Ad hoc announcement pursuant to Art. 53 LR
2
and risk-mitigated approaches to product development. In focusing on the optimization of existing
approved APIs, we hope to ensure well-established clinical safety and tolerability for the product concepts
identified at inception, giving us a running start in pursuing development of novel uses for these drugs. In
our view, this approach will enable us to rapidly and efficiently execute innovation that brings relief to
patients suffering from severe and debilitating conditions.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Reliefs drug candidate, RLF-100 (aviptadil), a
synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the
treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in
March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed
and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether InveniAI will bring to RELIEF THERAPEUTICS Holding
SA drug candidates that can be successfully developed by RELIEF THERAPEUTICS Holding SA, (ii) whether
RELIEF THERAPEUTICS Holding SA will successfully develop and ultimately market any drug candidate
identified by InveniAI, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases
and filings with the SIX, which could cause the actual results, financial condition, performance or
achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking statements. RELIEF
THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to
update any forward-looking statements contained herein as a result of new information, future events or
otherwise.