UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the Month of August, 2023
Commission File Number: 001-41174
RELIEF THERAPEUTICS Holding SA
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of registrant’s name into English)
Switzerland
(Jurisdiction of incorporation or organization)
Avenue de Sécheron 15
1202 Geneva
Switzerland
Tel: +41 22 545 11 16
(Address of principal executive offices)
Indicate by check mark if the registrant files or
will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) ☐
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7) ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On August 30, 2023, Relief
Therapeutics Holding SA (the “Company”) issued a press release entitled “Relief Therapeutics Announces New Exclusive Definitive
License Agreement for OLPRUVA™ (ACER-001) with Acer Therapeutics”. A copy of the press release is attached to this Form 6-K as Exhibit 99.1.
INDEX TO EXHIBITS
- 2 -
SIGNATURES
Pursuant to the requirements of the Securities Exchange
Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
RELIEF THERAPEUTICS Holding SA
By: /s/ Jack Weinstein
Jack Weinstein
Chief Executive Officer
Dated: August 31, 2023
- 3 -
Exhibit 99.1
Ad hoc announcement pursuant to Art. 53 LR
Relief Therapeutics Announces New Exclusive Definitive License Agreement for
OLPRUVA™ (ACER-001) with Acer Therapeutics
Acer Therapeutics buys Relief Therapeutics’
stake in OLPRUVA™ worldwide, excluding geographical Europe, providing an upfront payment of $10 million in cash to Relief Therapeutics
with the potential for an additional $46.5 million in milestone and royalty payments
The transition from a profit-based
to a revenue-based royalty stream model is expected to deliver earlier returns and enhanced predictability to Relief Therapeutics
GENEVA (AUG. 30,
2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief Therapeutics), a
biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today
announced it has entered into a new exclusive definitive licensing agreement with Acer Therapeutics Inc. (Acer Therapeutics) for the
development and commercialization of OLPRUVA™ (sodium phenylbutyrate, ACER-001) for the treatment of certain urea cycle
disorders (UCDs) and other potential indications. This agreement supersedes the March 2021 collaboration and license agreement
between the companies, which has been cancelled as part of this new agreement.
“We are very happy to have re-structured our
collaboration with Acer Therapeutics which includes provisions that we believe will benefit both parties, and ultimately those suffering
from UCDs and other potential rare metabolic conditions,” said Jack Weinstein, chief executive officer of Relief Therapeutics. “Our
collective goal with Acer is to maximize the global commercialization of OLPRUVA™ to ensure as many patients as possible will access
to this much needed, differentiated and convenient treatment alternative.”
Under the terms of the new agreement, Acer Therapeutics
will retain development and commercialization rights for OLPRUVA™ worldwide for the treatment of UCDs and any potential additional
indications in the U.S. and other countries worldwide, excluding geographical Europe. Acer Therapeutics will provide Relief Therapeutics
with a non-contingent $10 million upfront cash payment and an additional non-contingent $1.5 million cash payment on the one-year anniversary
of the agreement. Relief Therapeutics will also receive a 10 percent continuing royalty calculated on the net sales of OLPRUVA™
in the Acer Therapeutics territory, and 20 percent of any value received by Acer Therapeutics from licensing or divestment transactions
relating to OLPRUVA™, up to a cumulative amount of an additional $45 million. At the same time, Relief Therapeutics will retain
development and commercialization rights for OLPRUVA™ in geographical Europe, which includes the European Union, Liechtenstein,
San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo,
Montenegro, Serbia and North Macedonia. Acer Therapeutics will receive from Relief Therapeutics a variable, continuing royalty up
to a maximum of 10 percent of the net sales of OLPRUVA™ and 20 percent of any value received by Relief Therapeutics from sublicensing
transactions relating to OLPRUVA™ in geographical Europe, which going forward exclusively remains Relief Therapeutics' territories
to develop and commercialize OLPRUVA™.
1/3
“Relief Therapeutics remains an ideal partner
for OLPRUVA™ in Europe and we are eager to continue the development and commercialization of our innovative treatment option for
those suffering from rare metabolic disorders like UCDs,” said Chris Schelling, founder and chief executive officer of Acer Therapeutics.
In addition to the immediate cash influx strengthening
Relief Therapeutics’ capital position, the transition from a profit-based model to a revenue-based royalty stream model is expected
to offer Relief Therapeutics earlier returns, reduce certain associated risks and increase predictability in its royalty income. This
will also support Relief Therapeutics' ongoing operations, extending the cash runway and bolster investments in the Company’s pipeline,
including its efforts to seek approval to commercialize OLPRUVA™ in geographical Europe.
ABOUT OLPRUVA™
The U.S. Food and Drug Administration (FDA) approved
ACER-001 (sodium phenylbutyrate) for the treatment of certain UCDs in December 2022 and it is now marketed in the U.S. under the brand
name OLPRUVA™. OLPRUVA™ is also being studied as an investigational treatment for patients with maple syrup urine disease
(MSUD), a rare metabolic genetic disease that leads to toxic build-up of leucine and other branched-chain amino acids. Please see Important
Safety Information and full Prescribing Information, including Patient Information.
ABOUT RELIEF THERAPEUTICS
Relief Therapeutics is a commercial-stage biopharmaceutical
company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives
of patients living with select specialty and rare diseases. Relief Therapeutics' portfolio offers a balanced mix of marketed, revenue-generating
products, our proprietary, globally patented Physiomimic™ and TEHCLO™ platform technologies and a targeted clinical development
pipeline consisting of risk-mitigated assets focused in three core therapeutic areas, which include rare metabolic, rare dermatology and
rare respiratory diseases. In addition, Relief Therapeutics is commercializing several legacy products via licensing to distribution partners.
Relief Therapeutics' mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international
team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief
Therapeutics is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy.
Relief Therapeutics is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY.
For more information, please visit our website www.relieftherapeutics.com or follow Relief Therapeutics on LinkedIn and Twitter.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Catherine Day
Vice President, Investor Relations & Communications
catherine.day@relieftherapeutics.com
2/3
DISCLAIMER
This press release contains forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties and other factors, including (i) whether Relief Therapeutics
and Acer Therapeutics will be successful in their respective development and commercialization efforts for OLPRUVA™, (ii)
whether the new transaction structure will prove more or less profitable to Relief Therapeutics than the transaction structure included
in the original Collaboration Agreement between the parties, (iii) whether Relief Therapeutics will ultimately be successful in obtaining
the right to commercialize OLPRUVA™ in geographical Europe, and (iv) those factors described in Relief Therapeutics' filings
with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), all of which could cause the actual results, financial
condition, performance or achievements of Relief Therapeutics to be materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Copies of Relief Therapeutics' filings with the SEC are available on the SEC
EDGAR database at www.sec.gov. Relief Therapeutics does not undertake any obligation to update the information contained herein, which
speaks only as of this date.
3/3