RELIEF THERAPEUTICS Holding SA Announces an Out-Licensing Agreement with H&H Group

RELIEF THERAPEUTICS Holding SA (“Relief”, “the Company”) announces that it has concluded a licensing and co-development agreement (the “Agreement”) with Health and Happiness (H&H) Hong Kong Limited (“H&H”), part of H&H Group to develop products which are derived from whey and/or no-fat milk and have the potential to prevent allergies. The Agreement will follow a four-year development plan including pre-clinical and clinical milestones with the goal of reducing allergenicity or even preventing food (particularly milk) allergy in humans. The product(s) under development are based on the technology discovered by the French company Genclis SA (“Genclis”) that has established the role and consequences of Transcription Infidelity (TI) on allergy. This series of discoveries are the basis for their patent application referred to as the Molecular Origin of Allergy (WO 2017/158202) on which Relief has acquired in April 2018 a license for the development and commercialization of hypoallergenic milk produced without hydrolysis.

The global allergy market that includes diagnostic and therapeutic, is currently growing at a 5.5% CAGR per year and is estimated to reach $42.8 billion by 2022 (Grand View Research, January 2016).

The Agreement includes upfront and milestone payments as well as royalties on any products generated via the collaboration that, as contractually agreed, are distributed across the entire duration of the program. In addition, H&H will fund development to be conducted at Genclis as well as at H&H premises. Details of the overall financial contribution are not disclosed.

Patrice Malard, Chief Technology Officer of H&H declares: “The H&H group ambitions to become a global leader in advanced baby nutrition and care, this Agreement is an important step for our company to reach and serve in a disruptive manner this current $6 billion-hypoallergenic milk infant market. We have been positively impressed by the potential of the technology developed at Genclis and we are excited to work with both Relief and Genclis to translate this technology into novel commercial products.”

Bernard Bihain, Chief Executive Officer of Genclis adds: “We are thrilled to take part in this ambitious program relying on a disruptive basic science finding to obtain industrial application that will greatly benefit the general health and can provide powerful innovative solution for children of allergic parents.”

Gaël Hédou, Chief Executive Officer of Relief concludes by saying: “We are pleased to see that Relief could convey to H&H our appreciation of the groundbreaking and disruptive nature of Genclis’ discoveries. Given the fluidity and speed of the interaction that we experienced during the course of the discussions between the different stakeholders to reach this Agreement, we are confident that this collaboration will be efficient and rapidly productive”

About H&H

Health and Happiness (H&H) Hong Kong Limited is a subsidiary of Health and Happiness (H&H) International Holdings Limited which is listed on the Main Board of the Stock Exchange of Hong Kong and part of H&H Group. H&H Group was established in 1999, it operates through two core business segments - Baby Nutrition and Care and Adult Nutrition and Care. The Baby Nutrition and Care segment engages in production of infant formulas for children under seven years old and milk formulas for expectant and nursing mothers, production of probiotic supplements, and production of baby care products. The Adult Nutrition and Care Products segment is engaged in the production of vitamins, health supplements, skin care and sports nutrition products for adults. H&H Group currently owns four international brands: Biostime ® : global leader in premium infant nutrition; Swisse ®: Australia’s leading natural health brand; Healthy Times ®: a favorite organic baby food brand in the US since 1980’s; Dodie ®: French heritage brand since 1957 in baby bottles and accessories. H&H Group is a premium nutrition and wellness provider for the entire family, it aspires to make people healthier and happier.

About Relief Therapeutics Holding SA

RELIEF THERAPEUTICS Holding AG is a clinical-stage biotechnology company with a portfolio of drug candidates derived from natural human origins. Its two first candidates are Aviptadil for the treatment of sarcoidosis (to enter Phase III) and low dose interleukin-6 (Atexakin alfa) for the treatment of peripheral neuropathy (to enter Phase II). Aviptadil development in sarcoidosis addresses the orphan disease market, in which European regulators have indicated that a single pivotal Phase III trial would be sufficient to support approval. Atexakin alfa is the subject of an exclusive worldwide development and commercialization agreement with Merck KGaA, The current priority indication for Atexakin is to alleviate peripheral diabetic neuropathy, a market that is estimated to reach $4.1 billion in 2019 (source Datamonitor). In addition to these initial drug candidates, Relief has initiate a strategic collaboration with Genclis in April 2018 in order to co-develop and commercialize products arising from their disruptive technology.

About Genclis SA

Genclis is a privately-held biotechnology company incorporated in 2004 in Vandœuvre-lès-Nancy, France, that discovered a unique biological mechanism referred to as Transcription Infidelity (TI). TI produces RNA transcripts that differ from their originating DNA sequence. This mechanism explains the nonrandom occurrence of RNA to DNA divergences (RDD) that lead to translated proteins with sequences diverging from the canonical form. Genclis applies its artificial intelligence platform to extract, from large Genomic data sets, these low-intensity signals. Genclis has shown in both humans and animal models that specific RDD events shape selectively the repertoire of natural immunoglobulins and contribute to both allergy and other immunological disorders. Genclis has developed a diversified pipeline of disruptive diagnostic and therapeutic solutions that have and are completing pre-clinical evaluation. Genclis revenues grew >500 % to €2.2 million in fiscal year 2017 missing breakeven by less than 10 %. Genclis’ objectives for 2018 are to further expand commercial activities in both human and veterinary medicine as well as in the food industry to reach profitability, while relentlessly pursuing developments of several other novel disruptive pre-clinical assets.

About Transcription Infidelity

Transcription Infidelity (TI) is a newly discovered ubiquitous epigenetic mechanism that increases RNA-DNA sequence divergences (RDD). TI was initially described and patented by Genclis¹ and has since been confirmed by several independent academic teams². TI can lead to base substitutions, insertions and deletions. The latter cause translational frameshifts that have important consequences in determining protein immunogenicity³. Genclis currently focuses on defining the effects of TI proteins translated from gapped RNA on normal and pathological humoral immunity.

¹ Brulliard et al., 2007. PNAS, 104 (18): 7522–27 and “Transcription Infidelity, detection and uses thereof”, EP2046986, US8288091.
² Ju et al., 2011. Nature Genetics 43 (8): 745–52; Li et al., 2011. Science, 333 (6038): 53–58; Peng et al., 2012. Nat Biotechnol 30: 253–60, Reid-Bayliss and Loeb, 2017. PNAS 114 (35): 9415.
³ Genclis patent: “Molecular origin of allergy“, EP16305297, WO2017158202A1.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and is headquartered in Geneva, Switzerland.

For further information, please visit the Relief website at www.relieftherapeutics.com

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning Relief Therapeutics Holding SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, 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.

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Contact information

RELIEF THERAPEUTICS Holding SA
Dr. Gael Hédou
gael.hedou@relieftherapeutics.com
tel: +41 79 457 0937