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Relief Therapeutics Signs Non-Binding Letter of Intent with Renexxion for Reverse Merger

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Relief Therapeutics has signed a non-binding letter of intent for a reverse merger with Renexxion, a private U.S. biotech company focused on gastrointestinal disorders therapies. The proposed transaction values Relief's equity at USD 100 million and Renexxion's at USD 260 million, resulting in a 72.2% ownership for Renexxion shareholders and 27.8% for Relief shareholders. The combined entity would maintain listings on SIX Swiss Exchange and OTCQB. The deal includes a one-year post-closing reset mechanism and requires completion of due diligence, definitive agreement execution by December 31, 2024, Renexxion's private financing completion, and regulatory and shareholder approvals.

Relief Therapeutics ha firmato una lettera di intenti non vincolante per una fusione inversa con Renexxion, una compagnia biotech privata negli Stati Uniti che si concentra sulle terapie per i disturbi gastrointestinali. La transazione proposta valuta l'equità di Relief a 100 milioni di USD e quella di Renexxion a 260 milioni di USD, portando a una proprietà del 72,2% per gli azionisti di Renexxion e del 27,8% per gli azionisti di Relief. L'entità combinata manterrà le quotazioni sulla SIX Swiss Exchange e sull'OTCQB. L'accordo include un meccanismo di reset post-chiusura di un anno e richiede il completamento della due diligence, l'esecuzione dell'accordo definitivo entro il 31 dicembre 2024, il completamento del finanziamento privato di Renexxion e le approvazioni regolamentari e degli azionisti.

Relief Therapeutics ha firmado una carta de intención no vinculante para una fusión inversa con Renexxion, una compañía biotecnológica privada de EE. UU. centrada en terapias para trastornos gastrointestinales. La transacción propuesta valora el capital de Relief en 100 millones de USD y el de Renexxion en 260 millones de USD, resultando en una propiedad del 72,2% para los accionistas de Renexxion y del 27,8% para los accionistas de Relief. La entidad combinada mantendrá las cotizaciones en la SIX Swiss Exchange y en OTCQB. El acuerdo incluye un mecanismo de reinicio post-cierre de un año y requiere completar la debida diligencia, la ejecución del acuerdo definitivo antes del 31 de diciembre de 2024, la finalización del financiamiento privado de Renexxion y las aprobaciones regulatorias y de los accionistas.

Relief Therapeutics는 위장 질환 치료에 집중하는 미국의 비상장 생명공학 회사인 Renexxion과의 역합병을 위한 비구속적 의향서를 체결했습니다. 제안된 거래는 Relief의 자산 가치를 1억 달러로 평가하고 Renexxion의 자산 가치를 2억 6천만 달러로 평가하여 Renexxion 주주에게는 72.2%, Relief 주주에게는 27.8%의 지분을 제공합니다. 결합된 entity는 SIX 스위스 증권 거래소와 OTCQB에 상장된 상태를 유지합니다. 이 거래에는 1년의 종료 후 재설정 메커니즘이 포함되며, 2024년 12월 31일까지의 확정 계약 체결, Renexxion의 사모 투자 완료, 그리고 규제 및 주주 승인이 필요합니다.

Relief Therapeutics a signé une lettre d'intention non contraignante pour une fusion inversée avec Renexxion, une entreprise biopharmaceutique privée américaine spécialisée dans les thérapies pour les troubles gastro-intestinaux. La transaction proposée valorise les actions de Relief à 100 millions USD et celles de Renexxion à 260 millions USD, résultant en une participation de 72,2 % pour les actionnaires de Renexxion et de 27,8 % pour ceux de Relief. L'entité combinée maintiendra ses cotations sur la SIX Swiss Exchange et l'OTCQB. L'accord comprend un mécanisme de réinitialisation d'un an après la clôture et requiert l'achèvement de la due diligence, l'exécution de l'accord définitif d'ici le 31 décembre 2024, l'achèvement du financement privé de Renexxion et les approbations réglementaires et des actionnaires.

Relief Therapeutics hat einen unverbindlichen Absichtserklärung für eine Umkehrfusion mit Renexxion, einem privaten US-Biotech-Unternehmen, das sich auf Therapien für gastrointestinale Erkrankungen spezialisiert hat, unterzeichnet. Die vorgeschlagene Transaktion bewertet das Eigenkapital von Relief mit 100 Millionen USD und von Renexxion mit 260 Millionen USD, was zu einem Eigentumsanteil von 72,2 % für die Aktionäre von Renexxion und 27,8 % für die Aktionäre von Relief führt. Die kombinierte Einheit wird an der SIX Swiss Exchange und OTCQB notiert bleiben. Das Geschäft umfasst einen einjährigen Rücksetzmechanismus nach dem Abschluss und erfordert den Abschluss der Due Diligence, die Ausführung der endgültigen Vereinbarung bis zum 31. Dezember 2024, den Abschluss der privaten Finanzierung von Renexxion und Genehmigungen durch die Regulierungsbehörden und die Aktionäre.

Positive
  • Merger expands therapeutic pipeline in gastrointestinal disorders
  • Naronapride has FDA IND clearance for gastroparesis and PPI-non-responsive GERD trials
  • Combined entity maintains public market access through SIX and OTCQB listings
  • One-year post-closing reset mechanism protects Relief's legacy shareholders
Negative
  • Significant dilution for Relief shareholders with only 27.8% ownership retention
  • Transaction completion contingent on multiple conditions including additional financing
  • Non-binding agreement with no guarantee of completion
  • Merger subject to regulatory and shareholder approval risks

GENEVA, SWITZERLAND / ACCESSWIRE / November 4, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it has signed a non-binding letter of intent (LOI) with Renexxion, Inc. (Renexxion), a privately-held U.S.-based clinical-stage biotechnology company specializing in gastrointestinal disorders therapies. The proposed reverse merger between Relief and Renexxion aims to create a combined entity with an expanded therapeutic pipeline addressing critical unmet healthcare needs worldwide.

The transaction, if entered into and completed, is expected to strengthen the combined company's competitive position in the biotech industry while providing new growth initiatives through their complementary resources and expertise. This potential strategic merger is anticipated to enhance shareholder value, broaden access to capital, and accelerate the delivery of innovative therapies to patients.

"The contemplated merger with Renexxion represents an exceptional opportunity to build a more resilient and innovative business that stands to benefit our stakeholders, leveraging Relief's portfolio and proven expertise in rare and specialty diseases," said Dr. Raghuram Selvaraju, chairman of the board of directors of Relief. "After an extensive strategic review and careful consideration of multiple alternatives, Relief's board of directors has determined that this combination with Renexxion is the most promising path to deliver sustained value for our shareholders and accelerate our impact on critical healthcare needs worldwide."

"This prospective merger will be a transformative step forward in Renexxion's journey," said Dr. Peter G. Milner, chairman and CEO of Renexxion. "In partnership with Relief, we will be positioned to redefine the landscape of gastrointestinal healthcare by accelerating the clinical development of naronapride, our lead compound, to address critical unmet needs in conditions such as gastroparesis and PPI-non-responsive symptomatic GERD. The FDA IND clearance for U.S. trials in both of these indications underscores naronapride's strong safety and efficacy profile, positioning it as a potential best-in-class prokinetic. By combining Relief's resources and expertise with our proven development framework, we aim to accelerate the delivery of urgently needed treatments to patients and expand the therapeutic areas in which the combined company will operate. Together, we are committed to advancing GI therapeutics and becoming a global leader in this space, with a focus on innovation, patient safety, and impactful outcomes."

Transaction Overview
Pursuant to the terms of the LOI, the transaction will be structured as an equity combination in which Relief would acquire all outstanding shares of Renexxion in exchange for newly issued shares of Relief to be allocated to the Renexxion shareholders, subject to shareholder approval and other conditions. This exchange is based on pre-determined valuations of each company's equity interests. Relief's fully diluted equity is valued at USD 100 million, while Renexxion's equity is valued at USD 260 million, in each case subject to adjustment based on cash held by each company at closing. The initial merger ratio would therefore allocate approximately 72.2% ownership to Renexxion shareholders and 27.8% to Relief shareholders. Post-transaction, it is anticipated that the shares of the combined entity would continue to trade on the SIX Swiss Exchange and remain quoted in the U.S. on OTCQB.

The LOI also provides for a one-year post-closing reset mechanism to adjust the ownership ratio based on the combined entity's market value at that time within certain parameters. This provision is intended to protect Relief's legacy shareholders by ensuring that the ownership distribution continues to accurately reflect performance after the business combination.

Relief and Renexxion will continue negotiations to enter into a definitive merger agreement by December 31, 2024. Completion of the transaction is subject to customary conditions, including (i) the satisfactory completion of additional due diligence, (ii) the execution of a definitive merger agreement, (iii) the completion of a concurrent private financing by Renexxion, and (iv) regulatory and shareholder approvals. There can be no assurance that a definitive agreement will be reached or that the proposed transaction will be entered into or completed as proposed, or at all.

ABOUT RENEXXION
Renexxion, Inc. is a clinical-stage biopharmaceutical company pioneering therapies for gastrointestinal (GI) disorders. Renexxion's lead compound, naronapride, is a potential best-in-class, highly selective dual-action 5-HT4 agonist/D2-antagonist prokinetic agent designed to enhance GI motility with minimal systemic absorption. Naronapride is currently being studied in a Phase 2 clinical trial for gastroparesis in collaboration with Renexxion's strategic European partner, a leader in GI therapeutics.

The ongoing multi-center global study (ClinicalTrials.gov ID: NCT05621811) is evaluating naronapride's efficacy, safety and tolerability in a 320-patient, placebo-controlled Phase 2b (MOVE-IT) trial for gastroparesis. Following recent FDA clearance of the Investigational New Drug (IND) application, the trial has expanded to up to 25 sites across the United States. Top-line results are anticipated in 2025.

Gastroparesis is a serious and often underdiagnosed disorder characterized by delayed gastric emptying, affecting approximately 1.7% of the population in the U.S. and 1% in Europe with gastroparesis-like symptoms. Patients experience debilitating symptoms, such as nausea, vomiting, and bloating, often due to diabetic or idiopathic causes. Existing treatments, like metoclopramide, come with significant safety concerns, including a black-box warning, underscoring the need for safer, more effective alternatives. Naronapride's unique, topically active 5-HT4 and D2 activity has demonstrated acceleration of gastric emptying in healthy volunteers, and relief of symptoms in a range of Phase 2 studies of functional GI disorders.

Additionally, Renexxion has received FDA IND clearance for naronapride as a potential treatment for proton pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD). PPI-nrsGERD affects up to 10 million people in the U.S., with between 10-40% of patients not achieving adequate symptom control from PPIs alone. Published evidence shows that a combination of PPI treatment and GI prokinetics is more effective than PPIs alone for certain patients. As a locally acting prokinetic, naronapride addresses the GI motility issues underlying these symptoms, offering a promising adjunctive treatment. Renexxion, in conjunction with its European partner, has prioritized PPI-nrsGERD as the next focus in its global development plan.

Renexxion has a robust intellectual property portfolio which strengthens its competitive edge in the GI therapeutics sector. Through strategic partnerships, scientific advancements, and a commitment to addressing patients with high-unmet need, Renexxion aims to redefine GI healthcare and deliver transformative solutions for millions of patients worldwide.

For more information, visit Renexxion's websites at www.renexxion.com and www.rnexltd.ie.

ABOUT RELIEF
Relief 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's portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief 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, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief's filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date. The information provided on Renexxion within this press release and on Renexxion's website is provided by Renexxion. Relief makes no representation or warranty as to the accuracy, completeness, or reliability of such information and disclaims any obligation or liability in connection with it.

Participants in the Solicitation: Relief and Renexxion and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed business combination. Relief shareholders and other interested persons may obtain more detailed information regarding directors and officers of Relief in Relief's Report on Form 20-F for the year ended December 31, 2023, as filed with the SEC on April 30, 2024. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from Relief's and Renexxion's shareholders in connection with the proposed business combination will be included in the definitive proxy statement/prospectus that Relief, Renexxion or a combined company intends to file with the SEC.

No Offer or Solicitation: This press release does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Renexxion, Relief or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

SOURCE: Relief Therapeutics Holding SA



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FAQ

What is the ownership split in the Relief Therapeutics (RLFTY) and Renexxion merger?

Renexxion shareholders will own approximately 72.2% while Relief Therapeutics shareholders will retain 27.8% of the combined entity.

What is the equity valuation of Relief Therapeutics (RLFTY) in the proposed merger?

Relief Therapeutics' fully diluted equity is valued at USD 100 million in the proposed merger agreement.

When is the deadline for Relief Therapeutics (RLFTY) to complete the merger agreement?

Relief and Renexxion aim to enter into a definitive merger agreement by December 31, 2024.

What protections are in place for Relief Therapeutics (RLFTY) shareholders in the merger?

The merger includes a one-year post-closing reset mechanism to adjust ownership ratios based on the combined entity's market value.

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