28 July 2016
RELIEF THERAPEUTICS Holding AG (SIX:RLF) (“RELIEF” or “the Company”) announces today that it has executed a term sheet under which it shall acquire FirstString Research, Inc. (“FirstString”), a Delaware corporation headquartered in Charleston, South Carolina, USA, in an all-stock transaction that is slated to bring RELIEF another Phase 3-ready asset, Granexin® gel for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), along with a pipeline of preclinical and early-stage clinical assets based on FirstString’s pioneering characterization of the functions of connexin protein signaling.
The envisaged transaction would involve the issuance of new shares of RELIEF THERAPEUTICS Holding AG to the existing equity holders of FirstString Research, such that the existing equity holders of FirstString Research would own no less than 33% and no more than 40% of the final combined company.
Following the completion of the transaction, RELIEF THERAPEUTICS Holding AG is slated to have two Phase 3 programs in the form of aviptadil for the treatment of sarcoidosis and Granexin® gel for the treatment of DFUs and VLUs, both of which could begin enrollment next year. The proposed Granexin® Phase 3 program has been reviewed and approved by the United States Food and Drug Administration (FDA), with which FirstString has held a successful End-of-Phase 2 meeting. Each of these clinical programs could yield top-line data in 2018. RELIEF THERAPEUTICS Holding AG also holds worldwide rights to atexakin alfa, in-licensed from Merck KGaA, which is slated to enter Phase 2 testing in peripheral neuropathies in 2017. RELIEF THERAPEUTICS Holding AG is also slated to possess an extensive early-stage pipeline consisting of at least 10 projects spanning various therapeutic indications in oncology, ophthalmology, pulmonology and infectious disease.
Raghuram Selvaraju, Ph.D., Chairman of RELIEF, states: “The envisaged acquisition of FirstString Research brings a cost-effective, capital-efficient drug development operation under the aegis of RELIEF THERAPEUTICS Holding AG and significantly broadens our pipeline, having direct continuity with our goal of treating major complications of diabetes. We look forward to advancing both Granexin® gel for diabetic foot ulcers and venous leg ulcers as well as aviptadil for treatment of sarcoidosis into pivotal Phase 3 testing within the coming months, and welcome the FirstString team into the RELIEF organization.”
Gautam Ghatnekar, Ph.D., President and Chief Executive Officer of FirstString Research, states: “This transaction is aimed at transitioning FirstString Research into the public equities markets and forging a powerful combination with RELIEF THERAPEUTICS Holding AG, where we see highly attractive synergies between the FirstString and RELIEF pipelines. Notably, the potential concomitant development of a novel approach to the treatment of diabetic foot ulcers, Granexin® gel, and an innovative strategy for the treatment of peripheral neuropathies, including those seen in diabetic patients, could result in the comprehensive management of the most devastating co-morbidities due to diabetes.”
Chris Brown, Director and Founder of Global Emerging Markets (GEM), states: “This proposed acquisition transaction, which GEM identified and structured, continues to rapidly add breadth and depth to the RELIEF THERAPEUTICS Holding AG clinical-stage pipeline. Through the proposed integration of FirstString Research into RELIEF, we are continuing to act on our intent to build a world-class, innovative and significantly risk-mitigated biotechnology company with multiple shots on goal and late-stage clinical programs that could achieve final regulatory submission within the next couple of years.”
RELIEF THERAPEUTICS Holding AG is a clinical-stage biotechnology company with a portfolio of drug candidates derived from natural human origins. Its two most promising drug candidates are aviptadil for the treatment of sarcoidosis (already in Phase III) and low dose interleukin-6 (atexakin alfa) for the treatment of peripheral diabetic neuropathy (already in Phase II). Aviptadil development in sarcoidosis focuses the drug on an 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 the global established pharmaceutical firm Merck KGaA, and has been the subject of multiple clinical trials and over €100 million in total capital investment. Based on its unique mechanism of action, atexakin alfa could become the first regenerative therapeutic for peripheral neuropathy. The peripheral diabetic neuropathy market is estimated to reach $4.1 billion in 2019, according to Datamonitor. RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and is headquartered in Zurich, Switzerland.
FirstString Research is a privately-held clinical-stage biotechnology company, which was founded based on pioneering research from the Medical University of South Carolina characterizing the therapeutic role of connexin-based protein signalling. The company’s lead drug candidate, Granexin® gel (aCT-1), is a novel, proprietary peptide mimetic of the C-terminus of connexin43, which has been shown to play a fundamental role in processes that are critical to wound healing. Granexin® gel has demonstrated positive proof-of-concept efficacy and benign safety in three placebo-controlled, randomized, double-blinded clinical trials and is poised to enter Phase 3 development for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The market for DFUs alone in the United States and major European Union economies is estimated to reach $1.6 billion in 2017, according to GlobalData. FirstString Research is headquartered in Charleston, South Carolina.
For further information, please see the Relief website at www.relieftherapeutics.com
Relief Therapeutics Holding AG
Dr. Raghuram Selvaraju, +41 44 723 59 59
This communication expressly or implicitly contains certain forward-looking statements concerning Relief Therapeutics Holding AG 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 AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Relief Therapeutics Holding AG 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.