GENEVA, SWITZERLAND / ACCESSWIRE / April 19, 2021 / RELIEF THERAPEUTICS Holding AG (SIX:RLF)(OTCQB:RLFTF) ("Relief" or the "Company"), commented today on certain statements made by NeuroRx, Inc., its collaboration partner for the development of RLF-100TM (aviptadil) pursuant to that certain binding collaboration agreement, dated September 18, 2020 (the "Collaboration Agreement"), in Amendment No. 1 to the Form S-4 of Big Rock Partners Acquisition Corp.'s ("BPRA") that was filed on Friday, April 16, 2021 (the "Amendment"). The Amendment was filed by BRPA with respect to the proposed merger between NeuroRx and BRPA.
NeuroRx has elected to make statements in the Amendment with respect to pending disputes between Relief and NeuroRx under the terms of the Collaboration Agreement. As a result, Relief has concluded that it must inform the public about the nature of the pending disputes and its views regarding the positions regarding these issues taken by its collaboration partner. The issues currently in dispute include the following:
- NeuroRx has refused to share clinical trial data from its recently completed Phase 2b/3 trial with Relief, which data are required to be provided to Relief under the Collaboration Agreement. Further, NeuroRx has refused to allow NeuroRx's contract partners dealing with issues relating to the development of aviptadil to share information with Relief that Relief requires to develop its aviptadil product in its territories (including the E.U. and the U.K.). As a result, Relief believes that NeuroRx is in default under the Collaboration Agreement, and that NeuroRx's failure to provide this data is impairing Relief's ability to develop and execute a clinical and regulatory strategy for its territories.
- NeuroRx states in the Amendment that Relief owes it approximately $4,000,000 in unpaid invoices. Unfortunately, many of these alleged expenses have not been substantiated by valid, verifiable invoices that support that these expenses are reimbursable under the Collaboration Agreement. Further, there are disputes between the parties over whether expenses exceeding the budget established in the Collaboration Agreement are reimbursable. With respect to this information, Relief has been seeking information from NeuroRx in order to establish what may be due to NeuroRx under the Collaboration Agreement, and, accordingly, Relief intends to exercise its rights under the Collaboration Agreement to conduct a forensic audit of NeuroRx's books and records in order to determine the accuracy of the expense information that has been provided.
- NeuroRx has alleged in the Amendment that Relief has elected not to fund the recently initiated clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, Relief has requested certain information required for it to determine whether or not to fund this trial, and NeuroRx has refused to provide the requested information that is needed by Relief to make a decision on whether or not to fund this trial. It is Relief's position that until it is provided with sufficient information to make this decision, NeuroRx cannot bring in another source to specifically fund this trial.
- NeuroRx has stated in the Amendment that Relief's failure to fund expenses may result in a dispute with Relief over whether Relief's share of the net profits from sales of aviptadil in NeuroRx's territory should be less than that set forth in the Collaboration Agreement. Relief believes that the net profit splits between Relief and NeuroRx that are set forth in the Collaboration Agreement are not affected by any of these funding issues (including the recent warrant exercise reported in the Amendment by GEM Yield Bahamas Limited, a significant stockholder of Relief).
- NeuroRx makes allegations in the Amendment that raise questions about the formulation of aviptadil that Relief has contributed to the parties' collaboration. Relief notes that while there are stability issues with the formulation that Relief brought to the collaboration, all of these problems were understood by all parties at the time of the execution of the Collaboration Agreement and that efforts to resolve those issues were contemplated by the Collaboration Agreement. In all respects, Relief believes that the version of aviptadil which is in evaluation in NeuroRx's clinical trials is, in all respects, the drug product covered by the Collaboration Agreement.
Relief intends to continue its efforts to resolve amicably the pending disputes with NeuroRx over the Collaboration Agreement. However, if such disputes are not resolved amicably, Relief intends to take all necessary actions to enforce its rights under the Collaboration Agreement. While there can be no assurance, Relief believes that it will prevail in any such actions to enforce its rights under the Collaboration Agreement.
ABOUT RELIEF THERAPEUTICS HOLDING AG
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. Relief's 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.
RELIEF THERAPEUTICS Holding AG 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.
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RELIEF THERAPEUTICS Holding AG
Raghuram (Ram) Selvaraju, Ph.D., MBA
Chairman of the Board
Mail: [email protected]
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Anne Hennecke / Brittney Sojeva
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Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including the outcome of the pending disputes between Relief and NeuroRx if such disputes are not resolved amicably, 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.
SOURCE: Relief Therapeutics Holdings AG