Reneo Pharmaceuticals and OnKure Announce Proposed Merger
Summary
The combined company will focus on advancing OnKures pipeline candidates targeting oncogenic mutations in phosphoinositide 3-kinase alpha (PI3K), including its lead program OKI-219, which is currently in a Phase 1 clinical trial for the treatment of solid tumors. While novel drugs targeting PI3K have been approved, the lack of mutant selectivity of these therapeutics drives considerable on-target toxicity by inhibiting the normal version of this protein in various tissues. To address this challenge, OnKure is discovering and developing a portfolio of highly mutant-selective PI3K inhibitors with the goal of improving efficacy and safety with molecules that fully inhibit the mutant oncogene while sparing the wild-type enzyme in normal tissues. Actual events and circumstances, many of which are outside of the control of Reneo and OnKure, are difficult or impossible to predict and will differ from assumptions underlying forward-looking statements.These forward-looking statements are subject to a number of risks and uncertainties, including, among other things: the risk that the conditions to the closing of the Proposed Transactions are not satisfied, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect Reneo, OnKure or the combined company or that the approval of the stockholders of Reneo or OnKure is not obtained on the timeline expected, if at all; uncertainties as to the timing of the closing of the Proposed Transactions and the ability of each of Reneo and OnKure to consummate the Proposed Transactions; risks related to the ability of Reneo and OnKure to correctly estimate and manage their respective operating expenses and expenses associated with the Proposed Transactions pending the closing of the Proposed Transactions; risks associated with the possible failure to realize certain anticipated benefits of the Proposed Transactions, including with respect to future financial and operating results; the potential for the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Proposed Transactions and any agreements entered into in connection therewith; the possible effect of the announcement, pendency or completion of the Proposed Transactions on Reneos or OnKures business relationships, operating results and business generally; the risk that as a result of adjustments to the exchange ratio, Reneo stockholders and OnKure stockholders could own more or less of the combined company than is currently anticipated; risks related to the market price of Reneos common stock relative to the value suggested by the exchange ratio; unexpected costs, charges or expenses resulting from the Proposed Transactions; the potential for, and uncertainty associated with the outcome of, any legal proceedings that may be instituted against Reneo or OnKure or any of their respective directors or officers related to the Proposed Transactions; risks related to OnKures early stage of development; the uncertainties associated with OnKures product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses each of Reneo and OnKure has incurred since inception; the combined companys ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from the combined companys clinical trials; the outcome of preclinical testing and clinical trials of the combined companys product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the combined companys plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of the combined companys product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; the combined companys ability to attract, hire, and retain skilled executive officers and employees; the combined companys ability to protect its intellectual property and proprietary technologies; the combined companys reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Reneo, OnKure or the combined company may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Reneos Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 under the heading Item 1A. Risk Factors and in Reneos other filings with the U.S. Securities and Exchange Commission (SEC); and other risks.This press release also concerns product candidates that are under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration.