| Item 2.05 |
Costs Associated with Exit or Disposal Activities. |
In connection with the Reduction (as defined below), which was announced by Reneo Pharmaceuticals, Inc. (the “Company”) on December 14, 2023 and is expected to be completed on December 31, 2023, the Company estimates that it will incur charges of approximately $2.5 million associated with cash severance payments and other employee termination-related costs in the fourth quarter of 2023. The estimated charges that the Company expects to incur in connection with the Reduction, and the timing thereof, are subject to a number of assumptions, and actual amounts and timing may differ materially from these estimates. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the implementation of the Reduction.
On December 14, 2023, the Company announced its pivotal STRIDE study (NCT04535609) of mavodelpar in adult patients with primary mitochondrial myopathies did not meet its primary efficacy or secondary efficacy endpoint (the “STRIDE Results”). The primary efficacy endpoint of the trial was the change from baseline in the distance walked during the 12-minute walk test (12MWT) at week 24. The secondary efficacy endpoint was the change from baseline in the PROMIS® Short Form Fatigue 13a score.
The Company intends to implement immediate cost savings initiatives, including suspension of the ongoing STRIDE AHEAD study and all other mavodelpar development activities and a workforce reduction of approximately 70% (the “Reduction”).
The Company currently has over $100.0 million in cash, cash equivalents, and short-term investments.
Forward-Looking Statements
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the expected timing for completion of the Reduction, the anticipated charges related to the Reduction, and the implementation of cost savings initiatives. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will,” “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the Company’s business in general, and the other risks described in the Company’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.