PROSPECTUS SUMMARY
This summary highlights selected information from this prospectus and does not contain all of the information that you need to consider in
making your investment decision. You should carefully read the entire prospectus, the applicable prospectus supplement and any related free writing prospectus, including the risks of investing in our securities discussed under the heading Risk
Factors contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus. You should also carefully read the
information incorporated by reference into this prospectus, including our financial statements, and the exhibits to the registration statement of which this prospectus is a part.
Unless the context requires otherwise, references in this prospectus to Reneo, the company, we,
us, our or similar terms refer to Reneo Pharmaceuticals, Inc. and its wholly owned subsidiary.
Company Overview
Reneo is a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic
mitochondrial diseases, which are often associated with the inability of mitochondria to produce adenosine triphosphate. Our lead product candidate, REN001, is a potent and selective agonist of the peroxisome proliferator-activated receptor delta,
or PPARd. REN001 has been shown to increase transcription of genes involved in mitochondrial function and increase fatty acid oxidation, and may increase production of new mitochondria.
The PPAR family of nuclear hormone receptors, PPARa,
PPARg, and PPARd, control the transcription of genes critical for regulating energy metabolism and homeostasis.
PPARd is highly expressed in muscle, kidney, brain, and liver tissue. Activation of PPARd results in changes in the expression of genes involved with multiple
aspects of energy metabolism including uptake of fatty acids, utilization of fatty acids as an energy source, and mitochondrial biogenesis.
Increases in PPARd activity also correlate with a shift in muscle tissue towards oxidative, fat-consuming type I fibers that are associated with endurance as opposed to glycolytic, type II fibers. In preclinical and clinical studies, increased PPARd activity
through transgenic overexpression or pharmacological activation increases muscular strength and endurance across a variety of functional measures. REN001 was studied in healthy volunteers with one leg immobilized to produce muscle atrophy. Compared
to placebo, administration of REN001 resulted in statistically significant increases in expression of genes involved in mitochondrial oxidative phosphorylation, and statistically significant improvements in muscle strength. REN001 was also studied
in an open-label trial in patients with primary mitochondrial myopathies, or PMM. In this trial, administration of REN001 improved function, reduced symptoms, and increased expression of genes involved in mitochondrial activity.
As a PPARd agonist, REN001 may benefit patients with genetic mitochondrial myopathies who
experience weakness, fatigue, or deterioration in muscle due to impaired mitochondrial energy production. We are currently developing REN001 in rare genetic diseases that typically present with myopathy and have high unmet medical needs, including
PMM and long-chain fatty acid oxidation disorders. Patients with these diseases are unable to perform many everyday activities, can experience cardiomyopathy and other organ dysfunction, and typically have a reduced life expectancy.
Implications of Being an Emerging Growth Company and Smaller Reporting Company
We are an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We may take
advantage of certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our
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