Reneo Pharmaceuticals(RPHM) - 2022 Q3 - Quarterly Report

Financial Performance - Reneo Pharmaceuticals reported net losses of $38.4 million and $29.2 million for the nine months ended September 30, 2022, and 2021, respectively, with an accumulated deficit of $123.1 million as of September 30, 2022[92]. - The net loss for the nine months ended September 30, 2022, was $38.4 million, compared to a net loss of $29.2 million for the same period in 2021, indicating a deterioration of $9.2 million[112]. - The company has incurred significant operating losses since inception, with no product candidates approved for sale and no revenue generated from product sales[92]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[116]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $31.7 million, compared to $28.0 million for the same period in 2021[119]. Cash and Funding - The company has cash, cash equivalents, and short-term investments of $116.1 million, which are expected to fund operations into 2024[96]. - As of September 30, 2022, the company had $116.1 million in cash, cash equivalents, and short-term investments, expected to fund operations into 2024[125]. - Reneo entered into an at-the-market equity offering sales agreement to sell up to $20.0 million in shares of common stock, but has not yet sold any shares under this facility[93]. - The company plans to raise additional capital through various means, including public or private equity offerings, to support ongoing operations and product development[123]. Research and Development - REN001, the lead product candidate, showed an average increase of 104.4 meters in the 12-minute walk test and a 1.7 mL/kg/min increase in weight-adjusted peak oxygen consumption in PMM patients[89]. - The ongoing pivotal Phase 2b study of REN001 in adult PMM patients has achieved over 80% enrollment, with completion expected in Q1 2023 and topline results anticipated in Q4 2023[90]. - The Phase 1b study of REN001 in LC-FAOD patients showed significant improvements, with the LCHAD and CPT2 groups experiencing increases of 73.7 and 51.9 meters in the 12-minute walk test, respectively[91]. - The company anticipates substantial increases in research and development expenses as it advances product candidates through clinical trials and regulatory approvals[102]. - Research and development expenses for Q3 2022 were $9.9 million, an increase of $0.6 million from $9.3 million in Q3 2021, primarily due to a $1.4 million rise in clinical study and manufacturing costs[109]. Operating Expenses - General and administrative expenses for Q3 2022 were $3.9 million, up from $3.4 million in Q3 2021, reflecting increased costs associated with operating as a public company[110]. - Total operating expenses for the nine months ended September 30, 2022, were $39.3 million, compared to $29.2 million for the same period in 2021, representing an increase of $10.1 million[112]. - The company expects to continue incurring net operating losses for at least the next several years as it conducts ongoing and planned clinical trials[94]. Market Need and Designations - There are currently no approved therapies for PMM, with over 66,000 patients in the U.S. and 82,000 in Europe, indicating a high unmet medical need[87]. - Reneo has received orphan drug designation from the FDA for REN001 for PMM and LC-FAOD, as well as Fast Track designation for PMM in the U.S.[88]. Accounting Policies - The preparation of consolidated financial statements requires estimates and judgments affecting reported amounts of assets, liabilities, and expenses[130]. - There were no material changes to critical accounting policies during the nine months ended September 30, 2022, compared to the previous year[132]. - The company bases its estimates on historical experience, known trends, and various other factors deemed reasonable under the circumstances[131]. Other Income - The increase in other income for Q3 2022 was due to higher interest rates earned on short-term investments, rising to $833,000 from $17,000 in Q3 2021[111].