Mavodelpar

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a pharmaceutical company historically focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update. Fourth Quarter and Recent Highlights The pivotal STRIDE study of mavodelpar in adult patients with primary mitochondrial myopathies (PMM) did not meet its primary efficacy or secondary efficacy endpointsThe Company implemented cost savings initiatives, including suspension of all mavodelpar development activities and a total workforce reduction of approximately 90%The Company retained an independent financial advisor to initiate a formal process to evaluate potential strategic alternativesThe Company anticipates it will have approximately $82.0 million in cash, cash equivalents, and short-term investments as of March 31, 2024 Financial Results for Fourth Quarter and Full Year 2023 We reported a net loss of $23.6 million, or $0.70 per share, during the fourth quarter of 2023, compared to a net loss of $13.6 million, or $0.56 per share, for the same period in 2022. For the full year 2023, we reported a net loss of $77.4 million, or $2.52 per share, compared to a net loss of $52.0 million, or $2.12 per share, for the full year 2022. We had $103.0 million in cash, cash equivalents, and short-term investments as of December 31, 2023. Research and development (R&D) expenses were $17.6 million during the fourth quarter of 2023, compared to $10.4 million for the same period in 2022. For the full year 2023, R&D expenses were $56.6 million, compared to $37.7 million for the full year 2022. This increase during the full year 2023 was primarily due to an increase of $13.3 million related to clinical and manufacturing costs in our STRIDE and STRIDE AHEAD studies, which have now been completed and discontinued, respectively, an increase of $2.5 million in medical affairs, an increase of $1.7 million in personnel-related costs due to additional headcount and an increase of $1.7 million in severance payments related to our workforce reduction in December 2023, offset by a decrease of $0.6 million in other research and development. General and administrative (G&A) expenses were $7.4 million during the fourth quarter of 2023, compared to $4.2 million for the same period in 2022. For the full year 2023, G&A expenses were $26.4 million, compared to $16.1 million for the full year 2022. This increase during the full year 2023 was primarily due to an increase of $5.7 million in commercial development activities, an increase of $1.7 million in facility and personnel-related costs due to additional headcount, an increase of $0.8 million in severance expense related to our workforce reduction in December 2023 and an increase of $0.6 million in impairment charges as a result of the suspension of our mavodelpar development program. About Reneo Pharmaceuticals Reneo is a pharmaceutical company historically 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. For additional information, please see reneopharma.com. Forward-Looking Statements Statements contained in this press release 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 evaluation of strategic alternatives, anticipated cash, cash equivalents, and short-term investments as of March 31, 2024, 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 Reneo’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 Reneo’s business in general, and the other risks described in Reneo’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Reneo 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. RENEO PHARMACEUTICALS, INC.Consolidated Balance Sheets(In thousands, except share and par value data) December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $27,632 $19,927 Short-term investments 75,331 81,246 Prepaid expenses and other current assets 3,659 5,180 Total current assets 106,622 106,353 Property and equipment, net 134 453 Right-of-use assets 599 1,292 Other non-current assets 81 84 Total assets $107,436 $108,182 Liabilities and stockholders’ equity Current liabilities: Accounts payable $8,717 $1,893 Accrued expenses 9,129 4,827 Operating lease liabilities, current portion 331 404 Total current liabilities 18,177 7,124 Operating lease liabilities, less current portion 642 1,059 Performance award 7 29 Total liabilities 18,826 8,212 Commitments and contingencies Stockholders’ equity: Common stock, $0.0001 par value; 200,000,000 shares authorized at December 31, 2023 and December 31, 2022; 33,420,808 and 24,699,553 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 3 3 Additional paid-in capital 307,073 236,693 Accumulated deficit (218,474) (136,683)Accumulated other comprehensive income (loss) 8 (43)Total stockholders’ equity 88,610 99,970 Total liabilities and stockholders’ equity $107,436 $108,182 RENEO PHARMACEUTICALS, INC.Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data) Year Ended December 31, 2023 2022 Operating expenses: Research and development $56,613 $37,705 General and administrative 26,440 16,143 Total operating expenses 83,053 53,848 Loss from operations (83,053) (53,848)Other income 5,665 1,893 Net loss (77,388) (51,955)Unrealized gain (loss) on short-term investments 51 (77)Comprehensive loss $(77,337) $(52,032)Net loss per share attributable to common stockholders, basic and diluted $(2.52) $(2.12)Weighted-average shares used in computing net loss per share, basic and diluted 30,676,455 24,496,425 RENEO PHARMACEUTICALS, INC.Consolidated Statements of Cash Flows(In thousands) Year EndedDecember 31, 2023 2022 Cash flows from operating activities Net loss $(77,388) $(51,955)Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 5,112 4,320 Depreciation and amortization 170 88 Amortization/accretion on short-term investments (4,777) (817)Changes in the fair value of performance award (22) (415)Non-cash lease expense 355 441 Right-of-use and leasehold improvement impairment expenses 650 17 Changes in operating assets and liabilities: Prepaid and other assets 1,524 878 Accounts payable and accrued expenses 11,118 518 Operating lease liabilities (424) (437)Net cash used in operating activities (63,682) (47,362)Cash flows from investing activities Purchases of property and equipment (221) (346)Purchase of available-for-sale short-term investments (231,257) (101,596)Proceeds from maturities of available-for-sale short-term investments 242,000 44,100 Net cash provided by (used in) investing activities 10,522 (57,842)Cash flows from financing activities Proceeds from public offering of common stock, net of offering costs 58,862 — Proceeds from private placement of common stock, net of offering costs 4,667 193 Repurchase of common stock in connection with common stock repurchase agreement (4,403) — Proceeds from issuance of common stock under the at-the-market facility, net of offering costs 1,009 — Proceeds from issuance of common stock in connection with equity plans 730 278 Net cash provided by financing activities 60,865 471 Net increase (decrease) in cash and cash equivalents 7,705 (104,733)Cash and cash equivalents, beginning of year 19,927 124,660 Cash and cash equivalents, end of year $27,632 $19,927 Noncash operating activities: Right-of-use assets obtained in exchange for lease obligations $— $1,733 Contact: Danielle Spangler Investor Relations Reneo Pharmaceuticals, Inc. dspangler@reneopharma.com

Reneo Pharmaceuticals’ stock plunged by 82% as it revealed plans to slash 70% of its workforce after its only drug candidate disappointed in a registrational trial in rare genetic mitochondrial disorders. The company’s stock $RPHM closed at $1.32 on Thursday, down from Wednesday’s close of $7.75. The Phase IIb STRIDE study set mavodelpar against placebo in adults with primary mitochondrial myopathies. Mavodelpar is a selective PPAR-delta agonist designed to boost the transcription of genes involved in mitochondrial function and promote the creation of new mitochondria. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.