IRVINE, Calif., May 07, 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 first quarter ended March 31, 2024.
First Quarter and Recent Highlights
- In December 2023, the pivotal STRIDE study of mavodelpar in adult patients with primary mitochondrial myopathies did not meet its primary efficacy or secondary efficacy endpoints
- The 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 alternatives
Financial Results for Three Months Ended March 31, 2024
We reported a net loss of $8.4 million, or $0.25 per share, during the first quarter of 2024, compared to a net loss of $15.1 million, or $0.60 per share, for the same period in 2023. We had $82.8 million in cash, cash equivalents, and short-term investments as of March 31, 2024.
Research and development expenses were $4.9 million during the first quarter of 2024, compared to $11.0 million for the same period in 2023. This decrease was primarily due to the suspension of development activities for mavodelpar and cash preservation activities, including workforce reductions in December 2023 and February 2024.
General and administrative expenses were $4.6 million during the first quarter of 2024, compared to $5.1 million for the same period in 2023. This decrease was primarily due to the workforce reductions in December 2023 and February 2024.
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 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) | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 20,375 | $ | 27,632 | ||||
| Short-term investments | 62,460 | 75,331 | ||||||
| Prepaid expenses and other current assets | 1,092 | 3,659 | ||||||
| Total current assets | 83,927 | 106,622 | ||||||
| Property and equipment, net | 102 | 134 | ||||||
| Right-of-use assets | 546 | 599 | ||||||
| Other non-current assets | 64 | 81 | ||||||
| Total assets | $ | 84,639 | $ | 107,436 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 676 | $ | 8,717 | ||||
| Accrued expenses | 1,807 | 9,129 | ||||||
| Operating lease liabilities, current portion | 331 | 331 | ||||||
| Total current liabilities | 2,814 | 18,177 | ||||||
| Operating lease liabilities, less current portion | 576 | 642 | ||||||
| Performance award | 7 | 7 | ||||||
| Total liabilities | 3,397 | 18,826 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized at March 31, 2024 and December 31, 2023; 33,420,808 shares issued and outstanding at March 31, 2024 and December 31, 2023 | 3 | 3 | ||||||
| Additional paid-in capital | 308,151 | 307,073 | ||||||
| Accumulated deficit | (226,900 | ) | (218,474 | ) | ||||
| Accumulated other comprehensive (loss) income | (12 | ) | 8 | |||||
| Total stockholders’ equity | 81,242 | 88,610 | ||||||
| Total liabilities and stockholders’ equity | $ | 84,639 | $ | 107,436 | ||||
| RENEO PHARMACEUTICALS, INC. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 4,942 | $ | 10,991 | ||||
| General and administrative | 4,622 | 5,132 | ||||||
| Total operating expenses | 9,564 | 16,123 | ||||||
| Loss from operations | (9,564 | ) | (16,123 | ) | ||||
| Other income | 1,138 | 1,016 | ||||||
| Net loss | (8,426 | ) | (15,107 | ) | ||||
| Unrealized (loss) gain on short-term investments | (20 | ) | 55 | |||||
| Comprehensive loss | $ | (8,446 | ) | $ | (15,052 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.25 | ) | $ | (0.60 | ) | ||
| Weighted-average shares used in computing net loss per share, basic and diluted | 33,420,808 | 25,036,410 | ||||||
| RENEO PHARMACEUTICALS, INC. Consolidated Statements of Cash Flows (In thousands) (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (8,426 | ) | $ | (15,107 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,078 | 1,157 | ||||||
| Depreciation and amortization | 16 | 41 | ||||||
| Amortization/accretion on short-term investments | (906 | ) | (770 | ) | ||||
| Changes in the fair value of performance award | — | 295 | ||||||
| Non-cash lease expense | 67 | 120 | ||||||
| Loss on disposal of fixed asset | 16 | 3 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid and other assets | 2,584 | 1,952 | ||||||
| Accounts payable and accrued expenses | (15,363 | ) | 3,398 | |||||
| Operating lease liabilities | (80 | ) | (137 | ) | ||||
| Net cash used in operating activities | (21,014 | ) | (9,048 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of property and equipment | — | (172 | ) | |||||
| Purchase of available-for-sale short-term investments | (45,243 | ) | (28,321 | ) | ||||
| Proceeds from maturities of available-for-sale short-term investments | 59,000 | 47,000 | ||||||
| Net cash provided by investing activities | 13,757 | 18,507 | ||||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock under the at-the-market facility, net of offering costs | — | 1,009 | ||||||
| Net cash provided by financing activities | — | 1,009 | ||||||
| Net (decrease) increase in cash and cash equivalents | (7,257 | ) | 10,468 | |||||
| Cash and cash equivalents, beginning of period | 27,632 | 19,927 | ||||||
| Cash and cash equivalents, end of period | $ | 20,375 | $ | 30,395 | ||||
Contact:
Danielle Spangler
Investor Relations
Reneo Pharmaceuticals, Inc.
dspangler@reneopharma.com
