Reneo Pharmaceuticals Reports Fourth Quarter And Full Year 2023 Financial Results And Business Update
Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM) reported financial results for Q4 and full year 2023, highlighting a net loss of $23.6 million in Q4 and $77.4 million for the full year. The pivotal STRIDE study of mavodelpar in adult patients with primary mitochondrial myopathies did not meet efficacy endpoints, leading to cost-saving measures and workforce reduction. The company plans to evaluate strategic alternatives with $82.0 million in cash as of March 31, 2024.
Positive
Reneo Pharmaceuticals reported a net loss of $23.6 million in Q4 2023 and $77.4 million for the full year 2023.
The STRIDE study of mavodelpar did not meet efficacy endpoints, resulting in cost-saving measures and a workforce reduction of approximately 90%.
The company plans to assess strategic alternatives with $82.0 million in cash as of March 31, 2024.
Negative
The pivotal STRIDE study of mavodelpar did not meet primary efficacy or secondary efficacy endpoints.
The company implemented cost-saving initiatives, including suspension of all mavodelpar development activities and a total workforce reduction of approximately 90%.
R&D expenses increased to $56.6 million in 2023 from $37.7 million in 2022 primarily due to clinical and manufacturing costs in STRIDE and STRIDE AHEAD studies.
The pharmaceutical industry is characterized by high risks and potential high rewards, contingent on the successful development and commercialization of new drugs. Reneo Pharmaceuticals' announcement that the STRIDE study of mavodelpar did not meet its primary or secondary efficacy endpoints is a significant setback. This failure not only halts the development of mavodelpar but also necessitates a drastic reduction in workforce and an exploration of strategic alternatives.
For investors, the cessation of mavodelpar's development is a stark reminder of the volatility inherent in the biotech sector, especially for companies focused on rare diseases. The financials reflect increased R&D expenses, largely attributed to the now-discontinued studies, implying a heavy investment into a product that failed to yield the desired results. The reported net loss widening year-over-year indicates a growing cash burn rate, which is concerning without a clear path to profitability or a pipeline of products to offset the losses.
While the company's cash reserves may provide some buffer, the long-term viability will depend on the outcome of the strategic alternatives being explored. The pivot from the failed drug development could lead to a restructured business model or potential acquisition, which may have a significant impact on the stock's future trajectory.
The reported net loss and increased R&D and G&A expenses are red flags for Reneo Pharmaceuticals' financial health. The net loss per share increasing from the previous year indicates dilution and a potential concern for earnings quality. The cash position, while seemingly adequate in the short term, must be weighed against the company's ability to generate revenue or secure additional funding.
Investors should be mindful of the implications of the workforce reduction. While it may reduce operational costs in the short term, it also raises questions about the company's ability to maintain its pipeline and innovate. The retention of an independent financial advisor suggests that the company is actively seeking solutions, which could range from partnerships to a sale of the company, each with distinct implications for shareholder value.
The stock market reaction to such news typically reflects the uncertainty and realignment of the company's valuation. The specifics of the strategic alternatives pursued will be important in determining whether the current cash reserves are sufficient to bridge the company to a more stable future or merely a temporary reprieve from financial difficulties.
From a market perspective, Reneo Pharmaceuticals' situation exemplifies the broader challenges faced by companies in the rare genetic mitochondrial disease space. The failure of the STRIDE study to meet efficacy endpoints may dampen investor confidence not only in Reneo but also potentially in other companies within the same therapeutic area.
Strategic alternatives may include mergers, acquisitions, or shifts in business focus, each carrying potential market risks and opportunities. The impact on the stock will likely depend on the perceived value of Reneo's remaining assets, including its intellectual property and any other compounds in its pipeline. The biotech sector is often driven by speculative investment based on the potential of breakthrough therapies and setbacks such as this can lead to significant volatility.
Long-term implications for stakeholders will hinge on the effectiveness of the company's strategic pivot. If successful, there could be a positive reassessment of the company's market position. However, the current outlook suggests caution, as the company's future is now dependent on finding a viable strategic path forward.
03/28/2024 - 07:35 AM
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 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 The 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, $0.00 01 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 Ended December 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
What was Reneo Pharmaceuticals' net loss in Q4 2023?
Reneo Pharmaceuticals reported a net loss of $23.6 million in Q4 2023.
What study did not meet its efficacy endpoints?
The pivotal STRIDE study of mavodelpar did not meet its primary efficacy or secondary efficacy endpoints.
What cost-saving measures did the company implement?
The company implemented cost-saving initiatives, including suspension of all mavodelpar development activities and a total workforce reduction of approximately 90%.
How much cash does the company anticipate having as of March 31, 2024?
The company anticipates it will have approximately $82.0 million in cash, cash equivalents, and short-term investments as of March 31, 2024.
Why did R&D expenses increase in 2023?
R&D expenses increased to $56.6 million in 2023 from $37.7 million in 2022 primarily due to clinical and manufacturing costs in STRIDE and STRIDE AHEAD studies.