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Reneo Pharmaceuticals Reports First Quarter 2024 Financial Results

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Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM) reported its first quarter 2024 financial results, highlighting a net loss of $8.4 million, with $82.8 million in cash. The Company suspended mavodelpar development activities, leading to workforce reductions and cost-saving initiatives. Research and development expenses decreased due to these activities.

Positive
  • None.
Negative
  • The pivotal STRIDE study of mavodelpar in adult patients with primary mitochondrial myopathies did not meet primary or secondary efficacy endpoints, impacting the company's future prospects in developing therapies for rare genetic mitochondrial diseases.

  • The workforce reduction of approximately 90% and the suspension of all mavodelpar development activities indicate significant challenges faced by the company in progressing its drug pipeline, potentially affecting investor confidence and future revenue streams.

Insights

The reported net loss of Reneo Pharmaceuticals stands at $8.4 million, a significant decrease from last year's $15.1 million. This substantial reduction in net loss by almost 44% can be attributed to the company's aggressive cost-saving initiatives, including cessation of development for mavodelpar and workforce reductions. However, investors should note that the discontinuation of mavodelpar's development, following its failure to meet clinical endpoints, raises concerns about the company's pipeline robustness and future revenue streams.

With $82.8 million in cash reserves, the company appears to have a cushion for near-term operations. However, the sustainability of these reserves hinges on the company's strategic decisions following the cessation of mavodelpar development. The retention of an independent financial advisor signals that strategic alternatives, potentially including mergers, acquisitions, or asset sales, are on the table. Investors should monitor these developments closely, as they will significantly influence the company's financial health and stock performance.

Reneo Pharmaceuticals' strategic shift may impact investor sentiment, as it suggests a redirection of the company's focus. The company's historical dedication to rare genetic mitochondrial diseases is now in question and the market might perceive this uncertainty as a risk. The reduction in research and development expenses from $11.0 million to $4.9 million reflects a pivot away from these high-cost activities, which could either be interpreted as a prudent cost-saving measure or a sign of a lack of viable products in the pipeline.

Investors should consider the potential for value creation or destruction as Reneo explores strategic alternatives. In the short-term, such processes can create volatility in the stock's price depending on the nature of any announced deals or partnerships. In the long-term, the success of these strategic alternatives will be critical to the company's repositioning and growth potential in the pharmaceutical sector.

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


FAQ

What were Reneo Pharmaceuticals' financial results for the first quarter of 2024?

Reneo Pharmaceuticals 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.

Why did Reneo Pharmaceuticals implement cost-saving initiatives?

Reneo Pharmaceuticals implemented cost-saving initiatives, including suspension of all mavodelpar development activities and a total workforce reduction of approximately 90%, due to challenges faced in the pivotal STRIDE study of mavodelpar in adult patients with primary mitochondrial myopathies.

What were the research and development expenses for Reneo Pharmaceuticals in the first quarter of 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, primarily due to the suspension of development activities for mavodelpar and cost-saving activities.

Reneo Pharmaceuticals, Inc.

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Biotechnology
Pharmaceutical Preparations
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