Reneo Pharmaceuticals Reports First Quarter 2024 Financial Results

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