0001637715false00016377152024-05-072024-05-07

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 7, 2024

 

 

Reneo Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40315

47-2309515

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

18575 Jamboree Road, Suite 275-S

 

Irvine, California

 

92612

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 858 283-0280

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common stock, par value $0.0001 per share

 

RPHM

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On May 7, 2024, Reneo Pharmaceuticals, Inc. (the "Company") issued a press release reporting the Company’s financial results for the first quarter ended March 31, 2024 and providing a business update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 of this Current Report on 8-K (including Exhibit 99.1) is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
No.

 

Description

99.1

Press Release Announcing Financial Results, Dated May 7, 2024.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 


 

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Reneo Pharmaceuticals, Inc.

 

 

 

 

Date:

May 7, 2024

By:

/s/ Gregory J. Flesher

 

 

 

Gregory J. Flesher
President and Chief Executive Officer
(Principal Executive Officer)

 

 


img187185602_0.jpg 

 

 

Exhibit 99.1

 

Reneo Pharmaceuticals Reports First Quarter 2024 Financial Results

IRVINE, Calif., May 7, 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 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.

 


img187185602_0.jpg 

 

 

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.


img187185602_0.jpg 

 

 

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

 

 


img187185602_0.jpg 

 

 

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

 

 

 

 

 

 


img187185602_0.jpg 

 

 

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

 

 

 

 

 

 


img187185602_0.jpg 

 

 

Contact:

Danielle Spangler
Investor Relations
Reneo Pharmaceuticals, Inc.
dspangler@reneopharma.com

 

 


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May 07, 2024
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Entity Central Index Key 0001637715
Document Type 8-K
Document Period End Date May 07, 2024
Entity Registrant Name Reneo Pharmaceuticals, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-40315
Entity Tax Identification Number 47-2309515
Entity Address, Address Line One 18575 Jamboree Road
Entity Address, Address Line Two Suite 275-S
Entity Address, City or Town Irvine
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92612
City Area Code 858
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Security 12b Title Common stock, par value $0.0001 per share
Trading Symbol RPHM
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false

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