8-K
OnKure Therapeutics, Inc. (OKUR)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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): March 28, 2024 |
|---|
Reneo Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-40315 | 47-2309515 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>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<br>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 March 28, 2024, Reneo Pharmaceuticals, Inc. (the "Company") issued a press release reporting the Company’s financial results for the fourth quarter and year ended December 31, 2023 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<br>No. | Description |
|---|---|
| 99.1 | Press Release Announcing Financial Results, Dated March 28, 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: | March 28, 2024 | By: | /s/ Gregory J. Flesher |
| Gregory J. Flesher<br>President and Chief Executive Officer<br>(Principal Executive Officer) |
EX-99.1
Exhibit 99.1
Reneo Pharmaceuticals Reports Fourth Quarter And Full Year 2023 Financial Results And Business Update
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)
| 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, 0.0001 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 |
All values are in US Dollars.
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<br> diluted | 30,676,455 | 24,496,425 |
RENEO PHARMACEUTICALS, INC.
Consolidated Statements of Cash Flows
(In thousands)
| Year Ended<br>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 <br> stock repurchase agreement | (4,403 | ) | — | |||
| Proceeds from issuance of common stock under the at-the-market <br> 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