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
second quarter ended June 30, 2024.
Second Quarter and Recent Highlights
- On May 10, 2024, Reneo and OnKure, Inc. entered into a
definitive merger agreement to combine the companies in an
all-stock transaction (the “Merger”).
- The Merger is expected to create a Nasdaq-listed, clinical
stage biopharmaceutical company focused on advancing OnKure’s
portfolio of precision oncology therapies.
- The Merger and a concurrent $65 million private investment in
public equity (PIPE) financing are expected to close in the second
half of 2024, subject to receipt of stockholder approval and
satisfaction of other closing conditions.
- Including proceeds from the concurrent PIPE financing, the
combined company is expected to have approximately $120 million of
cash, cash equivalents and short-term investments at the closing of
the Merger.
Financial Results for Three Months Ended June 30,
2024
Reneo reported a net loss of $5.4 million, or $0.16 per share,
during the second quarter of 2024, compared to a net loss of $19.5
million, or $0.65 per share, for the same period in 2023. Reneo had
$76.7 million in cash, cash equivalents, and short-term investments
as of June 30, 2024.
Research and development expenses were $0.6 million during the
second quarter of 2024, compared to $14.4 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 $5.8 million during the
second quarter of 2024, compared to $6.6 million for the same
period in 2023. This decrease was primarily due to a decrease of
$1.6 million in facility and personnel-related costs related to
workforce reductions in December 2023 and February 2024 and a
decrease of $1.7 million in commercial development and consulting
costs due to the suspension of mavodelpar development activities,
offset by an increase of $2.4 million in legal and advisory fees
related to the proposed merger with OnKure.
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
This press release contains forward-looking statements within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, including but not limited
to, express or implied statements regarding the timing and
completion of the proposed business combination involving Reneo and
OnKure, the concurrent PIPE investment and any related proposed
transactions (collectively, the “Proposed Transactions”). Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Forward-looking statements generally are accompanied by words such
as “anticipate,” “believe,” “continue,” “estimate,” “expect,”
“future,” “goal,” “intend,” “may,” “outlook,” “plan,” “potential,”
“predict,” “project,” “seem,” “seek,” “should,” “target,” “will,”
“would,” and similar expressions that indicate future events or
trends or that are not statements of historical matters. These
forward-looking statements may include, but are not limited to,
statements regarding the Proposed Transactions; the combined
company’s cash, cash equivalents and short-term investments,
following the Proposed Transactions; the development of the
combined company’s current and future product candidates; and the
future operations of Reneo.
These forward-looking statements are subject to a number of
risks and uncertainties, including, among other things : the risk
that the conditions to the closing of the Proposed Transactions are
not satisfied, including the risk that any required regulatory
approvals are not obtained, are delayed or are subject to
unanticipated conditions that could adversely affect Reneo, OnKure
or the combined company or that the approval of the stockholders of
Reneo or OnKure is not obtained on the timeline expected, if at
all; uncertainties as to the timing of the closing of the Proposed
Transactions and the ability of each of Reneo and OnKure to
consummate the Proposed Transactions; risks related to the ability
of Reneo and OnKure to correctly estimate and manage their
respective operating expenses and expenses associated with the
Proposed Transactions pending the closing of the Proposed
Transactions; risks associated with the possible failure to realize
certain anticipated benefits of the Proposed Transactions,
including with respect to future financial and operating results;
the potential for the occurrence of any event, change or other
circumstance or condition that could give rise to the termination
of the Proposed Transactions and any agreements entered into in
connection therewith; the possible effect of the announcement,
pendency or completion of the Proposed Transactions on Reneo’s or
OnKure’s business relationships, operating results and business
generally; the risk that as a result of adjustments to the exchange
ratio, Reneo stockholders and OnKure stockholders could own more or
less of the combined company than is currently anticipated; risks
related to the market price of Reneo’s common stock relative to the
value suggested by the exchange ratio; unexpected costs, charges or
expenses resulting from the Proposed Transactions; the potential
for, and uncertainty associated with the outcome of, any legal
proceedings that may be instituted against Reneo or OnKure or any
of their respective directors or officers related to the Proposed
Transactions; risks related to OnKure’s early stage of development;
the uncertainties associated with OnKure’s product candidates, as
well as risks associated with the clinical development and
regulatory approval of product candidates, including potential
delays in the completion of clinical trials; the significant net
losses each of Reneo and OnKure has incurred since inception; the
combined company’s ability to initiate and complete ongoing and
planned preclinical studies and clinical trials and advance its
product candidates through clinical development; the timing of the
availability of data from the combined company’s clinical trials;
the outcome of preclinical testing and clinical trials of the
combined company’s product candidates, including the ability of
those trials to satisfy relevant governmental or regulatory
requirements; the combined company’s plans to research, develop and
commercialize its current and future product candidates; the
clinical utility, potential benefits and market acceptance of the
combined company’s product candidates; the requirement for
additional capital to continue to advance these product candidates,
which may not be available on favorable terms or at all; the
combined company’s ability to attract, hire, and retain skilled
executive officers and employees; the combined company’s ability to
protect its intellectual property and proprietary technologies; the
combined company’s reliance on third parties, contract
manufacturers, and contract research organizations; the possibility
that Reneo, OnKure or the combined company may be adversely
affected by other economic, business, or competitive factors; risks
associated with changes in applicable laws or regulations; those
factors discussed in Reneo’s Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2024 under the heading “Item 1A.
Risk Factors” and in Reneo’s other filings with the SEC; and other
risks.
Additional Information and Where to Find It
The information herein does not purport to be all-inclusive or
contain all the information that may be required to make a full
analysis of Reneo, OnKure, the combined company or the Proposed
Transactions. Readers should each make their own evaluation of
Reneo and OnKure and of the relevance and adequacy of the
information disclosed herein and made available elsewhere by Reneo
and OnKure, as described below, and should make such other
investigations as they deem necessary.
This press release may be deemed to be solicitation material in
respect of the Proposed Transactions. In connection with the
Proposed Transactions, Reneo has filed a registration statement on
Form S-4 (the “Form S-4”) that contains a proxy statement (the
“Proxy Statement”) and prospectus. This press release is not a
substitute for the Form S-4, the Proxy Statement or for any other
document that Reneo may file with the SEC and/or send to Reneo’s
stockholders in connection with the Proposed Transactions. BEFORE
MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF RENEO
AND ONKURE ARE URGED TO READ THE FORM S-4, THE PROXY STATEMENT AND
OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY
BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT RENEO, ONKURE, THE
COMBINED COMPANY, THE PROPOSED TRANSACTIONS AND RELATED
MATTERS.
After the Form S-4 is declared effective, the definitive Proxy
Statement included in the Form S-4 will be mailed to Reneo
stockholders as of a record date to be established for voting on
the matters to be considered at the Reneo special meeting of
stockholders being held in connection with the Proposed
Transactions. Investors and security holders may obtain free copies
of the Form S-4, the Proxy Statement and other documents filed by
Reneo with the SEC through the website maintained by the SEC at
www.sec.gov. Copies of the documents filed by Reneo with the SEC
are available free of charge on Reneo’s website at
www.reneopharma.com/investors or by contacting Reneo’s Investor
Relations at investors@reneopharma.com.
Participants in the Solicitation
Reneo, OnKure and their respective directors and certain of
their executive officers may be considered participants in the
solicitation of proxies from Reneo’s stockholders with respect to
the Proposed Transactions under the rules of the SEC. Information
about the directors and executive officers of Reneo and their
ownership of common stock of Reneo is set forth in its Annual
Report on Form 10-K for the year ended December 31, 2023, which was
filed with the SEC on March 28, 2024, as amended on April 26, 2024,
including under the sections entitled “Item 10. Directors,
Executive Officers and Corporate Governance”, “Item 11. Executive
Compensation”, “Item 12. Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters”, and “Item
13. Certain Relationships and Related Transactions, and Director
Independence”. To the extent the security holdings of directors and
executive officers of Reneo have changed since the amounts
described in this filing, such changes are set forth on Initial
Statements of Beneficial Ownership on Form 3 or Statements of
Change in Ownership on Form 4 filed with the SEC, which can be
found at no charge at the SEC’s website at www.sec.gov. In
addition, certain of Reneo’s executive officers are expected to
provide consulting services to the combined company following the
closing of the Proposed Transactions. Additional information
regarding the persons who may be deemed participants in the proxy
solicitations and a description of their direct and indirect
interests, by security holdings or otherwise, are included in the
Form S-4 and the Proxy Statement. You may obtain free copies of
this document as described above.
OnKure and its directors and executive officers, which consist
of R. Michael Carruthers, Isaac Manke, Ph.D., Andrew Phillips,
Ph.D., who are the non-employee members of the OnKure board of
directors, Nicholas A. Saccomano, Ph.D., OnKure’s President and
Chief Executive Officer and a member of the OnKure board of
directors, and Jason Leverone, OnKure’s Chief Financial Officer,
may be deemed to be participants in the solicitation of proxies
from Reneo stockholders in connection with the Proposed
Transactions. In the Proposed Transactions, certain outstanding,
unvested equity awards held by Dr. Saccomano will become fully
vested. Following the closing of the Proposed Transactions, Dr.
Saccomano and Mr. Leverone will be named the President and Chief
Executive Officer and Chief Financial Officer, respectively, of
Reneo. Additional information about the OnKure directors and
executive officers, including their direct and indirect interests
in Reneo, by security holdings or otherwise, are included in the
Form S-4 and the Proxy Statement. That document can be obtained
free of charge from the sources indicated above.
No Offer or Solicitation
This press release is for informational purposes only and is
neither an offer to sell, nor a solicitation of an offer to buy or
subscribe for, any securities of Reneo or OnKure, nor is it a
solicitation of any vote in any jurisdiction with respect to the
Proposed Transactions or otherwise.
RENEO PHARMACEUTICALS, INC.Consolidated
Balance Sheets(In thousands, except share and par
value data) |
|
|
|
June 30,2024 |
|
|
December 31,2023 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
35,970 |
|
|
$ |
27,632 |
|
Short-term investments |
|
|
40,704 |
|
|
|
75,331 |
|
Prepaid expenses and other current assets |
|
|
1,316 |
|
|
|
3,659 |
|
Total current assets |
|
|
77,990 |
|
|
|
106,622 |
|
Property and equipment,
net |
|
|
81 |
|
|
|
134 |
|
Right-of-use assets |
|
|
493 |
|
|
|
599 |
|
Other non-current assets |
|
|
153 |
|
|
|
81 |
|
Total assets |
|
$ |
78,717 |
|
|
$ |
107,436 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
64 |
|
|
$ |
8,717 |
|
Accrued expenses |
|
|
953 |
|
|
|
9,129 |
|
Operating lease liabilities, current portion |
|
|
331 |
|
|
|
331 |
|
Total current liabilities |
|
|
1,348 |
|
|
|
18,177 |
|
Operating lease liabilities,
less current portion |
|
|
492 |
|
|
|
642 |
|
Performance award |
|
|
8 |
|
|
|
7 |
|
Total liabilities |
|
|
1,848 |
|
|
|
18,826 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par
value; 200,000,000 shares authorized at June 30, 2024 and
December 31, 2023; 33,420,808 shares issued and outstanding at
June 30, 2024 and December 31, 2023 |
|
|
3 |
|
|
|
3 |
|
Additional paid-in
capital |
|
|
309,140 |
|
|
|
307,073 |
|
Accumulated deficit |
|
|
(232,261 |
) |
|
|
(218,474 |
) |
Accumulated other
comprehensive (loss) income |
|
|
(13 |
) |
|
|
8 |
|
Total stockholders’ equity |
|
|
76,869 |
|
|
|
88,610 |
|
Total liabilities and stockholders’ equity |
|
$ |
78,717 |
|
|
$ |
107,436 |
|
RENEO PHARMACEUTICALS, INC.Consolidated
Statements of Operations and Comprehensive Loss(In
thousands, except share and per share
data)(Unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
590 |
|
|
$ |
14,400 |
|
|
$ |
5,533 |
|
|
$ |
25,389 |
|
General and administrative |
|
|
5,774 |
|
|
|
6,639 |
|
|
|
10,396 |
|
|
|
11,771 |
|
Total operating expenses |
|
|
6,364 |
|
|
|
21,039 |
|
|
|
15,929 |
|
|
|
37,160 |
|
Loss from operations |
|
|
(6,364 |
) |
|
|
(21,039 |
) |
|
|
(15,929 |
) |
|
|
(37,160 |
) |
Other income |
|
|
1,003 |
|
|
|
1,508 |
|
|
|
2,142 |
|
|
|
2,522 |
|
Net loss |
|
|
(5,361 |
) |
|
|
(19,531 |
) |
|
|
(13,787 |
) |
|
|
(34,638 |
) |
Unrealized (loss) gain on short-term investments |
|
|
(1 |
) |
|
|
(43 |
) |
|
|
(21 |
) |
|
|
12 |
|
Comprehensive loss |
|
$ |
(5,362 |
) |
|
$ |
(19,574 |
) |
|
$ |
(13,808 |
) |
|
$ |
(34,626 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.25 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
|
33,420,808 |
|
|
|
30,215,321 |
|
|
|
33,420,808 |
|
|
|
27,640,172 |
|
RENEO PHARMACEUTICALS, INC.Consolidated
Statements of Cash Flows(In
thousands)(Unaudited) |
|
|
|
Six Months
EndedJune 30, |
|
|
|
2024 |
|
2023 |
|
Cash flows from operating
activities |
|
|
|
|
|
Net loss |
|
$ |
(13,787 |
) |
$ |
(34,638 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
Stock-based compensation |
|
|
2,067 |
|
|
2,364 |
|
Depreciation and amortization |
|
|
28 |
|
|
83 |
|
Amortization/accretion on short-term investments |
|
|
(1,644 |
) |
|
(2,011 |
) |
Changes in the fair value of performance award |
|
|
1 |
|
|
847 |
|
Non-cash lease expense |
|
|
129 |
|
|
241 |
|
Loss on disposal of fixed asset |
|
|
27 |
|
|
3 |
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
Prepaid and other assets |
|
|
2,360 |
|
|
1,542 |
|
Accounts payable and accrued expenses |
|
|
(16,829 |
) |
|
6,690 |
|
Operating lease liabilities |
|
|
(173 |
|
|
(283 |
) |
Net cash used in operating
activities |
|
|
(27,821 |
) |
|
(25,162 |
) |
Cash flows from investing
activities |
|
|
|
|
|
Purchases of property and equipment |
|
|
(2 |
) |
|
(177 |
) |
Purchase of available-for-sale short-term investments |
|
|
(67,750 |
) |
|
(132,327 |
) |
Proceeds from maturities of available-for-sale short-term
investments |
|
|
104,000 |
|
|
82,000 |
|
Net cash provided by (used in)
investing activities |
|
|
36,248 |
|
|
(50,504 |
) |
Cash flows from financing
activities |
|
|
|
|
|
Payments of deferred costs in connection with private placement
transaction |
|
(89 |
) |
|
— |
|
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 |
|
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 |
|
— |
|
|
282 |
|
Net cash (used in)
provided by financing activities |
|
(89 |
) |
|
64,820 |
|
Net increase
(decrease) in cash and cash equivalents |
|
8,338 |
|
|
(10,846 |
) |
Cash and cash
equivalents, beginning of period |
|
27,632 |
|
|
19,927 |
|
Cash and cash
equivalents, end of period |
$ |
35,970 |
|
|
$ |
9,081 |
|
Noncash
investing and financing activities: |
|
|
|
|
Property and
equipment in accounts payable |
$ |
— |
|
|
$ |
10 |
|
|
Contact:
Danielle Spangler Investor Relations Reneo Pharmaceuticals, Inc.
dspangler@reneopharma.com
Reneo Pharmaceuticals (NASDAQ:RPHM)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Reneo Pharmaceuticals (NASDAQ:RPHM)
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