Reneo Pharmaceuticals Reports Fourth Quarter And Full Year 2023 Financial Results And Business Update
March 28 2024 - 7:35AM
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) |
|
|
|
December 31, |
|
|
|
2023 |
|
|
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 |
|
|
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 diluted |
|
|
30,676,455 |
|
|
|
24,496,425 |
|
|
RENEO PHARMACEUTICALS, INC.Consolidated
Statements of Cash Flows(In
thousands) |
|
|
|
Year EndedDecember 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 stock
repurchase agreement |
|
|
(4,403 |
) |
|
|
— |
|
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 |
|
|
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
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