Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage
pharmaceutical company focused on the development and
commercialization of therapies for patients with rare genetic
mitochondrial diseases, today reported financial results for the
quarter and year ended December 31, 2022 and provided a
business update.
2022 and Recent Highlights
- Achieved the target enrollment of 200 patients in the pivotal
STRIDE study of mavodelpar (REN001) in adult patients with primary
mitochondrial myopathies (PMM); topline results anticipated in the
fourth quarter of 2023
- Enrolled 85% of eligible STRIDE study patients in the STRIDE
AHEAD study, the mavodelpar long-term safety clinical trial in
adult patients with PMM
- Received confirmation from the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) that
positive data from the STRIDE and STRIDE AHEAD studies could
potentially support registration of mavodelpar for adult patients
with PMM due to mitochondrial DNA (mtDNA) defects
- Disclosed plans to study mavodelpar in adult patients with PMM
due to nuclear DNA (nDNA) defects in the STRIDE AHEAD study
- Positive results from Phase 1b study in adult patients with
long-chain fatty acid oxidation disorder (LC-FAOD) and plans to
move the program forward into Phase 2 development
- Appointed Michael P. Cruse to the role of Chief Operating
Officer and Jennifer P. Lam to the role of Principal Financial and
Accounting Officer
- Appointed Paul W. Hoelscher and Roshawn Blunt to the Board of
Directors
“We made significant progress with our mavodelpar
development programs and expanded both our leadership team and
Board of Directors in 2022,” said Gregory J. Flesher, President and
CEO of Reneo Pharmaceuticals. “We recently achieved target
enrollment of the STRIDE study and anticipate announcing topline
results of this pivotal clinical trial in the fourth quarter of
2023. In addition, we anticipate dosing our first adult patient
with PMM due to nDNA defects in the coming months, and expect to
finalize our plans for the LC-FAOD Phase 2 program later this year.
Finally, as we move closer towards the potential commercialization
of mavodelpar, we have strengthened our financial, commercial, and
operational expertise by making key changes to the leadership team
and Board of Directors,” concluded Mr. Flesher.
Financial Results for Fourth Quarter and
Full Year 2022
We reported a net loss of $13.6 million, or $0.56
per share, during the fourth quarter of 2022, compared to a net
loss of $10.6 million, or $0.43 per share, for the same period in
2021. For the full year 2022, we reported a net loss of $52.0
million, or $2.12 per share, compared to a net loss of $39.8
million, or $2.19 per share, for the full year 2021. We had $101.2
million in cash, cash equivalents, and short-term investments as of
December 31, 2022.
Research and development (R&D) expenses were
$10.4 million during the fourth quarter of 2022, compared to $7.1
million for the same period in 2021. For the full year 2022,
R&D expenses were $37.7 million, compared to $28.2 million for
the full year 2021. The increase in R&D expense for 2022 was
primarily due to an increase of $6.4 million related to clinical
and manufacturing costs primarily related to our STRIDE and STRIDE
AHEAD studies and an increase of $2.8 million in personnel related
costs due to the additional headcount required to support our
clinical and manufacturing operations.
General and administrative (G&A) expenses were
$4.2 million during the fourth quarter of 2022, compared to $3.5
million for the same period in 2021. For the full year 2022,
G&A expenses were $16.1 million, compared to $11.6 million for
the full year 2021. This increase in G&A expenses for 2022 was
primarily due to an increase of $2.9 million in outside
professional services and an increase of $1.2 million in facility
and personnel related costs due to additional headcount.
About Reneo Pharmaceuticals
Reneo is a clinical-stage pharmaceutical company
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 (ATP). Our lead product candidate, mavodelpar, is a
potent and selective agonist of the peroxisome
proliferator-activated receptor delta (PPARδ). Mavodelpar has been
shown to increase transcription of genes involved in mitochondrial
function and increase fatty acid oxidation (FAO), and may increase
production of new mitochondria. For additional information, please
see reneopharma.com.
About Mavodelpar
Mavodelpar (REN001) is a potent and selective
peroxisome proliferator-activated receptor delta (PPARδ) agonist
currently in clinical development for two rare genetic
mitochondrial diseases that typically present with myopathy and
have high unmet medical needs: PMM and LC-FAOD. For additional
information, please see clinicaltrials.gov.
About PMM
PMM are a group of rare, genetic metabolic
disorders caused by mutations or deletions in the mtDNA or nDNA.
These genetic alterations hamper the ability of mitochondria to
generate energy from nutrient sources, resulting in energy deficits
that are most pronounced in tissues with high energy demand such as
muscle, brain, and heart. The symptoms of PMM include muscle
weakness, exercise intolerance, movement disorder, deafness,
blindness, and droopy eyelids among others. The prognosis for these
disorders ranges in severity from progressive weakness to
death.
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
potential development, registration and commercialization of
mavodelpar, results, conduct, progress, plans and timing of Reneo’s
clinical trials, announcement of topline data from the STRIDE study
and dosing of our first adult patient with PMM due to nDNA defects.
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, |
|
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
19,927 |
|
|
$ |
124,660 |
|
Short-term investments |
|
|
81,246 |
|
|
|
23,010 |
|
Prepaid expenses and other current assets |
|
|
5,180 |
|
|
|
6,064 |
|
Total current assets |
|
|
106,353 |
|
|
|
153,734 |
|
Property and equipment, net |
|
|
453 |
|
|
|
212 |
|
Right-of-use assets |
|
|
1,292 |
|
|
|
— |
|
Other non-current assets |
|
|
84 |
|
|
|
78 |
|
Total assets |
|
$ |
108,182 |
|
|
$ |
154,024 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,893 |
|
|
$ |
2,022 |
|
Accrued expenses |
|
|
4,827 |
|
|
|
4,180 |
|
Operating lease liabilities, current portion |
|
|
404 |
|
|
|
— |
|
Total current liabilities |
|
|
7,124 |
|
|
|
6,202 |
|
Operating lease liabilities, less current portion |
|
|
1,059 |
|
|
|
— |
|
Other long-term liabilities |
|
|
— |
|
|
|
167 |
|
Performance award |
|
|
29 |
|
|
|
444 |
|
Total liabilities |
|
|
8,212 |
|
|
|
6,813 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized
at December 31, 2022 and December 31, 2021;
24,699,553 shares issued and outstanding at December 31, 2022;
and 24,457,838 and 24,455,390 shares issued and outstanding at
December 31, 2021, respectively |
|
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
236,693 |
|
|
|
231,902 |
|
Accumulated deficit |
|
|
(136,683 |
) |
|
|
(84,728 |
) |
Accumulated other comprehensive (loss) income |
|
|
(43 |
) |
|
|
34 |
|
Total stockholders’ equity |
|
|
99,970 |
|
|
|
147,211 |
|
Total liabilities and stockholders’ equity |
|
$ |
108,182 |
|
|
$ |
154,024 |
|
RENEO PHARMACEUTICALS, INC.
Consolidated Statements of Operations and Comprehensive
Loss (In thousands, except share and per share
data)
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating
expenses: |
|
(Unaudited) |
|
|
|
|
|
|
|
Research and development |
|
$ |
10,357 |
|
|
$ |
7,100 |
|
|
$ |
37,705 |
|
|
$ |
28,169 |
|
General and administrative |
|
|
4,205 |
|
|
|
3,524 |
|
|
|
16,143 |
|
|
|
11,649 |
|
Total operating expenses |
|
|
14,562 |
|
|
|
10,624 |
|
|
|
53,848 |
|
|
|
39,818 |
|
Loss from
operations |
|
|
(14,562 |
) |
|
|
(10,624 |
) |
|
|
(53,848 |
) |
|
|
(39,818 |
) |
Other income |
|
|
962 |
|
|
|
17 |
|
|
|
1,893 |
|
|
|
48 |
|
Net
loss |
|
|
(13,600 |
) |
|
|
(10,607 |
) |
|
|
(51,955 |
) |
|
|
(39,770 |
) |
Unrealized (loss) gain on short-term investments |
|
|
(17 |
) |
|
|
17 |
|
|
|
(77 |
) |
|
|
34 |
|
Comprehensive loss |
|
$ |
(13,617 |
) |
|
$ |
(10,590 |
) |
|
$ |
(52,032 |
) |
|
$ |
(39,736 |
) |
Net loss per
share attributable to common stockholders, basic and
diluted |
|
$ |
(0.56 |
) |
|
$ |
(0.43 |
) |
|
$ |
(2.12 |
) |
|
$ |
(2.19 |
) |
Weighted-average shares used in computing net loss per share,
basic and diluted |
|
|
24,484,302 |
|
|
|
24,427,455 |
|
|
|
24,496,425 |
|
|
|
18,143,487 |
|
RENEO PHARMACEUTICALS, INC.
Consolidated Statements of Cash Flows (In
thousands)
|
|
Year Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash flows
from operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(51,955 |
) |
|
$ |
(39,770 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Stock-based compensation |
|
|
4,320 |
|
|
|
3,891 |
|
Depreciation and amortization |
|
|
88 |
|
|
|
50 |
|
Amortization/accretion on short-term investments |
|
|
(817 |
) |
|
|
202 |
|
Changes in the fair value of performance award |
|
|
(415 |
) |
|
|
444 |
|
Non-cash lease expense |
|
|
441 |
|
|
|
— |
|
Loss on disposal of fixed asset |
|
|
17 |
|
|
|
— |
|
Changes in
operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
878 |
|
|
|
(4,711 |
) |
Accounts payable and accrued expenses |
|
|
518 |
|
|
|
1,780 |
|
Operating lease liabilities |
|
|
(437 |
) |
|
|
— |
|
Other current and long-term liabilities |
|
|
— |
|
|
|
131 |
|
Net cash
used in operating activities |
|
|
(47,362 |
) |
|
|
(37,983 |
) |
Cash flows
from investing activities |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(346 |
) |
|
|
(198 |
) |
Purchase of available-for-sale short-term investments |
|
|
(101,596 |
) |
|
|
(31,406 |
) |
Proceeds from maturities of available-for-sale short-term
investments |
|
|
44,100 |
|
|
|
8,228 |
|
Net cash used in investing activities |
|
|
(57,842 |
) |
|
|
(23,376 |
) |
Cash flows
from financing activities |
|
|
|
|
|
|
Proceeds from issuance of Series B convertible preferred stock, net
of issuance costs |
|
|
— |
|
|
|
47,238 |
|
Proceeds from initial public offering, net of offering costs |
|
|
— |
|
|
|
84,612 |
|
Proceeds from at-the-market facility, net of offering costs |
|
|
193 |
|
|
|
— |
|
Proceeds from issuance of common stock in connection with equity
plans |
|
|
278 |
|
|
|
556 |
|
Net cash
provided by financing activities |
|
|
471 |
|
|
|
132,406 |
|
Net
(decrease) increase in cash and cash equivalents |
|
|
(104,733 |
) |
|
|
71,047 |
|
Cash and
cash equivalents, beginning of year |
|
|
124,660 |
|
|
|
53,613 |
|
Cash and
cash equivalents, end of year |
|
$ |
19,927 |
|
|
$ |
124,660 |
|
Noncash operating activities: |
|
|
|
|
|
|
Right-of-use
assets obtained in exchange for lease obligations |
|
$ |
1,733 |
|
|
$ |
— |
|
Noncash investing and financing activities: |
|
|
|
|
|
|
Vesting of
unvested exercised options |
|
$ |
— |
|
|
$ |
4 |
|
Contacts:
Danielle Spangler Investor Relations Reneo
Pharmaceuticals, Inc. dspangler@reneopharma.com
David Melamed, Ph.D. Media Inquiries Russo
Partners, LLC david.melamed@russopartnersllc.com
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