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 ended March 31, 2023 and provided a business update.
“In the first quarter we achieved a key milestone with the
completion of enrollment of the pivotal STRIDE study. We have been
encouraged by the patient interest in our mavodelpar program, which
led to an over-enrollment in STRIDE and high rate of rollover into
the STRIDE AHEAD open-label long-term extension trial,” said
Gregory J. Flesher, President and Chief Executive Officer of Reneo
Pharmaceuticals. “Subsequent to achieving this milestone, we raised
additional capital to strengthen our balance sheet. We expect that
this capital will be utilized to support the mavodelpar program
through completion and in preparation for commercialization
activities, including the potential filing of a new drug
application in the first half of 2024.”
First Quarter and Recent Highlights
- Completed
enrollment with 213 patients in the pivotal STRIDE study of
mavodelpar (REN001) in adult patients with primary mitochondrial
myopathies (PMM), exceeding the target enrollment of 200 patients;
topline results anticipated in the fourth quarter of 2023
- Enrolled over 100 patients in the
STRIDE AHEAD study, the mavodelpar open-label extension (OLE) trial
in adult patients with PMM; over 50 patients reaching 6-months in
the study
- The STRIDE AHEAD study was amended
to allow the enrollment of adult patients with PMM due to nuclear
DNA (nDNA) defects; initiate enrollment of nDNA patients in the
second quarter of 2023
- Received Fast Track Designation from
the United States (US) Food and Drug Administration (FDA) for
mavodelpar in a genotype of long-chain fatty acid oxidation
disorder (LC-FAOD)
- Presented preclinical poster at
Society for Inherited Metabolic Disorders (SIMD) Annual Meeting
entitled, PPARδ Agonist REN001 Improves Mitochondrial Function in
Skeletal Muscle: A Potential Treatment for Primary Mitochondrial
Myopathies
- Raised $68.3 million in gross
proceeds from a concurrent public offering and private placement in
May 2023
Financial Results for the Three Months Ended March 31,
2023
We reported a net loss of $15.1 million, or $0.60 per share,
during the first quarter of 2023, compared to a net loss of $13.0
million, or $0.53 per share, for the same period in 2022. We had
$93.8 million in cash, cash equivalents, and short-term investments
as of March 31, 2023.
Research and development (R&D) expenses were $11.0 million
during the first quarter of 2023, compared to $9.3 million for the
same period in 2022. This increase in R&D expenses was
primarily due to an increase of $1.4 million related to clinical
study costs in support of marketing registration of mavodelpar.
General and administrative (G&A) expenses were $5.1 million
during the first quarter of 2023, compared to $3.7 million for the
same period in 2022. This increase in G&A expenses was
primarily due to an increase of $1.1 million in facility and
personnel-related costs due to additional headcount.
On May 8, 2023, we completed a public offering in which we sold
an aggregate of 7,906,250 shares of common stock, which included
the full exercise of the underwriters’ option to purchase an
additional 1,031,250 shares of common stock, at a price of $8.00
per share. We received total net proceeds from the offering of
approximately $58.2 million, after deducting underwriting discounts
and commissions and offering expenses.
On May 9, 2023, we completed a concurrent private placement in
which we sold an aggregate of 625,000 shares of common stock to
Abingworth Bioventures 8 L.P., a holder of more than 5% of our
common stock, at a price of $8.00 per share. We received total net
proceeds from the private placement of approximately $4.7 million,
after deducting advisor fees and other estimated fees and
expenses.
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, timing for
the filing of a new drug application and for the first patient
enrolled in the STRIDE AHEAD study, announcement of topline data
from the STRIDE study and the use of the proceeds from our recent
public offering and private placement. 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)
|
|
March 31,2023 |
|
|
December 31,2022 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
30,395 |
|
|
$ |
19,927 |
|
Short-term investments |
|
|
63,392 |
|
|
|
81,246 |
|
Prepaid expenses and other current assets |
|
|
3,231 |
|
|
|
5,180 |
|
Total current assets |
|
|
97,018 |
|
|
|
106,353 |
|
Property and equipment, net |
|
|
581 |
|
|
|
453 |
|
Right-of-use assets |
|
|
1,188 |
|
|
|
1,292 |
|
Other non-current assets |
|
|
81 |
|
|
|
84 |
|
Total assets |
|
$ |
98,868 |
|
|
$ |
108,182 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,802 |
|
|
$ |
1,893 |
|
Accrued expenses |
|
|
8,316 |
|
|
|
4,827 |
|
Operating lease liabilities, current portion |
|
|
363 |
|
|
|
404 |
|
Total current liabilities |
|
|
10,481 |
|
|
|
7,124 |
|
Operating lease liabilities, less
current portion |
|
|
979 |
|
|
|
1,059 |
|
Performance award |
|
|
324 |
|
|
|
29 |
|
Total liabilities |
|
|
11,784 |
|
|
|
8,212 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value;
200,000,000 shares authorized at March 31, 2023 and
December 31, 2022; 25,107,430 and 24,699,553 shares issued and
outstanding at March 31, 2023 and December 31, 2022,
respectively |
|
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
238,859 |
|
|
|
236,693 |
|
Accumulated deficit |
|
|
(151,790 |
) |
|
|
(136,683 |
) |
Accumulated other comprehensive
income (loss) |
|
|
12 |
|
|
|
(43 |
) |
Total stockholders’ equity |
|
|
87,084 |
|
|
|
99,970 |
|
Total liabilities and stockholders’ equity |
|
$ |
98,868 |
|
|
$ |
108,182 |
|
RENEO PHARMACEUTICALS,
INC.Consolidated Statements of Operations and
Comprehensive Loss(In thousands, except share and
per share data)
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
10,991 |
|
|
$ |
9,278 |
|
General and administrative |
|
|
5,132 |
|
|
|
3,737 |
|
Total operating expenses |
|
|
16,123 |
|
|
|
13,015 |
|
Loss from operations |
|
|
(16,123 |
) |
|
|
(13,015 |
) |
Other income (loss) |
|
|
1,016 |
|
|
|
(21 |
) |
Net loss |
|
|
(15,107 |
) |
|
|
(13,036 |
) |
Unrealized gain on short-term investments |
|
|
55 |
|
|
|
30 |
|
Comprehensive loss |
|
$ |
(15,052 |
) |
|
$ |
(13,006 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.60 |
) |
|
$ |
(0.53 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
|
25,036,410 |
|
|
|
24,458,290 |
|
RENEO PHARMACEUTICALS,
INC.Consolidated Statements of Cash
Flows(In thousands)
|
|
Three Months
EndedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows from operating
activities |
|
|
|
|
|
|
Net loss |
|
$ |
(15,107 |
) |
|
$ |
(13,036 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Stock-based compensation |
|
|
1,157 |
|
|
|
1,107 |
|
Depreciation and amortization |
|
|
41 |
|
|
|
19 |
|
Amortization/accretion on short-term investments |
|
|
(770 |
) |
|
|
1 |
|
Changes in the fair value of performance award |
|
|
295 |
|
|
|
(387 |
) |
Non-cash lease expense |
|
|
120 |
|
|
|
143 |
|
Loss on disposal of fixed asset |
|
|
3 |
|
|
|
— |
|
Changes in operating assets and
liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
1,952 |
|
|
|
2,011 |
|
Accounts payable and accrued expenses |
|
|
3,398 |
|
|
|
1,251 |
|
Operating lease liabilities |
|
|
(137 |
) |
|
|
(108 |
) |
Net cash used in operating
activities |
|
|
(9,048 |
) |
|
|
(8,999 |
) |
Cash flows from investing
activities |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(172 |
) |
|
|
(44 |
) |
Purchase of available-for-sale short-term investments |
|
|
(28,321 |
) |
|
|
(16,029 |
) |
Proceeds from maturities of available-for-sale short-term
investments |
|
|
47,000 |
|
|
|
21,500 |
|
Net cash provided by investing
activities |
|
|
18,507 |
|
|
|
5,427 |
|
Cash flows from financing
activities |
|
|
|
|
|
|
Proceeds from at-the-market facility, net of offering costs |
|
|
1,009 |
|
|
|
6 |
|
Net cash provided by financing
activities |
|
|
1,009 |
|
|
|
6 |
|
Net increase (decrease) in cash
and cash equivalents |
|
|
10,468 |
|
|
|
(3,566 |
) |
Cash and cash equivalents,
beginning of period |
|
|
19,927 |
|
|
|
124,660 |
|
Cash and cash equivalents, end of
period |
|
$ |
30,395 |
|
|
$ |
121,094 |
|
Noncash operating
activities: |
|
|
|
|
|
|
Right-of-use assets obtained in
exchange for lease obligations |
|
$ |
— |
|
|
$ |
1,524 |
|
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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