Keros Therapeutics Reports Second Quarter 2024 Financial Results
August 07 2024 - 4:01PM
Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS),
a clinical-stage biopharmaceutical company focused on developing
and commercializing novel therapeutics to treat a wide range of
patients with disorders that are linked to dysfunctional signaling
of the transforming growth factor-beta (“TGF-ß”) family of
proteins, today reported financial results for the quarter ended
June 30, 2024.
“Keros continued to build upon the progress of all programs
across our pipeline in the second quarter of 2024, as evidenced by
our recent positive regulatory and data updates from the
elritercept (KER-050) program,” said Jasbir S. Seehra, Ph.D., Chair
and Chief Executive Officer. “We continue to be excited by the
strong enrollment activity we have seen to date in our Phase 2
clinical trial of cibotercept (KER-012) in patients with pulmonary
arterial hypertension and look forward to completing enrollment of
that trial in the fourth quarter of this year.”
Second Quarter 2024 Financial
Results
Keros reported a net loss of $45.3 million in the second quarter
of 2024 as compared to a net loss of $37.5 million in the second
quarter of 2023. The increase of $7.8 million for the second
quarter was largely due to increased research and development
efforts as well as additional investments to support the
achievement of Keros’ clinical and corporate goals.
Research and development expenses were $40.5 million for the
second quarter of 2024 as compared to $32.5 million for the same
period in 2023. The increase of $8.0 million was primarily due to
additional research and development efforts, manufacturing
activities and personnel expenses to support the advancement of
Keros’ pipeline.
General and administrative expenses were $10.0 million for the
second quarter of 2024 as compared to $8.8 million for the same
period in 2023. The increase of $1.2 million was primarily due to
increase in personnel expenses and other external expenses to
support Keros’ organizational growth.
Keros’ cash and cash equivalents as of June 30, 2024 was
$405.9 million compared to $331.1 million as of December 31, 2023.
Keros expects that the cash and cash equivalents it had on hand at
June 30, 2024 will enable Keros to fund its operating expenses
and capital expenditure requirements into 2027.
About Keros Therapeutics, Inc.
Keros is a clinical-stage biopharmaceutical company focused on
developing and commercializing novel therapeutics to treat a wide
range of patients with disorders that are linked to dysfunctional
signaling of the TGF-ß family of proteins. We are a leader in
understanding the role of the TGF-ß family of proteins, which are
master regulators of the growth, repair and maintenance of a number
of tissues, including blood, bone, skeletal muscle, adipose and
heart tissue. By leveraging this understanding, we have discovered
and are developing protein therapeutics that have the potential to
provide meaningful and potentially disease-modifying benefit to
patients. Keros’ lead product candidate, elritercept (KER-050), is
being developed for the treatment of low blood cell counts, or
cytopenias, including anemia and thrombocytopenia, in patients with
myelodysplastic syndromes and in patients with myelofibrosis.
Keros’ second product candidate, cibotercept (KER-012), is being
developed for the treatment of pulmonary arterial hypertension and
for the treatment of cardiovascular disorders. Keros’ third product
candidate, KER-065, is being developed for the treatment of obesity
and for the treatment of neuromuscular diseases.
Cautionary Note Regarding 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, as amended. Words such as “enable,” “expects,” “look
forward,” “progress” and “will” or similar expressions are intended
to identify forward-looking statements. Examples of these
forward-looking statements include statements concerning: Keros’
expectations regarding its growth, strategy, progress and the
design, objectives and timing of its clinical trials for
elritercept and cibotercept, including its regulatory plans; and
Keros’ expected cash runway. Because such statements are subject to
risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements.
These risks and uncertainties include, among others: Keros’ limited
operating history and historical losses; Keros’ ability to raise
additional funding to complete the development and any
commercialization of its product candidates; Keros’ dependence on
the success of its product candidates, elritercept, cibotercept and
KER-065; that Keros may be delayed in initiating, enrolling or
completing any clinical trials; competition from third parties that
are developing products for similar uses; Keros’ ability to obtain,
maintain and protect its intellectual property; and Keros’
dependence on third parties in connection with manufacturing,
clinical trials and preclinical studies.
These and other risks are described more fully in Keros’ filings
with the Securities and Exchange Commission (“SEC”), including the
“Risk Factors” section of the Company’s Quarterly Report on Form
10-Q, filed with the SEC on May 8, 2024, and its other documents
subsequently filed with or furnished to the SEC. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, Keros undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Investor Contact:
Justin Frantzjfrantz@kerostx.com 617-221-6042
|
KEROS THERAPEUTICS, INC.Condensed Consolidated
Statements of Operations(In thousands, except share and per share
data)(Unaudited) |
| |
THREE MONTHS ENDED JUNE 30, |
|
SIX MONTHS ENDED JUNE 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
REVENUE: |
|
|
|
|
|
|
|
|
Service and other revenue |
|
37 |
|
|
|
— |
|
|
|
120 |
|
|
|
— |
|
|
Total revenue |
|
37 |
|
|
|
— |
|
|
|
120 |
|
|
|
— |
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
(40,515 |
) |
|
|
(32,534 |
) |
|
|
(78,773 |
) |
|
|
(63,625 |
) |
|
General and administrative |
|
(9,961 |
) |
|
|
(8,803 |
) |
|
|
(20,269 |
) |
|
|
(16,581 |
) |
|
Total operating expenses |
|
(50,476 |
) |
|
|
(41,337 |
) |
|
|
(99,042 |
) |
|
|
(80,206 |
) |
| LOSS
FROM OPERATIONS |
|
(50,439 |
) |
|
|
(41,337 |
) |
|
|
(98,922 |
) |
|
|
(80,206 |
) |
| OTHER
INCOME (EXPENSE), NET |
|
|
|
|
|
|
|
|
Dividend income |
|
5,378 |
|
|
|
3,987 |
|
|
|
11,184 |
|
|
|
7,093 |
|
|
Other expense, net |
|
(196 |
) |
|
|
(155 |
) |
|
|
(633 |
) |
|
|
(196 |
) |
|
Total other income, net |
|
5,182 |
|
|
|
3,832 |
|
|
|
10,551 |
|
|
|
6,897 |
|
| Net
loss |
$ |
(45,257 |
) |
|
$ |
(37,505 |
) |
|
$ |
(88,371 |
) |
|
$ |
(73,309 |
) |
| Net loss attributable to
common stockholders—basic and diluted |
$ |
(45,257 |
) |
|
$ |
(37,505 |
) |
|
$ |
(88,371 |
) |
|
$ |
(73,309 |
) |
| Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(1.25 |
) |
|
$ |
(1.27 |
) |
|
$ |
(2.46 |
) |
|
$ |
(2.53 |
) |
| Weighted-average common stock
outstanding—basic and diluted |
|
36,103,187 |
|
|
|
29,602,458 |
|
|
|
35,894,305 |
|
|
|
28,989,361 |
|
|
KEROS THERAPEUTICS, INC.Condensed Consolidated
Balance Sheets(In thousands, except share and per share
data)(Unaudited) |
| |
JUNE 30,2024 |
|
DECEMBER 31,2023 |
| ASSETS |
|
|
|
| CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
405,863 |
|
|
331,147 |
|
|
Accounts receivable |
4 |
|
|
143 |
|
|
Prepaid expenses and other current assets |
26,847 |
|
|
16,003 |
|
|
Total current assets |
432,714 |
|
|
347,293 |
|
| Operating lease right-of-use
assets |
14,649 |
|
|
15,334 |
|
| Property and equipment,
net |
4,292 |
|
|
4,134 |
|
| Restricted cash |
1,212 |
|
|
1,212 |
|
| Other long-term assets |
2,155 |
|
|
2,052 |
|
|
TOTAL ASSETS |
455,022 |
|
|
370,025 |
|
| LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
| CURRENT LIABILITIES: |
|
|
|
| Accounts payable |
6,535 |
|
|
5,450 |
|
| Current portion of operating
lease liabilities |
1,096 |
|
|
1,005 |
|
| Accrued expenses and other
current liabilities |
13,614 |
|
|
17,918 |
|
|
Total current liabilities |
21,245 |
|
|
24,373 |
|
| Operating lease liabilities,
net of current portion |
12,861 |
|
|
13,439 |
|
|
Total liabilities |
34,106 |
|
|
37,812 |
|
| STOCKHOLDERS' EQUITY: |
|
|
|
| Preferred stock, par value of
$0.0001 per share; 10,000,000 shares authorized as of June 30, 2024
and December 31, 2023; no shares issued and outstanding |
— |
|
|
— |
|
| Common stock, par value of
$0.0001 per share; 200,000,000 shares authorized as of June 30,
2024 and December 31, 2023; 36,169,558 and 31,841,084 shares issued
and outstanding as of June 30, 2024 and December 31, 2023,
respectively |
3 |
|
|
3 |
|
|
Additional paid-in capital |
890,710 |
|
|
713,636 |
|
|
Accumulated deficit |
(469,797 |
) |
|
(381,426 |
) |
|
Total stockholders' equity |
420,916 |
|
|
332,213 |
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
455,022 |
|
|
370,025 |
|
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