Keros Therapeutics Reports Recent Business Highlights and Third Quarter 2023 Financial Results
November 06 2023 - 8:00AM
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 provided a business update and reported financial
results for the quarter ended September 30, 2023.
“Over the last quarter, we made strong progress across our
pipeline and executed upon our corporate goals. We continued to
advance our two open-label Phase 2 clinical trials evaluating
KER-050, one in patients with myelodysplastic syndrome (“MDS”) and
one in patients with myelofibrosis, and we look forward to sharing
additional data from both trials at the 65th American Society of
Hematology (“ASH”) Annual Meeting and Exposition later this
quarter,” said Jasbir S. Seehra, Ph.D., President and Chief
Executive Officer of Keros. “We also continued to progress our
ongoing TROPOS Phase 2 clinical trial evaluating KER-012 in
patients with pulmonary arterial hypertension (“PAH”), and
activities related to global clinical trial site activation ramped
up and continue to be a primary focus of our team.”
Recent Program Updates
- KER-050 (elritercept) for the treatment of ineffective
hematopoiesis to address cytopenias
- In November 2023, Keros announced that five abstracts will be
presented at the 65th ASH Annual Meeting and Exposition, which will
include clinical data from its two ongoing Phase 2 clinical trials
of KER-050, one in patients with very low-, low-, or
intermediate-risk MDS and one in patients with myelofibrosis.
- Following recommendation by the Safety Review Committee, dosing
for Part 2 of the KER-050 Phase 2 clinical trial in patients with
myelofibrosis was initiated at a starting dose of 3.75 mg/kg, with
an opportunity for patients to dose escalate to 5.0 mg/kg, in both
combination and monotherapy arms, and the first patient has been
dosed.
- KER-012 for the treatment of PAH and for the treatment
of cardiovascular disorders
- Keros has continued to build momentum for the TROPOS trial,
following dosing of the first patient.
- KER-065 for the treatment of neuromuscular
disease
- Keros expects to initiate the KER-065 Phase 1 clinical trial in
a healthy adult population in the first quarter of 2024. This trial
has been designed to enable the evaluation of any treatment-related
increases in skeletal muscle, decreases in fat and improvements in
bone health, and, as a consequence, the potential of KER-065 for
development opportunities ranging from neuromuscular indications to
metabolic syndromes, including obesity.
- KER-047 for the treatment of functional iron
deficiency
- As part of its ongoing portfolio management activities, Keros
has decided to deprioritize the KER-047 program. Accordingly, Keros
is in the process of early terminating the open-label Phase 2
clinical trial of KER-047 in MDS and myelofibrosis patients with
functional iron deficiency. Keros will continue to evaluate
strategic partnerships and/or transactions to progress development
of KER-047.
Third Quarter 2023 Financial Results
Keros reported a net loss of $39.4 million in the third quarter
of 2023 as compared to a net loss of $23.5 million in the third
quarter of 2022. The increase of $15.9 million for the third
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 $34.1 million for the
third quarter of 2023 as compared to $21.0 million for the same
period in 2022. The increase of $13.1 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 $9.1 million for the
third quarter of 2023 as compared to $6.9 million for the same
period in 2022. The increase of $2.2 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 September 30, 2023
was $287.9 million compared to $279.0 million as of December 31,
2022. Keros expects that the cash and cash equivalents it had on
hand at September 30, 2023 will enable Keros to fund its
operating expenses and capital expenditure requirements into the
fourth quarter of 2025.
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 blood
cells and a number of tissues, including bone, skeletal muscle,
adipose and heart tissue. By leveraging this understanding, we have
discovered and are developing large and small molecules that have
the potential to provide meaningful and potentially
disease-modifying benefit to patients. Keros’ lead protein
therapeutic product candidate, KER-050 (elritercept), is being
developed for the treatment of low blood cell counts, or
cytopenias, including anemia and thrombocytopenia, in patients with
MDS and in patients with myelofibrosis. Keros’ second product
candidate, 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 neuromuscular diseases,
with an initial focus on Duchenne muscular dystrophy.
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,” “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 KER-050, KER-012 and KER-065;
the potential of KER-065 for development opportunities in
neuromuscular indications and metabolic syndromes, including
obesity; 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, KER-050, KER-012 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 August 7, 2023, 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 SEPTEMBER 30, |
|
NINE MONTHS ENDED SEPTEMBER 30, |
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
REVENUE: |
|
|
|
|
|
|
|
Service revenue |
$ |
8 |
|
|
$ |
— |
|
|
$ |
8 |
|
|
$ |
— |
|
Total revenue |
|
8 |
|
|
|
— |
|
|
|
8 |
|
|
|
— |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
Research and development |
|
(34,140 |
) |
|
|
(21,039 |
) |
|
|
(97,765 |
) |
|
|
(62,398 |
) |
General and administrative |
|
(9,148 |
) |
|
|
(6,937 |
) |
|
|
(25,729 |
) |
|
|
(20,432 |
) |
Total operating expenses |
|
(43,288 |
) |
|
|
(27,976 |
) |
|
|
(123,494 |
) |
|
|
(82,830 |
) |
LOSS FROM OPERATIONS |
|
(43,280 |
) |
|
|
(27,976 |
) |
|
|
(123,486 |
) |
|
|
(82,830 |
) |
OTHER INCOME (EXPENSE),
NET |
|
|
|
|
|
|
|
Interest expense, net |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1 |
) |
Research and development incentive income |
|
— |
|
|
|
3,705 |
|
|
|
— |
|
|
|
7,081 |
|
Other income, net |
|
3,840 |
|
|
|
762 |
|
|
|
10,737 |
|
|
|
789 |
|
Total other income, net |
|
3,840 |
|
|
|
4,467 |
|
|
|
10,737 |
|
|
|
7,869 |
|
Net loss |
$ |
(39,440 |
) |
|
$ |
(23,509 |
) |
|
$ |
(112,749 |
) |
|
$ |
(74,961 |
) |
Net loss attributable to
common stockholders—basic and diluted |
$ |
(39,440 |
) |
|
$ |
(23,509 |
) |
|
$ |
(112,749 |
) |
|
$ |
(74,961 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(1.33 |
) |
|
$ |
(0.92 |
) |
|
$ |
(3.86 |
) |
|
$ |
(3.05 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
29,668,247 |
|
|
|
25,549,701 |
|
|
|
29,218,143 |
|
|
|
24,538,159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KEROS THERAPEUTICS,
INC.Condensed Consolidated Balance Sheets
(In thousands, except share and per share data) (Unaudited)
|
SEPTEMBER 30,2023 |
|
DECEMBER 31,2022 |
ASSETS |
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
287,893 |
|
|
279,048 |
|
Prepaid expenses and other current assets |
16,542 |
|
|
6,719 |
|
Total current assets |
304,435 |
|
|
285,767 |
|
Operating lease right-of-use
assets |
15,669 |
|
|
15,548 |
|
Property and equipment,
net |
3,357 |
|
|
2,021 |
|
Restricted cash |
1,212 |
|
|
1,327 |
|
Other long-term assets |
1,574 |
|
|
2,118 |
|
TOTAL ASSETS |
326,247 |
|
|
306,781 |
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable |
3,867 |
|
|
3,339 |
|
Current portion of operating
lease liabilities |
611 |
|
|
455 |
|
Accrued expenses and other
current liabilities |
12,223 |
|
|
12,753 |
|
Total current liabilities |
16,701 |
|
|
16,547 |
|
Operating lease liabilities,
net of current portion |
13,704 |
|
|
12,811 |
|
Total liabilities |
30,405 |
|
|
29,358 |
|
STOCKHOLDERS' EQUITY: |
|
|
|
Common stock, par value of
$0.0001 per share; 200,000,000 shares authorized as of September
30, 2023 and December 31, 2022, respectively; 29,679,143 and
27,543,453 shares issued and outstanding as of September 30, 2023
and December 31, 2022, respectively |
3 |
|
|
2 |
|
Additional paid-in capital |
637,022 |
|
|
505,855 |
|
Accumulated deficit |
(341,183 |
) |
|
(228,434 |
) |
Total stockholders' equity |
295,842 |
|
|
277,423 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
326,247 |
|
|
306,781 |
|
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