Keros Therapeutics Reports Recent Business Highlights and Second Quarter 2023 Financial Results
August 07 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 June 30, 2023.
“We are excited to share our initial development plans for
KER-065—an activin receptor ligand trap that is designed to
increase skeletal muscle and bone mass, increase fat metabolism and
reduce fibrosis—in Duchenne muscular dystrophy (“DMD”), a
debilitating disease with a serious unmet need, and look forward to
moving this important program into the clinic in the first quarter
of 2024,” said Jasbir S. Seehra, Ph.D., President and Chief
Executive Officer of Keros. “As highlighted by the progression of
KER-065 and the initiation of our Phase 2 clinical trial of KER-012
in patients with pulmonary arterial hypertension (“PAH”), we
continue to execute on our strategy of developing our pipeline of
differentiated assets designed to harness the powerful biology of
the TGF-ß family of proteins.”
Recent Program Highlights
- KER-050 for the treatment of ineffective hematopoiesis
to address cytopenias
- Following recommendation by the Safety Review Committee, dosing
for Cohort 4 of Keros’ ongoing Phase 2 clinical trial of KER-050 in
patients with myelofibrosis-associated cytopenias was initiated at
4.5 mg/kg in both combination and monotherapy arms. Keros expects
to announce dose escalation data from and initiate Part 2 of this
trial in the second half of 2023.
- KER-047 for the treatment of functional iron
deficiency
- Keros initiated an open-label Phase 2 clinical trial in
myelodysplastic syndromes (“MDS”) and myelofibrosis patients with
functional iron deficiency. The Company expects to report initial
data from this trial in the first half of 2024.
- KER-012 for the treatment of PAH and for the treatment
of cardiovascular disorders
- In July 2023, Keros announced that the U.S. Food and Drug
Administration cleared the Company's investigational new drug
application to conduct a randomized, double-blind,
placebo-controlled, global Phase 2 clinical trial, which Keros
refers to as the TROPOS trial, of KER-012 in combination with
background therapy in patients with PAH.
- The Company is hosting a conference call and webcast tomorrow,
August 8, 2023, at 8:00 a.m. Eastern time to provide an overview of
the TROPOS trial design.
- KER-065 for the treatment of neuromuscular
disease
- KER-065, which was nominated out of Keros' proprietary library
of activin receptor type II ligand traps, is being developed for
the treatment of neuromuscular diseases, with an initial focus on
DMD.
- The Company plans to commence a randomized, double-blind,
placebo-controlled, two-part Phase 1 clinical trial to evaluate the
safety and tolerability of single and multiple ascending doses of
KER-065 in healthy volunteers in the first quarter of 2024.
Second Quarter 2023 Financial Results
Keros reported a net loss of $37.5 million in the second quarter
of 2023 as compared to a net loss of $27.3 million in the second
quarter of 2022. The increase of $10.2 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 $32.5 million for the
second quarter of 2023 as compared to $23.3 million for the same
period in 2022. The increase of $9.3 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 $8.8 million for the
second quarter of 2023 as compared to $7.4 million for the same
period in 2022. The increase of $1.4 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, 2023 was
$322.0 million compared to $279.0 million as of December 31, 2022.
Keros expects that the cash and cash equivalents it had on hand at
June 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, 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’ lead small molecule product candidate,
KER-047, is being developed for the treatment of functional iron
deficiency. Keros’ third product candidate, KER-012, is being
developed for the treatment of pulmonary arterial hypertension and
for the treatment of cardiovascular disorders. Keros’ fourth
product candidate, KER-065, is being developed for the treatment of
neuromuscular diseases, with an initial focus on DMD.
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,” “plans,”
“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-047, KER-012 and KER-065; 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-047, 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 May 4, 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 JUNE 30, |
|
SIX MONTHS ENDED JUNE 30, |
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
Research and development |
|
(32,534 |
) |
|
|
(23,281 |
) |
|
|
(63,625 |
) |
|
|
(41,359 |
) |
General and administrative |
|
(8,803 |
) |
|
|
(7,447 |
) |
|
|
(16,581 |
) |
|
|
(13,495 |
) |
Total operating expenses |
|
(41,337 |
) |
|
|
(30,728 |
) |
|
|
(80,206 |
) |
|
|
(54,854 |
) |
LOSS
FROM OPERATIONS |
|
(41,337 |
) |
|
|
(30,728 |
) |
|
|
(80,206 |
) |
|
|
(54,854 |
) |
OTHER
INCOME (EXPENSE), NET |
|
|
|
|
|
|
|
Interest expense, net |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1 |
) |
Research and development incentive income |
|
— |
|
|
|
3,376 |
|
|
|
— |
|
|
|
3,376 |
|
Other income, net |
|
3,832 |
|
|
|
86 |
|
|
|
6,897 |
|
|
|
27 |
|
Total other income, net |
|
3,832 |
|
|
|
3,462 |
|
|
|
6,897 |
|
|
|
3,402 |
|
Net
loss |
$ |
(37,505 |
) |
|
$ |
(27,266 |
) |
|
$ |
(73,309 |
) |
|
$ |
(51,452 |
) |
Net loss attributable to
common stockholders—basic and diluted |
$ |
(37,505 |
) |
|
$ |
(27,266 |
) |
|
$ |
(73,309 |
) |
|
$ |
(51,452 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(1.27 |
) |
|
$ |
(1.13 |
) |
|
$ |
(2.53 |
) |
|
$ |
(2.14 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
29,602,458 |
|
|
|
24,053,977 |
|
|
|
28,989,361 |
|
|
|
24,024,004 |
|
KEROS THERAPEUTICS, INC.Condensed
Consolidated Balance Sheets (In thousands, except share
and per share data) (Unaudited) |
|
|
JUNE 30,2023 |
|
DECEMBER 31,2022 |
ASSETS |
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
322,026 |
|
|
279,048 |
|
Prepaid expenses and other current assets |
12,282 |
|
|
6,719 |
|
Total current assets |
334,308 |
|
|
285,767 |
|
Operating lease right-of-use
assets |
16,010 |
|
|
15,548 |
|
Property and equipment,
net |
3,087 |
|
|
2,021 |
|
Restricted cash |
1,327 |
|
|
1,327 |
|
Other long-term assets |
1,574 |
|
|
2,118 |
|
TOTAL ASSETS |
356,306 |
|
|
306,781 |
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable |
4,146 |
|
|
3,339 |
|
Current portion of operating
lease liabilities |
— |
|
|
455 |
|
Accrued expenses and other
current liabilities |
11,949 |
|
|
12,753 |
|
Total current liabilities |
16,095 |
|
|
16,547 |
|
Operating lease liabilities,
net of current portion |
13,951 |
|
|
12,811 |
|
Total liabilities |
30,046 |
|
|
29,358 |
|
STOCKHOLDERS' EQUITY: |
|
|
|
Common stock, par value of
$0.0001 per share; 200,000,000 shares authorized as of June 30,
2023 and December 31, 2022, respectively; 29,661,005 and 27,543,453
shares issued and outstanding as of June 30, 2023 and December 31,
2022, respectively |
3 |
|
|
2 |
|
Additional paid-in capital |
628,000 |
|
|
505,855 |
|
Accumulated deficit |
(301,743 |
) |
|
(228,434 |
) |
Total stockholders' equity |
326,260 |
|
|
277,423 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
356,306 |
|
|
306,781 |
|
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