Landos Biopharma Reports Second Quarter 2022 Results and Provides Business Update
11 Août 2022 - 2:30PM
Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage
biopharmaceutical company developing novel, oral medicines for
patients with autoimmune diseases, today announced financial
results for the second quarter ended June 30, 2022, and provided a
business update.
“Landos continues to make progress advancing our clinical-stage
programs – omilancor, NX-13 and LABP-104 – and positioning the
Company for the future,” said Gregory Oakes, President and CEO of
Landos. “We announced positive top-line results from our NX-13
Phase 1b trial, which showed a favorable safety and tolerability
profile in ulcerative colitis (UC) patients across a range of
doses, as well as promising early efficacy signals. The results
support our belief that NX-13 has the potential to be an important
new oral, once-daily treatment for UC. These positive results also
highlight our sharpened strategic focus on pursuing what we believe
are the most promising molecules and target indications.”
“As we finalize our comprehensive review of the Company’s
clinical development plans, Landos is well positioned to advance
our clinical stage assets and deliver on our mission of addressing
the therapeutic gap for patients with autoimmune diseases. We look
forward to providing a comprehensive update on our pipeline later
this year,” continued Mr. Oakes.
Clinical Development Updates
OmilancorOmilancor is a novel, oral,
gut-restricted LANCL2 agonist in development for the treatment of
UC as a once-daily oral treatment.
- Landos continues to optimize drug product formulation,
including a dose selection assessment. The Company expects to
announce both the timing and next steps in the development of
omilancor later this year.
NX-13NX-13 is a novel, oral, gut-restricted
NLRX1 agonist in development for the treatment of UC as a
once-daily oral treatment.
- The Company recently announced top-line results from its Phase
1b trial in UC patients. The data showed favorable safety and
tolerability across a range of doses, as well as signals of
clinical improvement as soon as two weeks in patients’ symptoms and
four weeks by endoscopy in exploratory endpoints.
- The Company provided additional information regarding results
of the NX-13 Phase 1b trial in a supplemental presentation posted
on the Company’s investor relations website.
- Landos plans to initiate a Phase 2 proof of concept clinical
trial of NX-13 in UC patients to evaluate the safety, efficacy, and
optimal dosing.
LABP-104LABP-104 is a novel, oral, systemically
distributed LANCL2 agonist in development for the treatment of
systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
as a once-daily oral treatment.
- Landos conducted a Phase 1a trial of LABP-104 in healthy
volunteers and expects topline results to be reported later this
year. The Company expects to announce both the timing and next
steps in the development of LABP-104 later this year.
Summary of Second Quarter 2022 Results
Cash, Cash Equivalents and Marketable
Securities:As of June 30, 2022, the Company had cash, cash
equivalents and marketable securities of $55.8 million, which it
believes will be sufficient to fund its planned operations for at
least the next 12 months. Upon completion of its portfolio
prioritization review later this year, the Company will provide
further details into its operating plans and capital
resources.Research and Development
Expenses:Research and development expenses were $6.6
million for the second quarter of 2022, compared to $11.5 million
in the second quarter of 2021. The decrease was primarily
attributed to a reduction in contract research and clinical data
management costs following the planned termination of further
enrollment in two clinical trials of omilancor for the treatment of
Crohn’s Disease. This was partially offset by an increase in
consulting and temporary labor costs for the three months ended
June 30, 2022.
General and Administrative Expenses:General and
administrative expenses were $4.7 million for the second quarter of
2022, compared to $2.6 million in the second quarter of 2021. The
increase was primarily attributable to increases in
employee-related expenses, including stock-based compensation, as
well as an increase in recruiting and legal fees.
About Landos BiopharmaLandos Biopharma is a
clinical-stage biopharmaceutical company focused on the discovery
and development of oral therapeutics for patients with autoimmune
diseases. We believe we were the first to identify and target
LANCL2, NLRX1 and PLXDC2, which are immunometabolic pathways or
targets. We have identified seven novel immunometabolic pathways or
targets based on predictions of immunometabolic function using a
proprietary advanced artificial intelligence-based integrated
computational and experimental precision medicine platform. Our
near-term focus is on our clinical-stage programs including
omilancor for the treatment of UC, NX-13 for the treatment of UC,
and LABP-104 for the potential treatment of systemic lupus
erythematosus and rheumatoid arthritis.
For more information, please visit www.landosbiopharma.com.
Cautionary note on Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects for Landos Biopharma, Inc. (the
“Company”), including statements about the Company’s strategy,
clinical development and regulatory plans for its product
candidates, including omilancor, NX-13 and LABP-104, and other
statements containing the words “anticipate”, “plan”, “expect”,
“may”, “will”, “could”, “believe”, “look forward”, “potential”, the
negatives thereof, variations thereon and similar expressions, or
any discussions of strategy constitute forward-looking statements.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: the uncertainties inherent in the initiation
and enrollment of future clinical trials, expectations of expanding
ongoing clinical trials, availability and timing of data from
ongoing clinical trials, expectations for regulatory approvals,
other matters that could affect the availability or commercial
potential of the Company’s product candidates and other similar
risks. Risks regarding the Company’s business are described in
detail in its Securities and Exchange Commission (“SEC”) filings,
including in its Annual Reports on Form 10-K and Quarterly Reports
on Form 10-Q, which are available on the SEC’s website at
www.sec.gov. Additional information will be made available in other
filings that the Company makes from time to time with the SEC. Such
risks may be amplified by the impacts of the COVID-19 pandemic. In
addition, the forward-looking statements included in this press
release represent the Company’s views only as of the date hereof.
The Company anticipates that subsequent events and developments
will cause the Company’s views to change. However, while the
Company may elect to update these forward-looking statements at
some point in the future, the Company specifically disclaims any
obligation to do so, except as may be required by law. These
forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date hereof.
Contacts
Tanner Kaufman / Kara SperryJoele Frank, Wilkinson Brimmer
Katcher212-355-4449
Landos Biopharma, Inc. Unaudited
Condensed Consolidated Statements of Operations (in thousands,
except share and per share amounts)
|
|
|
|
|
|
Three Months EndedJune 30, |
Six Months
EndedJune 30, |
|
|
2022 |
|
|
2021 |
|
2022 |
|
|
2021 |
|
Revenue - license fee: |
|
$— |
|
$18,000 |
|
$— |
|
$18,000 |
|
Operating expenses: |
|
|
|
|
Research and development |
$6,604 |
|
$11,522 |
$17,404 |
|
$18,776 |
|
General and administrative |
|
4,662 |
|
|
2,596 |
|
8,815 |
|
|
5,241 |
|
Total operating expenses |
|
11,266 |
|
|
14,118 |
|
26,219 |
|
|
24,017 |
|
(Loss) income from
operations |
|
(11,266) |
|
|
3,882 |
|
(26,219) |
|
|
(6,017) |
|
Other (loss) income, net |
|
(18) |
|
|
215 |
|
71 |
|
|
296 |
|
Net (loss) income |
$(11,284) |
|
$4,097 |
$(26,148) |
|
$(5,721) |
|
Net (loss) income per share,
basic and diluted |
$(0.28) |
|
$0.12 |
$(0.65) |
|
$(0.19) |
|
Weighted-average shares used
to compute net (loss) income per share, basic |
|
40,254,890 |
|
|
33,639,481 |
|
40,254,890 |
|
|
29,875,877 |
|
Weighted-average shares used
to compute net (loss) income per share, diluted |
|
40,254,890 |
|
|
34,384,784 |
|
40,254,890 |
|
|
29,875,877 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Landos Biopharma, Inc. Condensed
Consolidated Balance Sheets (in thousands)
|
June 30, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$19,241 |
|
|
$8,305 |
|
Marketable securities, available-for-sale |
|
36,510 |
|
|
|
82,575 |
|
Prepaid expenses and other current assets |
|
2,287 |
|
|
|
1,266 |
|
Total current assets |
|
58,038 |
|
|
|
92,146 |
|
Property and equipment,
net |
|
— |
|
|
|
707 |
|
Other assets |
|
— |
|
|
|
26 |
|
Total assets |
$58,038 |
|
|
$92,879 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$4,711 |
|
|
$12,908 |
|
Accrued liabilities |
|
1,799 |
|
|
|
3,703 |
|
Total current liabilities |
|
6,510 |
|
|
|
16,611 |
|
Total liabilities |
|
6,510 |
|
|
|
16,611 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Common stock |
|
403 |
|
|
|
403 |
|
Additional paid-in capital |
|
171,816 |
|
|
|
170,241 |
|
Accumulated other comprehensive loss |
|
(392) |
|
|
|
(225) |
|
Accumulated deficit |
|
(120,299) |
|
|
|
(94,151) |
|
Total stockholders’ equity |
|
51,528 |
|
|
|
76,268 |
|
Total liabilities and stockholders’ equity |
$58,038 |
|
|
$92,879 |
|
|
|
|
|
|
|
|
|
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