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 third quarter ended September 30, 2022, and
provided a business update.
“Landos has made significant progress advancing our
clinical-stage programs – omilancor, NX-13 and LABP-104,” said
Gregory Oakes, President and CEO of Landos. “In August, 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. We continue to believe in
NX-13’s potential to be an important new oral, once-daily treatment
for UC.”
“We are in the final stages of our comprehensive review of the
Company’s clinical development plans, and we are working through a
few remaining items. This thorough strategic review process has
only reinforced our confidence in the significant potential of our
promising pipeline and strong foundation of clinical data. We are
excited about our future and look forward to providing an update on
our plans to advance our clinical-stage assets and position Landos
for continued clinical success. We are finalizing our review and
expect to provide an update in the coming weeks,” 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
NLXR1 agonist in development for the treatment of UC as a
once-daily oral treatment.
- In August 2022, the Company 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 safety, efficacy, and
optimal dosing. The Company expects to announce the details and
timing of this trial later this year.
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 clinical trial of LABP-104 in
healthy volunteers and expects top-line 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 Third Quarter 2022 Results
Cash, Cash Equivalents and Marketable
Securities:As of September 30, 2022, the Company had cash,
cash equivalents and marketable securities of $48.0 million, which
it believes will be sufficient to fund its planned operations for
at least the next 12 months. The Company plans to provide further
details regarding its operating plans and capital resources upon
completion of the portfolio review later this year.Research
and Development Expenses:Research and development expenses
were $4.9 million for the third quarter of 2022, compared to $9.3
million in the third quarter of 2021. The decrease of
$4.4 million was primarily attributed to a decrease in
clinical research organization and clinical data management costs,
as well as a decrease in compensation costs upon terminating
further enrollment in two omilancor clinical trials for the
treatment of Crohn's Disease.
General and Administrative Expenses:General and
administrative expenses were $3.0 million for the third quarter of
2022, compared to $3.1 million in the third quarter of 2021. The
decrease of $0.1 million was primarily attributable to a
decrease in consulting costs, partially offset by increases in
employee-related expenses, including stock-based compensation, as
well as an increase in 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
InvestorsPatrick Truesdell, Principal
Accounting OfficerLandos Biopharmair@landosbiopharma.com
MediaTanner 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 Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue - license fee: |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
18,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,862 |
|
|
|
9,344 |
|
|
|
22,266 |
|
|
|
28,120 |
|
General and administrative |
|
|
2,967 |
|
|
|
3,059 |
|
|
|
11,782 |
|
|
|
8,300 |
|
Total operating expenses |
|
|
7,829 |
|
|
|
12,403 |
|
|
|
34,048 |
|
|
|
36,420 |
|
Loss from operations |
|
|
(7,829 |
) |
|
|
(12,403 |
) |
|
|
(34,048 |
) |
|
|
(18,420 |
) |
Other income (loss), net |
|
|
(67 |
) |
|
|
(201 |
) |
|
|
4 |
|
|
|
95 |
|
Net loss |
|
$ |
(7,896 |
) |
|
$ |
(12,604 |
) |
|
$ |
(34,044 |
) |
|
$ |
(18,325 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.85 |
) |
|
$ |
(0.50 |
) |
Weighted-average shares used to
compute net loss per share, basic and diluted |
|
|
40,254,890 |
|
|
|
39,962,069 |
|
|
|
40,254,890 |
|
|
|
36,662,627 |
|
Landos Biopharma, Inc. Condensed
Consolidated Balance Sheets (in thousands)
|
|
September 30, |
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
28,880 |
|
|
$ |
8,305 |
|
Marketable securities, available-for-sale |
|
|
19,111 |
|
|
|
82,575 |
|
Prepaid expenses and other current assets |
|
|
1,497 |
|
|
|
1,266 |
|
Total current assets |
|
|
49,488 |
|
|
|
92,146 |
|
Property and equipment, net |
|
|
— |
|
|
|
707 |
|
Other assets |
|
|
— |
|
|
|
26 |
|
Total assets |
|
$ |
49,488 |
|
|
$ |
92,879 |
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,204 |
|
|
$ |
12,908 |
|
Accrued liabilities |
|
|
2,271 |
|
|
|
3,703 |
|
Total current liabilities |
|
|
5,475 |
|
|
|
16,611 |
|
Total liabilities |
|
|
5,475 |
|
|
|
16,611 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Common stock |
|
|
403 |
|
|
|
403 |
|
Additional paid-in capital |
|
|
172,016 |
|
|
|
170,241 |
|
Accumulated other comprehensive loss |
|
|
(211 |
) |
|
|
(225 |
) |
Accumulated deficit |
|
|
(128,195 |
) |
|
|
(94,151 |
) |
Total stockholders’ equity |
|
|
44,013 |
|
|
|
76,268 |
|
Total liabilities and stockholders’ equity |
|
$ |
49,488 |
|
|
$ |
92,879 |
|
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