UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 23, 2023, Landos Biopharma, Inc. issued a press release announcing its financial results for the three and twelve months ended December 31, 2022. A copy of this press release is furnished as Exhibit 99.1 hereto.
The information in this Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d). Exhibits
Exhibit No. |
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Description |
99.1 |
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104 |
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Cover page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Landos Biopharma, Inc. |
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Date: |
March 23, 2023 |
By: |
/s/ Gregory Oakes |
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Gregory Oakes |
Exhibit 99.1
Landos Biopharma Provides Business Update and Reports Fourth Quarter and Full Year 2022 Results
On Track to Initiate Phase 2 Proof-of-Concept Trial in Ulcerative Colitis for NX-13 in the Second Quarter of 2023 and Report Topline Results by the Fourth Quarter of 2024
Projected Cash Runway into First Half of 2025
NEW YORK, March 23, 2023 –– Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2022.
“Meaningful progress has been made this year as we streamlined our product candidate portfolio to focus on our most promising asset. We believe Landos is uniquely positioned to transform the treatment paradigm for patients with ulcerative colitis with our novel, oral, once-daily treatment NX-13,” said Gregory Oakes, President and CEO of Landos. “Our capital efficient approach focuses resources towards advancing the clinical development of NX-13, while maximizing our ability to create value for our shareholders.”
NX-13 Clinical Development Updates
NX-13 is a novel, gut-selective NLXR1 agonist in development as a once-daily, oral treatment for ulcerative colitis (UC).
Corporate Updates
Summary of Fourth Quarter and Full Year 2022 Results
Cash, Cash Equivalents and Marketable Securities:
Quarter Ended December 31, 2022
Year Ended December 31, 2022
About Landos Biopharma
Landos Biopharma is a clinical stage biopharmaceutical company focused on the development of first-in-class, oral therapeutics for patients with autoimmune disease. Our mission is to create safer and more effective treatments that address the therapeutic gap in the current treatment paradigm.
We have a portfolio of novel targets anchoring two libraries of immunometabolic modulation pathways, including four potentially first-in-class, once-daily, oral therapies targeting eight indications in the immunology space.
We are currently focused on advancing the clinical development of NX-13 in UC and are on-track to initiate a Phase 2 proof-of-concept trial in the second quarter of 2023, with plans to share topline data by the fourth quarter of 2024.
For more information, please visit www.landosbiopharma.com.
Cautionary Note on Forward-Looking Statements
Statements 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 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, including the planned Phase 2 trial of NX-13, 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, the ability of Dr. Bassaganya-Riera and certain affiliated individuals and entities to successfully develop and commercialize the LANCL platform in order for Landos to receive royalties on sales of such products, our anticipated cash runway 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
Investors
Patrick Truesdell, Vice President and Controller
Landos Biopharma
ir@landosbiopharma.com
John Mullaly
LifeSci Advisors, LLC
jmullaly@lifesciadvisors.com
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Landos Biopharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
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Quarters Ended December 31, |
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Years Ended December 31, |
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2022 |
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2021 |
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2022 |
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2021 |
Revenue - license fee: |
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$ - |
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$ - |
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$ - |
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$ 18,000 |
Operating expenses: |
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Research and development |
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3,414 |
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13,444 |
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25,680 |
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41,564 |
General and administrative |
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3,099 |
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6,952 |
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14,881 |
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15,252 |
Total operating expenses |
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6,513 |
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20,396 |
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40,561 |
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56,816 |
Loss from operations |
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(6,513) |
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(20,396) |
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(40,561) |
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(38,816) |
Other income (loss), net |
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1,281 |
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299 |
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1,285 |
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394 |
Net loss |
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$ (5,232) |
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$ (20,097) |
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$ (39,276) |
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$ (38,422) |
Net loss per share, basic and diluted |
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$ (0.13) |
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$ (0.50) |
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$ (0.98) |
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$ (1.02) |
Weighted-average shares used to compute net loss per share, basic and diluted |
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40,254,890 |
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40,169,747 |
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40,254,890 |
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37,558,464 |
Landos Biopharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
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December 31, |
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December 31, |
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2022 |
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2021 |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 36,640 |
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$ 8,305 |
Marketable securities, available-for-sale |
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7,762 |
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82,575 |
Prepaid expenses and other current assets |
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851 |
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1,266 |
Total current assets |
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45,253 |
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92,146 |
Property and equipment, net |
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— |
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707 |
Other assets |
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— |
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26 |
Total assets |
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$ 45,253 |
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$ 92,879 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ 3,435 |
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$ 12,908 |
Accrued liabilities |
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2,687 |
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3,703 |
Total current liabilities |
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6,122 |
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16,611 |
Total liabilities |
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6,122 |
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16,611 |
Commitments and contingencies |
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Stockholders’ equity: |
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Common stock |
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403 |
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403 |
Additional paid-in capital |
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172,212 |
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170,241 |
Accumulated other comprehensive loss |
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(57) |
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(225) |
Accumulated deficit |
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(133,427) |
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(94,151) |
Total stockholders’ equity |
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39,131 |
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76,268 |
Total liabilities and stockholders’ equity |
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$ 45,253 |
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$ 92,879 |