UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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 21, 2024, Landos Biopharma, Inc. issued a press release announcing its financial results for the three and twelve months ended December 31, 2023. 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, as amended, 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 21, 2024 |
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 2023 Results
Top-line Results from the NEXUS Phase 2 Clinical Trial of NX-13 for Ulcerative Colitis
Planned for Q4 2024
Sufficient Cash to Fund Planned Operations into mid-2025
NEW YORK, March 21, 2024 –– Landos Biopharma, Inc. (NASDAQ: LABP) (“Landos” or “the Company”), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and reported financial results for the fourth quarter and the full year ended December 31, 2023.
“We were focused in 2023 on advancing the NX-13 clinical program and establishing Landos as a leader in targeting immunometabolic pathways and developing novel and first-in-class, oral therapies for autoimmune diseases,” said Gregory Oakes, President and CEO of Landos. “We continue to advance the NEXUS Phase 2 study of NX-13 in ulcerative colitis and are excited about the strong momentum we have generated.”
Fourth Quarter 2023 and Recent Highlights
Summary of Fourth Quarter and Full Year 2023 Financial Results
Cash and Cash Equivalents
Fourth Quarter 2023
Full Year 2023
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 diseases. Our mission is to create safer and more effective oral 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 multiple indications in the immunology space.
We are currently focused on advancing the clinical development of NX-13 in UC. We initiated the NEXUS Phase 2 proof-of-concept trial in the second quarter of 2023 and plan to report topline results in 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 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 current and future clinical trials, including the ongoing 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 Company’s 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. 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
Rebecca Mosig, Vice President, Corporate Development
Landos Biopharma
ir@landosbiopharma.com
Mike Moyer
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
Landos Biopharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
Operating expenses: |
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Research and development |
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$ 3,147 |
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$ 3,414 |
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$ 11,999 |
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$ 25,680 |
General and administrative |
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3,463 |
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3,099 |
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10,728 |
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14,881 |
Total operating expenses |
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6,610 |
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6,513 |
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22,727 |
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40,561 |
Loss from operations |
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(6,610) |
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(6,513) |
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(22,727) |
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(40,561) |
Other income, net |
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491 |
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1,281 |
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792 |
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1,285 |
Net loss |
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$ (6,119) |
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$ (5,232) |
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$ (21,935) |
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$ (39,276) |
Net loss per share, basic and diluted |
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$ (0.99) |
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$ (1.30) |
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$ (3.50) |
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$ (9.76) |
Weighted-average shares used to compute net loss per share, basic and diluted |
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6,207,637 |
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4,025,489 |
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6,275,856 |
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4,025,489 |
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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2023 |
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2022 |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 37,499 |
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$ 36,640 |
Marketable securities, available-for-sale |
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— |
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7,762 |
Restricted cash |
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50 |
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— |
Prepaid expenses and other current assets |
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491 |
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851 |
Total current assets |
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38,040 |
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45,253 |
Total assets |
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$ 38,040 |
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$ 45,253 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ 1,375 |
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$ 3,435 |
Accrued liabilities |
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4,874 |
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2,687 |
Total current liabilities |
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6,249 |
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6,122 |
Total liabilities |
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6,249 |
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6,122 |
Commitments and contingencies |
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Stockholders’ equity: |
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Common stock |
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31 |
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40 |
Additional paid-in capital |
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187,122 |
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172,575 |
Accumulated other comprehensive loss |
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— |
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(57) |
Accumulated deficit |
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(155,362) |
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(133,427) |
Total stockholders’ equity |
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31,791 |
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39,131 |
Total liabilities and stockholders’ equity |
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$ 38,040 |
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$ 45,253 |