Landos Biopharma provides business update and reports fourth quarter and full year 2023 results

Key results from the NEXUS Phase 2 clinical trial of NX-13 for ulcerative colitis Scheduled for Q4 2024

Sufficient cash to fund planned operations through mid-2025

NEW YORK, March 21, 2024 (GLOBE NEWSWIRE) — Landos Biopharma, Inc. (NASDAQ: LABP) (“Landos” or the “Company”) is a clinical-stage company developing novel oral medicines for patients with autoimmune diseases. is a biopharmaceutical company. today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.

“In 2023, we will advance our NX-13 clinical program to develop a novel, first-in-class, oral drug that targets immunometabolic pathways and treats autoimmune diseases,” said Gregory Oakes, President and CEO of Randos. “We are focused on establishing RANDOS as a leader in the development of treatments.” . “We continue to advance the NEXUS Phase 2 study of NX-13 in ulcerative colitis and are excited by the strong momentum we have generated.”

Q4 2023 and recent highlights

• NEXUS is a Phase 2 proof-of-concept clinical trial of NX-13, a novel gut-selective NLRX1 agonist being developed as a once-daily oral treatment for ulcerative colitis (“UC”).

  • The company continues to recruit, screen and randomize patients for trials in the United States and Europe, with 28 sites active to date.

  • NEXUS will evaluate the clinical efficacy, safety, and pharmacokinetics of oral NX-13 in a randomized, multicenter, double-blind, placebo-controlled, multiple-dose, 12-week induction study. Evaluate 80 patients with moderate to severe UC. Long Term Extension (LTE) is for one year. All subjects will be randomly assigned to receive either a 250 mg or 750 mg immediate-release dose of her NX-13 or a placebo (NCT05785715).

  • Best results are expected to be announced in the fourth quarter of 2024.

• In October 2023, the company presented two oral presentations and one poster at European Gastroenterology Week (UEGW) and three posters at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting. Announced. These presentations include additional results from the Phase 1b study of NX-13 for the treatment of UC, including detailed results on rapid symptom relief and improvement in multiple biomarkers observed in the study. It was included.

• In November 2023, a peer-reviewed manuscript describing the safety, tolerability, pharmacokinetic and clinical efficacy results of the NX-13 Phase 1b study in patients with UC was published. Journal of Crohn's Disease and Colitis.

• In February 2024, we presented six abstracts at the 19th Annual General Meeting of the European Crohn's and Colitis Organization (ECCO) in Stockholm, Sweden. These poster presentations highlighted new and additional data regarding immunometabolic regulation by activation of his NLRX1 and PLXDC2 by novel agonists such as NX-13 and LABP-69.

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Summary of fourth quarter and full year 2023 financial results

cash and cash equivalents

• As of December 31, 2023, the Company had cash and cash equivalents of $37.5 million, which it believes are sufficient to fund its planned operations through mid-2025.

Q4 2023

• Research and development expenses were $3.1 million in the fourth quarter of 2023, compared to $3.4 million in the fourth quarter of 2022. This decrease was primarily due to decreased clinical activity due to the termination of the Omilinochor and LABP-104 programs, as well as lower healthcare costs. NX-13 Phase 1b clinical trial costs were partially offset by the initiation of the NX-13 Phase 2 trial.

• General and administrative expenses were $3.5 million in the fourth quarter of 2023, compared to $3.1 million in the fourth quarter of 2022. This increase was primarily due to higher litigation costs, partially offset by lower insurance and indemnity costs.

Full year 2023

• Research and development expenses were $12.0 million for the year ended December 31, 2023 and $25.7 million for the year ended December 31, 2022. This decrease was primarily due to decreased clinical activity due to the termination of omilanochor and LABP. -104 program and his NX-13 Phase 1b clinical trial cost reduction. This was partially offset by the start of the NX-13 Phase 2 trial.

• General and administrative expenses were $10.7 million for the year ended December 31, 2023, compared to $14.9 million for the year ended December 31, 2022. This decrease was primarily due to lower compensation, insurance and consulting expenses, partially offset by lower fees. This is due to an increase in litigation costs.

About Landos Biopharma

Landos Biopharma is a clinical-stage biopharmaceutical company focused on developing first-in-class oral therapeutics for patients with autoimmune diseases. Our mission is to develop safer and more effective oral treatments that address treatment gaps in current treatment paradigms.

We have a portfolio of novel targets anchoring two libraries of immunometabolic regulatory pathways. This includes four potential first-in-class, once-daily oral treatments for multiple indications in immunology.

The Company is currently focused on advancing the clinical development of NX-13 in UC. The Company expects to begin its NEXUS Phase 2 proof-of-concept trial in the second quarter of 2023 and report top-line results in the fourth quarter of 2024.

For more information, please visit www.landosbiopharma.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding our future expectations, plans and prospects. This includes statements regarding our strategy, clinical development and regulatory plans for our product candidates, as well as other statements containing the words “anticipate,” “plan,” and “anticipate.” Any discussion of “may,” “will,” “could,” “believe,” “look forward to,” “could,” their negatives, variations thereof, and similar expressions, or strategies. These are forward-looking statements. Actual results may differ materially from those indicated in such forward-looking statements as a result of a variety of important factors, including: uncertainties inherent in the initiation and enrollment of current and future clinical trials, including the ongoing Phase 2 trial of NX-13; the availability and timing of data from ongoing clinical trials, expectations for regulatory approval and other matters that may affect the availability or commercial viability of our product candidates; anticipated financing channels and other similar risks; The risks associated with our business are described more fully in our filings with the Securities and Exchange Commission (the “SEC”), including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and the risks associated with the SEC's Available on the website (www). .sec.gov. Additional information will be made available in other filings we make with the SEC from time to time. Additionally, the forward-looking statements contained in this press release represent our beliefs only as of the date of this press release. We expect that subsequent events and developments may cause our views to change. However, although we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this document.

contact address

Rebecca Mosig, Vice President of Corporate Development
randos biopharma
ir@landosbiopharma.com

mike moyer
Lifecy Advisors LLC
mmoyer@lifesciadvisors.com