NLRX1

Six Presentations Highlight Landos’ Leadership in Targeting Immunometabolic Pathways as Novel Treatments for Autoimmune Diseases with Focus on Ulcerative ColitisNEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP) (“Landos” or the “Company”), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced that six abstracts were accepted for poster presentation at the 19th Annual Congress of the European Crohn’s and Colitis Organisation (ECCO). The abstracts highlight new and additional data on immunometabolism modulation by activating NLRX1 and PLXDC2 with novel agonists such as NX-13 and LABP-69. The ECCO congress will take place February 21-24, 2024 in Stockholm, Sweden. “Immunometabolic targets work to restrict entry into the inflammatory cascade to restore and maintain homeostasis and are poised to be the next frontier in treating autoimmune diseases. We are excited to present data from multiple studies including the impact of NX-13 on eosinophil infiltration and visceral hypersensitivity, as well as confirming its relevancy in multiple models and species. Additionally, we are pleased to share new preclinical insights into the potential role of PLXDC2 in ulcerative colitis,“ said Fabio Cataldi, M.D., Executive Vice-President & Chief Medical Officer at Landos. “The broad range of innovative research by our scientists and esteemed collaborators underscores our commitment to leveraging immunometabolism to create safer and more effective treatments for inflammatory bowel diseases, particularly in ulcerative colitis.” Landos has two novel targets anchoring libraries of immunometabolic modulation pathways, including four potentially first-in-class, once-daily, oral therapies targeting eight indications, including the clinical stage program NX-13 for ulcerative colitis (UC). Presentation Details All six posters will be presented as part of the guided poster session taking place on Friday, February 23, 2024 from 12:40-13:40 CEST at Poster Exhibition Hall A. Title: The Immunometabolic Bimodal Mechanism of NLRX1 Agonist NX-13 in a Pig Model of Ulcerative ColitisPresenter: Prof. Bram Verstockt, M.D., PhD; University Hospitals Leuven and KU Leuven, Leuven, BelgiumPoster number: P077 Title: Identification of a Novel Immunometabolic Target and Agonist for PLXDC2 for Amelioration of DSS Colitis Model in MicePresenter: Prof. Bram Verstockt, M.D., PhD; University Hospitals Leuven and KU Leuven, Leuven, BelgiumPoster number: P086 Title: Role of NLRX1 Agonist NX-13 in Reducing Visceral Hypersensitivity in Preclinical Gastrointestinal InflammationPresenter: Prof. Bram Verstockt, M.D., PhD; University Hospitals Leuven and KU Leuven, Leuven, BelgiumPoster number: P114 Title: Modulation of Immunometabolism via NLRX1 or PLXDC2: Novel Bimodal Mechanisms for the Treatment of Inflammatory Bowel DiseasesPresenter: Prof. Silvio Danese, M.D., PhD; IRCCS San Raffaele Hospital, Vita-Salute San Raffaele UniversityPoster number: P144 Title: The Effect of NLRX1 Activation on Eosinophils in Ulcerative Colitis and Inflammation: Translational Learnings Across Diseases and from Mouse to HumanPresenter: Prof. Bram Verstockt, M.D., PhD; University Hospitals Leuven and KU Leuven, Leuven, BelgiumPoster number: P571 Title: Translating Pharmacokinetic and Efficacy Outcomes of NLRX1 Agonist NX-13: Contrasting a Pig Model and a Human Phase 1b Clinical Trial in Ulcerative ColitisPresenter: Prof. Britta Siegmund, M.D., PhD; Charité – Universitätsmedizin, BerlinPoster number: P739 NX-13 is currently in a Phase 2 proof-of-concept trial (NEXUS: NCT05785715) to evaluate the safety, efficacy and pharmacokinetics in patients with moderate to severe UC. The Company expects to report topline results in the fourth quarter of 2024. 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 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 eight 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 April 2023 and expect 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 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 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, 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. 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 DevelopmentLandos Biopharmair@landosbiopharma.com Mike MoyerLifeSci Advisors, LLCmmoyer@lifesciadvisors.com

NX-13, a Novel, Oral, NLRX1 Agonist, was Observed to be Well Tolerated and Demonstrated Early Signs of Rapid Symptomatic Relief and Endoscopic Improvement in Patients with Ulcerative Colitis NEXUS Phase 2 Proof-of-Concept Study is Ongoing, with Top-Line Readout Expected in Q4 2024 NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced a peer-reviewed publication describing the safety, tolerability, pharmacokinetic and clinical efficacy results for the NX-13 Phase 1b trial in patients with ulcerative colitis (UC) in the Journal of Crohn’s and Colitis. “We are delighted to have our Phase 1b results of NX-13 in UC published in the Journal of Crohn’s and Colitis,” said Dr. Fabio Cataldi, Executive Vice-President & Chief Medical Officer at Landos. “The publication highlights the promising data that are the foundation for our ongoing NEXUS Phase 2 trial, which is on track for top-line readout in the fourth quarter of 2024.” The publication, titled "The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study”, reports the results of the Phase 1b trial which included 38 patients randomized to placebo (n=5), 250mg immediate release (IR) of NX-13 (n=11), 500mg IR of NX-13 (n=11) or 500mg delayed release NX-13 (n=11). NX-13 was found to be well tolerated in all patients studied. No deaths or severe adverse events were reported and all adverse events were mild to moderate. The majority of patients treated with NX-13 for four weeks showed consistent and rapid clinical improvement in total Mayo score and in symptoms relief (as measured by rectal bleeding and stool frequency). Additionally, the endoscopic improvement observed correlated closely with symptoms improvement. “Despite advances in UC treatments, the need for new and novel therapies such as NX-13 remains highly important for patients,” commented Bram Verstockt, M.D., Ph.D., and lead author. “The early signs of efficacy, along with a favorable safety profile, highlighted in this publication are encouraging. I am excited about the potential of NX-13 and immunometabolism in breaking the inflammatory cycle in UC, which remains a significant unmet need in effectively treating patients.” NX-13 is currently being evaluated in the NEXUS trial, a randomized, multicenter, double-blind, placebo-controlled, multiple dose, statistically powered, Phase 2 proof-of-concept study (NCT05785715) with top-line results expected in the fourth quarter of 2024. 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. We initiated the NEXUS Phase 2 proof-of-concept trial in April 2023 and expect to report top-line 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 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 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, 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. 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 DevelopmentLandos Biopharmair@landosbiopharma.com John MullalyLifeSci Advisors, LLCjmullaly@lifesciadvisors.com

NEXUS Phase 2 Clinical Trial of NX-13 for Ulcerative Colitis Remains On Track with Top-line Results Planned for Q4 2024 Sufficient Cash to Fund Planned Operations into First Half of 2025 NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- 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 quarter ended September 30, 2023. “The NX-13 Phase 2 clinical program (NEXUS) remains our top priority, and we are pleased with our execution and progress during the third quarter,” said Gregory Oakes, President and CEO of Landos. “We believe NX-13 can deliver on the potential of immunometabolism and its role in breaking the inflammatory cycle for the millions of patients suffering from moderate-to-severe ulcerative colitis.” Third Quarter 2023 Clinical Development Highlights NX-13 is a novel, gut-selective NLRX1 agonist in development as a once-daily, oral treatment for ulcerative colitis (UC). NEXUS Phase 2 proof-of-concept clinical trial: The NEXUS trial of NX-13 remains on track as the Company continues to recruit, screen and randomize patients for the trial.20 sites in the United States and Europe have been activated.NEXUS is a randomized, statistically powered, multicenter, double-blind, placebo-controlled, multiple dose, 12-week induction study evaluating 80 patients with moderate-to-severe UC with a long-term extension (LTE) period out to one year. All subjects will be randomized to receive either a 250 mg or 750 mg immediate release dose of NX-13 or placebo. The primary objective of the trial is to evaluate the clinical efficacy, safety and pharmacokinetics of oral NX-13 vs. placebo (NCT05785715 ClinicalTrials.gov).NEXUS top-line results are expected to be reported in the fourth quarter of 2024. In September 2023, the Company announced a strategic research collaboration with the Inflammatory Bowel Disease Team at KU Leuven and University Hospitals Leuven, a leading European research university and hospital network known for its innovation in Leuven, Belgium. The goal of this collaboration is to further characterize the effects of NX-13 on epithelial cells using UC patient-derived organoid models that mimic in vivo conditions while allowing for controlled in vitro studies. The results are expected to provide additional insights regarding the impact of NX-13 on gene expression, gene regulation and cytokine responses. Results from this research collaboration are expected to be presented at appropriate medical conferences in 2024.In October 2023, the Company presented additional findings from its Phase 1b study of NX-13 for the treatment of UC, including detailed results on the rapid symptomatic relief and improvement in multiple biomarkers observed in the study. Presented two oral presentations and one poster at the United European Gastroenterology Week (UEGW) 2023.Presented three posters at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting. Third Quarter 2023 Financial Highlights As of September 30, 2023, the Company had cash, cash equivalents and marketable securities of $42.5 million, which it believes will be sufficient to fund operating expenses and capital requirements into the first half of 2025.Research and development expenses were $3.1 million for the third quarter of 2023, compared to $4.9 million for the third quarter of 2022. The decrease was primarily attributable to the wind down of omilancor and LABP-104 clinical trials and a reduction in NX-13 Phase 1b clinical trial costs, partially offset by initiation of the NEXUS trial. Additionally, there were increases in compensation costs, partially offset by a decrease in consulting costs.General and administrative expenses were $2.1 million for the third quarter of 2023, compared to $3.0 million for the third quarter of 2022. The decrease was primarily attributable to decreased costs in consulting and Directors & Officers (D&O) insurance. 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 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. We initiated the NEXUS Phase 2 proof-of-concept trial in the second quarter of 2023 and expect to report topline results 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 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, 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. 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 DevelopmentLandos Biopharmair@landosbiopharma.com John MullalyLifeSci Advisors, LLCjmullaly@lifesciadvisors.com Landos Biopharma, Inc. Unaudited Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2023 2022 2023 2022Operating expenses: Research and development $3,063 $4,862 $8,852 $22,266 General and administrative 2,136 2,967 7,265 11,782 Total operating expenses 5,199 7,829 16,117 34,048 Loss from operations (5,199) (7,829) (16,117) (34,048)Other (expense) income, net (661) (67) 301 4 Net loss $(5,860) $(7,896) $(15,816) $(34,044)Net loss per share, basic and diluted $(0.94) $(1.96) $(2.51) $(8.46)Weighted-average shares used to compute net loss per share, basic and diluted 6,207,638 4,025,489 6,298,846 4,025,489 Landos Biopharma, Inc. Condensed Consolidated Balance Sheets (in thousands) September 30, December 31, 2023 2022 (Unaudited) Assets Current assets: Cash and cash equivalents $42,408 $36,640 Marketable securities, available-for-sale 62 7,762 Restricted cash 50 — Prepaid expenses and other current assets 710 851 Total current assets 43,230 45,253 Total assets $43,230 $45,253 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $1,135 $3,435 Accrued liabilities 4,431 2,687 Total current liabilities 5,566 6,122 Total liabilities 5,566 6,122 Commitments and contingencies Stockholders’ equity: Common stock 31 40 Additional paid-in capital 186,877 172,575 Accumulated other comprehensive loss (1) (57)Accumulated deficit (149,243) (133,427)Total stockholders’ equity 37,664 39,131 Total liabilities and stockholders’ equity $43,230 $45,253