LABP Landos Biopharma Inc.

11.27
-0.42  -4%
Previous Close 11.69
Open 11.62
52 Week Low 8.82
52 Week High 16.989
Market Cap $452,125,329
Shares 40,117,598
Float 4,639,108
Enterprise Value $370,239,064
Volume 76,339
Av. Daily Volume 54,126
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Upcoming Catalysts

Drug Stage Catalyst Date
NX-13
Ulcerative Colitis
Phase 1b
Phase 1b
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Omilancor (BT-11)
Crohn’s Disease
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Omilancor (BT-11)
Ulcerative Colitis
Phase 3
Phase 3
Phase 3 trial planned.
NX-13
Crohn’s Disease
Phase 2
Phase 2
Phase 2 trial to commence 1H 2022.

Latest News

  1. BLACKSBURG, Va., June 14, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late clinical-stage biopharmaceutical company utilizing its LANCE Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases, today announced that Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos, will present at the upcoming Raymond James Virtual Human Health Innovation Conference on Monday, June 21, 2021 at 2:00 PM EDT.

    A live webcast of the presentation will be accessible through the Investors/Media section of the Company's website at www.landosbiopharma.com. Following the event, the webcast will be archived on the Landos website.

    About Landos Biopharma

    Landos Biopharma…

    BLACKSBURG, Va., June 14, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late clinical-stage biopharmaceutical company utilizing its LANCE Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases, today announced that Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos, will present at the upcoming Raymond James Virtual Human Health Innovation Conference on Monday, June 21, 2021 at 2:00 PM EDT.

    A live webcast of the presentation will be accessible through the Investors/Media section of the Company's website at www.landosbiopharma.com. Following the event, the webcast will be archived on the Landos website.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage biopharmaceutical company utilizing its LANCE Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. LANCE has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel gut-restricted small molecule drug candidate for the treatment of ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, gut-restricted small molecule drug candidate for the treatment of inflammatory bowel disease, that targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com.

    Contacts:

    Michael K. Levitan (investors)

    Solebury Trout

    646-378-2920

    Hannah Gendel (media)

    Solebury Trout

    646-378-2943



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  2. BLACKSBURG, Va., June 14, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE Advanced Artificial Intelligence (A.I.) platform to discover and develop novel oral therapeutics for patients with autoimmune and inflammatory diseases, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for omilancor, its lead candidate in late-stage clinical development for the treatment of mild-to-moderate active ulcerative colitis (UC) patients. Landos and the FDA agreed on key elements necessary for regulatory approval, clearing a path forward for a global pivotal Phase 3 program with omilancor in patients with…

    BLACKSBURG, Va., June 14, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE Advanced Artificial Intelligence (A.I.) platform to discover and develop novel oral therapeutics for patients with autoimmune and inflammatory diseases, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for omilancor, its lead candidate in late-stage clinical development for the treatment of mild-to-moderate active ulcerative colitis (UC) patients. Landos and the FDA agreed on key elements necessary for regulatory approval, clearing a path forward for a global pivotal Phase 3 program with omilancor in patients with mild-to-moderate active UC.

    The global pivotal PACIFY program will include two global pivotal Phase 3 clinical trials (PACIFY I and PACIFY II) and evaluate a single dose of omilancor versus placebo, with primary endpoints of clinical remission at weeks 12 and 52 to support label claims of induction and maintenance of clinical remission measured using the 3-component Mayo score. Landos is working to finalize the details of the Phase 3 protocols based on feedback and guidance from the FDA.

    "We are pleased with the results of our End-of-Phase 2 meeting with the FDA and are excited to be able to progress omilancor into Phase 3 development as a potentially improved treatment option for a broad population of patients with mild-to-moderate active UC worldwide," said Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "Our Phase 2 results indicated omilancor was well-tolerated with strong efficacy signals, which we believe support its potential as a pre- and post-biologic broad-spectrum therapy for UC patients, and provided us with invaluable insights for the design of our Phase 3 PACIFY trials. We are appreciative of the support and guidance from the FDA and are working to initiate the Phase 3 global program in the U.S., Europe and Asia, to support regulatory approvals in the U.S., European and Asian markets."

    The Phase 3 design was supported by nonclinical and clinical safety and efficacy data, including encouraging results from a Phase 2 study that evaluated omilancor in 198 patients with mild-to-moderate active UC and which demonstrated statistically significant immunological and biomarker results that mirror activation of the novel LANCL2 mechanism by omilancor in the gut. Phase 1 and Phase 2 clinical data demonstrated that omilancor was well tolerated at all doses evaluated, with no dose-limiting toxicities.

    About Ulcerative Colitis (UC)

    UC is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation, and ulcers in the lining of the large intestine (colon) and rectum. Symptoms include abdominal pain, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss, and malnutrition. Having UC puts a patient at increased risk of developing colon cancer. Diagnosis typically occurs in early adulthood and the disease requires maintenance treatment for the remainder of the patient's life. UC is estimated to affect over 900,000 patients in the United States and over 1 million patients throughout the rest of the world. With 70% of addressable patients experiencing a second flare within one year and 30% of patients in remission failing to stay in remission for more than one year, there is an unmet medical need in UC for safer and more efficacious therapeutics.

    About Omilancor

    Discovered using Landos proprietary LANCE Advanced A.I. platform, omilancor is a novel, oral, gut-restricted small molecule investigational drug that targets the Lanthionine Synthetase C-Like 2 (LANCL2) pathway impacting the gastrointestinal tract. LANCL2 plays an important role in the immunoregulatory process. By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune cells, omilancor is designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory markers in regulatory T cells (Treg) within the site of inflammation. Landos reported initial Phase 2 results of omilancor evaluating patients with ulcerative colitis in 2021 and expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in patients with mild-to-moderately active UC. Additionally, Landos initiated a Phase 2 trial of omilancor in patients with Crohn's disease in the first half of 2021.

    About Landos Biopharma

    Landos is a clinical-stage biopharmaceutical company utilizing its LANCE Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. LANCE has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel gut-restricted small molecule drug candidate for the treatment of ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, gut-restricted small molecule drug candidate for the treatment of inflammatory bowel disease, that targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com.

    Cautionary Note on Forward-Looking Statements

    Any 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, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "anticipate", "plan", "expect", "may", "will", "could", the negatives thereof, variations thereon and similar expressions, or by 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 our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our 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 we make 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:

    Michael K. Levitan (investors)

    Solebury Trout

    646-378-2920

    Hannah Gendel (media)

    Solebury Trout

    646-378-2943



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  3. BLACKSBURG, Va., May 25, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late clinical-stage biopharmaceutical company utilizing its LANCE A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases, today announced that Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos, will present at the upcoming Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:00 AM EDT.

    A live webcast of the presentation will be accessible through the Investors/Media section of the Company's website at www.landosbiopharma.com. Following the event, the webcast will be archived on the Landos website.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage…

    BLACKSBURG, Va., May 25, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late clinical-stage biopharmaceutical company utilizing its LANCE A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases, today announced that Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos, will present at the upcoming Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:00 AM EDT.

    A live webcast of the presentation will be accessible through the Investors/Media section of the Company's website at www.landosbiopharma.com. Following the event, the webcast will be archived on the Landos website.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage biopharmaceutical company utilizing its LANCE A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. LANCE has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel gut-restricted small molecule drug candidate for the treatment of ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, gut-restricted small molecule drug candidate for the treatment of inflammatory bowel disease, that targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com.

    Contacts:

    Michael K. Levitan (investors)

    Solebury Trout

    646-378-2920

     

    Hannah Gendel (media)

    Solebury Trout

    646-378-2943

     



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  4. BLACKSBURG, Va., May 19, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc (NASDAQ:LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced the appointment of Tim M. Mayleben to its Board of Directors. Mr. Mayleben joins Landos with more than 20 years of executive experience leading development activities as well as successfully spearheading clinical and business strategies within the life sciences industry.

    "We are pleased to introduce Tim as the newest Board member, Compensation Committee Chair and member of the Audit Committee," commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "Over the course…

    BLACKSBURG, Va., May 19, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc (NASDAQ:LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced the appointment of Tim M. Mayleben to its Board of Directors. Mr. Mayleben joins Landos with more than 20 years of executive experience leading development activities as well as successfully spearheading clinical and business strategies within the life sciences industry.

    "We are pleased to introduce Tim as the newest Board member, Compensation Committee Chair and member of the Audit Committee," commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "Over the course of his impressive career, Tim has successfully brought an innovative therapeutic through development, regulatory approval and commercialization and led business strategies for multiple biotech and pharmaceutical companies. We look forward to leveraging his proven track record as a business veteran in biotech as Landos expands and advances its inflammation and immunology pipeline."

    "I am thrilled to join Landos' Board of Directors and have the opportunity to work alongside its members as well as the management team," said Mr. Mayleben. "I am excited to apply my experience in leading development and business activities within the healthcare industry to support and advise Landos as we continue to make great strides advancing our autoimmune pipeline that has the potential to significantly improve the lives of millions of patients."

    Mr. Mayleben was most recently the President, CEO and Director of Esperion Therapeutics, Inc., a pharmaceutical company focused on the development and commercialization of therapies for the treatment of patients with elevated levels of LDL-cholesterol. In this role, he oversaw the development, strategy and commercial product launch of Nexletol™/Nexlizet™, as well as initiated collaborations with key commercial and development partners. Mr. Mayleben has more than two decades of executive leadership experience in the life sciences industry including as former President, CEO and Director of Vericel Corporation (formerly Aastrom Biosciences, Inc.), former President, COO and Board member of Virtual Radiologics (formerly Nighthawk Radiology Holdings, Inc.), and former COO and CFO of the original Esperion Therapeutics, Inc. until its acquisition by Pfizer, Inc. (NYSE:PFE) in 2004. Mr. Mayleben also serves as an Independent Board member of Marinus Pharmaceuticals (NASDAQ:MRNS) and Kaleo, Inc. where he also serves as non-executive Chairman. Mr. Mayleben earned an M.B.A., with distinction, from the J.L. Kellogg Graduate School of Management at Northwestern University, and a B.B.A. from the University of Michigan, Ross School of Business.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage biopharmaceutical company utilizing its LANCE A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. LANCE has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel gut-restricted small molecule drug candidate for the treatment of ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, gut-restricted small molecule drug candidate for the treatment of inflammatory bowel disease, that targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com.

    Contacts:

    Michael K. Levitan (investors)

    Solebury Trout

    646-378-2920

    Hannah Gendel (media)

    Solebury Trout

    646-378-2943

     



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  5. Completed initial public offering of common stock, raising approximately $100 million in gross proceeds

    Following positive Phase 2 results of omilancor in ulcerative colitis, including statistically significant immunological and biomarker results, end-of-Phase 2 Meeting with FDA planned for Q2 2021

    Announced a potentially $218 million exclusive development and commercialization agreement with LianBio to conduct two clinical trials for omilancor and NX-13 in Greater China and select Asian markets

     Company expects to file at least three INDs in 2021

    BLACKSBURG, Va., May 17, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc (NASDAQ:LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics…

    Completed initial public offering of common stock, raising approximately $100 million in gross proceeds

    Following positive Phase 2 results of omilancor in ulcerative colitis, including statistically significant immunological and biomarker results, end-of-Phase 2 Meeting with FDA planned for Q2 2021

    Announced a potentially $218 million exclusive development and commercialization agreement with LianBio to conduct two clinical trials for omilancor and NX-13 in Greater China and select Asian markets

     Company expects to file at least three INDs in 2021

    BLACKSBURG, Va., May 17, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc (NASDAQ:LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced financial results for the first quarter ended March 31, 2021 and provided business updates.

    "We delivered on numerous significant milestones during the first quarter of 2021, including our successful initial public offering and Nasdaq listing, initiation of two clinical trials for omilancor and NX-13, a partnership with LianBio potentially worth in excess of $218 million in upfront, development and commercial milestone payments, as well as reported positive clinical study readouts," said Josep Bassaganya-Riera, Ph.D., Chairman, President, and CEO of Landos. "In February, we reported proof-of-concept data from the Phase 2 trial in ulcerative colitis, in which omilancor induced clinical and histological remission in a subset of patients that compared favorably to the rates seen in standard of care treatments. These supportive data of omilancor as a Phase 3-ready product candidate will be important for the upcoming end-of-Phase 2 meeting with the FDA in Q2 2021."

    Josep Bassaganya-Riera added, "On the heels of positive results from a Phase 1a study in NX-13 where all endpoints were met, we subsequently initiated a Phase 1b trial of NX-13 in patients with ulcerative colitis and anticipate topline results in Q1 2022. We have also initiated a Phase 2 study of omilancor in moderate-to-severe Crohn's disease patients. We believe the success of our two lead candidates to date is linked to Landos' differentiated approach to discover novel pathways through our proprietary LANCE advanced A.I. platform. We recently made several enhancements to LANCE, which will help us continue to identify the next generation of therapeutic targets and biomarkers. Following our IPO in which we raised approximately $100 million, Landos maintains a strong cash position and operating runway, expected through the end of 2023."

    Recent Highlights and Upcoming Milestones:

    Omilancor (BT-11)

    Omilancor is a novel, oral, gut-restricted LANCL2 agonist in development for the treatment of ulcerative colitis (UC), Crohn's disease (CD) and Eosinophilic Esophagitis (EoE). A topical form of omilancor is in development for psoriasis and atopic dermatitis.

    • In May 2021, Landos reported additional positive data from its Phase 2 trial in UC. The results demonstrated that omilancor induced increased levels of regulatory CD4+ T cells and myeloid cells and increased IL-10 expression in remitters (p = 0.036) as well as decreased TNF-a expressing myeloid cells (p = 0.037). These results are consistent with normalization of fecal calprotectin, occurring in 43.8% of patients (1000 mg of omilancor) and 40.6% of patients (500 mg of omilancor) compared to 21.4% of patients receiving placebo (p = 0.048) after 2 weeks of treatment.



    • In May 2021, Landos initiated a Phase 2 trial of omilancor designed to evaluate proof-of-concept efficacy and safety of omilancor for the treatment of moderate-to-severe CD. Results from the Phase 2 study are expected in Q2 2022.



    • In May 2021, Landos' presented a late-breaking abstract of omilancor in psoriasis at the 2021 American Association of Immunologists (AAI) Annual Meeting. The data showed that omilancor, when delivered topically, could significantly suppress inflammation and reduce disease severity in preclinical mouse models of psoriasis by activating key immunometabolic mechanisms. 



    • In  April 2021, the U.S. Food and Drug Administration (FDA) cleared the Company's IND application of omilancor for the treatment of Eosinophilic Esophagitis (EoE). This product candidate's new oral formulation is designed to enable exposure to omilancor in the upper gastrointestinal tract while retaining local action without systemic exposure. Landos expects to initiate a Phase 1b trial of omilancor for this indication in 2022.



    • In February 2021, the Company reported positive translational data from its Phase 2 trial for patients with mild-to-moderate UC. Overall, orally-administered omilancor was gut-restricted and well tolerated, with no treatment-related significant adverse events and it induced statistically significant changes in biomarkers. Based on this data, Landos plans to consult with the FDA on an end-of-Phase 2 meeting in Q2 2021, which has the potential to shape our future path to a Phase 3 pivotal trial for omilancor in UC.

    NX-13

    A novel, oral, gut-restricted NLRX1 targeting compound in development for the treatment of UC and CD.

    • In April 2021, the Company initiated a Phase 1b study of NX-13 to investigate the safety and pharmacokinetics of multiple dose levels of this product candidate in UC patients with active disease. Topline data from this trial is expected to readout in Q1 2022.
    • In March 2021, Landos reported positive results from a Phase 1a study of NX-13 that met all endpoints in healthy volunteers, demonstrating that the candidate was well-tolerated and gut-restricted pharmacokinetics and dose-dependent changes in fecal calprotectin were also observed. The maximum tolerated dose was identified to be 10-fold greater than the anticipated therapeutic dose.

    PX-69

    An oral PLXDC2 agonist for the treatment of rheumatoid arthritis and diabetic nephropathy.

    • In May 2021, Landos presented a late-breaking abstract of PX-69 in rheumatoid arthritis at the 2021 AAI Annual Meeting. The preclinical data demonstrated that activating the PLXDC2 pathway led to a decrease of inflammation and enhanced preservation of joint structure in animal models.



    • Landos expects to commence IND-enabling studies of PX-69 in the 2H 2021.

    Corporate Highlights:

    • In May 2021, Landos entered into a collaboration and license agreement with LianBio to develop and commercialize omilancor and NX-13 in Greater China and select Asian markets. Landos will receive an upfront cash payment of $18 million from LianBio and is eligible to receive development and commercial milestone payments of up to $200 million as well as low- to mid-double-digit royalties on omilancor and NX-13 net sales in the licensed territories. LianBio will participate in future global Phase 3 trials in Greater China and select Asian markets by enrolling a meaningful number of patients in these studies.



    • In February 2021, Landos completed an IPO in which the company issued and sold 6,250,000 shares of its common stock for net proceeds of $90.5 million. Landos expects its cash, cash equivalents and marketable securities, including the IPO net proceeds, will be sufficient to support Landos' operating costs through the end of 2023.

    First Quarter 2021 Financial Results

    • Cash, Cash Equivalents and Marketable Securities: As of March 31, 2021, the Company had cash, cash equivalents and marketable securities of $106.4 million, which it believes will be sufficient to fund its planned operations through the end of 2023. This amount does not include the $18 million upfront payment associated with the LianBio development and commercialization agreement.



    • Research and Development ("R&D") Expenses: Research and development expenses were $7.3 million for the three months ended March 31, 2021 compared to $4.7 million for the three months ended March 31, 2020. The increase of $2.6 million was primarily attributable to increased costs associated with ongoing clinical trial activities for omilancor and NX-13.



    • General and Administrative ("G&A") Expenses: General and administrative expenses were $2.6 million for the three months ended March 31, 2021 compared to $1.1 million for the three months ended March 31, 2020. The increase of $1.5 million was primarily attributable to increases in patent costs and cost associated with becoming a publicly traded company.



    • Net Loss: Our net loss was $9.8 million and $5.8 million for the three months ended March 31, 2021 and 2020, respectively.

    About Omilancor (BT-11)

    Discovered using Landos proprietary LANCE A.I. platform, omilancor is a novel, gut-restricted small molecule investigational drug that targets the Lanthionine Synthetase C-Like 2 (LANCL2) pathway impacting the gastrointestinal tract. LANCL2 plays an important role in the immunoregulatory process. By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune cells, omilancor is designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory markers in regulatory T cells (Treg) within the site of inflammation. The Company reported initial Phase 2 results of omilancor evaluating patients with ulcerative colitis in 2021 and expects to initiate a Phase 3 trial in the second half of 2021. Additionally, Landos initiated a Phase 2 trial of omilancor in patients with Crohn's disease in the first half of 2021.

    About NX-13

    Discovered using Landos' proprietary LANCE A.I. platform, NX-13 is a first-in-class, gut-restricted, small molecule therapeutic candidate for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). NX-13 targets NLRX1, a mitochondria-associated receptor with the ability to modulate immune responses. By activating the NLRX1 pathway, NX-13 increases autophagy and oxidative phosphorylation in immune cells, while decreasing differentiation of effector CD4+ T cells, reactive oxygen species, inflammasome formation and production of inflammatory cytokines. The Company reported positive results from the Phase 1a study of NX-13 in healthy volunteers in Q1 2021 and initiated a Phase 1b study of NX-13 in patients with ulcerative colitis in Q2 2021.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage biopharmaceutical company utilizing its LANCE A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. LANCE has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel gut-restricted small molecule drug candidate for the treatment of ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, gut-restricted small molecule drug candidate for the treatment of inflammatory bowel disease, that targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com.

    Cautionary Note on Forward-Looking Statements

    Any 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, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words  "anticipate", "plan", "expect", "may", "will", "could",  the negatives thereof, variations thereon and similar expressions, or by 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 our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our 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 we make 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:

    Michael K. Levitan (investors)

    Solebury Trout

    646-378-2920

    Hannah Gendel (media)

    Solebury Trout

    646-378-2943

    Landos Biopharma, Inc.
    Condensed Consolidated Balance Sheets
    (Unaudited)
    (in thousands, except share and per share amounts)
         
      March 31, December 31,
       2021   2020 
    Assets    
    Current assets:    
    Cash and cash equivalents $8,572  $2,416 
    Marketable securities, available for sale  97,786   25,718 
    Incentive and tax receivables  1   154 
    Prepaid expenses and other current assets  3,386   202 
    Deferred offering costs     1,398 
    Total current assets  109,745   29,888 
    Property, plant and equipment-net  465   444 
    Total assets $110,210  $30,332 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)    
    Current liabilities:    
    Accounts payable $8,200  $8,606 
    Accrued liabilities  364   1,939 
    Other current liabilities  255   489 
    Total current liabilities  8,819   11,034 
    Other liabilities  212   276 
    Total liabilities  9,031   11,310 
         
    Commitments and Contingencies      
    Convertible preferred stock, $0.01 par value; no shares authorized, issued or outstanding as of March 31, 2021; 11,260,608 shares authorized, issued and outstanding as of December 31, 2020: aggregate liquidation preference of $70,254 as of December 31, 2020     73,037 
         
    Stockholders' equity (deficit):    
    Preferred stock, $0.01 par value; 10,000,000 shares authorized, no shares issued or outstanding as of March 31, 2021

    Common stock, $0.01 par value; 200,000,000 shares authorized, 39,866,669 shares issued and outstanding as of March 31, 2021; 12,767,909 shares issued and outstanding as of December 31, 2020
      399   71 
    Additional paid-in-capital  166,429   1,633 
    Accumulated other comprehensive (loss) gain  (102)  10 
    Accumulated deficit  (65,547)  (55,729)
    Total stockholders' equity (deficit)  101,179   (54,015)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $110,210  $30,332 
         



    Landos Biopharma, Inc.
    Condensed Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)
    (in thousands, except share and per share amounts)
         
      Three Months Ended
      March 31,
       2021   2020 
    Operating expenses:    
    Research and development $7,254  $4,690 
    General and administrative  2,646   1,080 
    Total operating expenses  9,900   5,770 
    Loss from operations  (9,900)  (5,770)
    Other income (expenses):    
    Interest expense     (1)
    Gain/(loss) from foreign exchange  18   (222)
    Other income, net  64   197 
    Other income (expense), net  82   (26)
    Net loss  (9,818)  (5,796)
    Net loss per share, basic and diluted  (0.38)  (0.49)
    Weighted-average shares used to compute net loss per share, basic and diluted  26,070,455   11,874,723 
    Net loss  (9,818)  (5,796)
    Unrealized gain/(loss) on available-for-sale securities  (112)  (686)
    Comprehensive loss  (9,930)  (6,482)


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