Landos Biopharma Reports Third Quarter 2021 Financial Results and Provides Corporate Update

$LABP
Biotechnology: Pharmaceutical Preparations
Health Care
Get the next $LABP alert in real time by email

Enhancing Focus on High-Impact Clinical-Stage Programs to Ensure Optimal Path to Commercialization

Refining Ulcerative Colitis Clinical Development Plans for Omilancor to Generate Additional Phase 2b Data Prior to Initiating Pivotal Phase 3 Program

Determining Optimal Enrollment for Phase 2 Clinical Study of Omilancor in Crohn's Disease and Phase 1b Study of NX-13 in UC

Initiated Dosing for LABP-104 in Healthy Volunteers in October 2021 with Results Expected in 1H 2022

Corporate Update Conference Call Scheduled for 8:00 am ET Today

BLACKSBURG, Va., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases, today announced financial results for the third quarter ended September 30, 2021 and provided a corporate update on its clinical development plans.

"Landos is well-positioned to continue its evolution as a biopharmaceutical company. In parallel with our search for Landos' next leader, our Board, leadership team and advisors are reviewing our product development strategies and clinical plans to ensure that we are focusing on the most value-enhancing near-and long-term opportunities," said Tim Mayleben, Interim President and CEO of Landos. "Landos has already established itself as a research and discovery leader based on the productivity of the LANCE Advanced A.I. platform. Leveraging that success, we are taking steps to evaluate and optimize our product development and clinical strategies, and we will be prioritizing our three clinical-stage product candidates, omilancor, NX-13, and LABP-104, and concentrating on the immune-mediated inflammatory disease indications of ulcerative colitis, Crohn's disease, Eosinophilic Esophagitis, Systemic Lupus Erthematosus, and Rheumatoid Arthritis. In addition, we will be reviewing our preclinical programs to optimize the priorities and sequence of these product candidates and their respective clinical applications. We believe that narrowing our focus on advancing our core, high-impact clinical-stage programs will support the strongest outcomes for these product candidates and best position Landos for regulatory approval and commercial success in the future. We look forward to providing continued updates on our progress and deliver value for patients and our shareholders."

Clinical Development Updates

Omilancor

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) as a once-daily oral treatment.

  • In October 2021, Landos presented positive translational data from the Phase 2 trial of omilancor in mild-to-moderate UC at United European Gastroenterology Week (UEGW). Patients remaining on omilancor after the induction phase of the trial maintained low Mayo scores and showed little to no symptoms beyond 1 year of treatment, with nearly 90% of patients achieving remission thresholds in stool frequency and rectal bleeding after 36 weeks of open-label treatment.



  • Prior to initiating a pivotal Phase 3 study, Landos plans to leverage the results of the prior Phase 2 study of omilancor in mild-to-moderate UC patients to design and initiate a Phase 2b study in 2022. The Phase 2b study is expected to provide additional data to inform the pivotal Phase 3 study design and support regulatory approval.



  • Enrollment in the Phase 2 trial of omilancor in moderate-to-severe CD continues. Landos is actively evaluating the sample size to ensure the Company optimizes the powering of its data. Given the ongoing evaluation, Landos is removing prior guidance for the timing of top-line results.



  • Landos plans to file an orphan drug designation application for pediatric UC patients in Q4 2021.

NX-13

NX-13 is a novel, oral, gut-restricted NLXR1 agonist in development for the treatment of UC and CD as a once-daily oral treatment.

  • In October 2021, Landos presented results of its Phase 1a trial of NX-13 in healthy volunteers at UEGW 2021. The trial met all primary and secondary endpoints. The data also demonstrated a signal of efficacy in terms of lowering fecal calprotectin levels, increasing IL-10 concentrations and decreasing IL-6 concentrations in plasma.



  • Enrollment in the Phase 1b trial of NX-13 in the U.S. and Europe continues. Landos is actively evaluating the sample size to ensure the Company optimizes the powering of its data. Given the ongoing evaluation, Landos is removing prior guidance for the timing of top-line results.

LABP-104

LABP-104 is a novel, oral, systemically distributed LANCL2 agonist in development for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) as a once-daily oral treatment. LABP-104 activates the LANCL2 pathway to restore the immune system to homeostasis through the enhancement of regulatory T cell (Treg) function and increasing mitochondrial metabolism.

  • In September 2021, Landos announced that the preclinical results of LABP-104 in SLE were accepted for an oral presentation at the American College of Rheumatology Convergence 2021 in November. The presentation will highlight how oral treatment with LABP-104 resulted in enhanced Treg function, maintained kidney function and reduced type I interferon signaling.



  • Landos received FDA clearance in October 2021 of an IND for LABP-104 for the treatment of SLE and RA. A Phase 1 trial has been initiated to evaluate the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. Top-line results from this study are expected in 1H 2022.

Summary of Third Quarter 2021 Financial Results

Cash, Cash Equivalents and Marketable Securities:

As of September 30, 2021, the Company had cash, cash equivalents and marketable securities of $102.7 million, which it believes will be sufficient to fund planned operations through the end of 2023.

Research and Development ("R&D") Expenses:

Research and development expenses were $9.3 million for the three months ended September 30, 2021 compared to $7.0 million for the three months ended September 30, 2020. The increase of $2.3 million was primarily attributable to increased costs associated with ongoing development activities related to omilancor, NX-13 and LABP-104.

General and Administrative ("G&A") Expenses:

General and administrative expenses were $3.1 million for the three months ended September 30, 2021 compared to $1.5 million for the three months ended September 30, 2020. The increase of $1.6 million was primarily attributable to increases in D&O insurance costs and administrative expenses related to increased headcount.

Other Income (Expense):

Other expense, net was $0.2 million for the three months ended September 30, 2021 compared to other income, net of $0.2 million in the three months ended September 30, 2020. The change of $0.4 million was due to amortization of bond premium from investment activity and the gains (losses) from foreign exchange.

Conference Call Information

Landos will host a corporate update conference call today at 8:00 am ET. A webcast for this call can be accessed at https://ir.landosbiopharma.com/, or by dialing 1-877-317-6789 (Toll Free) or 1-412-317-6789 (International) and asking to join the Landos Corporate Update call. The webcast will be archived and be available for replay on the Company's investor relations 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. Using the LANCE® platform, the Company discovers new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways at the interface of immunity and metabolism. Landos' lead product candidate, omilancor, targets the LANCL2 pathway and is a novel oral, gut-restricted, small molecule first-in-class therapeutic in development for the treatment of ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis. Landos' second product candidate, NX-13, targets the NLRX1 pathway and is a novel, oral, gut-restricted small molecule first-in-class therapeutic in development for the treatment of ulcerative colitis. Landos discovered and is also developing LABP-104, a novel, oral systemically distributed small molecule first-in-class therapeutic targeting the LANCL2 pathway for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).

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, 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 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, 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 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

Andi Rose / Tanner Kaufman / Kara Sperry

Joele Frank, Wilkinson Brimmer Katcher

212-355-4449

Landos Biopharma, Inc.

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

 September 30,

2021
 December 31,

2020
Assets     
Current assets:     
Cash and cash equivalents$17,893  $2,416 
Marketable securities, available for-sale 84,777   25,718 
Incentive and tax receivables 3   154 
Prepaid expenses and other current assets 1,645   202 
Deferred offering costs    1,398 
Total current assets 104,318   29,888 
Property, plant and equipment, net 780   444 
Total assets$105,098  $30,332 
Liabilities, convertible preferred stock and stockholders' equity (deficit)     
Current liabilities:     
Accounts payable$10,114  $8,606 
Accrued liabilities 726   1,939 
Other current liabilities 255   489 
Total current liabilities 11,095   11,034 
Other liabilities 85   276 
Total liabilities 11,180   11,310 
Commitments and contingencies     
Convertible preferred stock, $0.01 par value; no shares authorized, issued or outstanding as of September 30, 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)     
Common stock, $0.01 par value; 200,000,000 shares authorized, 40,053,157 and 12,767,909 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively 401   71 
Additional paid-in-capital 167,440   1,633 
Accumulated other comprehensive income 131   10 
Accumulated deficit (74,054)  (55,729)
Total stockholders' equity (deficit) 93,918   (54,015)
Total liabilities, convertible preferred stock and stockholders' equity (deficit)$105,098  $30,332 



Landos Biopharma, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

 Three Months Ended

September 30,
 Nine Months Ended

September 30,
 
  2021  2020   2021  2020  
Revenue – License Fee$ $  $18,000 $  
Operating expenses:          
Research and development 9,344  6,966   28,120  15,379  
General and administrative 3,059  1,453   8,300  3,898  
Total operating expenses 12,403  8,419   36,420  19,277  
Loss from operations (12,403) (8,419)  (18,420) (19,277) 
Other income (expense):          
Gain (loss) from foreign exchange (10) 84   3  37  
Other income (expense), net (191) 105   92  437  
Other income (expense), net (201) 189   95  474  
Net loss$(12,604)$(8,230) $(18,325)$(18,803) 
Net loss per share, basic and diluted$(0.32)$(0.67) $(0.50)$(1.56) 
Weighted-average number of shares used to compute net loss per share, basic and diluted 39,962,069  12,260,804   36,662,627  12,068,515  
Net loss$(12,604)$(8,230) $(18,325)$(18,803) 
Unrealized gain on available-for-sales securities 273  25   121  113  
Comprehensive loss$(12,331)$(8,205) $(18,204)$(18,690) 

 



Primary Logo

Get the next $LABP alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$LABP

DatePrice TargetRatingAnalyst
4/12/2022$30.00 → $1.40Buy → Hold
Jefferies
1/3/2022$15.00 → $7.00Neutral
JP Morgan
11/16/2021$20.00 → $16.00Outperform → Market Perform
SVB Leerink
10/20/2021$45.00Buy
Craig-Hallum
10/19/2021$50.00Buy
HC Wainwright & Co.
9/23/2021$39.00Buy
JonesTrading
7/30/2021$33.00 → $35.00Outperform
Raymond James
More analyst ratings

$LABP
Press Releases

Fastest customizable press release news feed in the world

See more
  • AbbVie Completes Acquisition of Landos Biopharma

    -   Adds first-in-class investigational asset, NX-13, to AbbVie's pipeline with the potential to offer a novel approach to the treatment of ulcerative colitis (UC) and Crohn's disease (CD) NORTH CHICAGO, Ill., May 23, 2024 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced today that it has completed its acquisition of Landos Biopharma, Inc. (NASDAQ:LABP). With the completion of the acquisition, Landos is now part of AbbVie. Landos' lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family), which is currently in Phase 2 for the treatment of moderate to severe UC (NEXUS study; NCT05785715). NLRX1 regulates immunometabolism and inflammation,

    $ABBV
    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Stockholder Alert: Ademi LLP continues Investigation of the Fairness of Landos Biopharma, Inc.'s transaction with AbbVie

    MILWAUKEE, April 16, 2024 /PRNewswire/ -- Ademi LLP investigation of Landos (NASDAQ:LABP) continues now that Landos has filed a preliminary proxy statement seeking stockholder approval for its transaction with AbbVie. Click here to learn how to join the https://www.ademilaw.com/case/landos-biopharma-inc or call Guri Ademi toll-free at 866-264-3995.  There is no cost or obligation to you. In the transaction, Landos shareholders will receive only $20.42 per share in cash upon closing, or approximately $137.5 million in the aggregate, plus one non-tradable contingent value right

    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • AbbVie to Acquire Landos Biopharma, Further Strengthening its Portfolio in Inflammatory and Autoimmune Diseases

    Landos' lead asset, NX-13, is a first-in-class, oral NLRX1 agonist in Phase 2 for the treatment of ulcerative colitis (UC)NORTH CHICAGO, Ill. and NEW YORK, March 25, 2024 /PRNewswire/ -- AbbVie Inc. (NYSE:ABBV) ("AbbVie") and Landos Biopharma, Inc. (NASDAQ:LABP) ("Landos") today announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos' lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family) with a bimodal mechanism of action (MOA), which is anti-inflammatory and facilitates

    $ABBV
    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care

$LABP
Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

See more

$LABP
Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

See more

$LABP
SEC Filings

See more

$LABP
Leadership Updates

Live Leadership Updates

See more
  • Stockholder Alert: Ademi LLP continues Investigation of the Fairness of Landos Biopharma, Inc.'s transaction with AbbVie

    MILWAUKEE, April 16, 2024 /PRNewswire/ -- Ademi LLP investigation of Landos (NASDAQ:LABP) continues now that Landos has filed a preliminary proxy statement seeking stockholder approval for its transaction with AbbVie. Click here to learn how to join the https://www.ademilaw.com/case/landos-biopharma-inc or call Guri Ademi toll-free at 866-264-3995.  There is no cost or obligation to you. In the transaction, Landos shareholders will receive only $20.42 per share in cash upon closing, or approximately $137.5 million in the aggregate, plus one non-tradable contingent value right

    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Landos Biopharma Provides Business Update & Reports Second Quarter 2023 Results

    Initiated NEXUS Phase 2 Clinical Trial of NX-13 for Ulcerative Colitis NEXUS Remains On Track With Top-line Results Planned for Q4 2024 Sufficient Cash to Fund Planned Operations into First Half of 2025 NEW YORK, Aug. 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 second quarter ended June 30, 2023. "We continued to advance and execute the NX-13 Phase 2 clinical program (NEXUS) during the second quarter. We have activated sites in the US and are actively recruiting and screening pa

    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Landos Biopharma Expands Board of Directors with Appointment of Alka Batycky, Ph.D.

    NEW YORK, May 30, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced the appointment of Alka Batycky, Ph.D. to its Board of Directors and Audit Committee. "Dr. Batycky is an accomplished biopharmaceutical executive and an important addition to Landos' Board," said Gregory Oakes, President and CEO of Landos. "Dr. Batycky has a proven track record, and we look forward to her contributions as we execute upon our focused strategy in immunology." Dr. Batycky brings with her over 25 years of global drug development experience in the biopharmaceutical in

    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care

$LABP
Financials

Live finance-specific insights

See more
  • Landos Biopharma Provides Comprehensive Update on Clinical Development Plans

    Advancing NX-13 Clinical Development for Treatment of Ulcerative Colitis On Track to Initiate Phase 2 Proof-of-Concept Trial for NX-13 in the Second Quarter of 2023 and Report Topline Data by the Fourth Quarter of 2024 Broader, Novel Pipeline Poised for Partnering and Continued Development in the Future; Significant Optionality for Omilancor, LABP-104 and Four Promising Pre-Clinical Programs Secures Additional $16.7 Million Investment Disciplined Financial Approach Expected to Maintain Cash Runway into First Half of 2025 Company to Host Investor Call at 8:00 AM ET NEW YORK, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP) ("Landos" or the "Company"), a clinical

    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Landos Biopharma Reports Third Quarter 2021 Financial Results and Provides Corporate Update

    Enhancing Focus on High-Impact Clinical-Stage Programs to Ensure Optimal Path to Commercialization Refining Ulcerative Colitis Clinical Development Plans for Omilancor to Generate Additional Phase 2b Data Prior to Initiating Pivotal Phase 3 Program Determining Optimal Enrollment for Phase 2 Clinical Study of Omilancor in Crohn's Disease and Phase 1b Study of NX-13 in UC Initiated Dosing for LABP-104 in Healthy Volunteers in October 2021 with Results Expected in 1H 2022 Corporate Update Conference Call Scheduled for 8:00 am ET Today BLACKSBURG, Va., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a clin

    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Landos Biopharma to Host Corporate Update Call

    BLACKSBURG, Va., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma Inc. (NASDAQ:LABP) today announced that it will report third quarter 2021 financial results and host a conference call to provide a corporate update on November 15, 2021. Following the release of the financial results, Landos will host a live webcast at 8:00 am ET. The webcast can be accessed through the Company's investor relations website at https://ir.landosbiopharma.com/, or by dialing 1-877-317-6789 (Toll Free) or 1-412-317-6789 (International) and asking to join the Landos Corporate Update call. The webcast will be archived and be available for replay on the Company's investor relations website. About Landos Biopha

    $LABP
    Biotechnology: Pharmaceutical Preparations
    Health Care

$LABP
Large Ownership Changes

This live feed shows all institutional transactions in real time.

See more