Artificial Intelligence
Landos Biopharma Reports First Quarter 2022 Results and Provides Business Update
On Track to Complete Review of Clinical Development Plans by Mid-2022
Top-Line Results for NX-13 Phase 1b and LABP-104 Phase 1 Trials Remain On Track for Mid-2022
Plans to Announce Timing of Phase 2b Trial of Omilancor Later this Year
NEW YORK, May 12, 2022 (GLOBE NEWSWIRE) — Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced financial results for the first quarter ended March 31, 2022, and provided a business update.
“We are making strong progress on the review of our clinical development plans and look forward to providing a comprehensive update by mid-year,” said Chris Garabedian, Chairman of the Board. “Our entire team remains focused on advancing our three clinical-stage product candidates – omilancor, NX-13 and LABP-104. We are confident in our path forward as we build momentum for these programs.”
“We are pleased with our progress in building a drug-development-focused team and streamlining the Company. We remain highly confident in the scientific foundations of Landos and the potential of our clinical-stage programs to address the therapeutic needs of patients suffering from autoimmune diseases,” said Tim Mayleben, Interim President and CEO of Landos. “Our team is finalizing focused development plans for omilancor, NX-13 and LABP-104, which we believe will optimize successful outcomes for these programs. We look forward to providing our clinical development roadmap as we deliver on our goals of enhancing value for patients, physicians and shareholders.”
Clinical Development Updates
Omilancor
Omilancor is a novel, oral, gut-restricted LANCL2 agonist in development for the treatment of ulcerative colitis (UC) as a once-daily oral treatment.
- Landos is continuing to work on a reformulated drug product candidate, including a dose selection assessment. The Company expects to announce both the timing and next steps in the development of omilancor later this year.
NX-13
NX-13 is a novel, oral, gut-restricted NLXR1 agonist in development for the treatment of UC as a once-daily oral treatment.
- The Phase 1b trial of NX-13 in moderate UC patients is expected to achieve data base lock in the second quarter of 2022, with top-line results on track for the third quarter of 2022.
- Long-term toxicology studies for NX-13 are now complete, with results on track for the third quarter of 2022.
- The timing for initiation of a Phase 2 clinical trial of NX-13 in moderate-to-severe UC patients is expected to be announced later this year.
LABP-104
LABP-104 is a novel, oral, systemically distributed LANCL2 agonist in development for the potential treatment of systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA) as a once-daily oral treatment.
- Landos is conducting a Phase 1a trial of LABP-104 evaluating the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. Landos expects to report top-line results from this trial in mid-2022.
- Landos expects to announce the timing for the initiation of a Phase 2 trial of LABP-104 later this year.
Summary of First Quarter 2022 Results
Cash, Cash Equivalents and Marketable Securities:
As of March 31, 2022, the Company had cash, cash equivalents and marketable securities of approximately $73.8 million, which it believes will be sufficient to fund planned operations into the second half of 2023.
Research and Development Expenses:
Research and development expenses were $10.8 million for the first quarter of 2022, compared to $7.3 million in the first quarter of 2021. The increase was primarily attributable to increased costs associated with the Company’s ongoing development activities related to omilancor, NX-13 and LABP-104. Costs in the first quarter of 2022 include those related to closing two trials of omilancor for the treatment of patients with moderate-to-severe Crohn’s Disease.
General and Administrative Expenses:
General and administrative expenses were $4.2 million for the first quarter of 2022, compared to $2.6 million in the first quarter of 2021. The increase was primarily attributable to increased compensation related expenses, including stock-based compensation, increased expenses related to professional services and insurance, other costs associated with becoming a public company and a one-time charge incurred in connection with a lease termination of approximately $0.3 million.
About Landos Biopharma
Landos Biopharma is a clinical-stage biopharmaceutical company focused on the discovery and development of oral therapeutics for patients with autoimmune diseases. We believe we were the first to identify and target LANCL2, NLRX1 and PLXDC2, which are immunometabolic pathways or targets. Our core expertise is the discovery of novel pathways at the interface of immunity and metabolism. We leverage our proprietary advanced artificial intelligence-based integrated computational and experimental precision medicine platform, our LANCE platform, to identify novel therapeutic targets based on predictions of immunometabolic function. We then identify and create novel therapeutic candidates to engage those novel targets in areas of unmet medical need. We have identified seven novel immunometabolic pathways or targets. Our near-term focus is on our clinical-stage programs including omilancor for the treatment of UC, NX-13 for the treatment of UC and LABP-104 for the potential treatment of SLE and/or 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, the impact of the Company’s reallocation of resources and anticipated related cost savings 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 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 Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended March 31, |
|||||||
| 2022 | 2021 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 10,800 | $ | 7,254 | |||
| General and administrative | 4,153 | 2,646 | |||||
| Total operating expenses | 14,953 | 9,900 | |||||
| Loss from operations | (14,953 | ) | (9,900 | ) | |||
| Interest and other income, net | 89 | 82 | |||||
| Net loss | $ | (14,864 | ) | $ | (9,818 | ) | |
| Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.38 | ) | |
| Weighted-average number of shares used to compute net loss per share, basic and diluted | 40,254,890 | 26,070,455 | |||||
Landos Biopharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
| March 21, 2022 | December 31, 2021 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 11,288 | $ | 8,305 | |||
| Marketable securities, available-for-sale | 62,508 | 82,575 | |||||
| Prepaid expenses and other current assets | 3,563 | 1,266 | |||||
| Total current assets | 77,359 | 92,146 | |||||
| Property and equipment, net | 224 | 707 | |||||
| Other assets | 27 | 26 | |||||
| Total assets | $ | 77,610 | $ | 92,879 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 9,803 | $ | 12,908 | |||
| Accrued liabilities | 5,704 | 3,703 | |||||
| Total current liabilities | 15,507 | 16,611 | |||||
| Total liabilities | 15,507 | 16,611 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock | 403 | 403 | |||||
| Additional paid-in-capital | 171,182 | 170,241 | |||||
| Accumulated other comprehensive loss | (467 | ) | (225 | ) | |||
| Accumulated deficit | (109,015 | ) | (94,151 | ) | |||
| Total stockholders’ equity | 62,103 | 76,268 | |||||
| Total liabilities and stockholders’ equity | $ | 77,610 | $ | 92,879 | |||
Artificial Intelligence
THE 2024 GLOBAL EXPLORATION SUMMIT IS ANNOUNCED AT THE 120th EXPLORERS CLUB ANNUAL GALA IN NEW YORK
Porto and Terceira Island to Host the ‘Davos of Exploration’ – The GLEX Summit
NEW YORK, April 24, 2024 /PRNewswire/ — The Explorers Club and Expanding World, are thrilled to announce the fifth edition of The GLEX Summit, known as the ‘Davos of Exploration,’ set to take place from June 15 to 19 on Porto city and Terceira Island in the Azores, Portugal.
This year, Porto will Ignite the summit, followed by two days of discussions and exploration in the historic city of Angra do Heroísmo on Terceira Island. From the depths of the oceans to new space missions, the power and future of exploration will be explored in these two World Heritage cities, deeply connected to the history of exploration.
The 2024 GLEX Summit will revolve around the latest discoveries and groundbreaking missions shaping the future of our planet. Highlights of the summit include the Artemis mission, which plans to send astronauts back to the moon for the first time since 1972, and the role of Space and the Oceans in researching and mitigating the effects of climate change. Notable sessions will also delve into the unfortunate incident of the submersible implosion that took place on Titan and the recording of an episode of the BBC’s acclaimed science comedy show ‘The Infinite Monkey Cage,’ hosted by physicist Brian Cox and comedian Robin Ince.
This prestigious event will bring together over three dozen explorer and scientist legends from around the world. Confirmed physicist and researcher Brian Cox, NASA Chief Scientist James Garvin, Aquanaut Fabien Cousteau, Oceanographer David Gallo, Cosmonaut Mike Massimino, Nasa ISS CapCom Tess Caswell, among many others global Explorers and Scientists.
For further inquiries about The GLEX Summit and press accreditation, please contact:
Marco Barbosa [email protected], +351917345744
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Hillstone Networks delivers advanced Microsegmentation across different verticals..
SANTA CLARA, Calif., April 24, 2024 /PRNewswire/ — Hillstone Networks, a leading provider of cybersecurity solutions, has been included in the Forrester Microsegmentation Solutions Landscape, Q2 2024 report. The report offers an overview of the Microsegmentation market, focused on the vendors who deliver solutions for protection of critical resources, combating ransomware, and contributing to compliance adherence. The report provides security professionals a snapshot of these named vendors, considering factors such as size, geographic focus, and use cases to select the most suitable option for their targeted use cases or needs.
In the Landscape Report, Forrester states that “Zero Trust is all about replacing bodies of implicit trust with explicit policy. In physical and virtual networks, the application of this principle is referred to as microsegmentation…. [It] was one of the first true Zero Trust technologies developed after Forrester published the initial Zero Trust reports.”
Forrester states in the report that the main trend is “organizations are finally getting serious about Zero Trust. Some, proactively, are implementing microsegmentation as part of a Zero Trust strategy or initiative. Others are implementing it because they got hit by ransomware and are trying to avoid it again. But all of them are doing Zero Trust with microsegmentation.”
“Being recognized as a vendor in the Microsegmentation solution landscape underscores for us the pivotal role our technology plays in safeguarding critical assets and thwarting ransomware threats. We believe it reaffirms our commitment to providing cutting-edge security measures built on an innovative and AI-powered platform that help our customers defend against evolving cyber risks, ensuring resilience and trust,” states Tim Liu, CTO and Co-founder at Hillstone Networks.
Hillstone’s Microsegmentation solution provides the following key benefits:
Advanced and extensive Microsegmentation for physical servers, virtual machines, cloud hosts, and containers, seamlessly compatible with multiple platforms.Comprehensive, integrated Layer 4 to 7 security and malware features (Next Generation Firewall, Intrusion Prevention System, AntiVirus, URL filtering, DDoS, and bot defense), and complete vulnerability management across the entire application lifecycle.Distributed architecture for easy scaling and portability.Centralized and comprehensive visibility to reduce gaps in the threat surface.Learn more about Hillstone Networks solutions here.
About Hillstone Networks
Hillstone Networks’ Integrative Cybersecurity approach is based on a visionary, AI-powered, and accessible platform, delivering coverage, control, and consolidation to secure over 28,000 global enterprises.
Media ContactZeyao Hu+1 [email protected]
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Artificial Intelligence
Tetra Pharm Technologies and Glysious Announce Collaboration to Develop Transdermal Combination Drugs Targeting the Endocannabinoid System
The collaboration brings together Tetra Pharm Technologies’ expertise in enabling technology with Glysious’ proprietary transdermal drug delivery system, renowned for its effectiveness, comfort, and convenience.
COPENHAGEN, Denmark, April 24, 2024 /PRNewswire/ — Tetra Pharm Technologies and Glysious are pleased to announce a strategic collaboration aimed at developing a ground-breaking transdermal drug delivery system complementing several of Tetra Pharm Technologies’ pipeline candidates. The joint invention aims to revolutionize transdermal release of “difficult-to-formulate” compounds targeting the endocannabinoid system.
Tetra Pharm Technologies has focused intensively on formulation expertise, that is, how the molecules are effectively integrated with a drug delivery system to reach their desired targets. Glysious has worked rigorously on the development of an adhesive patch for transdermal drug delivery since the company’s incorporation in 2020.
“The Glysious technology enables precision, sustained dosing, and allows for a high drug load and effective emptying of patches. The transdermal patches remain in place and are very comfortable and convenient to use, resulting in improved patient compliance. However, we have identified challenges with standard formulation strategies, not providing acceptable drug release due to shortcomings of the formulation matrix”, says Professor, Dr.Techn. Anne Ladegaard Skov, Chief Scientific Officer, Glysious.
Back in 2023 Glysious and Tetra Pharm Technologies performed early in-vitro feasibility tests, integrating Tetra Pharma Technologies’ proprietary enabling technology for delivery of poorly soluble compounds with Glysious’ patch.
Dr. Morten Allesø, Chief Scientific Officer, Tetra Pharm Technologies, adds: “Although both parties were aware of the uniqueness of our respective technologies, we were positively surprised to find a five-fold increase in performance of our combination product compared to conventional formulation technologies. This is truly remarkable, and we consider it our shared obligation to further advance this technology to the benefit of the patients.”
The objectives of the collaboration include conducting comprehensive in-vitro and in-vivo studies to evaluate the performance and efficacy of the combined drug delivery system. Additionally, Tetra Pharm Technologies and Glysious plan to pursue a common patent for the joint invention, ensuring that their innovative technology remains protected and exclusive.
“We are excited to collaborate with the innovative team in Tetra Pharm Technologies on this transdermal drug delivery system paving the way for commercialization and scaling of the Glysious technology within the pharma segment”, says Stina Bjerg Nielsen, Chief Executive Officer, Glysious.
Martin Rose, Chief Executive Officer, Tetra Pharm Technologies, concludes: “The collaboration represents a unique opportunity to harness the synergies between our respective technologies. By combining our expertise, we aim to develop a transdermal drug delivery system that offers superior efficacy, convenience, and patient compliance, supporting several of our pipeline programs”.
As part of the collaboration, the partners will exchange expertise, knowledge, and resources. In addition, Tetra Pharm Technologies and Glysious will conduct joint research, experiments, and tests as required for the development of a joint patent. The scope of the collaboration is focused on disease indications such as pain, sleep disorders, and appetite regulation.
About Tetra Pharm Technologies
Tetra Pharm Technologies is a Danish biopharmaceutical company established in 2018 with a vision to be a leader in research and development of pharmaceutical drugs for the treatment of diseases related to the endocannabinoid system. For more information, please visit www.tetrapharm.eu
About Glysious
Glysious is a Danish medtech company, incorporated in 2020, that develops patches, creams, spray, and foams with controlled release of active ingredients for cosmetics and life science applications. For more information, please visit www.glysious.com
For further informationJacob SchlundtChief Marketing OfficerTetra Pharm [email protected]+45 51976225
Stina Bjerg NielsenChief Executive [email protected]+45 3053 5393
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