ABCL AbCellera Biologics Inc.

28.35
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Drug Pipeline

Drug Stage Notes
BamlanivimabLY-CoV555
COVID-19 Antibody
Approved
Approved
Emergency Use Authorization (EUA) announced November 9, 2020.

Latest News

  1. - Bamlanivimab (LY-CoV555) has greater affinity and potency relative to other RBD-binding and ACE2-blocking antibodies tested in this study

    - Because of its potency, bamlanivimab provides a therapeutic foundation to be administered with another antibody to expand the protection against viral variants

    - Study was the first of its kind to show a neutralizing antibody can decrease SARS-CoV-2 viral shedding and transmission by blocking virus replication in the upper airway

    - Bamlanivimab moved from first screen to clinical testing in 90 days1 and is the world's first monoclonal antibody specifically developed against SARS-CoV-2 to receive FDA Emergency Use Authorization (EUA)2

    - Since EUA, bamlanivimab has been used to treat approximately 400,000

    - Bamlanivimab (LY-CoV555) has greater affinity and potency relative to other RBD-binding and ACE2-blocking antibodies tested in this study

    - Because of its potency, bamlanivimab provides a therapeutic foundation to be administered with another antibody to expand the protection against viral variants

    - Study was the first of its kind to show a neutralizing antibody can decrease SARS-CoV-2 viral shedding and transmission by blocking virus replication in the upper airway

    - Bamlanivimab moved from first screen to clinical testing in 90 days1 and is the world's first monoclonal antibody specifically developed against SARS-CoV-2 to receive FDA Emergency Use Authorization (EUA)2

    - Since EUA, bamlanivimab has been used to treat approximately 400,000 high-risk COVID-19 patients in the U.S. alone and has been authorized in more than 15 countries

    AbCellera (NASDAQ:ABCL) and collaborators today announced the publication of research in Science Translational Medicine characterizing the high potency of bamlanivimab (LY-CoV555) to neutralize SARS-CoV-2 by uniquely binding both the up and down confirmations of the spike receptor-binding domain (RBD) and inhibiting critical interactions with the angiotensin converting enzyme 2 (ACE2) cellular receptor necessary for viral entry. Data generated in a preclinical model showed prophylactic treatment with bamlanivimab resulted in significant decreases in viral load and replication in the upper and lower respiratory tracts after SARS-CoV-2 exposure, indicating the potential of bamlanivimab to reduce viral shedding and transmission. These data, which were generated prior to initiating clinical trials in June 2020 and published today, support the observed substantial clinical efficacy of bamlanivimab in treating and preventing COVID-19.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210405005386/en/

    The unique binding of bamlanivimab to the SARS-CoV-2 spike protein: The spike protein exists as a trimer of three identical monomers on the surface of the SARS-CoV-2 virus. Structural modeling (left panel) of the spike trimer in shades of pink and white is shown with the target-binding fragments (Fabs) of bamlanivimab (in green and yellow) bound to the RBD of the spike protein. This analysis shows three bamlanivimab Fab fragments bound to one spike trimer. One of the spike proteins is in the up position (dark pink) with the other two in the down position (light pink and white). The middle panel shows an isolated view of the spike monomers (dark pink, white and light pink) with the bound bamlanivimab Fab fragments in green and yellow. In the right panel, two spike monomers bound in the up and down positions by the bamlanivimab Fab fragments are overlaid. 3D structural model provided by JS McLellan Group, University of Texas.

    The unique binding of bamlanivimab to the SARS-CoV-2 spike protein: The spike protein exists as a trimer of three identical monomers on the surface of the SARS-CoV-2 virus. Structural modeling (left panel) of the spike trimer in shades of pink and white is shown with the target-binding fragments (Fabs) of bamlanivimab (in green and yellow) bound to the RBD of the spike protein. This analysis shows three bamlanivimab Fab fragments bound to one spike trimer. One of the spike proteins is in the up position (dark pink) with the other two in the down position (light pink and white). The middle panel shows an isolated view of the spike monomers (dark pink, white and light pink) with the bound bamlanivimab Fab fragments in green and yellow. In the right panel, two spike monomers bound in the up and down positions by the bamlanivimab Fab fragments are overlaid. 3D structural model provided by JS McLellan Group, University of Texas.

    Previously Reported Clinical Trial Results

    Bamlanivimab has been evaluated both alone and together with other antibodies in more than 5,000 patients across multiple clinical trials and is currently authorized in more than 15 countries. Bamlanivimab alone versus placebo has been shown to reduce hospitalization by 70% in high-risk patients with early COVID-19 infection3 and reduce the risk of contracting COVID-19 by up to 80% in nursing home residents when used as a prophylactic.4

    Because of its potency, bamlanivimab also provides a therapeutic foundation to be administered with other antibodies to expand the protection against viral variants. The first of these, bamlanivimab together with etesevimab, has been authorized in the U.S. and within the European Union, and Phase 3 data show that this antibody therapy reduces COVID-19-related hospitalizations and death by 87%.5 Most importantly, across all the clinical trials, all COVID-19-related deaths occurred in patients taking the placebo; no deaths occurred in patients who received an antibody therapy, either bamlanivimab alone or together with another antibody.5

    "At the beginning of our pandemic response to COVID-19, we made a decision with our partners and collaborators to develop a single antibody, emphasizing speed and scalability so that we would be able to help as many people as possible," said Carl Hansen, Ph.D., CEO and President of AbCellera. "Over the past four months, bamlanivimab has been used to treat hundreds of thousands of people across the world -- more than any other COVID-19 antibody therapy. We believe this has kept thousands of people out of the hospital, reducing the burden on our healthcare systems, and, most importantly, has saved thousands of lives."

    Discussion of Data Published Today in Science Translational Medicine

    Data from multiple in vitro assays of the 24 lead antibodies identified by AbCellera and collaborators indicated bamlanivimab displayed greater neutralization potency despite similar RBD-binding affinities, suggesting bamlanivimab has a unique binding profile to the SARS-CoV-2 spike protein. Structural analysis using X-ray crystallography and electron microscopy demonstrated that bamlanivimab binds to an area on the spike protein overlapping the ACE2 binding site that is predicted to be fully accessible in both the up and down conformations. The RBD portion of the spike protein is the primary target for virus neutralization as it mediates the conserved mechanism of viral entry to infect cells. The spike exists in an up or down position, with the up position enabling interaction with the ACE2 receptor and the down position potentially contributing to immune system evasion. Regardless of the state of the spike protein, bamlanivimab has high binding potency to the RBD of SARS-CoV-2 spike protein.

    "The unique ability of bamlanivimab to bind the spike protein in both the up and down position could underlie bamlanivimab's greater neutralization potency compared to other antibodies," said Bo Barnhart, Ph.D., Scientific Director at AbCellera. "These preclinical data show that modest doses of bamlanivimab provided protection against SARS-CoV-2 infection, which has since been confirmed in clinical trials to protect residents and staff in long-term care facilities and nursing homes. Neutralizing antibodies, like bamlanivimab, are designed to protect our most vulnerable populations for whom vaccines are less effective. These data with bamlanivimab further confirm that neutralizing antibodies have the potential to reduce SARS-CoV-2 viral transmission and prevent infection and can provide immediate benefit when a life-saving treatment is needed."

    To determine the potential of neutralizing antibodies to prevent SARS-CoV-2 infection, nonhuman primates (NHPs) were prophylactically treated with 1, 2.5, 15, or 50 mg/kg of bamlanivimab 24 hours prior to viral challenge. Critically, viral replication as well as viral load were significantly reduced in the upper respiratory tract on Day 1 at multiple doses. Additionally, viral load and replication were significantly reduced or undetectable in the lower respiratory tract at several doses. At doses of 2.5 mg/kg and higher serum concentrations were associated with maximal protection in this model.

    "The data published today give insights into why bamlanivimab is so potent and further support all of our clinical experience and data showing that bamlanivimab is a safe and effective therapy to treat and prevent COVID-19, when administered early in the course of infection," said Ester Falconer, Ph.D., Chief Technology Officer at AbCellera and senior author of the paper. "Furthermore, bamlanivimab's unique potency allows for lower dosing and enables administration with another antibody to address SARS-CoV-2 variants. Over the past year, we have continued to screen patient samples, identifying thousands of human antibodies and generating massive amounts of information about how the human immune system responds to COVID-19. We have tracked the variants closely and identified a next-generation antibody that is predicted to neutralize all circulating variant strains of concern of SARS-CoV-2. This antibody, currently referred to as 1404, moved into preclinical development and manufacturing in January with our partner, Eli Lilly and Company, and we are continuing to work closely with them and our collaborators for rapid advancement."

    The preclinical data for bamlanivimab was published online today in Science Translational Medicine and can be found at: https://science.sciencemag.org/lookup/doi/10.1126/science.abf1906.

    About AbCellera's Response to COVID-19

    Bamlanivimab was developed from an antibody that was discovered from the blood of a recovered COVID-19 patient using AbCellera's pandemic response platform, in partnership with the Vaccine Research Center (VRC) at National Institute of Allergy and Infectious Diseases (NIAID). Within one week of receiving the sample, AbCellera screened over five million antibody-producing cells to identify and isolate approximately 500 unique antibodies that bind to SARS-CoV-2, the virus that causes COVID-19. The binding antibodies were then tested by AbCellera, the VRC, and Eli Lilly and Company (Lilly) to find those most effective in neutralizing the virus. Bamlanivimab was selected as the lead candidate from this group of antibodies and was the first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials in North America. Bamlanivimab was the first monoclonal antibody to receive EUA from the FDA and is currently being assessed in several clinical trials alone and together with other antibodies.

    AbCellera's pandemic response capabilities were developed over the past three years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) program. The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen. AbCellera's ongoing efforts to respond to the pandemic have identified more than 2,300 unique anti-SARS-CoV-2 human antibodies from multiple patient samples. These antibodies are in various stages of testing by AbCellera and its partners.

    About Bamlanivimab (LY-CoV555)

    Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at NIAID VRC. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

    Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

    Bamlanivimab alone and together with etesevimab are authorized under special/emergency pathways, in the context of the pandemic, in the U.S. and the European Union. In addition, bamlanivimab alone is authorized for emergency use in Canada, Panama, Kuwait, the UAE, Israel, Rwanda, Morocco and numerous other countries. Through Lilly's work with the Bill & Melinda Gates Foundation, Lilly is providing doses of bamlanivimab free of charge in Rwanda and Morocco.

    About AbCellera Biologics Inc.

    AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development. For more information, visit www.abcellera.com.

    AbCellera Forward-looking Statements

    This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

    In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

    __________________________

    1 AbCellera's Rapid Pandemic Response Platform Contributes to the World's First COVID-19 Clinical Trial for a Potential Monoclonal Antibody Treatment. June 1, 2020. https://www.abcellera.com/news/2020-06-01-worlds-first-covid-19-clinical-trial-for-a-potential-monoclonal-antibody-treatment

    2 AbCellera-Discovered Antibody Receives U.S. FDA Emergency Use Authorization as a Monotherapy for the Treatment of COVID-19, November 9, 2020. https://www.abcellera.com/news/2020-11-09-bamlanivimab-us-fda-eua

    3 Interim Data Reported for AbCellera-Discovered COVID-19 Antibody in Phase 2 Clinical Trials

    https://www.abcellera.com/news/2020-09-16-interim-data-phase-2-clinical-trials

    4 AbCellera-Discovered Antibody Prevented COVID-19 in Nursing Homes and Reduced Risks by up to 80% for Residents, January 21, 2021. https://www.abcellera.com/news/2021-01-21-abcellera-discovered-antibody-prevented-covid-19-in-nursing-homes

    5 AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19, March 10, 2021. https://www.abcellera.com/news/2021-03-10-bamlanivimab-together-with-etesevimab-reduced-hospitalizations-and-prevented-death-in-phase-3-trial-for-early-covid-19

    Source: AbCellera Biologics Inc.

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  2. Expanded collaboration includes an eight-target discovery partnership leveraging AbCellera's entire technology stack, including the Trianni Mouse® and the OrthoMabTM bispecific platforms

    AbCellera (NASDAQ:ABCL) today announced agreements to expand its collaboration with Gilead Sciences, Inc. (Gilead) including a multi-year, multi-target antibody discovery collaboration and access to AbCellera's humanized mouse technology, the Trianni Mouse®. Under the financial terms of the agreements, AbCellera will receive an upfront payment and is eligible for milestone payments and royalties based on the development and commercialization of antibodies generated by AbCellera under this collaboration.

    Building on the successful completion of the first collaboration…

    Expanded collaboration includes an eight-target discovery partnership leveraging AbCellera's entire technology stack, including the Trianni Mouse® and the OrthoMabTM bispecific platforms

    AbCellera (NASDAQ:ABCL) today announced agreements to expand its collaboration with Gilead Sciences, Inc. (Gilead) including a multi-year, multi-target antibody discovery collaboration and access to AbCellera's humanized mouse technology, the Trianni Mouse®. Under the financial terms of the agreements, AbCellera will receive an upfront payment and is eligible for milestone payments and royalties based on the development and commercialization of antibodies generated by AbCellera under this collaboration.

    Building on the successful completion of the first collaboration together, under the new agreement AbCellera will generate panels of antibodies for up to eight new targets, across multiple indications, selected by Gilead. The expanded collaboration will leverage the full breadth of AbCellera's technology stack, including the recently added capabilities for sourcing diverse, fully-humanized antibodies using the Trianni Mouse® platform and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.

    "We are excited to build on the success of the first program and deepen our relationship with the team at Gilead," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We are particularly pleased to see the value created for our partners by quickly integrating the Trianni Mouse® and OrthoMabTM platforms, which we acquired in second half of 2020."

    AbCellera's partners benefit from an operating system designed to support many antibody modalities, unlock new targets, and increase the speed and the probability of success of their therapeutic antibody discovery programs. AbCellera's AI-powered technology stack brings together microfluidics, single cell analysis, machine learning, computation, custom robotics, and automation to compound the power of each step in the discovery process.

    About AbCellera Biologics Inc.

    AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development. For more information, visit www.abcellera.com.

    AbCellera Forward-looking Statements

    This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

    In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

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    • Total revenue of $233 million1 in 2020, up 1,908% year-over-year
    • Total revenue from research fees of $20 million, up 71% year-over-year
    • Total programs under contract of 103, up 72% year-over-year
    • EPS of $0.53 (basic) and $0.45 (diluted) compared to $0.01 loss per share in 2019

    AbCellera (NASDAQ:ABCL), a technology company with a centralized operating system for next-generation antibody discovery, today announced financial results for the full year 2020 with the following highlights.

    "AbCellera had a breakthrough year, demonstrating strong growth across every area of the business and the effectiveness of our technology and business model through our discovery of the first monoclonal antibody therapy for COVID-19," said Carl Hansen…

    • Total revenue of $233 million1 in 2020, up 1,908% year-over-year
    • Total revenue from research fees of $20 million, up 71% year-over-year
    • Total programs under contract of 103, up 72% year-over-year
    • EPS of $0.53 (basic) and $0.45 (diluted) compared to $0.01 loss per share in 2019

    AbCellera (NASDAQ:ABCL), a technology company with a centralized operating system for next-generation antibody discovery, today announced financial results for the full year 2020 with the following highlights.

    "AbCellera had a breakthrough year, demonstrating strong growth across every area of the business and the effectiveness of our technology and business model through our discovery of the first monoclonal antibody therapy for COVID-19," said Carl Hansen, Ph.D., President and CEO of AbCellera. "Each program improves our platform, and we continue to invest in new technologies that enhance and expand our capabilities to discover high-quality, potent antibodies for our partners. With our strong cash position, profitability, and cash generation, we are aggressively executing on building our centralized operating system to help bring new antibody therapies to patients faster and more efficiently."

    2020 Business Highlights

    • Strong financial performance led by $233 million in total revenue, including $213 million in milestones and royalties.
    • Generated $119 million in net earnings, up from a $2 million loss in 2019.
    • Expanded partnership business to 103 cumulative programs under contract with 27 partners generating $20 million in research fees (71% growth over $12 million in 2019).
    • Established strong liquidity position with approximately $720 million raised from gross equity financings ($75 million series A2, $90 million convertible note, and $555 million IPO proceeds), and $23 million in positive cash flow from operations to end the year with $594 million in cash and cash equivalents, and $212 million in accrued accounts receivable. AbCellera's strong cash position will be used to build capacity, expand platform capabilities, and pursue business development initiatives.
    • Secured $126 million from the Government of Canada for future infrastructure investments, including CMC and GMP manufacturing capabilities.
    • Acquired Trianni for $90 million to add new capabilities that expand diversity and reduce program timelines by sourcing fully human antibodies from rodents.
    • Acquired the OrthoMab™ bispecific platform to integrate capabilities for engineering bispecific antibodies.
    • Achieved notable COVID-19 program milestones, including bamlanivimab entering clinical trials and receiving authorization in 15 countries across North America, the European Union, the Middle East, and Africa.
    • Announced the appointment of John Montalbano and Peter Thiel to the Board of Directors.

    Key Business Metrics2

    As of December 31, 2020, AbCellera had 103 discovery programs (up 72% from 60 in 2019) that are either completed, in progress, or under contract with 27 partners (up from 22 in 2019). AbCellera has started discovery on a cumulative total of 52 of these programs (up from 43 in 2019).

    Bamlanivimab, being developed by partner Eli Lilly and Company (Lilly), is the first antibody discovered by AbCellera to have reached the clinic and commercial markets. Bamlanivimab is the first monoclonal antibody therapy for COVID-19 in the world to reach human testing and to be authorized for emergency use.

     

     

    Year Ended December 31,

     

     

    Change

     

    Metric

     

    2019

     

     

    2020

     

     

    %

     

    Number of discovery partners

     

     

    22

     

     

     

    27

     

     

     

    23

    %

    Programs under contract, cumulative

     

     

    60

     

     

     

    103

     

     

     

    72

    %

    Program starts, cumulative

     

     

    43

     

     

     

    52

     

     

     

    21

    %

    Programs in the clinic

     

     

    -

     

     

     

    1

     

     

    N/M

     

    Discussion of 2020 Financial Results

     

     

    Year Ended December 31,

     

     

    Change

     

     

     

    2019

     

     

    2020

     

     

    Amount

     

     

    %

     

     

     

    (in thousands, except percentages)

     

    Revenue

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research fees

     

    $

    11,612

     

     

    $

    19,848

     

     

    $

    8,236

     

     

     

    71

    %

    Milestone payments

     

     

    -

     

     

     

    15,000

     

     

     

    15,000

     

     

    N/A

     

    Royalty revenue

     

     

    -

     

     

     

    198,307

     

     

     

    198,307

     

     

    N/A

     

    Total revenue

     

    $

    11,612

     

     

    $

    233,155

     

     

    $

    221,543

     

     

     

    1908

    %

    • Revenue - Total revenue was $233.2 million in 2020, up 1,908% from $11.6 million in 2019. Research fees increased by $8.2 million, or 71%, as a result of growth in our partnership business. The success of bamlanivimab generated our first milestone payments of $15.0 million and our first royalty revenue of $198.3 million.
    • Royalty fees - Royalty fees to the National Institutes of Health, attributable entirely to royalty payments on bamlanivimab, were $27.1 million as compared to $0 in 2019.
    • Research & Development (R&D) expenses - R&D expenses were $29.4 million in 2020, as compared to $10.1 million in 2019, reflecting investments in the technology platform and increased partnership activity. R&D expenses included non-recurring charges of $4.0 million for IPR&D related to the acquisition of the OrthoMab platform and $4.3 million related to Liability Classified Options in connection with the company's conversion to USD as functional currency.
    • Sales & Marketing (S&M) expenses - S&M expenses were $3.8 million in 2020, as compared to $1.3 million in 2019, driven by an expansion of the team.
    • General & Administrative (G&A) expenses - G&A expenses were $11.9 million in 2020, as compared to $2.7 million in 2019, with the increase driven by investments to support the growth of the company and preparations to be a listed company, as well as non-recurring charges of $1.9 million supporting financing activities.
    • Net Earnings - Net earnings in 2020 were $118.9 million, or $0.53 per share and $0.45 per share on a basic and diluted basis, respectively, as compared to a net loss of $2.2 million, or $0.01 per share on both a basic and diluted basis in 2019.
    • Liquidity - AbCellera ended 2020 with $594.1 million of cash and cash equivalents and $212.3 million in accrued accounts receivable, most of which have subsequently been received. AbCellera ended the year with $2.4 million in debt from a Government of Canada zero interest repayable funding program. The company retired all other debt agreements in the year and incurred a non-recurring $4.2 million expense charge for interest and cancellation fees for early retirement.

    Conference Call and Webcast

    AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Daylight Time (5:00 p.m. Eastern Daylight Time).

    The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera's Investor Relations website at https://investors.abcellera.com. A replay of the webcast will be available through the same link following the conference call.

    About AbCellera Biologics Inc.

    AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce costs, and tackle the toughest problems in drug development. To learn more, please visit us at www.abcellera.com.

    Definition of Key Business Metrics

    We regularly review the following key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions. We believe that the following metrics are important to understand our current business. These metrics may change or may be substituted for additional or different metrics as our business develops. For example, as our business matures and to the extent programs are discontinued, we anticipate updating these metrics to reflect such changes.

    Number of discovery partners represents the unique number of partners with whom we have executed partnership contracts. We view this metric as an indication of the competitiveness of our technology stack and our current level of market penetration. The metric also relates to our opportunities to secure programs under contract.

    Programs under contract represent the number of antibody development programs that are under contract for delivery of discovery research activities. A program under contract is counted when a contract is executed with a partner under which we commit to discover antibodies against one selected target. A target is any relevant antigen for which a partner seeks our support in developing binding antibodies. We view this metric as an indication of commercial success and technological competitiveness. It further relates to revenue from technology access fees. The cumulative number of programs under contract with downstream participation is related to our ability to generate future revenue from milestone payments and royalties.

    Program starts represent the number of unique programs under contract for which we have commenced the discovery effort. The discovery effort commences on the later of (i) the day on which we receive sufficient reagents to start discovery of antibodies against a target and (ii) the day on which the kick-off meeting for the program is held. We view this metric as an indication of our operational capacity to execute on programs under contract. It is also an indication of the selection and initiation of discovery projects by our partners and the resulting near-term potential to earn research fees. Cumulatively, program starts with downstream participation indicate our total opportunities to earn downstream revenue from milestone fees and royalties in the mid- to long-term.

    Programs in the clinic represent the count of unique programs for which an Investigational New Drug, or IND, New Animal Drug or Pre-Market Approval, or PMA, application, or equivalents under other regulatory regimes, has been filed based on an antibody that was discovered by us. Where the date of such application is not known to us, the date of the first public announcement of clinical trials will be used instead for the purpose of this metric. We view this metric as an indication of our near- and mid-term potential revenue from milestone fees and potential royalty payments in the long term.

    AbCellera Forward-looking Statements

    This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

    In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

    AbCellera Biologics Inc.

    Condensed Consolidated Statement of Operations

    (Expressed in thousands of U.S. dollars except share and per share data)

     

     

     

     

    2019

     

     

    2020

    Revenue

     

     

     

     

     

     

     

     

     

    Research fees

     

     

    $

    11,612

     

     

    $

    19,848

     

    Milestone payments

     

     

     

    -

     

     

     

    15,000

     

    Royalty revenue

     

     

     

    -

     

     

     

    198,307

     

    Total revenue

     

     

     

    11,612

     

     

     

    233,155

     

    Operating expenses

     

     

     

     

     

     

     

     

     

    Royalty fees

     

     

     

    -

     

     

     

    27,143

     

    Research and development3

     

     

     

    10,113

     

     

     

    29,393

     

    Sales and marketing3

     

     

     

    1,263

     

     

     

    3,842

     

    General and administrative3

     

     

     

    2,749

     

     

     

    11,910

     

    Depreciation and amortization

     

     

     

    1,604

     

     

     

    4,836

     

    Total operating expenses

     

     

     

    15,729

     

     

     

    77,124

     

    Income (loss) from operations

     

     

     

    (4,117

    )

     

     

    156,031

     

    Other (income) expense

     

     

     

     

     

     

     

     

     

    Interest income

     

     

     

    (155

    )

     

     

    (293

    )

    Interest and other expense

     

     

     

    209

     

     

     

    6,511

     

    Foreign exchange (gain) loss

     

     

     

    (186

    )

     

     

    300

     

    Grants and incentives

     

     

     

    (1,774

    )

     

     

    (8,320

    )

    Total other (income) expense

     

     

     

    (1,906

    )

     

     

    (1,802

    )

    Net earnings (loss) before income tax

     

     

     

    (2,211

    )

     

     

    157,833

     

    Provision for income tax

     

     

     

    -

     

     

     

    38,915

     

    Net earnings (loss) and comprehensive income (loss) for the period

     

     

    $

    (2,211

    )

     

    $

    118,918

     

    Net earnings (loss) per share to common shareholders

     

     

     

     

     

     

     

     

     

    Basic

     

     

    $

    (0.01

    )

     

    $

    0.53

     

    Diluted

     

     

    $

    (0.01

    )

     

    $

    0.45

     

    Weighted-average common shares outstanding

     

     

     

     

     

     

     

     

     

    Basic

     

     

     

    151,327,560

     

     

     

    159,195,023

     

    Diluted

     

     

     

    151,327,560

     

     

     

    263,129,765

     

    AbCellera Biologics Inc.

    Condensed Consolidated Balance Sheet

    (Expressed in thousands of U.S. dollars except share data)

     

     

     

    December 31,

    2019

     

     

    December 31,

    2020

    Assets

     

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    7,553

     

     

    $

    594,116

    Accounts receivable

     

     

    2,124

     

     

     

    903

    Accrued accounts receivable

     

     

    1,152

     

     

     

    212,336

    Other current assets

     

     

    1,811

     

     

     

    5,970

    Total current assets

     

     

    12,640

     

     

     

    813,325

    Long term assets

     

     

     

     

     

     

     

    Property and equipment, net

     

     

    8,480

     

     

     

    17,923

    Intangible assets

     

     

    -

     

     

     

    115,153

    Goodwill

     

     

    -

     

     

     

    31,500

    Equity investee

     

     

    -

     

     

     

    19,247

    Other long-term assets

     

     

    585

     

     

     

    8,388

    Loans to related parties

     

     

    1,783

     

     

     

    -

    Total long-term assets

     

     

    10,848

     

     

     

    192,211

    Total assets

     

    $

    23,488

     

     

    $

    1,005,536

    Liabilities and shareholders' equity

     

     

     

     

     

     

     

    Current liabilities

     

     

     

     

     

     

     

    Accounts payable and accrued liabilities

     

    $

    2,579

     

     

    $

    20,005

    Current portion of contingent consideration payable

     

     

    -

     

     

     

    13,411

    Income taxes payable

     

     

    -

     

     

     

    36,152

    Accrued royalties payable

     

     

    -

     

     

     

    27,143

    Deferred revenue

     

     

    3,236

     

     

     

    6,589

    Current portion of long-term debt

     

     

    2,080

     

     

     

    190

    Total current liabilities

     

     

    7,895

     

     

     

    103,490

    Long-term liabilities

     

     

     

     

     

     

     

    Operating lease liability

     

     

    2,642

     

     

     

    3,715

    Long-term debt

     

     

    1,363

     

     

     

    2,198

    Deferred revenue and grant funding

     

     

    1,336

     

     

     

    25,894

    Contingent consideration payable

     

     

    -

     

     

     

    9,148

    Deferred tax liability

     

     

    -

     

     

     

    26,161

    Other long-term liabilities

     

     

    -

     

     

     

    4,422

    Total long-term liabilities

     

     

    5,341

     

     

     

    71,538

    Total liabilities

     

    $

    13,236

     

     

    $

    175,028

    Shareholders' equity

     

     

     

     

     

     

     

    Common shares: no par value, unlimited authorized shares at

    December 31, 2019 and 2020: 151,681,382 and 269,497,768

    shares issued and outstanding at December 31, 2019 and 2020

    respectively

     

     

    5,122

     

     

     

    710,387

    Convertible preferred shares unlimited authorized shares at

    December 31, 2019 and 2020: 2,105,264 and nil issued and

    outstanding at December 31, 2019 and 2020 respectively

     

     

    7,546

     

     

     

    -

    Additional paid-in capital

     

     

    2,300

     

     

     

    5,919

    Accumulated earnings (deficit)

     

     

    (4,716

    )

     

     

    114,202

    Total shareholders' equity

     

     

    10,252

     

     

     

    830,508

    Total liabilities and shareholders' equity

     

    $

    23,488

     

     

    $

    1,005,536

     

    AbCellera Biologics Inc.

    Condensed Consolidated Statement of Cash Flows

    (Expressed in thousands of U.S. dollars)

     

     

     

    2019

     

    2020

    Cash flows from operating activities:

     

     

     

     

     

     

     

     

    Net income (loss)

     

    $

    (2,211

    )

     

    $

    118,918

     

    Cash flows from operating activities

     

     

     

     

     

     

     

     

    Depreciation of property and equipment

     

     

    1,604

     

     

     

    2,317

     

    Amortization of intangible assets

     

     

    -

     

     

     

    2,519

     

    Amortization of operating lease right-of-use-assets

     

     

    243

     

     

     

    435

     

    Stock-based compensation

     

     

    890

     

     

     

    8,397

     

    Extinguishment of long-term debt

     

     

    -

     

     

     

    3,700

     

    Accretion and other

     

     

    194

     

     

     

    830

     

    Deferred tax expense

     

     

    -

     

     

     

    2,098

     

    Unrealized foreign exchange gains and losses

     

     

    -

     

     

     

    177

     

    Changes in operating assets and liabilities

     

     

     

     

     

     

     

     

    Accounts and accrued research fees receivable

     

     

    (1,803

    )

     

     

    (5,467

    )

    Accrued royalties receivable

     

     

    -

     

     

     

    (197,553

    )

    Investment tax credit receivable

     

     

    1,593

     

     

     

    -

     

    Income taxes payable

     

     

    -

     

     

     

    36,412

     

    Accounts payable and accrued liabilities

     

     

    150

     

     

     

    6,601

     

    Operating lease liabilities

     

     

    2,784

     

     

     

    (350

    )

    Deferred revenue

     

     

    (6

    )

     

     

    21,810

     

    Accrued royalties payable

     

     

    -

     

     

     

    27,143

     

    Other operating assets and liabilities

     

     

    (744

    )

     

     

    (5,297

    )

    Net cash provided by operating activities

     

     

    2,694

     

     

     

    22,690

     

    Cash flows from investing activities

     

     

     

     

     

     

     

     

    Purchases of property and equipment

     

     

    (3,997

    )

     

     

    (9,673

    )

    Purchase of intangible assets

     

     

    -

     

     

     

    (5,000

    )

    Repayment (issuance) of related party loans

     

     

    (1,783

    )

     

     

    1,783

     

    Acquisition of Trianni

     

     

    -

     

     

     

    (87,643

    )

    Investment in equity investees

     

     

    -

     

     

     

    (19,247

    )

    Net cash used in investing activities

     

     

    (5,780

    )

     

     

    (119,780

    )

    Cash flows from financing activities

     

     

     

     

     

     

     

     

    Repayment of long-term debt

     

     

    (399

    )

     

     

    (19,942

    )

    Proceeds from long-term debt

     

     

    193

     

     

     

    15,490

     

    Proceeds from convertible debentures

     

     

    -

     

     

     

    89,990

     

    Short-term borrowings

     

     

    387

     

     

     

    (387

    )

    Issuance of common shares pursuant to exercise of stock options

     

     

    25

     

     

     

    1,000

     

    Net proceeds from issuance of common shares

     

     

    -

     

     

     

    522,840

     

    Proceeds from issuance of preferred shares - series A1 financing

     

     

    (11

    )

     

     

    -

     

    Proceeds from issuance of preferred shares - series A2 financing

     

     

    -

     

     

     

    74,662

     

    Net cash provided by financing activities

     

    $

    195

     

     

    $

    683,653

     

    Increase (decrease) in cash and cash equivalents

     

     

    (2,891

    )

     

     

    586,563

     

    Cash and cash equivalents, beginning of year

     

     

    10,444

     

     

     

    7,553

     

    Cash and cash equivalents, end of year

     

    $

    7,553

     

     

    $

    594,116

     

     


    1 All financials are reported in USD.

    2 See definitions of Key Business Metrics

    3 Exclusive of depreciation and amortization

    Source: AbCellera Biologics Inc.

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  3. Patients who received bamlanivimab and etesevimab together had an 87% reduction in hospitalizations and death; no patients died who received the therapy

    AbCellera (NASDAQ:ABCL) today announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly and Company (Lilly), and etesevimab 1400 mg (LY-CoV16) together reduced COVID-19-related hospitalizations and deaths by 87% in high-risk patients recently diagnosed with COVID-19. These results mark the second positive Phase 3 trial readout for bamlanivimab and etesevimab together, adding to the growing safety and efficacy data that has resulted in the following key milestones accelerating the adoption of the antibody therapy globally:

    • Emergency

    Patients who received bamlanivimab and etesevimab together had an 87% reduction in hospitalizations and death; no patients died who received the therapy

    AbCellera (NASDAQ:ABCL) today announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly and Company (Lilly), and etesevimab 1400 mg (LY-CoV16) together reduced COVID-19-related hospitalizations and deaths by 87% in high-risk patients recently diagnosed with COVID-19. These results mark the second positive Phase 3 trial readout for bamlanivimab and etesevimab together, adding to the growing safety and efficacy data that has resulted in the following key milestones accelerating the adoption of the antibody therapy globally:

    • Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).
    • Expanded access in the European Union through the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
    • Recommended use by the National Institutes of Health through its COVID-19 Treatment Guidelines.
    • Delivery of up to 1.2 million doses to the U.S. government through a purchase agreement with Lilly.

    "Across the two Phase 3 cohorts of the BLAZE-1 study, there were no deaths in patients who received bamlanivimab together with etesevimab, as compared to 14 deaths in patients receiving placebo, 13 of which were categorized as COVID-19-related," said Carl Hansen, Ph.D., CEO and President of AbCellera. "No COVID-19-related deaths have been observed across the thousands of patients who have been treated with bamlanivimab alone or together with etesevimab in clinical trials. These antibody therapies can be powerful tools in keeping COVID-19 patients out of the hospital and preventing death."

    The results from this new randomized, double-blind, placebo-controlled Phase 3 BLAZE-1 study provide additional efficacy and safety data that support the use of the dose recently granted both EUA by the U.S. FDA, and a positive scientific opinion by the EMA CHMP.

    Key details from the study, which included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258), are as follows:

    • 87% reduction in COVID-19-related hospitalizations and deaths versus placebo (p<0.0001).
    • No COVID-19-related deaths in the treatment group. All deaths occurred in patients treated with the placebo.
    • A safety profile consistent with those observed from other Phase 1, Phase 2, and Phase 3 trials evaluating these antibodies.

    Details regarding Lilly's BLAZE-1 trial can be found here.

    Bamlanivimab alone and together with etesevimab are authorized under special/emergency pathways, in the context of the pandemic, in the U.S. and the European Union. In addition, bamlanivimab alone is authorized for emergency use in Canada, Panama, Kuwait, the UAE, Israel, Rwanda, Morocco, and numerous other countries. Through Lilly's work with the Bill & Melinda Gates Foundation, Lilly is providing doses of bamlanivimab free of charge in Rwanda and Morocco.

    About AbCellera's Response to COVID-19

    Bamlanivimab was developed from an antibody that was discovered from the blood of a recovered COVID-19 patient using AbCellera's pandemic response platform, in partnership with the Vaccine Research Center (VRC) at National Institute of Allergy and Infectious Diseases (NIAID). Within one week of receiving the sample, AbCellera screened over five million antibody-producing cells to identify and isolate approximately 500 unique antibodies that bind to SARS-CoV-2, the virus that causes COVID-19. The binding antibodies were then tested by AbCellera, the VRC, and Lilly to find those most effective in neutralizing the virus. Bamlanivimab was selected as the lead candidate from this group of antibodies, and was the first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials in North America. Bamlanivimab was the first monoclonal antibody to receive EUA from the FDA and is currently being assessed in several clinical trials alone and together with other antibodies.

    AbCellera's pandemic response capabilities were developed over the past three years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) program. The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen. AbCellera's ongoing efforts to respond to the pandemic have identified more than 2,300 unique anti-SARS-CoV-2 human antibodies from multiple patient samples. These antibodies are in various stages of testing by AbCellera and its partners.

    About Bamlanivimab

    Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at NIAID VRC. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

    Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

    About AbCellera Biologics Inc.

    AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development. For more information, visit www.abcellera.com.

    AbCellera Forward-looking Statements

    This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

    In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

    Source: AbCellera Biologics Inc.

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  4. Positive European Union (EU)-level scientific opinion provides a pathway for more EU countries to access the antibodies to treat COVID-19 before formal marketing authorizations are granted

    AbCellera (NASDAQ:ABCL) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP…

    Positive European Union (EU)-level scientific opinion provides a pathway for more EU countries to access the antibodies to treat COVID-19 before formal marketing authorizations are granted

    AbCellera (NASDAQ:ABCL) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP recommendation provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies, which can be used by EU member states when making decisions on the possible use of the therapies at a national level prior to market authorization.

    "Bamlanivimab has been used to treat hundreds of thousands of patients globally, and its impact continues to grow as the use of COVID-19 antibody therapies accelerates," said Carl Hansen, Ph.D., CEO and President of AbCellera. "Several EU countries have authorized bamlanivimab, and the EMA's CHMP recommendation provides a mechanism for more EU countries to quickly access these antibodies to treat patients in need."

    The EMA reviewed Phase 2 and Phase 3 results from Eli Lilly and Company's (Lilly) BLAZE-1 trial to support the CHMP opinion. Results from BLAZE-1 demonstrated bamlanivimab alone reduced viral load and rates of symptoms and also reduced hospitalization by approximately 70%, and bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70% in non-hospitalized high-risk patients with mild to moderate COVID-19. Details regarding the CHMP opinion and Lilly's plans to make COVID-19 therapies broadly available to patients can be found here.

    Bamlanivimab has been authorized in more than 10 countries, and bamlanivimab together with etesevimab received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on February 9, 2021. The EUA was followed by a $210 million purchase agreement for Lilly to provide 100,000 doses of bamlanivimab and etesevimab to the U.S. government through to March 31, 2021. The U.S. government will have the option to purchase up to an additional 1,100,000 doses through November 25, 2021. This purchase agreement is in addition to the 1,450,000 doses of bamlanivimab alone that the US government previously committed to purchase: to date, more than 1 million doses have been delivered, and Lilly has agreed to deliver 450,000 additional doses by March 31, 2021. AbCellera is eligible to receive royalties in the low- to mid-teens for aggregate sales below $125.0 million and mid-teens to mid-twenties on aggregate sales above $125.0 million. Sales of bamlanivimab in 2020 were $871 million.

    About AbCellera's Response to COVID-19

    Bamlanivimab was developed from an antibody that was discovered from the blood of a recovered COVID-19 patient using AbCellera's pandemic response platform, in partnership with the Vaccine Research Center (VRC) at National Institute of Allergy and Infectious Diseases (NIAID). Within one week of receiving the sample, AbCellera screened over five million antibody-producing cells to identify and isolate approximately 500 unique antibodies that bind to SARS-CoV-2, the virus that causes COVID-19. The binding antibodies were then tested by AbCellera, the VRC, and Lilly to find those most effective in neutralizing the virus. Bamlanivimab was selected as the lead candidate from this group of antibodies, and was the first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials in North America. Bamlanivimab was the first monoclonal antibody to receive EUA from the FDA and is currently being assessed in several clinical trials alone and together with other antibodies.

    AbCellera's pandemic response capabilities were developed over the past three years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) program. The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen. AbCellera's ongoing efforts to respond to the pandemic have identified more than 2,300 unique anti-SARS-CoV-2 human antibodies from multiple patient samples. These antibodies are in various stages of testing by AbCellera and its partners.

    About Bamlanivimab

    Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at NIAID VRC. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

    Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

    About AbCellera Biologics Inc.

    AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development. For more information, visit www.abcellera.com

    AbCellera Forward-looking Statements

    This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

    In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

    Source: AbCellera Biologics Inc.

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