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Risks Related to Our Business and Strategy
−Removed: We have incurred losses in certain years since inception and we may not be able to generate sufficient revenue to maintain profitability.
+Added: We have incurred losses in certain years since inception, including in 2023, and we may not be able to generate sufficient revenue to achieve profitability.
We expect to continue investing in our business.
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We may incur losses that are materially larger than what we have previously incurred.
−Removed: We have incurred losses in certain years since our inception and anticipate that we may incur significant losses for the foreseeable future.
+Added: During the year ended December 31, 2023, we incurred a net loss of approximately $146.4 million.
+Added: We have also incurred losses in certain other years since our inception and anticipate that we may incur significant losses for the foreseeable future.
We expect that our operating expenses will continue to increase significantly, including as we:
−Removed: invest in research and development activities to improve our discovery and development engine;
+Added: • invest in research and development activities to improve our discovery and development engine and initiate and advance internal programs;
• market our solutions to new and existing partners;
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• prosecute and defend our ongoing and any future patent litigation;
−Removed: build our new GMP manufacturing facility;
+Added: • continue to build our new GMP manufacturing facility;
• create additional infrastructure to support our operations, including expanding our sales and marketing organization;
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Our expenses could increase beyond expectations for a variety of reasons, including our growth strategy and the increase in our operations.
−Removed: Since our inception, we have financed our operations primarily from royalty revenue, revenue from upfront payments generated through our receipt of technology access fees and discovery research fees through the performance of service contracts with our partners, payments from partners upon the satisfaction of clinical milestones, government funding and one-off government grants, the incurrence of indebtedness, and from private placements of our common and convertible preferred shares.
+Added: Since our inception, we have financed our operations primarily from royalty revenue, revenue from upfront payments generated through our receipt of technology access fees and discovery research fees through the performance of service contracts with our partners, payments from partners upon the satisfaction of clinical milestones, government funding and one-off government grants, incurring debt, and from private placements of our common and convertible preferred shares.
Given our strategy and plans to invest in enhancing and scaling our business, we will need to generate significant additional revenue to achieve and sustain future profitability.
−Removed: Even though we have achieved profitability, we cannot be sure that we will remain profitable for any sustained period of time.
−Removed: We may not be able to generate sufficient revenue to sustain profitability and our recent and historical growth should not be considered indicative of our future performance.
+Added: Even though we have achieved profitability in recent periods, we cannot be sure that we will remain profitable for any sustained period of time.
+Added: We may not be able to generate sufficient revenue to achieve profitability and our recent and historical growth should not be considered indicative of our future performance.
Our revenue has fluctuated from period to period, and our revenue for any historical period may not be indicative of results that may be expected for any future period.
During the years ended December 31, 2021, 2022, and 2023, we received payments from our partnership contracts generated upon the satisfaction of clinical milestones, licensing revenue derived from use of the Trianni platform, research fees for research performed for our partners, and royalty payments on sales of bamlanivimab and bebtelovimab.
−Removed: In 2022, we continued to receive royalty payments primarily on sales of bebtelovimab.
Upfront technology access fees are generated upon execution of our partnership agreements.
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We are also eligible to receive royalty payments upon net sales of antibodies that we have discovered for our partners.
−Removed: In 2020, 2021, and 2022, these royalty payments related to our partnership with Lilly upon sales of bamlanivimab and bebtelovimab, antibodies designed to treat and prevent COVID-19.
−Removed: Therefore, royalty payments that we have received in recent periods are derived from a compound developed in a single partnership, and there can be no assurance that the revenues we have generated in such periods will be replicated in future periods.
−Removed: For example, in November 2022, the FDA announced bebtelovimab was no longer authorized for emergency use in any U.S.
−Removed: region and, as a result, we do not expect to generate significant revenue from royalties associated with Lilly’s sales of our COVID-19 antibodies.
−Removed: We currently do not generate significant recurring revenue and, until such time as we establish significant recurring revenue, if at all, we will be prone to regular fluctuations in our revenue dependent on the timing of our entry into partnership agreements, our partners initiating discovery programs, and our partners achieving development milestones or commercial sales with respect to drug candidates utilizing antibodies discovered using our discovery and development engine.
−Removed: We do not expect to generate significant recurring revenue unless and until such time as we secure additional programs under contract that, in the aggregate, result in regular and continuous execution of new partnership contracts, research discovery activities, achievement of
−Removed: development milestones or commencement of commercial sales.
+Added: 2022, these royalty payments related to our partnership with Lilly upon sales of bamlanivimab and bebtelovimab, antibodies designed to treat and prevent COVID-19.
+Added: Therefore, royalty payments that we have received in recent periods are derived from a compound developed in a single partnership.
+Added: In November 2022, the FDA announced that bamlanivimab and bebtelovimab, respectively, were no longer authorized for emergency use and, as a result, we do not expect to generate revenue from royalties associated with Lilly’s sales of our COVID-19 antibodies going forward.
+Added: For the twelve months ended December 31, 2023, we did not generate any royalty revenues.
+Added: We currently do not generate significant recurring revenue and, until such time as we establish significant recurring revenue, if at all, we will be prone to regular fluctuations in our revenue dependent on the timing of our entry into partnership agreements, our partners initiating discovery programs, our partners achieving development milestones or commercial sales, or the progress of our internal discovery programs, with respect to drug candidates utilizing antibodies discovered using our discovery and development engine.
+Added: We do not expect to generate significant recurring revenue unless and until such time as we secure additional programs under contract that, in the aggregate, result in regular and continuous execution of new partnership contracts, research discovery activities, achievement of development milestones or commencement of commercial sales.
However, we are unable to predict whether and the extent to which the minimum annual payments under our partnership agreements will be exceeded, or the timing of the achievement of any milestones under these agreements, if they are achieved at all.
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• the level of demand for our antibody discovery and development engine and solutions, which may vary significantly;
−Removed: royalty payments received from our partnership with Lilly upon sales of bamlanivimab or bebtelovimab, which may vary significantly and are dependent on obtaining emergency use authorization by the FDA;
−Removed: the timing and cost of, and level of investment in, research, development and commercialization activities relating to our discovery and development engine and technology, which may change from time to time;
+Added: • royalty payments received from our partnership with Lilly upon sales of bamlanivimab or bebtelovimab, which have varied significantly and were dependent on obtaining emergency use authorization by the FDA;
+Added: • the timing and cost of, and level of investment in, research, development and commercialization activities relating to our discovery and development engine and initiation and advancement of internal programs, which may change from time to time;
• the start and completion of programs in which our discovery and development engine is utilized;
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• expenditures that we may incur to acquire, develop or commercialize additional technologies;
−Removed: expenditures involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including costs related to our intellectual property litigation with Berkeley Lights, and the outcome of this and any other future patent litigation we may be involved in;
−Removed: costs related to our civil litigation with the Estate of John Schrader, or Schrader, and the outcome of this and any other future civil litigations we may be involved in;
+Added: • expenditures involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including costs related to our intellectual property litigation with Bruker, and the outcome of this and any other future patent litigation we may be involved in;
+Added: • costs related to our civil litigation with the Estate of John Schrader, or Schrader, and the outcome of this and any other future civil litigation we may be involved in;
• the degree of competition in our industry and any change in the competitive landscape of our industry, including consolidation among our competitors or future partners;
−Removed: natural disasters, outbreaks of disease or public health crises, such as the ongoing COVID-19 pandemic;
+Added: • natural disasters, outbreaks of disease or public health crises, such as the COVID-19 pandemic;
• the timing and nature of any future acquisitions or strategic partnerships;
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For example, 2020 was the first year in which we received payments from a partner beyond upfront fees.
−Removed: The antibody, bamlanivimab developed by Lilly, has undergone clinical testing and has received EUA from the FDA, and we have received associated milestone payments and royalties on net sales in 2020, 2021, and 2022.
+Added: The antibody, bamlanivimab, developed by Lilly, has undergone clinical testing and previously received emergency use authorization, or EUA, from the FDA, although the FDA in November 2022 announced that bamlanivimab is no longer authorized for emergency use in the U.S.
+Added: We have received associated milestone payments and royalties on net sales in 2020, 2021, and 2022.
Lilly progressed into these clinical trials at a greatly accelerated pace as a result of the Coronavirus Treatment Acceleration Program, which is a special emergency program for possible coronavirus therapies created by the FDA in 2020 to expedite the development of potentially safe and effective life-saving treatments to combat the COVID-19 pandemic.
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Investors should not rely on our past results as an indication of our future performance.
−Removed: We may need to raise additional capital to fund our existing operations, improve our discovery and development engine or expand our operations.
+Added: We may need to raise additional capital to fund our existing operations, improve our discovery and development engine, advance internal programs, or expand our operations.
If we are unable to raise additional capital on terms acceptable to us or at all or generate cash flows necessary to maintain or expand our operations, we may not be able to compete successfully, which would harm our business, operations, and financial condition.
−Removed: Based on our current business plan, we believe our existing cash and cash equivalents, marketable securities, and anticipated cash flows from operations, will be sufficient to meet our working capital and capital expenditure needs over at least the next 36 months following the date of this report.
+Added: Based on our current business plan, we believe our available liquidity from existing cash and cash equivalents, marketable securities, and anticipated cash flows from operations and government contributions, will be sufficient to meet our working capital and capital expenditure needs and expenditure required for later stage development of our internal pipeline to IND.
+Added: We do not anticipate the need of additional external funding over at least the next 36 months following the date of this report.
If our available cash resources together with our anticipated cash flow from operations are insufficient to satisfy our liquidity requirements including because of lower demand for our antibody discovery and development engine, or the realization of other risks described in this annual report, we may be required to raise additional capital prior to such time through issuances of equity or convertible debt securities, entrance into a credit facility or another form of third-party funding or seek other debt financing.
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• increase our sales and marketing efforts to drive market recognition of our discovery and development engine and address competitive developments;
−Removed: fund development and marketing efforts of our current and future programs;
+Added: • fund development and marketing efforts of our current and future internal and partner programs;
• expand the capabilities of our discovery and development engine into adjacent therapeutic modalities, including vaccine development and cell therapy;
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• the cost of expanding our operations, including our sales and marketing efforts;
−Removed: our rate of progress in selling access to our discovery and development engine and marketing activities associated therewith;
+Added: • our rate of progress in selling access to our discovery and development engine, the initiation and advancement internal programs and marketing activities associated therewith;
• our rate of progress in, and cost of research and development activities associated with, antibody discovery;
• the effect of competing technological and market developments;
−Removed: the continued impact of the ongoing COVID-19 pandemic on global social, political and economic conditions;
−Removed: the economic and geopolitical impact of the ongoing conflict in the Ukraine;
−Removed: the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including costs related to our intellectual property litigation with Berkeley Lights, and the outcome of this and any other future patent litigation we may be involved in;
−Removed: costs related to our civil litigation with Schrader, and the outcome of this and any other future civil litigations we may be involved in;
+Added: • the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including costs related to our intellectual property litigation with Bruker, and the outcome of this and any other future patent litigation we may be involved in;
+Added: • costs related to our civil litigation with Schrader, and the outcome of this and any other future civil litigation we may be involved in;
• costs related to any domestic and international expansion.
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Our general business strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions.
−Removed: The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other geopolitical events.
−Removed: Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.
+Added: The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other geopolitical events such as the conflict in Israel and the Gaza Strip and additional escalating conflicts in the Middle East, and the related impact on our business and the markets generally.
+Added: Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also adversely impact the financial
+Added: markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.
+Added: Moreover, there has been recent instability of the global banking system.
+Added: Continued disruptions in the banking system, both in the U.S.
+Added: or abroad, may impact our or our customers’ liquidity and, as a result, negatively impact our business and operating results.
If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive.
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In addition, there is a risk that one or more of our current service providers, manufacturers and other partners may not survive an economic downturn, which could directly affect our ability to attain our operating goals on schedule and on budget.
−Removed: Our commercial success depends on the quality of our antibody discovery and development engine and technological capabilities and their acceptance by new and existing partners in our industry.
+Added: Our commercial success depends on the quality of our antibody discovery and development engine and technological capabilities, the advancement of internal programs, and their acceptance by new and existing partners in our industry.
We utilize our antibody discovery and development engine to identify antibodies for further development and potential commercialization by our partners.
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• our ability to execute on our strategy to enter into new partnerships with new or existing partners and establish a robust internal pipeline of antibody discovery programs;
+Added: • our ability to partner our internally developed pipeline;
• our ability to increase awareness of the capabilities of our technology and solutions;
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Failure to execute our business strategy could adversely impact our growth and profitability.
−Removed: Our strategy is on the development of antibody-based drugs and improving the way these drugs are discovered and developed.
+Added: Our strategy focuses on the development of antibody-based drugs and improving the way these drugs are discovered and developed.
Our strategy assumes a certain degree of capital and capacity growth development.
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Business” included elsewhere in this Form 10-K.
+Added: We allocate our resources to pursue a particular development candidate or indication and, as a result, may fail to capitalize on other development candidates or indications that may be more profitable or for which there is a greater likelihood of success.
+Added: We allocate our resources on certain research programs and development candidates.
+Added: As a result, we may forgo or delay pursuit of opportunities with other development candidates or for our current development candidates in other indications that later prove to have greater commercial potential.
+Added: Our resource allocation decisions may cause us to fail to capitalize on viable and profitable market opportunities.
+Added: Our spend on current and future research and development programs and development candidates for specific indications may not yield any commercially viable drugs.
+Added: If we do not accurately evaluate the commercial potential or target market for a particular development candidate, we may relinquish valuable rights to that candidate through collaboration, licensing or other commercialization opportunities.
If we cannot maintain and expand current partnerships and agreements and enter new partnerships that generate discovery programs for antibodies, our business could be adversely affected.
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Even if an agreement is reached, the resulting relationship may not be successful, including due to our inability to discover any usable antibodies for the selected targets or the antibodies that we do discover may not be successfully developed or commercialized by our partners.
−Removed: In such circumstances, we would not generate any substantial revenues from such a collaboration in the form of discovery research fees, milestone payments, royalties or otherwise.
+Added: In such circumstances, we
+Added: would not generate any substantial revenues from such a collaboration in the form of discovery research fees, milestone payments, royalties or otherwise.
Speculation in the biotechnology industry about our existing or potential partnerships can be a catalyst for adverse speculation about us, or our data packages, which can adversely affect our reputation and our business.
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Furthermore, our partners continue to search for ways to maximize the return on their investments with a focus on lowering research and development costs per drug candidate.
−Removed: Fluctuations in the expenditure
−Removed: amounts in each phase of the research and development budgets of these researchers and their organizations could have a significant effect on the demand for our products and services.
−Removed: R esearch and development budgets fluctuate due to changes in available resources, mergers of pharmaceutical and biotechnology companies, spending priorities (including available resources of our biotechnology partners, particularly those that are cash-negative, who may be highly focused on rationing their liquid assets in a challenging funding environment), general economic conditions, institutional budgetary policies and the impact of government regulations, including potential drug pricing legislation.
+Added: Fluctuations in the expenditure amounts in each phase of the research and development budgets of these researchers and their organizations could have a significant effect on the demand for our products and services.
+Added: Research and development budgets fluctuate due to changes in available resources, mergers of pharmaceutical and biotechnology companies, spending priorities (including available resources of our biotechnology partners, particularly those that are cash-negative, who may be highly focused on rationing their liquid assets in a challenging funding environment), general economic conditions, institutional budgetary policies and the impact of government regulations, including potential drug pricing legislation.
Available funding for biotechnology partners in particular may be affected by the capital markets, investment objectives of venture capital investors and priorities of biopharmaceutical industry sponsors.
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For example, royalty revenue for years ended December 31, 2021 and 2022, have come exclusively from our partnership with Lilly.
−Removed: Milestone payments and licensing revenue for the years ended December 31, 2020, 2021, and 2022, have come exclusively from our partnership with Lilly and use of the Trianni platform.
−Removed: Because a significant portion of our revenue in 2020, 2021, and 2022 was derived from sales of bamlanivimab and bebtelovimab, the reduction in sales of these compounds that we have experienced in recent periods have reduced our royalty revenues attributed to sales of this compound.
+Added: Milestone payments have primarily come from our partnership with Lilly and all licensing revenue has come from the use of the Trianni platform for the years ended December 31, 2021, 2022, and 2023.
+Added: Because a significant portion of our revenue in 2021 and 2022 was derived from sales of bamlanivimab and bebtelovimab, the reduction in sales of these compounds that we have experienced in recent periods have reduced or eliminated our royalty revenues attributed to sales of this compound.
+Added: For example, for the twelve months ended December 31, 2023, we did not receive any royalty revenues from our partnership with Lilly.
If these reductions are not offset by increases in other sources of revenue, our results of operations for future periods may be materially and adversely affected.
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As a result, if we fail to maintain our relationships with our partners or if any of our partners discontinue their programs, our future results of operations could be materially and adversely affected.
−Removed: Development of a biological molecule is inherently uncertain, and it is possible that none of the antibody-drug candidates discovered using our antibody discovery and development engine that are further developed by our partners will receive marketing approval or become viable commercial products, on a timely basis, or at all.
+Added: Development of a biological molecule is inherently uncertain, and it is possible that none of the antibody-drug candidates discovered using our antibody discovery and development engine that are further developed by us or our partners will receive marketing approval or become viable commercial products, on a timely basis, or at all.
We use our discovery and development engine to offer antibodies to partners who are engaged in antibody discovery and development.
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While we have received milestone and royalty payments from this collaboration, there can be no assurance that we will receive additional milestone payments or any royalties in the future.
+Added: For example, in November 2022, the FDA announced bebtelovimab is no longer authorized for emergency use in the U.S., and Lilly and its authorized distributors have paused commercial distribution until further notice by the FDA.
Furthermore, there can be no assurance that Lilly will be successful in its further development of bebtelovimab.
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Furthermore, approved drugs may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited.
−Removed: Likewise, we or our partners have to make decisions about which clinical stage and preclinical drug candidates to develop and
−Removed: advance, and we or our partners may not have the resources to invest in all of the drug candidates that contain antibodies discovered using our discovery and development engine , or clinical data and other development considerations may not support the advancement of one or more drug candidates.
+Added: Likewise, we or our partners have to make decisions about which clinical stage and preclinical drug candidates to develop and advance, and we or our partners may not have the resources to invest in all of the drug candidates that contain antibodies discovered using our discovery and development engine, or clinical data and other development considerations may not support the advancement of one or more drug candidates.
Decision-making about which drug candidates to prioritize involves inherent uncertainty, and our partners’ development program decision-making and resource prioritization decisions, which are outside of our control, may adversely affect the potential value of those partnerships.
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We are also subject to industry-wide FDA and other regulatory risk.
−Removed: The number of new drug applications, or NDAs, and biologics license applications, or BLAs, approved by the FDA varies significantly over time and if there were to be an extended reduction in the number of NDAs and BLAs approved by the FDA, the biotechnology industry would contract and our business would be materially harmed.
+Added: The number of new drug applications, or NDAs, and biologics license applications, or BLAs, approved by the FDA varies significantly over time and if there were
+Added: to be an extended reduction in the number of NDAs and BLAs approved by the FDA, the biotechnology industry would contract and our business would be materially harmed.
The failure to effectively advance, market and sell suitable drug candidates with the antibodies that we discover could have a material adverse effect on our business, financial condition, results of operations and prospects, and cause the market price of our common shares to decline.
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Improving our technology and processes have required us to hire and retain additional scientific, engineering, sales and marketing, software, manufacturing, distribution and quality assurance personnel.
−Removed: As a result, we have experienced rapid headcount growth, resulting in approximately 500 employees as of December 31, 2022.
We currently serve partners around the world and plan to continue to expand to new international jurisdictions as part of our growth strategy, which will lead to increased dispersion of our employees.
−Removed: Moreover, we expect that we will need to hire additional accounting, finance and other personnel in connection with our efforts to comply with the requirements of being a public company.
−Removed: a public company, our management and other personnel need to devote a substantial amount of time towards maintaining compliance with these requirements.
+Added: Moreover, we may need to hire additional accounting, finance and other personnel in connection with our efforts to continue to comply with the requirements of being a public company.
+Added: As a public company, our management and other personnel need to devote a substantial amount of time towards maintaining
+Added: compliance with these requirements.
A risk associated with maintaining this rate of growth, for example, is that we may face challenges integrating, developing and motivating our rapidly growing and increasingly dispersed employee base.
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The time and resources required to improve our existing systems and procedures, implement new systems and procedures and to adequately staff such existing and new systems and procedures is uncertain, and failure to complete this in a timely and efficient manner could adversely affect our operations and negatively impact our business and financial results.
−Removed: We have invested, and expect to continue to invest, in research and development efforts that further enhance our antibody discovery and development engine.
+Added: We have invested, and expect to continue to invest, in research and development efforts that further enhance our technology and platform.
Such investments in technology are inherently risky and may affect our operating results.
If the return on these investments is lower or develops more slowly than we expect, our revenue and operating results may suffer.
−Removed: We use our discovery and development engine for the discovery of antibodies and, since our inception, we have dedicated a substantial portion of our resources on the development of our engine and the technology that we incorporate to further enhance our antibody discovery and development engine.
+Added: Since our inception, we have dedicated a substantial portion of our resources on the development of our engine and the technology that we incorporate to further enhance our antibody discovery and development engine, and our internal pipeline.
These investments may involve significant time, risks, and uncertainties, including the risk that the expenses associated with these investments may affect operating results and that such investments may not generate sufficient technological advantage relative to alternatives in the market which would, in turn, impact revenues to offset liabilities assumed and expenses associated with these new investments.
The industry in which we operate changes rapidly as a result of technological and drug developments, which may render our solutions less desirable.
−Removed: We believe that we must continue to invest a significant amount of time and resources in our discovery and development engine to maintain and improve our competitive position.
−Removed: If we do not achieve the benefits anticipated from these investments, if the achievement of these benefits is delayed, or if our discovery and development engine is not able to accelerate the process of antibody discovery as quickly as we anticipate, our revenue and operating results may be adversely affected.
+Added: We believe that we must continue to invest a significant amount of time and resources in our discovery and development engine, and our internal pipeline, to maintain and improve our competitive position.
+Added: If we do not achieve the benefits anticipated from these investments, if the achievement of these benefits is delayed, if our discovery and development engine is not able to accelerate the process of antibody discovery as quickly as we anticipate, or if our internal pipeline is not successful, our revenue and operating results may be adversely affected.
Our partners have significant discretion in determining when and whether to make announcements, if any, about the status of our partnerships, including about clinical developments and timelines for advancing collaborative programs, and the price of our common shares may decline as a result of announcements of unexpected results or developments.
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If our partners determine not to proceed with the future development of a drug candidate discovered or initially developed utilizing our discovery and development engine, or if they implement preclinical, clinical or regulatory strategies that ultimately do not result in the further development or approval of the therapeutic candidate, we will not receive the benefits of our partnerships, which may have a material and adverse effect on our operations.
−Removed: The life sciences and biotechnology platform technology market is highly competitive, and if we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue, or sustain profitability.
+Added: We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
+Added: We may not be able to file INDs for our internal pipeline candidates on the timelines we expect.
+Added: For example, we may experience delays with IND-enabling studies or manufacturing delays.
+Added: Moreover, we cannot be sure that submission of an IND will result in the FDA allowing further clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials.
+Added: Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements in the future.
+Added: These considerations also apply to new clinical trials we may submit as amendments to a new IND.
+Added: Any failure to file INDs on the timelines we expect or to obtain regulatory approvals for our trials may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.
+Added: We have no marketed proprietary products and have not yet independently started clinical development, which makes it difficult to assess our ability to independently develop future product candidates and monetize any resulting products.
+Added: As a company, we have no previous experience in advancing and completing clinical trials, and navigating and complying with the related regulatory requirements, including with respect to the submission of a New Drug Application,
+Added: or NDA, or equivalent submission.
+Added: We have not yet demonstrated our ability to independently conduct clinical development and obtain regulatory approval.
+Added: To execute on our business plan, we will need to successfully reach agreement with multiple regulatory agencies on clinical and pre-clinical studies required for registration, execute our clinical development and manufacturing plans;
+Added: and manage our spending as costs and expenses increase due to clinical trials, and regulatory approvals.
+Added: If we are unsuccessful in accomplishing these objectives, we will not be able to develop any future product candidates independently and could fail to realize the potential advantages of doing so.
+Added: The life sciences and biotechnology platform technology market is highly competitive, and if we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue, or achieve profitability.
We face significant competition in the life sciences technology market.
−Removed: Our technologies address antibody therapeutic discovery challenges that are addressed by other platform technologies controlled by companies that have a variety of business models, including the development of internal pipelines of therapeutics, technology licensing, and the sale of instruments and devices.
+Added: Our technologies address antibody therapeutic discovery and development challenges that are addressed by other platform technologies controlled by companies that have a variety of business models, including the development of internal pipelines of therapeutics, technology licensing, and the sale of instruments and devices.
Examples of technical competition at different steps of our discovery and development engine include:
−Removed: In the field of single-cell screening, companies that provide access to similar technologies such as Berkeley Lights, HiFiBio Inc., Ligand Pharmaceuticals Inc., and Sphere Fluidics Ltd.
+Added: • In the field of single-cell screening, companies that provide access to similar technologies such as Bruker, Twist Bioscience Corp, HiFiBio Inc., Ligand Pharmaceuticals Inc., and Sphere Fluidics Ltd.
• In antibody RepSeq, companies that provide access to similar technologies such as 10X Genomics Inc., Adaptive Biotechnologies Corp., Atreca Inc.
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There can be no guarantee that our discovery and development engine will meet the expectations of pharmaceutical and biotechnology companies.
−Removed: If we are unable to support demand for our antibody discovery and development engine, including ensuring that we have adequate teams and facilities to meet increased demand, or if we are unable to successfully manage our anticipated growth, our business could suffer.
−Removed: We have experienced significant growth in the number of programs under contract in recent periods for which we are conducting research discovery activities.
−Removed: As we secure additional programs under contract and as our partners initiate discovery programs, our operational capacity to execute such research activities may become strained.
−Removed: We are also planning to devote significant resources to vertical integration into our discovery and development engine.
−Removed: As a result, our strategy requires us to successfully scale our teams and facilities to meet future demand for our solutions.
−Removed: Our ability to grow our capacity will depend on our ability to expand our workforce and our facilities and increase efficiency through automation and software solutions.
+Added: If we are unable to support demand for our antibody discovery and development engine, including ensuring that we have adequate teams and facilities to meet our current and future pipeline, or if we are unable to successfully manage our anticipated growth, our business could suffer.
+Added: As we initiate discovery programs and progress on internal programs, our operational capacity to execute such research activities may become strained.
We may also need to purchase additional equipment, some of which can take several months or more to procure and set up.
−Removed: There is no assurance that any of these increases in scale, expansion of personnel, equipment, software and computing capacities or process enhancements will be successfully implemented and in a timely manner.
−Removed: For example, we are currently expanding our facilities in Vancouver and internationally.
+Added: There is no assurance that the allocation of these resources, and investment in additional resources, will be successfully implemented and in a timely manner.
+Added: For example, we are currently expanding our facilities in Vancouver, British Columbia.
Such facilities require purpose-built buildings often with rezoning requirements.
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A failure in any one of these areas could make it difficult for us to meet market expectations for our data packages and could damage our reputation and the prospects for our business.
−Removed: Our management uses certain key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions and such metrics may not accurately reflect all of the aspects of our business needed to make such evaluations and decisions, in particular as our business continues to grow.
+Added: Our management uses certain key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions and such metrics may not
+Added: accurately reflect all of the aspects of our business needed to make such evaluations and decisions, in particular as our business continues to grow.
In addition to our consolidated financial results, our management regularly reviews a number of operating and financial metrics, including number of programs under contract, the trend of potential downstream revenue terms (milestones and royalties) of the portfolio, the performance of the portfolio in probability of success in achieving clinical milestones as compared to historical averages and the performance of the portfolio in the time taken to achieve clinical milestones, to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions.
−Removed: We believe that
−Removed: these metrics are representative of our current business;
+Added: We believe that these metrics are representative of our current business;
however, these metrics may not accurately reflect all aspects of our business and we anticipate that these metrics may change or may be substituted for additional or different metrics as our business grows and as we introduce new solutions.
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We must adapt to rapid and significant technological change and respond to introductions of new products and technologies by competitors to remain competitive.
−Removed: We provide our antibody discovery solution and capabilities in industries that are characterized by significant enhancements and evolving industry standards.
−Removed: As a result, our partners’ needs are rapidly evolving.
−Removed: If we do not appropriately innovate and invest in new technologies, our discovery and development engine may become less desirable in the markets we serve, and our partners could move to new technologies offered by our competitors or engage in antibody discovery themselves.
−Removed: Though we believe partners in our markets display a significant amount of loyalty to their supplier of research or a particular product or service, we also believe that because of the initial time investment required by many of our partners to reach a decision about whether to partner with us, it may be difficult to regain that customer once the customer enters into a partnership or collaboration agreement with a competitor.
+Added: The industries we serve are characterized by significant enhancements and evolving industry standards.
+Added: As a result, our and our partners’ needs are rapidly evolving.
+Added: If we do not appropriately innovate and invest in new technologies, our discovery and development engine and internal pipeline may become less desirable in the markets we serve, our partners could move to new technologies offered by our competitors or engage in antibody discovery themselves, and the internal pipeline we invest in could be less successful.
Without the timely introduction of new solutions and technological enhancements, our offerings will likely become less competitive over time, in which case our competitive position and operating results could suffer.
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Information technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious software, bugs or viruses, human acts and natural disasters.
−Removed: Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer
−Removed: viruses and similar disruptive problems.
+Added: Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems.
Any disruption or loss of information technology or telecommunications systems on which critical aspects of our operations depend could have an adverse effect on our business and our reputation, and we may be unable to regain or repair our reputation in the future.
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Any such breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen.
−Removed: Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), and regulatory penalties.
+Added: Any such access, disclosure or other loss of information could result in legal claims or
+Added: proceedings, liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), and regulatory penalties.
Although we have implemented security measures and a formal enterprise security program to prevent unauthorized access to sensitive data, there is no guarantee that we can protect our systems from breach.
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For example, the California Consumer Privacy Act (“CCPA”), which became effective on January 1, 2020, gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt-out of certain sales of personal information.
−Removed: The CCPA provides for civil penalties for violations as well as a limited private right of action for data breaches, which
−Removed: may increase the volume of data breach litigation.
+Added: The CCPA provides for civil penalties for violations as well as a limited private right of action for data breaches, which may increase the volume of data breach litigation.
While limited CCPA exemptions may apply to portions of our business, the recency of the CCPA’s implementing regulations and the California Attorney General’s enforcement activity means our obligations under the CCPA could evolve in the future, which may increase our compliance costs and potential liability.
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Such proposed legislation, if enacted, may add additional complexity, variation in requirements, restrictions and potential legal risk, require additional investment of resources in compliance programs, impact strategies and the availability of previously useful data and could result in increased compliance costs and/or changes in business practices and policies.
−Removed: The existence of comprehensive privacy laws in different states in the country would make our compliance obligations more complex and costly and may increase the likelihood that we may be subject to enforcement actions or otherwise incur liability for noncompliance.
+Added: The existence of comprehensive privacy laws in different states in the country would make our
+Added: compliance obligations more complex and costly and may increase the likelihood that we may be subject to enforcement actions or otherwise incur liability for noncompliance.
We may also become subject to laws and regulations in non-U.S.
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On June 4, 2021, the EC issued new forms of standard contractual clauses for data transfers from controllers or processors in the EU/EEA (or otherwise subject to the GDPR) to controllers or processors established outside the EU/EEA.
−Removed: The new standard contractual clauses replace the standard contractual clauses that were adopted previously under the EU Data Protection
+Added: The new standard contractual clauses replace the standard contractual clauses that were adopted previously under the EU Data Protection Directive.
The UK is not subject to the EC’s new standard contractual clauses but has published its own transfer mechanism, the International Data Transfer Agreement and International Data Transfer Addendum (“IDTA”), which enable transfers from the UK, and has also implemented a similar Transfer Impact Assessment requirement.
We will be required to implement these new safeguards and carry out Transfer Impact Assessments when conducting restricted data transfers under the GDPR and doing so will require significant effort and cost, and may result in us needing to make strategic considerations around where EEA or UK personal data is stored and transferred, and which service providers we can utilize for the processing of EEA/UK personal data.
+Added: On July 10, 2023, the European Commission adopted an adequacy decision for the new EU-US Data Privacy Framework (“DPF”), the new transatlantic framework designed to support transfers of personal data from the EU to companies in the US that self-certify compliance with the DPF’s privacy requirements, without having to implement
+Added: additional safeguards.
+Added: The DPF replaces the Privacy Shield, which was invalidated by the European Court of Justice in July 2020.
+Added: As with the previous two transatlantic frameworks, it remains to be seen whether the DPF will withstand review by the European courts.
Although the UK is regarded as a third country under the EU GDPR, the European Commission has issued a decision recognizing the UK as providing adequate protection under the EU GDPR (“Adequacy Decision”) and, therefore, transfers of personal data originating in the EEA to the UK remain unrestricted.
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A successful cyberattack could cause serious negative consequences for us, including, without limitation, the disruption of operations, the misappropriation of confidential business information, including financial information, trade secrets, financial loss and the disclosure of corporate strategic plans.
−Removed: Although we devote resources to protect our information systems, we realize that cyberattacks are a threat, and there can be no assurance that our efforts will prevent information security breaches that would result in business, legal, financial, or reputational harm to us, or would have a material adverse effect on our results of operations and financial condition.
+Added: Although we devote resources to protect our information systems, we realize that cyberattacks are a threat, and there can be no assurance
+Added: that our efforts will prevent information security breaches that would result in business, legal, financial, or reputational harm to us, or would have a material adverse effect on our results of operations and financial condition.
If we were to experience an attempted or successful cybersecurity attack of our information systems or data, the costs associated with the investigation, remediation and potential notification of the attack to counterparties, data subjects, regulators or others, including costs to deploy additional personnel and protection technologies, train employees, and engage third-party experts and consultants, could be material.
+Added: Failure to report any such material cybersecurity incidents in a timely manner to the Securities Exchange Commission, on Form 8-K, may result in adverse impacts to our reputation.
In addition, following any such attack, our remediation efforts may not be successful.
−Removed: Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or
−Removed: patients’ personal data could result in significant liability under state, federal and international law and may cause a material adverse impact to our reputation, affect our ability to conduct new studies, and potentially disrupt our business.
−Removed: Our marketing department is expanding, and if we are unable to continue this growth and effectively execute on our marketing strategy, our business may be adversely affected.
−Removed: We continue to expand our commercial organization in order to effectively market our solutions to existing and new partners.
−Removed: Competition for employees capable of negotiating and entering into partnerships with pharmaceutical and biotechnology companies is intense.
−Removed: We may not be able to attract and retain personnel or be able to build an efficient and effective sales organization, which could negatively impact sales and market acceptance of our discovery and development engine and limit our revenue growth and potential profitability.
−Removed: In addition, the time and cost of establishing a specialized sales, marketing and service force for a particular service may be difficult to justify in light of the revenue generated or projected.
−Removed: To perform sales, marketing, and partner support successfully, we will face a number of risks, including that our sales, marketing force may be unable to initiate and execute successful commercialization activities with respect to new products or markets we may seek to enter.
−Removed: If our sales and marketing efforts are not successful, our new technologies and products may not gain market acceptance, which could materially impact our business operations.
−Removed: Our expected future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees.
−Removed: Our future financial performance and our ability to successfully sell our programs and to compete effectively will depend, in part, on our ability to manage this potential future growth effectively, without compromising quality.
+Added: Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’ personal data could result in significant liability under state, federal and international law and may cause a material adverse impact to our reputation, affect our ability to conduct new studies, and potentially disrupt our business.
The loss of any member of our senior management team or our ability to attract and retain talent across the Company, including senior management, could adversely affect our business.
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A key risk in this area, for example, is that certain of our employees are at-will, which means that either we or the employee may terminate their employment at any time.
+Added: Our restructuring and reorganization activities may be disruptive to our operations or ineffective.
+Added: Recently, in November 2023, we underwent restructuring to better align our efforts towards the clinical development of new antibody medicines for patients.
+Added: Headcount was reduced by approximately 10% and the restructuring plans may yield unintended consequences, such as attrition beyond our intended reduction in workforce and reduced employee morale, which may cause our employees who were not affected by the reduction in workforce to seek alternate employment.
+Added: We cannot be certain that any of our restructuring efforts will be successful, or that we will be able to realize other anticipated benefits, savings and improvements from our current restructuring plan.
+Added: We may also discover that these restructuring measures will make it difficult for us to pursue new opportunities and initiatives and may require us to hire qualified replacement personnel, which may require us to incur additional and unanticipated costs and expenses.
+Added: We may also take similar steps in the future as we seek to realize operating synergies, optimize our operations to achieve our target operating model and profitability objectives, respond to market forces or better reflect changes in the strategic direction of our business.
+Added: Our failure to successfully accomplish any of the above activities and goals may have a material adverse impact on our business, financial condition and results of operations.
We have made technology acquisitions and expect to acquire businesses or assets or make investments in other companies or technologies that could negatively affect our operating results, dilute our shareholders’ ownership, increase our debt or cause us to incur significant expense.
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We cannot guarantee that we will be able to fully recover the costs of any acquisition.
−Removed: Integration of an acquired company also may disrupt ongoing operations and require management resources that we would otherwise focus on developing our existing
+Added: Integration of an acquired company also may disrupt ongoing operations and require management resources that we would otherwise focus on developing our existing business.
We may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.
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If the price of our common shares is low or volatile, we may not be able to acquire companies or assets using our securities as consideration.
−Removed: Our business could become subject to government regulation and the regulatory approval and maintenance process may be expensive, time-consuming and uncertain both in timing and in outcome.
+Added: Our business is subject to government regulation and the regulatory approval and maintenance process may be expensive, time-consuming and uncertain both in timing and in outcome, and certain agreements to which we are a party contain covenants and other obligations that constrain our business activities.
Our data packages are currently not subject to approval by the FDA.
However, our business could in the future become subject to regulation by the FDA, or comparable international agencies.
−Removed: For example, in May 2020, we announced that we received a commitment from the Government of Canada under Innovation, Science and Economic Development’s, or ISED, Strategic Innovation Fund, or SIF, of up to CAD $175.6 million ($129.7 million as of December 31, 2022) , the proceeds of which are being used to build a GMP facility in Vancouver, British Columbia, which will house our manufacturing and manufacturing support infrastructure.
+Added: For example, in May 2020, we announced that we received a commitment from the Government of Canada under Innovation, Science and Economic Development’s, or ISED, Strategic Innovation Fund, or SIF, of up to CAD $175.6 million ($125.6 million) , the proceeds of which are being used to build a GMP facility in Vancouver, British Columbia, which will house our manufacturing and manufacturing support infrastructure.
This facility, once completed, will become subject to various regulations, which could include regular inspections, certifications and audits.
+Added: Further, in May 2023, we entered into multi-year contribution agreements where up to CAD $225.0 million ($166.7 million) and CAD $75.0 million ($55.6 million) was committed by the Government of Canada and the Government of British Columbia, respectively, to build new capabilities in Canada to develop, manufacture, and deliver antibody medicines to patients through Phase 1 clinical trials and build expertise in translational science, technical operations, and clinical operations and research.
Such regulatory approval processes or clearances may be expensive, time-consuming and uncertain, and our failure to obtain or comply with such approvals and clearances could have an adverse effect on our business, financial condition and operating results.
In addition, changes to the current regulatory framework, including the imposition of additional or new regulations, including regulation of our data packages, could arise at any time, which may negatively affect our ability to obtain or maintain FDA or comparable regulatory approval of our data packages or future products, if required.
+Added: Our agreements with the Government of Canada and Government of British Columbia includes certain financial and non-financial covenants and other obligations in relation to the project, including restrictions on dividend payments
+Added: that would prevent the Company from satisfying the obligations under the agreements, the maintenance of certain gross capital expenditures in Canada, certain research and development expenditures in Canada, and the achievement of certain headcount requirements in Canada.
+Added: In addition, the Company has agreed to notice and consent rights to the counterparties upon certain events related to a change in control of the Company.
+Added: Breach of the covenants and obligations under the respective agreements with the Government of Canada and British Columbia, subject to applicable cure, may result in suspending, or terminating funding under the respective agreements, demanding repayment of funding previously received and/or terminating the respective agreements, reputational damages that could impact future government relationships, and have adverse consequences on our business.
+Added: We may not have enough available cash or be able to obtain financing at the time we are required to repay any such amounts.
Our billing and collections processing activities are time-consuming, and any delay in transmitting invoices or failure to comply with applicable billing requirements, could have an adverse effect on our future revenue.
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Moreover, insurance coverage is becoming increasingly expensive and in the future we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses.
−Removed: A successful liability claim, or series of claims, in which judgments exceed our insurance coverage could adversely affect our business, financial condition, results of operations and prospects, including preventing or limiting the use of our discovery and development engine to discover antibodies.
+Added: A successful liability claim, or series of claims, in which judgments exceed our insurance coverage could adversely affect our
+Added: business, financial condition, results of operations and prospects, including preventing or limiting the use of our discovery and development engine to discover antibodies.
Operating as a public company makes it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage, seek alternative insurance options or incur substantially higher costs to obtain the same or similar coverage.
14 unchanged sentences
Unauthorized access, loss or dissemination could also disrupt our operations and damage our reputation, any of which could adversely affect our business.
−Removed: International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of Canada and the United States.
−Removed: We currently have operations in Canada, the United States, Australia and the United Kingdom and our business strategy incorporates future international expansion.
+Added: Growth of our international business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of Canada and the United States.
+Added: We currently have entities in Canada, the United States, Australia, and the United Kingdom.
Doing business internationally involves a number of risks including:
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Our business is subject to risks relating to foreign currency exchange rates.
−Removed: We currently have operations in Canada, the United States, Australia and the United Kingdom and our business strategy incorporates future international expansion.
+Added: We currently have entities in Canada, the United States, Australia, and the United Kingdom.
Substantially all of our revenue is paid in US dollars.
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We cannot predict the impact of such changes and cannot be certain of our future compliance.
−Removed: Our discovery and development engine utilizes various species of animals that could contract disease or die and could otherwise subject us to controversy and adverse publicity, which may interrupt our business operations or harm our reputation.
+Added: Our discovery and development engine, and internal programs, utilize various species of animals that could contract disease or die and could otherwise subject us to controversy and adverse publicity, which may interrupt our business operations or harm our reputation.
Our discovery and development engine utilizes animals to discover and produce antibodies.
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Any interruption in the supply of components or materials, or our inability to obtain substitute components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our partners, which would have an adverse effect on our business.
−Removed: Although we expect our recent business acquisitions will result in synergies and other benefits to us, we may not realize those benefits because of difficulties related to integration and uncertainties related to certain assets acquired as a result of the acquisitions .
−Removed: In November 2020, we consummated the Trianni acquisition.
+Added: Although we expect business acquisitions will result in synergies and other benefits to us, we may not realize those benefits because of difficulties related to integration and uncertainties related to certain assets acquired as a result of the acquisitions.
In September 2021, we consummated the TetraGenetics acquisition.
−Removed: We expect that the integration process will require significant time and resources, and we may not be able to manage the process successfully.
−Removed: Potential difficulties we may encounter as part of the integration process include (i) the challenge of integrating complex systems, operating procedures, regulatory compliance programs, technology, networks and other assets of the acquisitions in a seamless manner that minimizes any adverse impact on our employees, patients, suppliers and other business partners;
−Removed: and (ii) potential unknown liabilities, liabilities that are significantly larger than we currently anticipate and unforeseen increased expenses or delays associated with the acquisitions, including costs to integrate the businesses that may exceed the costs that we currently anticipate.
−Removed: As part of our ongoing research and development we may make changes in our planned use of in process research and development which could result in a future impairment of the corresponding intangible asset.
−Removed: For instance, in connection with the acquisition, we acquired a suite of transgenic humanized rodent lines currently being validated and available for discovery projects in the near future.
−Removed: There can be no assurance that these rodent lines will ever be validated or available for use by us or our partners.
−Removed: Further, it is possible that we will experience disruption of either company’s or both companies’ ongoing businesses, including as we continue to service Trianni’s existing contracts for the foreseeable future.
−Removed: In addition, we have only recently begun to generate licensing revenue from our Trianni humanized rodent platform.
−Removed: There can be no assurance that we will continue to generate or expand our licensing revenue from this product offering in future periods.
−Removed: Accordingly, the contemplated benefits of the Trianni acquisition may not be realized fully, or at all, or may take longer to realize than expected.
+Added: As we continue to integrate our processes, programs and other components of our business, we expect our ongoing efforts to include additional costs and resources.
+Added: we are not able to optimize integration of TetraGenetics, or if we change our planned use of in process research and development, we might not realize synergies and other benefits to us and/or there could be a future impairment of the corresponding intangible asset.
Risks Related to Our Intellectual Property
−Removed: If we are unable to obtain and maintain sufficient intellectual property protection for our technology, including our discovery and development engine and Celium, our proprietary antibody visualization software, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies or a platform similar or identical to ours, and our ability to successfully sell our data packages may be impaired.
+Added: If we are unable to obtain and maintain sufficient intellectual property protection for our technology, including our discovery and development engine, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies or a platform similar or identical to ours, and our ability to successfully sell our data packages may be impaired.
We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions to protect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep a competitive advantage.
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It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.
−Removed: We may not have the right to control the preparation, filing and prosecution of patent
−Removed: applications, or to maintain the rights to patents licensed to third parties.
+Added: We may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents licensed to third parties.
Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.
+Added: We may incorrectly interpret the terms of intellectual property or licensing agreements, which could result in unexpected expenses to be incurred by the Company.
As of December 31, 2023, we owned or exclusively licensed over 80 issued or allowed patents and over 80 pending patent applications worldwide.
−Removed: We own registered trademarks and trademark applications for AbCellera, AbCellera Australia Pty.
−Removed: (formerly Channel Bio) , Celium, Trianni, the Trianni Mouse, and AbCellera Boston (formerly TetraGenetics Inc.) in the U.S., Canada, Australia and Europe.
−Removed: It is possible that none of our pending patent applications will result in issued patents in a timely fashion or at all, and even if patents are granted, they may not provide a basis for intellectual property protection of commercially viable products or services, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties.
+Added: We own registered trademarks and trademark applications for AbCellera, Celium, Orthomab, TetraGenetics, TetraExpress, Trianni, and the Trianni Mouse in the U.S., Canada, Australia and/or Europe.
+Added: It is possible that none of our pending patent applications will result in issued patents in a timely fashion or at all, and even if patents are granted, they may not provide a basis for intellectual property protection of commercially viable products or
+Added: services, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties.
It is possible that others will design around our current or future patented technologies.
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The America Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent litigation.
−Removed: These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings.
−Removed: Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third-party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same
−Removed: evidence would be insufficient to invalidate the claim if first presented in a district court action.
+Added: These include allowing third-party submission of prior art to the
+Added: USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings.
+Added: Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third-party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.
Accordingly, a third - party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third - party as a defendant in a district court action.
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No assurance can be given that other patent applications will not have priority over our patent applications.
−Removed: In addition, changes to the patent laws of the United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain.
+Added: In addition, changes to the patent laws of the United States allow for various post-grant opposition
+Added: proceedings that have not been extensively tested, and their outcome is therefore uncertain.
Furthermore, if third parties bring these proceedings against our patents, we could experience significant costs and management distraction.
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Some of our license agreements impose, and we expect that any future exclusive in-license agreements will impose, various development, diligence, commercialization and other obligations on us.
−Removed: We may enter into engagements in the future, with other licensors under which we obtain certain intellectual property rights relating to our discovery and development engine.
−Removed: These engagements take the form of exclusive license or of actual ownership of intellectual property rights or technology from third parties.
+Added: We may enter into agreements in the future, with other licensors under which we obtain certain intellectual property rights relating to our discovery and development engine.
+Added: These agreements take the form of exclusive license or of actual ownership of intellectual property rights or technology from third parties.
Our rights to use the technology we license are subject to the continuation of and compliance with the terms of those agreements.
1 unchanged sentence
Moreover, disputes may arise with respect to our licensing or other upstream agreements, including:
−Removed: the scope of rights granted under the agreements and other interpretation-related issues;
+Added: • the scope of rights and obligations granted under the agreements and other interpretation-related issues;
• the extent to which our systems and consumables, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
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• the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;
+Added: • the interpretation of any financial obligation related to our in-licensing agreements;
• the priority of invention of patented technology.
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The owners of these non-exclusively licensed technologies are therefore free to license them to third parties, including our competitors, on terms that may be superior to those offered to us, which could place us at a competitive disadvantage.
−Removed: Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights.
+Added: Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the
+Added: licensor’s rights.
In addition, certain of our agreements with third parties may provide that intellectual property arising under these agreements, such as data that could be valuable to our business, will be owned by the counterparty, in which case, we may not have adequate rights to use such data or have exclusivity with respect to the use of such data, which could result in third parties, including our competitors, being able to use such data to compete with us.
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If these licenses are terminated, or if the underlying intellectual property fails to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, technologies identical to ours.
−Removed: This could have a
−Removed: material adverse effect on our competitive position, business, financial condition, results of operations and prospects.
+Added: This could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.
Additionally, termination of these agreements or reduction or elimination of our rights under these agreements, or restrictions on our ability to freely assign or sublicense our rights under such agreements when it is in the interest of our business to do so, may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology or impede, or delay or prohibit the further development or commercialization of one or more technologies that rely on such agreements.
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The legal systems of many other countries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the misappropriation or other violations of our intellectual property rights including infringement of our patents in such countries.
−Removed: Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us.
+Added: Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted
+Added: narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us.
We may not prevail in any lawsuits that we initiate, or that are initiated against us, and the damages or other remedies awarded, if any, may not be commercially meaningful.
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However, trade secrets and know-how can be difficult to protect.
−Removed: In addition to pursuing patents on our technology, we take steps to protect our intellectual property and proprietary technology by entering into agreements, including confidentiality agreements, non-disclosure agreements and intellectual property assignment agreements, with our employees, consultants, academic institutions, corporate
−Removed: partners and, when needed, our advisers.
+Added: In addition to pursuing patents on our technology, we take steps to protect our intellectual property and proprietary technology by entering into agreements, including confidentiality agreements, non-disclosure agreements and intellectual property assignment agreements, with our employees, consultants, academic institutions, corporate partners and, when needed, our advisers.
However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
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In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own.
−Removed: The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property.
+Added: The assignment of intellectual property rights may not be self-executing, or the assignment
+Added: agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property.
Any of the foregoing could harm our business, financial condition, results of operations and prospects.
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Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
−Removed: We are and in the future may be involved in litigation and other proceedings related to intellectual property, which could be time-intensive and costly and may adversely affect our business, financial condition, results of operations and prospects.
+Added: We are currently, and in the future may be, involved in litigation and other proceedings related to intellectual property, which could be time-intensive and costly and may adversely affect our business, financial condition, results of operations and prospects.
In recent years, there has been significant litigation in the United States and other jurisdictions involving intellectual property rights.
18 unchanged sentences
We are also aware of issued U.S.
−Removed: patents and patent applications with subject matter related to our discovery and development engine, systems, workflows and processes, and there may be other related third party patents or patent applications of which we are not aware.
+Added: patents and patent applications with subject matter related to our discovery and development engine,
+Added: systems, workflows and processes, and there may be other related third-party patents or patent applications of which we are not aware.
It is possible that we are or may become aware of patents or pending patent applications that we think do not relate to our technology or that we believe are invalid or unenforceable, but that may nevertheless be interpreted to encompass our technology and to be valid and enforceable.
Thus, we do not know with certainty that our technology, or our development and commercialization thereof, do not and will not infringe, misappropriate or otherwise violate any third-party’s intellectual property.
−Removed: In addition, we may receive in the future, correspondence from third parties referring to the relevance of such third parties’ intellectual property to our technology, our workflows or our advanced automated systems, and we are currently engaged in litigation with such third parties (i.e., Berkeley Lights and Schrader).
+Added: In addition, we may receive in the future, correspondence from third parties referring to the relevance of such third parties’ intellectual property to our technology, our workflows or our advanced automated systems, and we are currently engaged in litigation with such third parties (i.e., Bruker and Schrader).
Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our current or future programs or technologies may infringe.
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In addition, our agreements with some of our partners, suppliers or other entities with whom we do business require us to defend or indemnify these parties to the extent they become involved in infringement claims, including the types of claims described above.
−Removed: We could also voluntarily agree to defend or indemnify third parties in instances where we are not obligated to do so if we determine
−Removed: it would be important to our business relationships.
+Added: We could also voluntarily agree to defend or indemnify third parties in instances where we are not obligated to do so if we determine it would be important to our business relationships.
If we are required or agree to defend or indemnify third parties in connection with any infringement claims, we could incur significant costs and expenses that could adversely affect our business, financial condition, results of operations and prospects.
Any uncertainties resulting from the initiation and continuation of any litigation or administrative proceeding could have a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.
−Removed: The outcome of our litigation with Berkeley Lights may adversely affect our business, financial condition, results of operations and prospects.
−Removed: In July 2020, we filed a complaint against Berkeley Lights, in the United States District Court for the District of Delaware, alleging that Berkeley Lights infringed and continues to infringe, directly and indirectly, the following patents exclusively licensed by the Company, including U.S.
−Removed: 10,421,936 and 10,704,018, by making, using, offering for sale, selling and/or importing Berkeley Lights’ Beacon Optofluidic System.
−Removed: In August 2020, we filed an additional related complaint against Berkeley Lights in the United States District Court for the District of Delaware, alleging that Berkeley Lights infringed and continues to infringe, directly and indirectly, U.S.
+Added: The outcome of our litigation with Bruker Cellular Analysis may adversely affect our business, financial condition, results of operations and prospects.
+Added: In July 2020, we filed a complaint against Bruker Cellular Analysis (formerly known as Berkeley Lights, Inc.;
+Added: Berkeley Lights, Inc.
+Added: rebranded itself as PhenomeX and was later acquired by Bruker Cellular Analysis) ("Bruker"), in the United States District Court for the District of Delaware, alleging that Bruker infringed and continues to infringe, directly and indirectly, the following patents exclusively licensed by the Company, including U.S.
+Added: 10,421,936 and 10,704,018, by making, using, offering for sale, selling and/or importing Bruker's Beacon Optofluidic System.
+Added: In August 2020, we filed an additional related complaint against Bruker in the United States District Court for the District of Delaware, alleging that Bruker infringed and continues to infringe, directly and indirectly, U.S.
10,746,737 and 10,753,933.
−Removed: In September 2020, we filed another complaint against Berkeley Lights in the United States District Court for the District of Delaware, alleging that Berkeley Lights infringed and continues to infringe, directly and indirectly, U.S.
+Added: In September 2020, we filed another complaint against Bruker in the United States District Court for the District of Delaware, alleging that Bruker infringed and continues to infringe, directly and indirectly, U.S.
10,775,377 and 10,775,378.
−Removed: On December 3, 2020, the judge assigned to these three lawsuits ordered that they be transferred to the U.S.
+Added: On December 3, 2020, the three lawsuits were transferred to the U.S.
District Court for the Northern District of California.
In these lawsuits, we are seeking, among other things, a judgment of infringement, a permanent injunction and damages (including lost profits, a reasonable royalty, reasonable costs and attorney’s fees and treble damages for willful infringement).
−Removed: In February 2021, these lawsuits were consolidated and assigned to the Honorable Judge Lucy Koh.
−Removed: In February 2021, Berkeley Lights filed a motion seeking leave to amend its counterclaims to add the allegations of unfair competition (as plead in the case described below) against AbCellera only.
−Removed: In July 2021, the Court allowed Berkeley to amend its counterclaims to add the unfair competition claims subject to our right to seek dismissal with prejudice should the counterclaims not overcome objections previously presented by us to the court.
−Removed: The Company is continuing to oppose the unfounded counterclaim and we intend to seek dismissal with prejudice.
−Removed: In March 2021, the court set this matter down for a jury trial with a December 12, 2022 start date.
−Removed: In July 2021, Berkeley Lights filed a Petition for inter partes review of U.S.
−Removed: 10,087,408 that we exclusively license from the University of British Columbia.
−Removed: In July 2021, Berkeley Lights filed a second Petition for inter partes review of U.S.
−Removed: 10,421,936 that we exclusively license from the University of British Columbia.
−Removed: In August 2021, Berkeley Lights filed a third Petition for inter partes review of U.S.
−Removed: 10,738,270 that we exclusively license from the University of British Columbia.
−Removed: In August 2021, the court stayed the patent litigation against Berkeley Lights in view of the Petitions for inter partes review filed by Berkeley Lights.
−Removed: In January 2022, the PTAB denied one petition and instituted one petition.
−Removed: In February 2022, the PTAB denied the final petition.
−Removed: Trial on the instituted petition occurred in November 2022.
−Removed: In January 2023, the PTAB issued its Final Written Decision with respect to our U.S.
−Removed: 10,087,408 rejecting all of Berkeley Lights’ grounds of unpatentability and determining that none of the challenged claims are unpatentable.
−Removed: Because the three aforementioned inter partes review matters have been resolved, we intend to seek relief from the Court to lift the pending stay and resume our patent infringement action against Berkeley Lights.
−Removed: In August 2020, Berkeley Lights filed a complaint in the Northern District of California against us and our wholly-owned subsidiary Lineage Inc.
−Removed: The complaint includes two counts of unfair competition and one count of non-infringement of a U.S.
−Removed: 10,058,839 (the “’839 patent”).
−Removed: Berkeley Lights is seeking, among other things, damages and a declaratory judgment of non-infringement of the ’839 patent.
−Removed: We filed a motion to dismiss the action for lack of jurisdiction and failure to state a claim upon which relief can be granted pursuant to Federal Rules of Civil Procedure 12(b) 1, 2, and 6.
−Removed: In January 2021, the Court determined that there was no jurisdiction over AbCellera or Lineage and dismissed the unfair competition claims but ordered jurisdictional discovery on a limited basis with respect to AbCellera only regarding Berkeley Lights’ request for declaratory judgment on the ’839 patent.
−Removed: In July 2021, Berkeley Lights voluntarily dismissed this lawsuit.
−Removed: In the event that Berkeley Lights were to prevail in the litigation against us, as a result of which Berkeley Lights could continue to sell its products, it could reduce our competitive advantage and differentiation in the market place, impairing our ability to bring in new business.
−Removed: Furthermore, Berkeley Lights may seek to invalidate the asserted patents during the litigation.
−Removed: If Berkeley Lights succeeds in invalidating the asserted patents, the strength of our intellectual property portfolio could be adversely affected and our ability to protect our technology, business and reputation or to generate licensing revenue from our intellectual property would be adversely impacted.
+Added: In February 2021, these lawsuits were consolidated.
+Added: In 2021, Bruker filed Petitions for inter partes review of U.S.
+Added: 10,087,408, 10,421,936, and 10,738,270.
+Added: The PTAB subsequently denied two Petition but instituted one Petition.
+Added: Trial on the instituted Petition occurred in November 2022 and in January 2023, the PTAB issued its Final Written Decision with respect to U.S.
+Added: 10,087,408 rejecting all of Bruker's grounds of unpatentability and determining that none of the challenged claims are unpatentable.
+Added: The PTAB issued a second written opinion denying Bruker's request for rehearing of its prior written decision.
+Added: On July 26, 2023, Bruker filed a Notice of Appeal in IPR2021-1249 matter to the United States Court of Appeals for the Federal Circuit.
+Added: The Company believes the IPR appeal is meritless and that the PTAB's decision will be upheld.
+Added: The district court cases are continuing to move forward with discovery.
+Added: A trial date has not been set.
+Added: In the event that Bruker were to prevail in the litigation against us, as a result of which Bruker could continue to sell its products, it could reduce our competitive advantage and differentiation in the market place, impairing our ability to bring in new business.
+Added: Furthermore, Bruker may seek to invalidate the asserted patents during the litigation.
+Added: If Bruker succeeds in invalidating the asserted patents, the strength of our intellectual property portfolio could be adversely affected and our ability to protect our technology, business and reputation or to generate licensing revenue from our intellectual property would be adversely impacted.
The outcome of our civil litigation with Schrader may adversely affect our business, financial condition, results of operations and prospects.
−Removed: The Company recently became aware of a civil lawsuit filed by the Estate of John Schrader and another corporate entity naming as co-defendants the Company, some of its affiliates and Dr.
+Added: On October 14, 2022, the Estate of John Schrader and ImmVivos Pharmaceuticals Inc.
+Added: filed a lawsuit naming as co-defendants the Company, some of its affiliates and Dr.
Carl Hansen, the Company's CEO.
−Removed: The lawsuit was filed in October 2022, in the Supreme Court of British Columbia (Vancouver).
+Added: The lawsuit was filed in the Supreme Court of British Columbia (Vancouver).
The complaint alleges breach of an implied partnership or joint venture between Dr.
2 unchanged sentences
The complaint seeks financial damages as well as other declarations.
−Removed: The Company believes that the claims are meritless and frivolous in all respects and intends to defend itself appropriately.
+Added: The Company recently filed a Notice of Application seeking to dismiss certain Company affiliates from the matter.
+Added: No hearing date has been set.
+Added: All co-defendants have been served.
+Added: The Company is proceeding to seek dismissal of certain Company affiliates for lack of jurisdiction.
+Added: No other activity is occurring with respect to this matter.
+Added: The Company believes that Plaintiffs’ claim is meritless and frivolous in all respects and intends to defend itself appropriately.
Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
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Litigation may be necessary for us to enforce our patent and proprietary rights or to determine the scope, coverage and validity of the proprietary rights of others.
−Removed: We are currently engaged in a lawsuit with Berkeley Lights based upon our allegations of its infringement of our intellectual property rights and we may become involved in additional lawsuits in the future.
+Added: We are currently engaged in a lawsuit with Bruker based upon our allegations of its infringement of our intellectual property rights and we may become involved in additional lawsuits in the future.
We are also engaged in a civil lawsuit with Schrader based upon allegations of, among other things, infringement of their intellectual property.
7 unchanged sentences
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on issued United States and most foreign patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States at several stages over the lifetime of the patents and/or applications in order to maintain such patents and patent applications.
−Removed: We have systems in place to remind us to pay these fees, and we engage an outside service and rely on our outside
−Removed: counsel to pay these fees due to non-U.S.
+Added: We have systems in place to remind us to pay these fees, and we engage an outside service
+Added: and rely on our outside counsel to pay these fees due to non-U.S.
patent agencies.
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government may have certain rights to intellectual property embodied in our technology pursuant to the Bayh-Dole Act of 1980, or Bayh-Dole Act, and implementing regulations.
−Removed: government rights in certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.
+Added: government rights in certain inventions developed under a government-funded program include a
+Added: non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.
In addition, the U.S.
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government requires that any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the United States.
−Removed: The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made
−Removed: to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.
+Added: The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.
This preference for U.S.
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We expect that significant additional capital will be needed in the future to continue our planned operations, including expanded research and development activities, and costs associated with operating as a public company.
−Removed: To raise capital, we may sell common shares, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.
+Added: capital, we may sell common shares, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.
If we sell common shares, convertible securities or other equity securities, investors may be materially diluted by subsequent sales.
−Removed: Such sales may also result in material dilution to our existing shareholders, and new investors could gain rights, preferences, and privileges senior to the holders of our common shares, including common shares sold in our IPO.
−Removed: Pursuant to our incentive plan, that we adopted in connection with our IPO, our management is authorized to grant equity incentive awards to our employees, directors and consultants.
+Added: Such sales may also result in material dilution to our existing shareholders, and new investors could gain rights, preferences, and privileges senior to the holders of our common shares.
+Added: Pursuant to our incentive plan, our management is authorized to grant equity incentive awards to our employees, directors and consultants.
Initially, the aggregate number of our common shares that may be issued pursuant to share awards under the EIP was 21,280,000 shares.
4 unchanged sentences
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder.
−Removed: The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to
−Removed: acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
+Added: The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or grant licenses on terms unfavorable to us.
2 unchanged sentences
In addition, we may enter into agreements that prohibit us from paying cash dividends without prior written consent from our contracting parties, or which other terms prohibiting or limiting the amount of dividends that may be declared or paid on our common shares.
+Added: For example, our multi-year contribution agreements with the Government of Canada and the Government of British Columbia that we entered into in May 2023 contain restrictions on our ability to declare and pay dividends.
Any return to shareholders will therefore be limited to the appreciation of their common shares, which may never occur.
22 unchanged sentences
Certain provisions of our articles and certain provisions under the BCBCA, together or separately, could discourage, delay or prevent a merger, acquisition or other change in control of us that shareholders may consider favorable, including transactions in which they might otherwise receive a premium for their common shares.
−Removed: These provisions include the establishment of a staggered
−Removed: board of directors, which divides the board into three groups, with directors in each group serving a three-year term.
+Added: These provisions include the establishment of a staggered board of directors, which divides the board into three groups, with directors in each group serving a three-year term.
The existence of a staggered board can make it more difficult for shareholders to replace or remove incumbent members of our board of directors.
54 unchanged sentences
GAAP, requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes.
−Removed: We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, as provided in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates.” The results of these estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
+Added: We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, as provided in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates.” The results of these estimates form the basis for making judgments about the carrying values of assets and liabilities, including the determination of contingent liabilities, that are not readily apparent from other sources.
Our results of operations may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our results of operations to fall below the expectations of securities analysts and investors, resulting in a decline in the trading price of our common shares.
20 unchanged sentences
In addition, a Ten Percent Shareholder that realizes gain from the sale or exchange of shares in a CFC may be required to classify a portion of such gain as dividend income rather than capital gain.
−Removed: An individual that is a Ten Percent Shareholder with respect to a CFC generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a Ten Percent Shareholder that is
+Added: An individual that is a Ten Percent Shareholder with respect to a CFC generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a Ten Percent Shareholder that is a U.S.
Failure to comply with these reporting obligations may subject a Ten Percent Shareholder to significant monetary penalties and may prevent the statute of limitations with respect to such Ten Percent Shareholder’s U.S.
34 unchanged sentences
Treasury Regulations.
−Removed: Recent proposed changes to PFIC regulations, if adopted, would expand the definition of “U.S.
+Added: Recent proposed changes to PFIC regulations, if adopted,
+Added: would expand the definition of “U.S.
Holder” for purposes of the CFC/PFIC overlap rule and other PFIC rules, elections, and reporting requirements discussed below.
23 unchanged sentences
A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities.
−Removed: For example, the U.S.
+Added: For example, the Canada Revenue Agency, the U.S.
Internal Revenue Service or another tax authority could challenge our allocation of income by tax jurisdiction and the amounts paid between our affiliated companies pursuant to our intercompany arrangements and transfer pricing policies, including amounts paid with respect to our intellectual property development.
5 unchanged sentences
federal, state, and local and non-U.S.
−Removed: taxation are constantly under review by persons involved in the legislative process, the Internal Revenue Service, the U.S.
+Added: taxation are constantly under review by persons involved in the legislative process, the U.S.
+Added: Internal Revenue Service, the U.S.
Treasury Department and other taxing authorities.
3 unchanged sentences
In recent years, many such changes have been made, and changes are likely to continue to occur in the future.
−Removed: As we expand the scale of our business activities, any changes in the U.S.
+Added: As we expand our business activities, any changes in the U.S.
taxation of such activities may increase our effective tax rate and harm our business, financial condition, and results of operations.
General Risk Factors
−Removed: Our business has been and may continue to be adversely affected by the ongoing COVID-19 pandemic.
−Removed: In late 2019, a novel strain of coronavirus, SARS-CoV-2, which resulted in the evolving COVID-19 pandemic, surfaced in Wuhan, China.
−Removed: Since then, COVID-19 has spread across the globe and to multiple regions within the United States and Canada, including British Columbia, where our primary office and laboratory space is located.
−Removed: The COVID-19 pandemic to date has led to the implementation of various responses, including government imposed shelter-in-place orders, quarantines, travel restrictions and other public health safety measures, as well as reported adverse impacts on healthcare resources, facilities and providers, in Canada, across the United States and in other countries.
−Removed: In the event that government authorities were to further modify current restrictions, our employees conducting research and development or manufacturing activities may not be able to access our laboratory and manufacturing space, and our core activities may be significantly limited or curtailed, possibly for an extended period of time.
−Removed: As a result of the ongoing COVID-19 pandemic, or similar pandemics and outbreaks, we have experienced and may continue to experience severe delays and disruptions, including, for example:
−Removed: interruption of or delays in receiving products and supplies from third parties;
−Removed: limitations on our business operations by local, state, provincial and/or federal governments that could impact our ability to sell our data packages;
−Removed: delays in negotiations with partners and potential partners;
−Removed: increases in facilities costs to comply with physical distancing guidance;
−Removed: business disruptions caused by workplace, laboratory and office closures and an increased reliance on employees working from home, travel limitations, cyber-security and data accessibility, or communication or mass transit disruptions;
−Removed: limitations on employee resources that would otherwise be focused on the conduct of our activities, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people.
−Removed: Any of these factors could severely impact our research and development activities, business operations and sales, or delay necessary interactions with local regulators, manufacturing sites and other important contractors and partners.
−Removed: These and other factors arising from the COVID-19 pandemic could worsen in countries that are already afflicted with COVID-19, could continue to spread to additional countries, or could return to countries where the pandemic has been partially contained, and could further adversely impact our ability to conduct our business generally and have a material adverse impact on our operations and financial condition and results.
−Removed: The extent to which the COVID-19 pandemic may negatively impact our operations and results of operations or those of our stakeholders will depend on future developments, which are highly uncertain and cannot be predicted with confidence.
−Removed: The ongoing military action between Russia and Ukraine and related sanctions could adversely affect our business, financial condition, and patent administration.
−Removed: In February of 2022, Russian military forces invaded Ukraine, and sustained conflict and disruption in the region is likely.
−Removed: Although the length, impact and outcome of the ongoing military conflict in Ukraine is highly unpredictable, this conflict could lead to significant market disruptions, including significant volatility in commodity prices and supply of energy resources, instability in financial markets, higher inflation, supply chain interruptions, political and social instability, cyber attacks and cybersecurity threats, and could also aggravate the other risk factors that we identify herein.
−Removed: In addition, the impact of sanctions against Russia and the potential retaliatory acts from Russia, could have a material adverse effect on our business and intellectual property rights.
−Removed: For example, we may be unable to obtain patent rights to our Trianni and microfluidic platforms as well as bamlanivimab which are protected in other jurisdictions around the world.
Impairment charges pertaining to goodwill, identifiable intangible assets or other long-lived assets from our mergers and acquisitions could have an adverse impact on our results of operations and the market value of our common stock.
27 unchanged sentences
• significant lawsuits, including patent or shareholder litigation;
−Removed: the impact of the ongoing COVID-19 pandemic on our business;
−Removed: general political and economic conditions, including those resulting from the conflict between Russia and Ukraine and the attendant sanctions;
+Added: • general political and economic conditions, including those resulting from the conflict between Russia and Ukraine and the attendant sanctions, in addition to the conflict in Israel and the Gaza strip, as well as social and political unrest in the Middle East and the related impact on our business and the markets generally;
• other events or factors, many of which are beyond our control.
3 unchanged sentences
This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, financial condition and results of operations.
−Removed: Requirements associated with being a public company will increase our costs significantly, as well as divert significant company resources and management attention.
+Added: Requirements associated with being a public company could increase our costs significantly, as well as divert significant company resources and management attention.
As of this report, we are subject to the reporting requirements of the Exchange Act or the other rules and regulations of the SEC and any securities exchange relating to public companies.
4 unchanged sentences
We cannot assure you that we will satisfy our obligations as a public company on a timely basis.
−Removed: We expect the rules and regulations applicable to public companies to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly.
+Added: The rules and regulations applicable to public companies require substantial legal and financial compliance costs and make some activities time-consuming and costly.
If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect on our business, financial condition and results of operations.
−Removed: The increased costs will decrease our net income or increase our net loss and may require us to reduce costs in other areas of our business.
−Removed: In addition, as a public company, it may be more difficult or more costly for us to obtain certain types of insurance, including directors’ and officers’ liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.
+Added: These costs decrease our net income or increase our net loss and may require us to reduce costs in other areas of our business.
+Added: In addition, as a public company, it is more difficult or more costly for us to obtain certain types of insurance, including directors’ and officers’ liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.
The impact of these events could also make it more difficult for us to attract and retain qualified personnel to serve on our board of directors, our board committees or as executive officers.
2 unchanged sentences
If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our shares could decrease, which might cause our share price and trading volume to decline.
−Removed: Unresolved Staff Comments.
+Added: Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results of operations.
+Added: The majority of our cash and cash equivalents are maintained in high credit quality and liquid held for trading marketable securities, bank accounts and term deposits at Canadian banking institutions.
+Added: Cash and cash equivalent held in depository accounts may exceed the C$100,000 Canadian Deposit Insurance Corporation insurance limits.
+Added: Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.
+Added: For example, in the first quarter of 2023, a number of financial institutions in the U.S.
+Added: were placed into receivership by the Federal Deposit Insurance Corporation.
+Added: Any material loss that we may experience in the future could have a material adverse effect on our financial condition and could materially impact our ability to pay our operational expenses or make other payments.
+Added: Although we were not a depositor with any such financial institution placed into receivership, if the banking institutions that hold our deposits were to fail, we could lose all or a portion of those amounts held in excess of applicable insurance limitations.
+Added: In such an event, our access to our cash in amounts adequate to finance our operations could be significantly impaired by the financial institutions with which we have arrangements directly facing liquidity constraints or failures.
+Added: In addition, if we were to borrow money in the future and if any of our lenders or counterparties to any such instruments were to be placed into receivership, we may be unable to access such funds.
+Added: In addition, if any of our customers, suppliers or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay or perform their obligations to us or to enter into new commercial arrangements requiring additional payments to us or additional funding could be adversely affected.
+Added: Our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect our company, the financial institutions with which the Company has credit agreements or arrangements directly, or the financial services industry or economy in general.
+Added: These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry.
+Added: These factors could involve financial institutions or financial
+Added: services industry companies with which we have financial or business relationships, but could also include factors involving financial markets or the financial services industry generally.
+Added: The results of events or concerns that involve one or more of these factors could include a variety of material and adverse impacts on our current and projected business operations and our financial condition and results of operations.
+Added: These could include, but may not be limited to, the following:
+Added: • Delayed access to deposits or other financial assets or the uninsured loss of deposits or other financial assets;
+Added: • Potential or actual breach of statutory, regulatory or contractual obligations, including obligations that require the Company to maintain letters of credit or other credit support arrangements;
+Added: • Termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.