BenevolentAl Therapeutics Pipeline and Triage
Risk Factors
Any investment in Odyssey or the Company involves numerous risks and uncertainties related to the Company's business and the Proposed Transactions that may result for investors in a partial or total loss of their investment. The following
is a non-exclusive selection of key risks that, alone or in combination with other events or circumstances, could have a material adverse effect on the Company's business, financial condition, results of operations and prospects as well as the
Proposed Transactions. Investors should read, understand and carefully consider the risks and uncertainties described below. This summary is not comprehensive and the below key risks are subject to change. An additional discussion of
the risks and uncertainties of the Company and the Proposed Transaction will be included in under the heading "Risk Factors" contained in the circular and prospectus in connection with the proposed business combination.
Risks Related to the Company's Business and Industry
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We have a history of significant operating losses, and we expect to incur losses over the next several years.
Our operating history and business model may make it difficult for you to evaluate the success of our business to date and to assess our future viability, which may depend on us obtaining additional capital, which might not be
available on economically acceptable terms, or at all.
Our interim and annual results may fluctuate significantly, which could adversely impact the value of our shares.
We have no products approved for commercial sale, our revenues to date have been derived from a single source and it may take several years before we generate revenue from product sales, if at all.
If we and our present and future collaborators are unable to successfully develop and commercialise drug products, our revenues may be insufficient for us to achieve or maintain profitability.
All of our drug candidates are in early-stage preclinical development or in clinical development. If we are unable to advance our drug candidates through clinical development, to obtain regulatory approval and ultimately to
commercialise our drug candidates, or if we experience significant additional costs or significant delays in doing so, our business, financial condition, results of operations and prospects will be materially harmed.
We are substantially dependent on our technology platform to identify promising drug targets to accelerate drug discovery and development. Our platform technology may fail to discover and design molecules with therapeutic
potential or may not result in the discovery and development of commercially viable products for us or our collaborators.
If we cannot maintain existing partnerships, including data partnerships, and/or enter into new partnerships or similar business arrangements, our business could be adversely affected.
We face substantial competition, which may result in others discovering, developing or commercialising products before or more successfully than we do, requiring us to rapidly adapt our approach to significant technological
change and respond to the introduction of new products and technologies to remain competitive.
We contract with third parties, including, but not limited to, a number of contract research organisations ("CROS"), site providers, laboratory testing service providers, and universities for assay and experimental work for all of our
drug programmes, including where applicable the manufacture of our drug candidates for preclinical development and clinical testing, and expect to continue to do so for commercialisation. This reliance on third parties
increases the risk of non-performance or delay to some or all of our drug programmes, or that we will not have sufficient quantities of our drug candidates or products or such quantities at an acceptable cost, which could
delay, prevent or impair our development or commercialisation efforts.
Because we have multiple programmes and drug candidates in our development pipeline, we may expend our limited resources to pursue a particular drug candidate and fail to capitalise on development opportunities or drug
candidates that may be more profitable or for which there is a greater likelihood of success.
Clinical development involves a lengthy and expensive process with uncertain outcomes. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our drug candidates, we may incur
additional costs or experience delays in completing, or ultimately be unable to complete, the development of such drug candidate.
If we are unable to obtain, maintain, enforce and protect patent or other intellectual property right protection for our technology and drug candidates or if the scope of such protection obtained is not sufficiently broad, our
competitors could develop and commercialise technology and products similar or identical to ours, and our ability to successfully develop and commercialise our technology and drug candidates, as well as the value of our
brand and our business, may be adversely affected.
Our internal information technology systems, or those of our third-party vendors (including providers of cloud-based infrastructure), contractors or consultants, may fail or suffer security breaches, loss or leakage of data and other
disruptions, which could result in a material disruption of our services, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise
adversely affecting our business.
If we fail to comply with our obligations under any our existing intellectual property licence agreements and data licensing agreements or under any future such agreements, or otherwise experience disruptions to our business
relationships with our current or any future licensors, we could lose intellectual property rights (including access to data) that are important to our business.
We make use of the UK's small and medium sized enterprises research and development tax relief regime, through which we have obtained cash tax credits from Her Majesty's Revenue & Customs ("HMRC"). HMRC could seek to
challenge the historical cash tax credits paid, or a change of law or our circumstances could restrict our ability to claim additional such cash tax credits.
Current and future healthcare and artificial intelligence legislative reform measures may have a material adverse effect on our business and results of operations.
Regulatory authorities may implement additional regulations or restrictions on the development and commercialisation of our product candidates. Such changes can be difficult to predict, may require significant systems
changes, divert the attention of our personnel, subject us to additional liabilities and may adversely adversely affect our business.
Compliance with stringent and evolving global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with
such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
The effects of health epidemics, including the ongoing COVID-19 pandemic, in regions where we, or the third parties on which we rely, have business operations could adversely affect our business, including our preclinical studies
and clinical trials, as well as the business or operations of our CROS or other third parties with whom we conduct business.
Our current and future clinical trials or those of our current or future collaborators may reveal significant adverse events not seen in our preclinical or nonclinical studies and may result in a safety profile that could inhibit
regulatory approval or market acceptance of any of our future drug candidates.
Interim, "topline" and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit or verification procedures that could
result in material variations in our final data.
If we experience delays or difficulties in the enrolment of patients and/or provision of medical data in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
Al
Benevolent
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