▸ Certain of our product candidates are being tested, and future product candidates may be used, in combination with one or more cancer therapies. The uncertainty resulting from the use of our product candidates in combination with other cancer· · · · ● 1 ▸ Ensuring that our future business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. It is possible that governmental authorities will conclude that our business· · · · ● 1 ▸ We currently rely, and expect to continue to rely, on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may· · · · ● 1 ▸ We invest significant amounts in developing new products and technologies. Our success and revenue growth, if any, will depend in part on our identification, development, approval by regulatory authorities and commercialization of new· · · · ● 1 ▸ Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.· · · ● ● 2 ▸ Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.· · ● ● ● 3 ▸ Development of combination therapies may present more or different challenges than development of single agent therapies.· · ● ● ● 3 ▸ Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.· · ● ● ● 3 rw ▸ Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, could adversely affect our business operations, financial condition and results of operations.· ● ● ● ● 4 ▸ If we cannot obtain new patents, maintain our existing patents and protect the confidentiality and proprietary nature of our trade secrets and other intellectual property, our business and competitive position may be harmed.· ● ● ● ● 4 ▸ In our industry, much of an innovative product’s commercial value is realized while it has market exclusivity.· ● ● ● ● 4 ▸ It is possible that we could lose market exclusivity for a product earlier than expected, which may harm our competitive position.· ● ● ● ● 4 ▸ Our future commercial success depends on gaining regulatory approval for new products and obtaining approvals for new indications.· ● ● ● ● 4 ▸ We expect our operating results to fluctuate significantly in the future as our business advances· ● ● ● ● 4 ▸ If biomarker assay development companies experience any delays developing and launching the biomarkers we have identified for patient selection and/or target engagement, our clinical trials may be delayed or may not identify sufficient· · · ● · 1 ▸ If the principal investigators or CROs do not perform clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with regulatory requirements, the development, regulatory approval and commercialization of our product· · · ● · 1 ▸ We may from time to time indicate the intent to publicly disclose certain clinical trial data at a future date. We have, for example, noted that we will provide a clinical update on the TNG462 clinical trial and clinical data on the TNG260 clinical· · · ● · 1 ▸ Efforts to educate the medical community and third-party payors on the benefits of our current product candidates and any future product candidates may require significant resources and may not be successful. If our current product candidates· · ● · · 1 ▸ GBM is excluded from the clinical trial as TNG462 does not cross the blood-brain barrier in preclinical non-human primate models.· · ● · · 1 ▸ If the FDA determines that a product candidate offers a treatment for a serious condition and, if approved, the product would provide a significant improvement in safety or effectiveness, the FDA may designate the product candidate for priority· · ● · · 1 ▸ Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale,· · ● · · 1 ▸ Public health crises such as pandemics or similar outbreaks, such as COVID-19 could adversely impact our business. The extent to which pandemics or epidemics impacts our operations or those of our third-party partners, including our· · ● · · 1 ▸ Some of the sensitive technology, techniques and proprietary compounds used in our business are protected as trade secrets. Among other things, we enter into confidentiality agreements and license agreements to protect proprietary· · ● · · 1 ▸ We may from time to time be party to license and collaboration agreements with third parties to advance our research or allow commercialization of current or future product candidates. For example, in March 2020 we entered into a License· · ● · · 1 ▸ We may seek a breakthrough therapy designation for some of our product candidates. A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a· · ● · · 1 ▸ Delayed access to deposits or other financial assets or the uninsured loss of deposits or other financial assets; or· ● · · · 1 ▸ If we or third-parties are unable to successfully develop screening technology for biomarkers that enable patient selection, or experience significant delays in doing so, we may not realize the full commercial potential of our product candidates.· ● · · · 1 ▸ Termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.· ● · · · 1 ▸ During the COVID-19 pandemic, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications.● ● · · · 2 rw ▸ If we are unable to adequately protect and enforce our trade secrets, our business and competitive position would be harmed.● · · · · 1 ▸ If we do not obtain patent term extension for our product candidates, our business may be materially harmed.● · · · · 1 ▸ If we or third-party CMOs, CROs or other contractors or consultants fail to comply with U.S. and international data protection laws and regulations, it could result in government enforcement actions (which could include civil or criminal● · · · · 1 ▸ Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government● · · · · 1 ▸ The COVID-19 pandemic, or a similar pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates.● · · · · 1 ▸ We contract with third parties for the manufacture of our product candidates for preclinical development and expect to continue to do so for clinical testing and commercialization. This reliance on third parties increases the risk that we will● · · · · 1 ▸ We have entered into collaborations and may enter into additional collaborations in the future, and we might not realize the anticipated benefits of such collaborations.● · · · · 1 ▸ We may not be able to file INDs for our precision oncology and other programs to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.● ● · · · 2 ▸ We may not obtain or grant licenses or sublicenses to intellectual property rights in all markets on equally or sufficiently favorable terms with third parties.● · · · · 1 ▸ We may seek to establish additional collaborations, and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.● · · · · 1 ▸ An active trading market for our common stock may not be sustained, and you may not be able to resell your shares at the price you paid.● ● ● ● ● 5 ▸ Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.● ● ● ● ● 5 ▸ Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our current or future product candidates.● ● ● ● ● 5 ▸ Clinical product development involves a lengthy and expensive process, with an uncertain outcome.● ● ● ● ● 5 ▸ Comprehensive tax reform legislation could adversely affect our business and financial condition.● ● ● ● ● 5 ▸ European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.● ● ● ● ● 5 ▸ Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.● ● ● ● ● 5 ▸ If our current product candidates or any future product candidates do not achieve broad market acceptance, the revenue that we generate from their sales may be limited, and we may never become profitable.● ● ● ● ● 5 ▸ If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.● ● ● ● ● 5 ▸ If we experience delays in obtaining, or if we fail to obtain, approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenue will be materially impaired.● ● ● ● ● 5 ▸ If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.● ● ● ● ● 5 ▸ If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.● ● ● ● ● 5 ▸ Intellectual property litigation and administrative patent office patent validity challenges in one or more countries could cause us to spend substantial resources and distract our personnel from their normal responsibilities.● ● ● ● ● 5 ▸ Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.● ● ● ● ● 5 ▸ Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● ● ● 5 ▸ Our bylaws designate specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.● ● ● ● ● 5 ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● ● ● ● ● 5 ▸ Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.● ● ● ● ● 5 ▸ Our future success depends on our ability to retain key executives and experienced scientists and to attract, retain and motivate qualified personnel.● ● ● ● ● 5 ▸ Our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.● ● ● ● ● 5 rw ▸ Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.● ● ● ● ● 5 ▸ group Risks Related to Commercialization● ● ● ● ● 5 ▸ group Risks Related to Employee Matters and Managing Anticipated Growth● ● ● ● ● 5 rw ▸ group Risks Related to Government Regulation● ● ● ● ● 5 ▸ group Risks Related to Our Common Stock● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ Risks Related to Our Limited Operating History, Financial Position, and Capital Requirements● ● ● ● ● 5 ▸ group Risks Related to Our Reliance on Third Parties● ● ● ● ● 5 ▸ Risks Related to the Development of our Precision Oncology and Other Programs and Product Candidates● ● ● ● ● 5 ▸ Should any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects.● ● ● ● ● 5 ▸ The FDA, the EMA and other regulatory authorities may implement additional regulations or restrictions on the development and commercialization of our product candidates, and such changes can be difficult to predict.● ● ● ● ● 5 ▸ The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.● ● ● ● ● 5 ▸ Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.● ● ● ● ● 5 ▸ We are a precision oncology company with a limited operating history.● ● ● ● ● 5 ▸ We conduct clinical trials for our product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.● ● ● ● ● 5 rw ▸ We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.● ● ● ● ● 5 ▸ We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.● ● ● ● ● 5 ▸ We have incurred significant net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.● ● ● ● ● 5 ▸ We have no products approved for commercial sale and have not generated any revenue from product sales.● ● ● ● ● 5 ▸ We may be subject to securities litigation, which is expensive and could divert management attention.● ● ● ● ● 5 ▸ We may incur additional costs or experience delays in initiating or completing, or ultimately be unable to complete, the development and commercialization of our product candidates.● ● ● ● ● 5 ▸ We may initiate, become a defendant in, or otherwise become party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming, and unsuccessful.● ● ● ● ● 5 ▸ We may seek orphan drug designation for certain of our product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.● ● ● ● ● 5 ▸ We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.● ● ● ● ● 5 ▸ We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives.● ● ● ● ● 5 rw