Tango Therapeutics (TNGX) risk factors, FY2024 10-K

Risks Related to Our Limited Operating History, Financial Position, and Capital Requirements

1. 01We are a precision oncology company with a limited operating history
2. 02We have incurred significant net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future
3. 03We expect our operating results to fluctuate significantly in the future as our business advances
4. 04 future accounting pronouncements or changes in our accounting policies
5. 05We have no products approved for commercial sale and have not generated any revenue from product sales
6. 06We will need to raise substantial additional funding. If we are unable to raise capital when needed or on terms acceptable to us, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts
7. 07Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing and/or collaboration agreements to fund our business objectives
8. 08Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates

Risks Related to the Development of our Precision Oncology and Other Programs and Product Candidates

1. 09We have never successfully completed any clinical trials and we may be unable to do so for any product candidates we develop. Certain of our programs are still in preclinical development and may never advance to clinical development
2. 10Our programs are focused on the development of oncology therapeutics for patients with genetically defined or biomarker-driven cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs is novel and may never lead to approved or marketable products
3. 11Clinical product development involves a lengthy and expensive process, with an uncertain outcome
4. 12If we are unable to successfully validate, develop and obtain regulatory approval for diagnostic tests for our product candidates that require or would commercially benefit from such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these product candidates
5. 13Initial, interim and top-line data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to confirmation, audit and verification procedures that could result in material changes in the final data
6. 14We 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
7. 15 regulatory developments with respect to our competitors’ products, including any developments, litigation or public concern about the safety of such products
8. 16If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
9. 17We anticipate that certain of our current and future product candidates could be used in combination with third-party drugs or biologics, some of which are still in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such other drugs or biologics
10. 18Development of combination therapies may present more or different challenges than development of single agent therapies
11. 19Our 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 product candidates
12. 20We 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
13. 21We may fail to identify viable new product candidates for clinical development for a number of reasons. If we fail to identify additional product candidates, our business could be materially harmed
14. 22If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired
15. 23Public health crises, such as a 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 and the initiation and completion of clinical trials

Risks Related to Commercialization

1. 24We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
2. 25likely to be their efficacy, safety, convenience, price, level of generic competition and novel competition that utilize the same or similar mechanism of action and availability of reimbursement from government and other third-party payors
3. 26If the market opportunities for our programs and product candidates are smaller than we estimate or if any regulatory approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially
4. 27If 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. 28precision oncology, immuno-oncology or the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our product candidates

Risks Related to Our Reliance on Third Parties

1. 29 collaborations might be terminated, which could result in a need for additional capital to pursue further research, development and/or commercialization of our product candidates
2. 30Any one or more of these risks, if realized, could reduce or eliminate future revenue from product candidates under our collaborations, and could have a material adverse effect on our business, financial condition, results of operations and/or growth prospects
3. 31The third parties upon whom we rely for the supply of the active pharmaceutical ingredients and drug product to be used in our product candidates are our sole sources of supply, and the loss of any of these suppliers could significantly harm our business

Risks Related to Our Intellectual Property

1. 32If 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
2. 33Our success depends in part on our ability to obtain and maintain patent and regulatory protections for our products candidates, to preserve our trade secrets and other proprietary rights and to prevent third parties from infringing on our rights and our proprietary technology
3. 34In our industry, much of an innovative product’s commercial value is realized while it has market exclusivity
4. 35We 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. 36Intellectual 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
6. 37continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect on our business, results of operations, financial condition and prospects
7. 38If we fail to comply with our obligations in any agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
8. 39our best efforts, our licensors might conclude that we have materially breached our license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technologies covered by these license agreements
9. 40Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our current or future product candidates
10. 41We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our current or future product candidates
11. 42Intellectual property rights do not guarantee commercial success of current or future product candidates or other business activities. Numerous factors may limit any potential competitive advantage provided by our intellectual property rights

Risks Related to Government Regulation

1. 43Our future commercial success depends on gaining regulatory approval for new products and obtaining approvals for new indications
2. 44Obtaining 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
3. 45We 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
4. 46We 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. 47The 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
6. 48Delays as a result of an increased or lengthier regulatory approval process or further restrictions on the development of our product candidates can be costly and could negatively impact our ability to complete clinical trials and commercialize our current and future product candidates in a timely manner, if at all
7. 49In addition, government funding of the SEC and other government agencies on which our operations may rely, and those that fund research and development activities that is required by third parties we enter into agreements with, is subject to the political process, which is inherently fluid and unpredictable
8. 50Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates
9. 51Healthcare legislative reform measures may have a material adverse effect on our business and results of operations
10. 52 the availability of capital
11. 53 neither experimental nor investigational
12. 54If 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
13. 55 injunctions or the imposition of civil or criminal penalties
14. 56European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information
15. 57Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs
16. 58Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations

Risks Related to Employee Matters and Managing Anticipated Growth

1. 59Our future success depends on our ability to retain key executives and experienced scientists and to attract, retain and motivate qualified personnel
2. 60commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited
3. 61We may be unable to adequately protect our information technology systems from cyberattacks, cyber intrusions or otherwise which could result in damage to our information technology system and unauthorized disclosure or use of confidential or proprietary information, including personal data
4. 62Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data
5. 63We 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

Risks Related to Our Common Stock

1. 64Our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval
2. 65Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
3. 66Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
4. 67 the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval, which preferred stock may include rights superior to the rights of the holders of common stock
5. 68Our 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
6. 69Our 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
7. 70Because 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
8. 71The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock
9. 72We 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
10. 73Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
11. 74If 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
12. 75We may be subject to securities litigation, which is expensive and could divert management attention
13. 76Adverse 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
14. 77Comprehensive tax reform legislation could adversely affect our business and financial condition
15. 78Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
16. 79An 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