Traws Pharma (TRAW) risk factors, FY2024 10-K

Other

1. 01Summary of Principal Risk Factors

Risks Related to Our Financial Position and Capital Needs

1. 02Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new financings
2. 03The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern
3. 04We need to obtain additional funding to execute our business plans; if we are unable to meet our needs for additional funding in the future, we will be required to limit, scale back or cease operations
4. 05We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future
5. 06We currently have no source of product revenue and may never become profitable
6. 07Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
7. 08We maintain our cash at financial institutions, often in balances that exceed federally insured limits
8. 09International trade disputes could result in tariffs and other protectionist measures that could have a material adverse effect on our business, financial condition and results of operations
9. 10Changes in United States and China relations, as well as relations with other countries, and/or regulations may adversely impact our business, our operating results, our ability to raise capital and the market price of our shares
10. 11We may be adversely affected by the effects of inflation

Risks Related to Our Business and Industry

1. 12Our product development efforts may not be successful
2. 13Our future success is dependent primarily on the regulatory approval and commercialization of our product candidates
3. 14The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results. Any product candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or receive regulatory approval
4. 15Clinical drug development involves a lengthy and expensive process with an uncertain outcome
5. 16Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authority
6. 17Failure to follow the FDA’s applicable regulatory requirements may result in enforcement action
7. 18Changes in product candidate manufacturing or formulation may result in additional costs or delay
8. 19We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations
9. 20Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain
10. 21Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
11. 22We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
12. 23If we breach our license agreements or fail to negotiate new agreements pertaining to our product candidates, we could lose the ability to continue the development and potential commercialization of these product candidates
13. 24Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
14. 25We may engage in future business combinations or collaborations that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results
15. 26We depend on information technology and computer systems to operate our business; our business and operations would suffer in the event of any failures or interruptions of our computer system, such as a data breach or cybersecurity incident
16. 27result in financial, legal, business or reputational harm to us. In addition, our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyberattacks and other related breaches
17. 28Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses
18. 29Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel
19. 30The widespread outbreak of a communicable disease, such as the recent COVID-19 pandemic, could adversely impact our business, including our clinical trials, drug manufacturing and nonclinical activities
20. 31There is no guarantee that the Merger will increase stockholder value
21. 32Stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger, including the issuance of our common stock upon conversion of all outstanding shares of our Series C Preferred issued in the Merger and Financing
22. 33The failure to successfully integrate the businesses of Onconova and Trawsfynydd in the expected timeframe would adversely affect Traws Pharma’s future results
23. 34Our future results will suffer if we do not effectively manage our expanded operations
24. 35We expect to incur substantial expenses related to the integration of Trawsfynydd

Risks Related to Our Dependence on Third Parties

1. 36We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates
2. 37If we lose our relationships with CROs, our drug development efforts could be delayed
3. 38We have entered into certain related party transactions and may continue to rely on related parties for certain development and support activities

Risks Related to Our Intellectual Property

1. 39We could be required to incur significant expenses to perfect our intellectual property rights, and our intellectual property rights may be inadequate to protect our competitive position. If we are unable to protect our intellectual property rights, our competitive position could be harmed
2. 40We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful
3. 41Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business
4. 42We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers

Risks Related to Ownership of Our Securities

1. 43We may be required to raise additional financing by issuing new securities with terms or rights superior to those of our existing securityholders, which could adversely affect the market price of shares of common stock and our business
2. 44If we are unable to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock could be delisted, which could affect our common stock's market price and liquidity and reduce our ability to raise capital
3. 45If we are unable to implement and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock may decline
4. 46Future issuances of stock or other securities could dilute the holdings of stockholders and could materially affect the price of the shares of our common stock
5. 47Our share price and the liquidity of our stock may be volatile and result in substantial losses to our stockholders
6. 48We may be subject to securities litigation, which is expensive and could divert management attention
7. 49We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. Accordingly, stockholders must rely on capital appreciation, if any, for any return on their investment
8. 50Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management
9. 51stock entitled to vote in any election of directors to elect all of the directors standing for election; and