Rein Therapeutics (RNTX) risk factors, FY2024 10-K

Risks Related to Our Financial Condition

1. 01unfavorable global economic conditions, which may exacerbate the magnitude of the factors discussed above
2. 02Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern
3. 03Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to LTI-03, LTI-01 or other product candidates
4. 04We have a limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our prospects and likelihood of success
5. 05invest in or in-license other technologies or product candidates
6. 06We hold a portion of our cash and cash equivalents that we use to meet our working capital and operating expense needs in deposit accounts that could be adversely affected if the financial institutions holding such funds fail

Risks Related to the Discovery, Development and Commercialization of Product Candidates

1. 07Our business is highly dependent on the success of our product candidates, LTI-03 and LTI-01 and any other product candidates that we advance into clinical development
2. 08For each product candidate, we must demonstrate its safety and efficacy in humans, obtain regulatory approval in one or more jurisdictions, obtain manufacturing supply, capacity and expertise, and substantially invest in marketing efforts before we are able to generate any revenue from such product candidate
3. 09varying interpretations of data by the FDA and similar foreign regulatory agencies
4. 10Our approach to drug research and development in the area of fibrotic diseases, with a focus on Cav1-related peptides, is unproven and may not result in marketable products
5. 11In addition, while we have utilized cell assays, precision cut lung slice models, and in vivo animal models to assess both anti-fibrotic and epithelium preservation functions of Cav1-related peptides, there can be no assurance that our technology will yield its intended benefits in human patients
6. 12We are conducting and may in the future choose to conduct clinical trials for current or future product candidates outside of the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials
7. 13We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of LTI-03, LTI-01 or any other product candidates
8. 14the FDA or other comparable foreign regulatory authorities may require us to submit additional data such as long-term toxicology studies or impose other requirements before permitting us to initiate a clinical trial
9. 15Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies or earlier clinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of our product candidates
10. 16Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome
11. 17the proprietary rights of others and their competing products and technologies that may prevent one of our product candidates from being commercialized
12. 18If we encounter difficulties enrolling and retaining patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
13. 19the risk that patients enrolled in clinical trials will drop out of the trials or are discontinued from trials at the recommendation of the principal investigator before completion
14. 20If approved, our product candidates that are regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
15. 21Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay
16. 22Due to our limited resources and access to capital, we must make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business
17. 23We may not be successful in our efforts to identify or discover additional product candidates in the future
18. 24potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be medicines that will receive marketing approval and achieve market acceptance
19. 25We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us
20. 26If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of our product candidates
21. 27decline in our share price

Risks Related to Marketing Approval

1. 28We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any product candidate
2. 29Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
3. 30If government and other third-party payors do not provide coverage and adequate reimbursement levels for any products we commercialize, market acceptance and commercial success would be reduced
4. 31System, a clinical trials portal overseen by the EMA and available to clinical trial sponsors, competent authorities of the EU Member States and the public
5. 32the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
6. 33Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability or that of any collaborators we may have to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price
7. 34The design or execution of our ongoing and future clinical trials may not support marketing approval
8. 35Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our future clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates

Risks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance

1. 36injunctions or the imposition of civil or criminal penalties
2. 37Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives, which would harm our business
3. 38Recently enacted and future legislation may increase the difficulty and cost for us and our future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain for any products that are approved in the U.S. or foreign jurisdictions
4. 39for which we may obtain marketing approval and may affect our overall financial condition and ability to develop or commercialize product candidates
5. 40The prices of prescription pharmaceuticals in the U.S. and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when licensed
6. 41Governments outside of the U.S. tend to impose strict price controls, which may adversely affect our revenues from the sales of our products, if any
7. 42EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the European member states
8. 43We may seek to obtain certain regulatory designations for our product candidates. We may not receive such designations, and even if we do, such designation may not lead to a faster development or regulatory review or approval process
9. 44Accelerated approval by the FDA, even if granted for any of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
10. 45Our employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
11. 46If 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
12. 47Additional laws and regulations governing international operations could negatively impact or restrict our operations
13. 48Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results
14. 49and cost of alternative sources of supply of materials we purchase from companies in China or other countries targeted with tariffs
15. 50We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations

Risks Related to Our Dependence on Third Parties

1. 51Because we rely on third-party manufacturing and supply vendors, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality
2. 52in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products
3. 53The manufacture of our clinical and, if approved, commercial drug supply of LTI-01 involves a highly complex manufacturing process that is subject to a number of risks
4. 54Our existing collaborations and future collaborations are and will be important to our business. If we are unable to enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected
5. 55collaborations may be terminated by the collaborator, and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates
6. 56Additionally, if one of our existing or future collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities could be adversely affected

Risks Related to Our Intellectual Property

1. 57Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection
2. 58We cannot be certain that we were the first to file any patent application related to our technology, including our product candidates, and, if we were not, we may be precluded from obtaining patent protection for our technology, including our product candidates
3. 59Should any of these or similar events occur, they could significantly harm our business, financial condition, results of operations, and prospects
4. 60the priority of invention of patented technology
5. 61Reliance on third parties requires us to share our proprietary information, which increases the possibility that such information will be misappropriated or disclosed
6. 62Competitors may infringe our patents or the patents of our current or future licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming
7. 63If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
8. 64Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts
9. 65first to file a patent application related to our technology, we cannot be certain that a third-party is or will be filing and prosecuting patent applications related to our technology or related to our field, which could have a material adverse effect on our business
10. 66redesigning our product candidates or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time
11. 67We may not be able to protect our intellectual property rights throughout the world
12. 68Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
13. 69Our collaborators may assert ownership or commercial rights to inventions they develop from research we support or that we develop from our use of samples or other materials, which they provide to us, or otherwise arising from the collaboration
14. 70We may be subject to claims challenging the inventorship of our patents and other intellectual property
15. 71Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets
16. 72Any current or future patents, if issued, covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO
17. 73Changes in patent law in the U.S. and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
18. 74We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
19. 75Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
20. 76If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed
21. 77If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Related to Employee Matters and Managing Growth

1. 78We may encounter difficulties in managing our growth, which could adversely affect our operations
2. 79improving our operational, financial and management controls, reporting systems and procedures
3. 80If we lose key management personnel or consultants, or if we fail to recruit additional highly skilled personnel, our ability to develop current product candidates or identify and develop new product candidates will be impaired, could result in loss of markets or market share and could make us less competitive
4. 81Our internal computer systems, or those of our vendors or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs
5. 82We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster, including outbreak of disease or other natural disasters
6. 83Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations

Risks Related to Our Common Stock

1. 84If we fail to maintain compliance with the requirements for continued listing on the Nasdaq Capital Market, our common stock could be delisted from trading, which would adversely affect the liquidity of our common stock
2. 85An active trading market for our common stock may not be sustained
3. 86If 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
4. 87The price of our stock may be volatile, and you could lose all or part of your investment
5. 88other events or factors, many of which are beyond our control
6. 89We could be subject to securities class action litigation
7. 90We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
8. 91We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices
9. 92Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
10. 93We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards
11. 94We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
12. 95A significant portion of our total outstanding shares may be sold into the market at any time, which could cause the market price of our common stock to drop significantly, even if our business is doing well
13. 96We have also registered all shares of common stock that we may issue under our equity compensation plans, including upon exercise of outstanding options. These shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates
14. 97warrants, options and any other rights to acquire our common stock, and without giving effect to the foregoing beneficial ownership limitations on Series X Preferred Stock and the warrants, the Bios Entities would, as of March 27, 2025, own 36.4% of our common stock on a fully diluted basis
15. 98Provisions in our corporate 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
16. 99require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws