What the changes say
- Rein Therapeutics faces going concern doubts after reporting a $50.6 million operating loss in 2025 and an accumulated deficit of $401.3 million.
- The company indefinite paused development of product candidate LTI-01 due to capital limitations, increasing reliance on lead candidate LTI-03.
- Macroeconomic pressures include a 10% tariff on imports from China announced in February 2025.
What changed since the prior 10-K
New
- NewRisks Related to Our Financial Condition
We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future and do not expect to achieve or maintain profitability; Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern
The company reported operating losses of $50.6 million in 2025 and $65.1 million in 2024, with an accumulated deficit of $401.3 million raising going concern doubts.
- NewRisks Related to Our Financial Condition
Global and macroeconomic developments can disrupt our supply chains and adversely affect our financial condition and results of operations
Macroeconomic instability, inflation, and a 10% tariff on imports from China announced in February 2025 could disrupt supply chains and clinical trials.
- NewRisks Related to the Discovery, Development and Commercialization of Product Candidates
Our business is highly dependent on the success of our lead product candidate, LTI-03
The business relies heavily on lead product candidate LTI-03, which is currently in Phase 2 clinical development for idiopathic pulmonary fibrosis.
- NewRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control
Regulatory compliance demands ongoing spending on manufacturing, production, quality control, post-marketing Phase 4 trials, and potential REMS programs.
- NewRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
accelerated approval preapproval of promotional materials, which could adversely impact the timing of the commercial launch of the product
FDA preapproval requirements for promotional materials and uncertain surrogate endpoints could delay the commercial launch of product candidates.
- NewRisks Related to Our Dependence on Third Parties
before approving our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the GCP requirements
Reliance on third-party clinical trial contractors creates risks if they fail to comply with GCP regulations, recruit enough patients, or violate fraud laws.
- NewRisks Related to Our Dependence on Third Parties
budget. In addition, the new manufacturer must comply with the aforementioned quality-related regulatory requirements
The company depends on third-party manufacturers to maintain quality control and regulatory compliance for LTI-03 production.
- NewRisks Related to Our Intellectual Property
misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the U.S
Intellectual property litigation could compromise trade secrets and negative public announcements could depress the price of common stock.
Dropped
- DroppedRisks Related to Our Financial Condition
Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern
- DroppedRisks Related to the Discovery, Development and Commercialization of Product Candidates
Our 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
Covered 2024 cash runway into August 2025 with $12.9 million in cash.
- DroppedRisks Related to the Discovery, Development and Commercialization of Product Candidates
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay
- DroppedRisks Related to the Discovery, Development and Commercialization of Product Candidates
Due 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
- DroppedRisks Related to the Discovery, Development and Commercialization of Product Candidates
We may not be successful in our efforts to identify or discover additional product candidates in the future
- DroppedRisks Related to the Discovery, Development and Commercialization of Product Candidates
potential 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
- DroppedRisks Related to Marketing Approval
System, a clinical trials portal overseen by the EMA and available to clinical trial sponsors, competent authorities of the EU Member States and the public
Covered risks for both LTI-03 and LTI-01 product candidates.
- DroppedRisks Related to Marketing Approval
the 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
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
injunctions or the imposition of civil or criminal penalties
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
Even 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
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
Recently 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
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
for which we may obtain marketing approval and may affect our overall financial condition and ability to develop or commercialize product candidates
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
The 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
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
Governments 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
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the European member states
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
Our employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
- DroppedRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
and cost of alternative sources of supply of materials we purchase from companies in China or other countries targeted with tariffs
- DroppedRisks Related to Our Dependence on Third Parties
The 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
- DroppedRisks Related to Our Dependence on Third Parties
Our 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
- DroppedRisks Related to Our Dependence on Third Parties
collaborations 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
- DroppedRisks Related to Our Dependence on Third Parties
Additionally, 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
Covered risks from changing manufacturing methods and formulations during development.
- DroppedRisks Related to Our Intellectual Property
first 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
Covered resource allocation decisions among limited product candidate programs.
- DroppedRisks Related to Employee Matters and Managing Growth
We may encounter difficulties in managing our growth, which could adversely affect our operations
Covered risks of failing to identify or discover additional product candidates.
- DroppedRisks Related to Employee Matters and Managing Growth
improving our operational, financial and management controls, reporting systems and procedures
Covered preclinical Cav1-related peptides lacking a finalized systemic formulation.
- DroppedRisks Related to Employee Matters and Managing Growth
If 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
- DroppedRisks Related to Employee Matters and Managing Growth
We 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
- DroppedRisks Related to Employee Matters and Managing Growth
Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
- DroppedRisks Related to Our Common Stock
We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
- DroppedRisks Related to Our Common Stock
We 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
- DroppedRisks Related to Our Common Stock
We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards
- DroppedRisks Related to Our Common Stock
warrants, 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
Covered the EMA clinical trials portal and trial design disagreements.
Reworded
- 100% rewrittenRisks Related to Our Financial Condition
invest in or in-license other technologies or product candidates
Added specific going concern warnings regarding depressed common stock price and potential difficulties in obtaining future financing or collaborators.
- 86% rewrittenRisks Related to Our Intellectual Property
Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts
Minor phrasing adjustments regarding third-party intellectual property infringement claims and USPTO administrative proceedings.
- 83% rewrittenRisks Related to Our Dependence on Third Parties
in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products
Retained commercial demand and fill-finish contractor compliance risks with minor wording edits.
- 80% rewrittenRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
Accelerated 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
Updated accelerated approval pathway descriptions regarding surrogate endpoints and FDA feedback.
- 72% rewrittenRisks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results
Added a specific mention of the U.S. government's announced 10% tariff on imports from China in February 2025.
- 66% rewrittenRisks Related to Marketing Approval
We 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
Refined language regarding FDA refusal to accept NDAs or BLAs for substantive review.
- 64% rewrittenRisks Related to Our Financial Condition
We 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
Updated to reflect that development of LTI-01 was paused in the fourth quarter of 2025 due to capital limitations, leaving LTI-03 as the main focus.
- 49% rewrittenRisks Related to Marketing Approval
If 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
Retained third-party payor coverage, reimbursement, and Boxed Warning descriptions with slight wording polishes.
- 44% rewrittenRisks Related to the Discovery, Development and Commercialization of Product Candidates
If approved, our product candidates that are regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
- 43% rewrittenRisks Related to Our Dependence on Third Parties
Because 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
- 40% rewrittenRisks Related to Our Common Stock
We 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
- 38% rewrittenRisks Related to Marketing Approval
Any 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
- 28% rewrittenRisks Related to Our Common Stock
Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
- 24% rewrittenRisks Related to Marketing Approval
Even 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
All 76 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Financial Condition
- 01unfavorable global economic conditions, which may exacerbate the magnitude of the factors discussed above
- 02Raising 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
- 03We have a limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our prospects and likelihood of success64% rewritten
- 04We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future and do not expect to achieve or maintain profitability; Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concernNew
- 05invest in or in-license other technologies or product candidates100% rewritten
- 06Global and macroeconomic developments can disrupt our supply chains and adversely affect our financial condition and results of operationsNew
- 07We 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
- 08Our business is highly dependent on the success of our lead product candidate, LTI-03New
- 09For 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
- 10varying interpretations of data by the FDA and similar foreign regulatory agencies
- 11Our 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
- 12In 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
- 13We 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
- 14We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of LTI-03
- 15the 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
- 16Our 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
- 17Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome
- 18the proprietary rights of others and their competing products and technologies that may prevent one of our product candidates from being commercialized
- 19If we encounter difficulties enrolling and retaining patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
- 20the 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
- 21If approved, our product candidates that are regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway44% rewritten
- 22We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us
- 23If 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
- 24decline in our share price
Risks Related to Marketing Approval
- 25We 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 candidate66% rewritten
- 26Even 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 success24% rewritten
- 27If 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 reduced49% rewritten
- 28Any 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 price38% rewritten
- 29The design or execution of our ongoing and future clinical trials may not support marketing approval
- 30Delays 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
- 31responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality controlNew
- 32We 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
- 33Accelerated 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 approval80% rewritten
- 34accelerated approval preapproval of promotional materials, which could adversely impact the timing of the commercial launch of the productNew
- 35If 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
- 36Additional laws and regulations governing international operations could negatively impact or restrict our operations
- 37Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results72% rewritten
- 38We 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
- 39before approving our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the GCP requirementsNew
- 40Because 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 quality43% rewritten
- 41budget. In addition, the new manufacturer must comply with the aforementioned quality-related regulatory requirementsNew
- 42in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products83% rewritten
Risks Related to Our Intellectual Property
- 43Our 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
- 44We 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
- 45Should any of these or similar events occur, they could significantly harm our business, financial condition, results of operations, and prospects
- 46the priority of invention of patented technology
- 47Reliance on third parties requires us to share our proprietary information, which increases the possibility that such information will be misappropriated or disclosed
- 48Competitors 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
- 49misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the U.SNew
- 50If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
- 51Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts86% rewritten
- 52redesigning our product candidates or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time
- 53We may not be able to protect our intellectual property rights throughout the world
- 54Obtaining 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
- 55Our 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
- 56We may be subject to claims challenging the inventorship of our patents and other intellectual property
- 57Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets
- 58Any current or future patents, if issued, covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO
- 59Changes 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
- 60We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
- 61Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
- 62If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed
- 63If 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
- 64Our 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
Risks Related to Our Common Stock
- 65If 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
- 66An active trading market for our common stock may not be sustained
- 67If 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
- 68The price of our stock may be volatile, and you could lose all or part of your investment
- 69other events or factors, many of which are beyond our control
- 70We could be subject to securities class action litigation
- 71Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition28% rewritten
- 72We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
- 73A 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
- 74We 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 affiliates40% rewritten
- 75Provisions 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
- 76require 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
Other Rein Therapeutics 10-Ks
- FY2024 10-K risk factors99 risks
Clinical-stage biopharmaceutical company focusing on fibrosis treatments LTI-03 and LTI-01.
Filed Apr 07, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.