Lineage Cell Therapeutics (LCTX) FY2025 10-K Risk Factors: 25 New, 13 Dropped

What the changes say

Company faces clinical and regulatory hurdles for nascent allogeneic cell therapies requiring surgical delivery.
R&D spending increased to $17.7 million in 2025.

What changed since the prior 10-K

New

NewRisks Related to Our Business Operations and Capital Requirements
approval for these product candidates, manufacturing, marketing, and selling any approved products, and satisfying any post-marketing regulatory requirements
Cell therapy is a nascent field with limited regulatory precedent, making development and approval time and cost unpredictable.
NewRisks Related to Our Business Operations and Capital Requirements
partners to reduce their interest in cell therapy programs more broadly, demand more extensive safety data before entering into collaborations, or seek more favorable terms reflecting perceived sector-wide risk
Partners may reduce interest in cell therapy or demand more extensive safety data due to perceived sector-wide risks.
NewRisks Related to Our Business Operations and Capital Requirements
We may fail to enter into new strategic relationships or may not realize the benefits of any strategic relationships that we have entered into, either of which could materially adversely affect our business, financial condition, commercialization prospects, and results of operations
We may fail to form new strategic relationships for product development and commercialization, or fail to realize their benefits.
NewRisks Related to Our Business Operations and Capital Requirements
we may not achieve the revenue, specific net income, or other anticipated benefits that justify our having entered into, or otherwise led us to enter into, the collaboration
Collaborators may terminate agreements or discontinue development programs, depriving us of expected revenues and milestone payments.
NewRisks Related to Our Business Operations and Capital Requirements
Our decisions regarding whether to advance our programs internally or through strategic relationships may not maximize the value of our pipeline for our shareholders, and misjudgments in these decisions could materially adversely affect our business
Misjudgments in whether to advance programs internally or through partnerships may fail to maximize pipeline value for shareholders.
NewRisks Related to Our Business Operations and Capital Requirements
Any of the foregoing could materially adversely affect our business, financial condition, results of operations, and prospects, as well as the market price of our common shares
Acquisitions or licensing of new technologies and assets could fail, disrupt our business, or result in shareholder dilution.
NewRisks Related to Our Business Operations and Capital Requirements
litigation or other claims in connection with an acquired company, including claims from terminated employees, vendors, former shareholders or other third parties
Foreign acquisitions and licensing arrangements subject us to cultural, currency, tax, and compliance risks that could harm our financial condition.
NewRisks Related to Our Business Operations and Capital Requirements
The administration of our cell therapy product candidates requires surgical transplantation, which exposes us to additional regulatory, clinical, operational and commercial risks that could materially adversely affect our business, results of operations and prospects
Surgical transplantation of cell therapies requires specialized delivery tools and increases risks of tissue injury or severe adverse events.
NewRisks Related to Government Regulation
If we or our strategic collaborators are unable to obtain FDA or comparable foreign regulatory authority approvals for our product candidates on a timely basis, or at all, our product candidates may not be marketed or sold and our business will be substantially harmed
Failure to obtain timely FDA or foreign regulatory approvals via Biologics License Applications will substantially harm our business.
NewRisks Related to Government Regulation
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders our clinical data insufficient for approval, including, for example, as a result of positive or negative data from third parties regarding other cell-based products or product candidates
Changes in FDA approval policies or third-party clinical data could render our clinical data insufficient for approval.
NewRisks Related to Government Regulation
Our reliance on pluripotent cell lines that may be exempt from certain donor eligibility requirements could create regulatory, labeling, and commercialization constraints, and could require us to undertake additional steps that delay, limit, or prevent commercialization of one or more product candidates
Our hES cell lines like OpRegen and OPC1 were derived prior to current donor eligibility rules, creating regulatory constraints.
NewRisks Related to Government Regulation
additional clinical trials, which would be costly and time-consuming and delay or permanently halt our development of our product candidates
Conducting clinical trials outside the United States exposes us to foreign regulatory, economic, and political risks.
NewRisks Related to Government Regulation
orphan drug designation may include a waiver of the marketing application fee. However, the orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
If we or our collaborators experience delays or difficulties enrolling or retaining patients in clinical trials of our product candidates, our research and development efforts and business, financial condition, and results of operations could be materially adversely affected
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
the availability of, and clinicians’ and patients’ satisfaction with, existing and new therapies approved for the indication the clinical trial is investigating
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
For example, positive data from the Phase 1/2a clinical trial of OpRegen are not necessarily predictive of results that may be seen from the ongoing Phase 2a clinical trial of RG6501 (OpRegen) being conducted by Roche. We do not yet know how OpRegen will perform in that Phase 2a trial or future clinical trials
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
capabilities, we may need to rely on third parties to manufacture and supply any products we develop and there is no assurance that we would be able to identify third parties to whom we can transfer the production process and are capable of manufacturing our product candidates on acceptable terms or at all
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
No assurances can be given that we will be able to continue to consistently manufacture clinical quantities of our product candidates in accordance with cGMP from a master and working cell bank system, or at a cost-effective or commercially viable scale, for one or more of our product candidates
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
Emerging, unknown, or previously unidentified infectious agents could affect one or more of our foundational cell lines or cell banks, require abandonment of a cell line, and materially delay or halt development of all product candidates dependent on that line
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
Our cell lines, cell banks, and product candidates may be affected by contaminants associated with animal- or human-derived materials used historically during IVF, derivation, or early expansion, and there can be no assurance that all such contaminants can be identified, tested for, or ruled out
NewRisks Related to the Development and Clinical Testing of Our Product Candidates
without obvious signs, and sterility tests have inherent limitations, including the potential for false negatives and the inability to detect certain organisms or low-level contamination in all circumstances
NewRisks Related to Ownership of Our Common Shares
Our largest shareholder, who is affiliated with a member of our board of directors, owns a significant percentage of our common shares and will be able to exert substantial influence over the election of directors and matters subject to shareholder approval, including potential change of control transactions
NewRisks Related to Ownership of Our Common Shares
common shares. Our subsidiaries may also issue their own preferred shares with a similar impact on our ownership of the subsidiaries
NewRisks Related to Ownership of Our Common Shares
The use of social media platforms present risks and challenges
NewRisks Related to Ownership of Our Common Shares
Unfavorable macroeconomic conditions and wars or armed conflicts could have an adverse impact on our business, financial condition and results of operations, including our clinical trials

Dropped

DroppedRisks Related to Our Business Operations and Capital Requirements
We are dependent on our third-party collaboration with Roche to develop and commercialize OpRegen. If Roche is not successful in developing and commercializing OpRegen and/or Roche terminates the collaboration, we will lose a significant source of potential revenue
Dependence on third-party collaboration with Roche to develop and commercialize OpRegen.
DroppedRisks Related to Our Business Operations and Capital Requirements
marketing, if any. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our planned operations
DroppedRisks Related to Our Business Operations and Capital Requirements
trials, and manufacturing operations, due to natural disasters, public health emergencies, geopolitical conflicts, political and economic instability, acts of terrorism, or hardware, software, telecommunication or electrical failures, which could significantly disrupt or harm our business
DroppedRisks Related to Our Business Operations and Capital Requirements
Political uncertainty may have an adverse impact on our operating performance and results of operations
DroppedRisks Related to Government Regulation
If we or our strategic collaborators do not receive regulatory approvals, our product candidates may not be marketed or sold
DroppedRisks Related to Government Regulation
We or our collaborators will have to conduct expensive and time-consuming clinical trials of new products. The full cost of conducting and completing clinical trials necessary to obtain FDA and foreign regulatory approval of a new product cannot be presently determined but could exceed our current financial resources
DroppedRisks Related to Government Regulation
Data obtained from preclinical and clinical studies is susceptible to varying interpretations and regulatory changes that could delay, limit, or prevent regulatory agency approvals
Seeking additional capital due to favorable market conditions or strategic considerations.
DroppedRisks Related to Government Regulation
Disruptions at the FDA and other government agencies caused by funding shortages or other events or conditions outside of their control could negatively impact our business
DroppedRisks Related to Our Clinical Development and Commercial Operations
variability in interpretation and analysis of study data
DroppedRisks Related to our Intellectual Property
advantage of any opportunity to protect trade secrets or other confidential information, our competitors could use such information to compete with us, which would significantly harm our business
DroppedRisks Related to our Dependence on Third Parties
Insiders continue to have substantial influence over our company, which could limit your ability to influence the outcome of key transactions, including a change of control
DroppedRisks Related to our Dependence on Third Parties
If we, or our personnel or third parties upon whom rely, fail, or are perceived to have failed, to address or comply with applicable data privacy, security, protection and transfer requirements, we could face significant consequences
DroppedRisks Related to our Dependence on Third Parties
Our results of operations are affected by prevailing economic and political conditions and other factors beyond our control, such as the rate of inflation, fluctuations in costs, particularly due to changes in labor costs and material costs, levels of business confidence, and wars or armed conflicts
Manufacturing operations disruption in Jerusalem, Israel due to natural disasters or conflicts.

Reworded

96% rewrittenRisks Related to Our Business Operations and Capital Requirements
Our failure to address these risks or other problems encountered in connection with acquisitions and investments could cause us to fail to realize the anticipated benefits of these acquisitions or investments, cause us to incur unanticipated liabilities, and harm our business generally
Updated to focus broadly on risks from acquisitions and investments rather than specifically on the Jerusalem manufacturing facility.
94% rewrittenRisks Related to Our Business Operations and Capital Requirements
Our investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges. We or our collaborators may not succeed in developing any of our product candidates
Added context that there is currently only one FDA-approved allogeneic RPE cell-based product, which is encapsulated and does not integrate into the retina.
88% rewrittenRisks Related to the Development and Clinical Testing of Our Product Candidates
greater than anticipated cost of clinical studies of our product candidates
Replaced COVID-19 pandemic references with specific consequences of clinical trial delays on patent protection and competitor entry.
83% rewrittenRisks Related to Government Regulation
The FDA has granted orphan drug designation to OPC1 for the treatment of acute SCIs. However, there is no guarantee we will be able to maintain this designation, receive this designation for any other product candidate, or obtain the benefits associated with such designation, including marketing exclusivity
Truncated the discussion of orphan drug designation benefits for OPC1.
82% rewrittenRisks Related to Ownership of Our Common Shares
Securities analysts may not initiate coverage or continue to cover our common shares, and this may have a negative impact on the market price of our common shares
Retained substantially similar language regarding analyst coverage and its impact on common share trading market.
81% rewrittenRisks Related to Our Business Operations and Capital Requirements
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations
Updated tax risk to incorporate the One Big Beautiful Bill Act signed in July 2025 permitting domestic R&D expensing.
78% rewrittenRisks Related to Our Business Operations and Capital Requirements
We will continue to spend a substantial amount of our capital on research and development, but we might not succeed in identifying or developing product candidates that are safe and effective for their target indications or are commercially viable
Updated R&D expense figures to $17.7 million for fiscal 2025 from $12.5 million for fiscal 2024.
Was: We will continue to spend a substantial amount of our capital on research and development, but we might not succeed in identifying or developing product candidates that are safe and effective for their target indications or commercially viable
78% rewrittenRisks Related to Our Business Operations and Capital Requirements
If we fail to meet our obligations under our in-license agreements, we may lose our rights to key technologies on which our business depends
Expanded technology in-license risks to explicitly include cell lines licensed from third parties.
69% rewrittenRisks Related to our Dependence on Third Parties
We may become dependent on possible future collaborations to develop and commercialize many of our product candidates and to provide the regulatory compliance, sales, marketing and distribution capabilities required for the success of our business
68% rewrittenRisks Related to Our Business Operations and Capital Requirements
We may expend our limited resources to pursue particular product candidates and fail to capitalize on other product candidates that may be more profitable or for which there is a greater likelihood of success
64% rewrittenRisks Related to Our Business Operations and Capital Requirements
Because a portion of our expenses are incurred in currencies other than the U.S. Dollar, our results of operations may be harmed by currency fluctuations
62% rewrittenRisks Related to our Intellectual Property
If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could limit opportunities for us to generate revenues by licensing our technology and selling products
60% rewrittenRisks Related to Our Business Operations and Capital Requirements
We have incurred operating losses since inception, and we do not know if or when we will attain profitability
51% rewrittenRisks Related to Our Business Operations and Capital Requirements
Our business could be adversely affected if we lose the services of the key personnel upon whom we depend or if we fail to attract and retain senior management and key scientific personnel
50% rewrittenRisks Related to Ownership of Our Common Shares
If we or our subsidiaries issue additional common shares or preferred shares, investors in our common shares may experience dilution of their ownership interests
37% rewrittenRisks Related to Government Regulation
If these third-party payors do not consider our products to be cost-effective compared to other therapies, they may not cover our products as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis
32% rewrittenRisks Related to our Intellectual Property
Confidentiality agreements with employees and third parties may not prevent disclosure of trade secrets and other proprietary information
29% rewrittenRisks Related to Government Regulation
Government-imposed bans or restrictions and religious, moral, and ethical concerns about the use of hES cells could prevent us from developing and successfully marketing stem cell products
24% rewrittenRisks Related to Our Business Operations and Capital Requirements
it may adversely affect the interest of other third parties in pursuing strategic collaborations relating to our product candidates, including OpRegen, or technology or the terms of any such potential collaboration
24% rewrittenRisks Related to the Development and Clinical Testing of Our Product Candidates
Clinical development of new therapeutic products is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome
23% rewrittenRisks Related to our Intellectual Property
Our intellectual property may be insufficient to protect our products
22% rewrittenRisks Related to Our Business Operations and Capital Requirements
Our ability to use our net operating losses and other tax attributes to offset future taxable income or taxes may be limited, which may effectively increase our future income tax obligations
Was: Our ability to use net operating losses and other tax attributes to offset future taxable income or taxes may be subject to limitations
21% rewrittenRisks Related to Our Business Operations and Capital Requirements
Our international business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States

All 87 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business Operations and Capital Requirements

01the loss or impairment of intellectual property rights related to OpRegen
02it may adversely affect the interest of other third parties in pursuing strategic collaborations relating to our product candidates, including OpRegen, or technology or the terms of any such potential collaboration24% rewritten
03We have incurred operating losses since inception, and we do not know if or when we will attain profitability60% rewritten
04approval for these product candidates, manufacturing, marketing, and selling any approved products, and satisfying any post-marketing regulatory requirementsNew
05Our investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges. We or our collaborators may not succeed in developing any of our product candidates94% rewritten
06partners to reduce their interest in cell therapy programs more broadly, demand more extensive safety data before entering into collaborations, or seek more favorable terms reflecting perceived sector-wide riskNew
07We will continue to spend a substantial amount of our capital on research and development, but we might not succeed in identifying or developing product candidates that are safe and effective for their target indications or are commercially viable78% rewritten
08Raising additional capital may cause dilution to our existing shareholders, restrict our operations, or require us to relinquish rights to or dilute our economic interest in our product candidates or technology on terms unfavorable to us
09Our ability to raise capital through equity or convertible debt financings may be limited by applicable rules of the SEC and NYSE American
10We may expend our limited resources to pursue particular product candidates and fail to capitalize on other product candidates that may be more profitable or for which there is a greater likelihood of success68% rewritten
11If we fail to meet our obligations under our in-license agreements, we may lose our rights to key technologies on which our business depends78% rewritten
12We may fail to enter into new strategic relationships or may not realize the benefits of any strategic relationships that we have entered into, either of which could materially adversely affect our business, financial condition, commercialization prospects, and results of operationsNew
13we may not achieve the revenue, specific net income, or other anticipated benefits that justify our having entered into, or otherwise led us to enter into, the collaborationNew
14Our decisions regarding whether to advance our programs internally or through strategic relationships may not maximize the value of our pipeline for our shareholders, and misjudgments in these decisions could materially adversely affect our businessNew
15Any of the foregoing could materially adversely affect our business, financial condition, results of operations, and prospects, as well as the market price of our common sharesNew
16litigation or other claims in connection with an acquired company, including claims from terminated employees, vendors, former shareholders or other third partiesNew
17Our failure to address these risks or other problems encountered in connection with acquisitions and investments could cause us to fail to realize the anticipated benefits of these acquisitions or investments, cause us to incur unanticipated liabilities, and harm our business generally96% rewritten
18Our international business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States21% rewritten
19regulatory and compliance risks that may fall within the purview of the U.S. Foreign Corrupt Practices Act, UK Bribery Act, anti-boycott laws and other anti-corruption laws
20The administration of our cell therapy product candidates requires surgical transplantation, which exposes us to additional regulatory, clinical, operational and commercial risks that could materially adversely affect our business, results of operations and prospectsNew
21Our business could be adversely affected if we lose the services of the key personnel upon whom we depend or if we fail to attract and retain senior management and key scientific personnel51% rewritten
22Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations81% rewritten
23Our ability to use our net operating losses and other tax attributes to offset future taxable income or taxes may be limited, which may effectively increase our future income tax obligations22% rewritten
24Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability
25Because a portion of our expenses are incurred in currencies other than the U.S. Dollar, our results of operations may be harmed by currency fluctuations64% rewritten

Risks Related to Government Regulation

26If we or our strategic collaborators are unable to obtain FDA or comparable foreign regulatory authority approvals for our product candidates on a timely basis, or at all, our product candidates may not be marketed or sold and our business will be substantially harmedNew
27the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders our clinical data insufficient for approval, including, for example, as a result of positive or negative data from third parties regarding other cell-based products or product candidatesNew
28Government-imposed bans or restrictions and religious, moral, and ethical concerns about the use of hES cells could prevent us from developing and successfully marketing stem cell products29% rewritten
29Our reliance on pluripotent cell lines that may be exempt from certain donor eligibility requirements could create regulatory, labeling, and commercialization constraints, and could require us to undertake additional steps that delay, limit, or prevent commercialization of one or more product candidatesNew
30Some of our product candidates, may be considered combination products by the FDA and other regulatory authorities, which could increase the complexity, cost and timeline for their development and regulatory approval
31If these third-party payors do not consider our products to be cost-effective compared to other therapies, they may not cover our products as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis37% rewritten
32additional clinical trials, which would be costly and time-consuming and delay or permanently halt our development of our product candidatesNew
33Legislation and legislative, executive and regulatory proposals intended to contain health care costs may adversely affect our business
34The ACA and future changes to that law may adversely affect our business
35created a licensure framework for follow on biologic products
36If we fail to comply with the extensive legal and regulatory requirements affecting the healthcare industry, we could face increased costs, penalties and loss of business
37Additionally, conditions and regulations governing the health care industry in the U.S. are subject to greater risk of change and uncertainty as a result of changes in legislative and regulatory priorities and personnel
38Even if we receive approval to market a product candidate, we may be subject to extensive post-approval regulatory obligations that may have a significant adverse effect on our business, results of operations, financial condition and reputation
39The FDA has granted orphan drug designation to OPC1 for the treatment of acute SCIs. However, there is no guarantee we will be able to maintain this designation, receive this designation for any other product candidate, or obtain the benefits associated with such designation, including marketing exclusivity83% rewritten
40orphan drug designation may include a waiver of the marketing application fee. However, the orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval processNew
41Regenerative Medicine Advanced Therapy designation may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that a product candidate will receive marketing approval
42Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent healthcare reform legislation has strengthened these laws

Risks Related to the Development and Clinical Testing of Our Product Candidates

43Clinical development of new therapeutic products is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome24% rewritten
44greater than anticipated cost of clinical studies of our product candidates88% rewritten
45If we or our collaborators experience delays or difficulties enrolling or retaining patients in clinical trials of our product candidates, our research and development efforts and business, financial condition, and results of operations could be materially adversely affectedNew
46the availability of, and clinicians’ and patients’ satisfaction with, existing and new therapies approved for the indication the clinical trial is investigatingNew
47For example, positive data from the Phase 1/2a clinical trial of OpRegen are not necessarily predictive of results that may be seen from the ongoing Phase 2a clinical trial of RG6501 (OpRegen) being conducted by Roche. We do not yet know how OpRegen will perform in that Phase 2a trial or future clinical trialsNew
48capabilities, we may need to rely on third parties to manufacture and supply any products we develop and there is no assurance that we would be able to identify third parties to whom we can transfer the production process and are capable of manufacturing our product candidates on acceptable terms or at allNew
49No assurances can be given that we will be able to continue to consistently manufacture clinical quantities of our product candidates in accordance with cGMP from a master and working cell bank system, or at a cost-effective or commercially viable scale, for one or more of our product candidatesNew
50Changes in or disruptions to our manufacturing operations could materially and adversely affect our business
51Emerging, unknown, or previously unidentified infectious agents could affect one or more of our foundational cell lines or cell banks, require abandonment of a cell line, and materially delay or halt development of all product candidates dependent on that lineNew
52Our cell lines, cell banks, and product candidates may be affected by contaminants associated with animal- or human-derived materials used historically during IVF, derivation, or early expansion, and there can be no assurance that all such contaminants can be identified, tested for, or ruled outNew
53without obvious signs, and sterility tests have inherent limitations, including the potential for false negatives and the inability to detect certain organisms or low-level contamination in all circumstancesNew

Risks Related to Commercialization of our Product Candidates

54The commercial success of any of our current or future product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payors, other healthcare providers and others in the medical community
55the pricing and availability of coverage and adequate reimbursement by third-party payors and government agencies
56If the market opportunities for our product candidates prove to be significantly smaller than we estimate, our business prospects may suffer
57decreased demand for any marketed products
58We currently have no marketing and sales force or distribution capabilities. If we are unable to establish effective internal capabilities or effectively collaborate with third parties to market and sell our product candidates, if approved, our ability to generate product revenue will suffer

Risks Related to our Intellectual Property

59Our intellectual property may be insufficient to protect our products23% rewritten
60we may not be successful in developing additional proprietary technologies that are patentable
61Confidentiality agreements with employees and third parties may not prevent disclosure of trade secrets and other proprietary information32% rewritten
62If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could limit opportunities for us to generate revenues by licensing our technology and selling products62% rewritten
63There is no certainty that our pending or future patent applications will result in the issuance of patents
64Intellectual property we may develop using grants received from governmental entities are subject to rights maintained by those governments
65We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business
66There is no certainty that we will be able to obtain licenses to intellectual property rights owned by third parties

Risks Related to our Dependence on Third Parties

67We may become dependent on possible future collaborations to develop and commercialize many of our product candidates and to provide the regulatory compliance, sales, marketing and distribution capabilities required for the success of our business69% rewritten
68We do not have the ability to independently conduct clinical trials required to obtain regulatory approvals for our product candidates and we rely on third parties over whom we have limited control to perform important clinical and preclinical development activities for us
69They or their third-party manufacturers may not perform as agreed, may terminate their agreements, or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute on a commercial scale, if approved
70They or their third-party manufacturers may not obtain or maintain intellectual property rights necessary for the development, manufacture and, if approved, commercialization of the systems or devices
71We may be subject to product liability exposure arising out of use of the systems or devices to administer our product candidates in clinical trials or, if approved, for commercial use, and our insurance may not cover all potential claims

Risks Related to Ownership of Our Common Shares

72The market price of our common shares has been and may continue to be volatile, and you could lose all or part of your investment
73other factors described in this Risk Factors section
74Because we do not intend to pay cash dividends, our common shares may not be a suitable investment for anyone who needs to earn dividend income
75Our largest shareholder, who is affiliated with a member of our board of directors, owns a significant percentage of our common shares and will be able to exert substantial influence over the election of directors and matters subject to shareholder approval, including potential change of control transactionsNew
76If we or our subsidiaries issue additional common shares or preferred shares, investors in our common shares may experience dilution of their ownership interests50% rewritten
77common shares. Our subsidiaries may also issue their own preferred shares with a similar impact on our ownership of the subsidiariesNew
78The issuance of common shares upon exercise of warrants would cause immediate and substantial dilution to existing shareholders
79Our business could be negatively affected as a result of actions of activist shareholders, and such activism could affect the trading value of our securities
80Securities analysts may not initiate coverage or continue to cover our common shares, and this may have a negative impact on the market price of our common shares82% rewritten
81The use of social media platforms present risks and challengesNew
82Failure of our internal control over financial reporting could harm our business and financial results
83Unfavorable macroeconomic conditions and wars or armed conflicts could have an adverse impact on our business, financial condition and results of operations, including our clinical trialsNew
84Adverse litigation judgments or settlements resulting from legal proceedings in which we may be involved could expose us to monetary damages or limit our ability to operate our business
85Our business could be materially and adversely affected in the future by the effects of a public health crisis
86refusal of the FDA to accept data from clinical trials in affected geographies
87Our business could be negatively impacted by environmental, social and corporate governance (“ESG”) matters or our reporting of such matters

Other Lineage Cell Therapeutics 10-Ks

FY2024 10-K risk factors
75 risks
Company is heavily reliant on Roche for OpRegen development and revenue.
Filed Mar 10, 2025

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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.