Cue Biopharma (CUE) FY2025 10-K Risk Factors: 16 New, 10 Dropped

What the changes say

Cue Biopharma prioritized autoimmune programs, licensing CUE-501 to BI and CUE-100 series to IMSCP.
The company terminated collaborations with Ono and LG Chem for certain programs.
Nasdaq issued a deficiency letter in May 2025 regarding minimum bid price requirements.

What changed since the prior 10-K

New

NewRisks Related to Our Business
regulatory approvals for any drug product candidates in the United States or any foreign market. Therefore, any estimated timing for our drug product candidates to be commercialized would be highly speculative
Substantial funding and regulatory compliance are required to commercialize any drug product candidates based on our Albert Einstein College of Medicine license.
NewRisks Related to Our Business
We are substantially dependent on the success of our drug product candidates, and significant additional research and development and clinical testing will be required before we can potentially seek regulatory approval for or commercialize any of our drug product candidates
Our preclinical candidates like CUE-401 and CUE-501 require significant additional clinical testing and FDA approval before commercialization.
NewRisks Related to Our Business
to make payments to us that include licensing fees, milestone payments and sales royalties. This agreement does not commit LG Chem to a long-term relationship, and LG Chem may disengage with us at any time
We terminated our Ono collaboration for CUE-401 and regained rights from LG Chem for CUE-101, exposing us to independent development costs.
NewRisks Related to Our Business
In July 2024, we determined to prioritize and strategically focus on our autoimmune programs, including CUE-401 and CUE-501
We granted BI an exclusive worldwide license to develop CUE-501 and other B cell depletion molecules during a four-year research term.
NewRisks Related to Our Business
collaborations, to develop our drug product candidates, the costs for us to independently develop our drug product candidates may be higher than we currently anticipate, which could materially harm our business prospects, financial condition and results of operation
Collaborators have broad discretion and may deprioritize, delay, or abandon our drug product candidates based on their own strategic focus.
NewRisks Related to Our Business
These restrictions on our development, manufacturing, and commercialization activities could impact our ability to successfully develop certain drug product candidates, which could harm our future business prospects for commercializing drugs for those drug product candidates
Limited capital forces us to prioritize certain drug product candidates, and wrong prioritization decisions could harm our business prospects.
NewRisks Related to Our Business
In July 2024, we decided to strategically focus on our autoimmune programs, including CUE-401 and CUE-501
Research programs to identify new drug product candidates and additional indications require substantial resources and may ultimately fail.
NewRisks Related to Our Business
Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results
New 2025 U.S. tariffs, executive orders, and retaliatory measures from China and Canada create trade policy uncertainties.
NewRisks Related to Our Business
July 24, 2026. For those countries that have concluded trade deals with the United States, the tariff rates agreed to – including with regard to pharmaceuticals and pharmaceutical ingredients – have now reverted to 10% until July 24, 2026
Agreed tariff rates have reverted to 10% until July 2026, and pending Section 301 investigations may introduce additional tariffs.
NewRisks Related to Our Business
Neither the Supreme Court’s decision nor the Executive Order revoking the IEEPA tariffs addressed refunds, leaving the issue to renewed proceedings before the U.S. Court of International Trade, where importers may need to pursue administrative remedies and/or litigation amid continued uncertainty
Imported branded or patented drugs face a 100% tariff unless pharmaceutical manufacturing facilities are built in the U.S.
NewRisks Related to Our Business
Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition
The Inflation Reduction Act and the One Big Beautiful Bill Act introduce new tax provisions and a one percent stock repurchase excise tax.
NewRisks Related to Government Regulation
Trials Regulation (Regulation EU No 536/2014). Since the UK left the EU prior to the date on which the EU CTR took effect, the UK legal framework did not benefit from the same revisions as occurred at EU level
Post-Brexit UK regulations establish a new international recognition procedure with unclear functioning that could delay UK approvals.
NewRisks Related to Government Regulation
that our employees will comply with company policies and applicable regulations regarding the promotion of products for unapproved uses
NewRisks Related to Government Regulation
While the FDA’s review of marketing applications and other activities for new drugs and biologics is largely funded
NewRisks Related to Government Regulation
significant coverage barriers, or refusing to cover these products outright, arguing that accelerated approval drugs have insufficient or limited evidence despite meeting the FDA’s standards for accelerated approval
NewRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
Thereafter, on November 11, 2025, we received a written notice from the Staff granting us an additional 180 calendar day compliance period (until May 11, 2026), or the Second Compliance Period, to regain compliance with the Minimum Bid Requirement

Dropped

DroppedRisks Related to Our Business
regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug product candidates
DroppedRisks Related to Our Business
We may not be successful in our efforts to identify additional drug product candidates. Due to our limited resources and access to capital, we must prioritize the development of certain drug product candidates; these decisions may prove to be wrong and may adversely affect our business
DroppedRisks Related to Our Business
success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities
DroppedRisks Related to Our Business
no assurance that we could find satisfactory replacements for our current and future key scientific and management employees on terms that would not be unduly expensive or burdensome to us
DroppedRisks Related to Government Regulation
approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product
DroppedRisks Related to Government Regulation
individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects
DroppedRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
We hold a portion of our cash and cash equivalents that we use to meet our working capital and operating expense needs in deposit accounts, and our liquidity and operations could be adversely affected if a financial institution holding such funds fails
Adverse clinical side effects could hinder patient recruitment and force us to abandon trials.
DroppedRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
We have a loan agreement that requires us to meet certain operating covenants and place restrictions on our operating and financial flexibility
DroppedRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
negative pledge, and certain other customary exclusions. Because of the security interest, SVB’s rights to repayment from a liquidation of the assets subject to that security interest would be senior to the rights of other creditors
DroppedRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
than 4.99% of our outstanding common stock immediately after exercise, which limitation we refer to as the November 2022 Beneficial Ownership Limitation. The holders may increase or decrease their November 2022 Beneficial Ownership Limitation to a percentage not in excess of 19.99% by giving notice to us

Reworded

95% rewrittenRisks Related to Government Regulation
Any regulatory approval to market our products will be limited by indication. If we fail to comply or are found to be in violation of FDA regulations restricting the promotion of our products for unapproved uses, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards
Added a concluding statement noting uncertainty regarding off-label promotion enforcement.
93% rewrittenRisks Related to Our Business
We plan to continue to seek collaborations or strategic alliances. However, we may not be able to establish such relationships, and relationships we have established may not provide the expected benefits
Updated to reflect the March 2025 termination of the LG Chem CUE-101 rights.
91% rewrittenRisks Related to Our Business
rapid technological change may make our technology and drug product candidates obsolete
Updated to detail the April 2025 BI license for CUE-501 and November 2025 IMSCP license for CUE-101 and CUE-102.
91% rewrittenRisks Related to Our Business
We currently do not have, and may never develop, any FDA-approved or commercialized products
Removed mention of Einstein license foundation and future capital investment details.
81% rewrittenRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
If we fail to regain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price and liquidity of our common stock and our ability to access the capital markets could be negatively impacted
Added specifics about receiving a Nasdaq deficiency letter on May 12, 2025 regarding the minimum bid price.
Was: If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
73% rewrittenRisks Related to Government Regulation
change their approval policies or adopt new regulations
Retained substantially similar text regarding foreign regulatory policies and clinical trial requirements.
71% rewrittenRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
In addition, we have filed registration statements registering all shares of common stock that we may issue under our equity compensation plans. These shares can be freely sold in the public market upon issuance, subject to black-out periods and volume limitations applicable to affiliates
Added specific figures for common stock and pre-funded warrants issued in the November 2022 private placement.
62% rewrittenRisks Related to Government Regulation
Failure to obtain marketing approval in foreign jurisdictions would prevent any of our drug product candidates from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue
Retained the risk description regarding foreign marketing approvals and reimbursement hurdles.
59% rewrittenRisks Related to Our Business
Our collaboration agreements with each of LG Chem and BI contain exclusivity provisions that restrict our research and development activities
Was: Our collaboration agreement with LG Chem contains exclusivity provisions that restrict our research and development activities
57% rewrittenRisks Related to Our Business
If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to identify and develop new or next generation drug product candidates will be impaired, could result in loss of markets or market share and could make us less competitive
53% rewrittenRisks Related to Government Regulation
The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if approved
47% rewrittenRisks Related to Government Regulation
We may seek orphan drug designation for one or more of our drug product candidates, but even if such designation is granted, we may be unable to maintain any benefits associated with orphan drug designation, including market exclusivity that prevents the FDA or the EMA from approving other competing products
40% rewrittenRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
If a significant number of our total outstanding shares are sold into the market, the market price of our common stock could drop significantly, even if our business is performing well
40% rewrittenRisks Related to Government Regulation
the protection of computing systems maintaining electronic PHI
39% rewrittenRisks Related to Our Business
Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern
39% rewrittenRisks Related to Our Business
varying interpretations of data by the FDA and foreign regulatory authorities
37% rewrittenRisks Related to Our Reliance on Third Parties
We rely on certain sole or limited sources of supply for our drug product candidates and disruptions in the chain of supply have in the past, and may in the future, cause delays in developing, obtaining approval for, and commercializing our drug product candidates
32% rewrittenRisks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights
26% rewrittenRisks Related to Our Business
We are a clinical-stage biopharmaceutical company, have no history of generating commercial revenue, have a history of operating losses and may never achieve or maintain profitability

All 74 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business

01Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern39% rewritten
02We are a clinical-stage biopharmaceutical company, have no history of generating commercial revenue, have a history of operating losses and may never achieve or maintain profitability26% rewritten
03We currently do not have, and may never develop, any FDA-approved or commercialized products91% rewritten
04regulatory approvals for any drug product candidates in the United States or any foreign market. Therefore, any estimated timing for our drug product candidates to be commercialized would be highly speculativeNew
05rapid technological change may make our technology and drug product candidates obsolete91% rewritten
06We are substantially dependent on the success of our drug product candidates, and significant additional research and development and clinical testing will be required before we can potentially seek regulatory approval for or commercialize any of our drug product candidatesNew
07We have limited experience in conducting clinical trials and no history of commercializing biologic products, which may make it difficult to evaluate the prospects for our future viability
08varying interpretations of data by the FDA and foreign regulatory authorities39% rewritten
09Success in preclinical studies or early clinical trials may not be indicative of results obtained in later trials
10We plan to continue to seek collaborations or strategic alliances. However, we may not be able to establish such relationships, and relationships we have established may not provide the expected benefits93% rewritten
11to make payments to us that include licensing fees, milestone payments and sales royalties. This agreement does not commit LG Chem to a long-term relationship, and LG Chem may disengage with us at any timeNew
12In July 2024, we determined to prioritize and strategically focus on our autoimmune programs, including CUE-401 and CUE-501New
13collaborations, to develop our drug product candidates, the costs for us to independently develop our drug product candidates may be higher than we currently anticipate, which could materially harm our business prospects, financial condition and results of operationNew
14our collaborators may own or co-own intellectual property covering our potential products that results from our collaboration with them, and in such case, we would not have the exclusive right to commercialize such intellectual property without our collaborators’ involvement and consent
15Our collaboration agreements with each of LG Chem and BI contain exclusivity provisions that restrict our research and development activities59% rewritten
16These restrictions on our development, manufacturing, and commercialization activities could impact our ability to successfully develop certain drug product candidates, which could harm our future business prospects for commercializing drugs for those drug product candidatesNew
17In July 2024, we decided to strategically focus on our autoimmune programs, including CUE-401 and CUE-501New
18We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results than our drug product candidates
19If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to identify and develop new or next generation drug product candidates will be impaired, could result in loss of markets or market share and could make us less competitive57% rewritten
20Our internal computer systems, or those used by third-party CROs, manufacturers or other contractors or consultants, may fail or suffer security breaches
21Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating resultsNew
22July 24, 2026. For those countries that have concluded trade deals with the United States, the tariff rates agreed to – including with regard to pharmaceuticals and pharmaceutical ingredients – have now reverted to 10% until July 24, 2026New
23Neither the Supreme Court’s decision nor the Executive Order revoking the IEEPA tariffs addressed refunds, leaving the issue to renewed proceedings before the U.S. Court of International Trade, where importers may need to pursue administrative remedies and/or litigation amid continued uncertaintyNew
24Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial conditionNew
25War, terrorism, other acts of violence, or natural or manmade disasters may affect the markets in which we operate, our patients and resources required in our research and development activities

Risks Related to Our Reliance on Third Parties

26We rely completely on third parties to manufacture our preclinical and clinical drug supplies for our drug product candidates
27We rely on certain sole or limited sources of supply for our drug product candidates and disruptions in the chain of supply have in the past, and may in the future, cause delays in developing, obtaining approval for, and commercializing our drug product candidates37% rewritten

Risks Related to Intellectual Property and Other Legal Matters

28If we or our licensor(s) are unable to protect our or its intellectual property, then our financial condition, results of operations and the value of our technology and potential products could be adversely affected
29If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and potential products could be adversely affected
30If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are important to our business
31If we are unable to patent and protect the intellectual property used in our potential products, others may be able to copy our innovations, which may impair our ability to compete effectively in our markets
32If we are the target of claims by third parties asserting that our potential products or intellectual property infringe upon the rights of others, we may be forced to incur substantial expenses or divert substantial employee resources from our business
33Patent terms may be inadequate to protect our competitive position on our drug product candidates for an adequate amount of time
34If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug product candidates
35the inability to commercialize any product candidate

Risks Related to Government Regulation

36We are subject to regulation in respect of our research and federal funding
37Failure to obtain marketing approval in foreign jurisdictions would prevent any of our drug product candidates from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue62% rewritten
38Trials Regulation (Regulation EU No 536/2014). Since the UK left the EU prior to the date on which the EU CTR took effect, the UK legal framework did not benefit from the same revisions as occurred at EU levelNew
39We may seek orphan drug designation for one or more of our drug product candidates, but even if such designation is granted, we may be unable to maintain any benefits associated with orphan drug designation, including market exclusivity that prevents the FDA or the EMA from approving other competing products47% rewritten
40If approved, our drug product candidates that are licensed and regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
41We may in the future conduct clinical trials for certain of our drug product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations and the conduct of trials outside the United States could subject us to additional delays and expense
42To obtain the necessary approval of our potential products, as a precondition, we will need to conduct various preclinical and clinical tests, all of which will be costly and time consuming, and may not provide results that will allow us to seek regulatory approval
43change their approval policies or adopt new regulations73% rewritten
44issue injunctions or impose civil or criminal penalties
45Any regulatory approval to market our products will be limited by indication. If we fail to comply or are found to be in violation of FDA regulations restricting the promotion of our products for unapproved uses, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards95% rewritten
46that our employees will comply with company policies and applicable regulations regarding the promotion of products for unapproved usesNew
47While the FDA’s review of marketing applications and other activities for new drugs and biologics is largely fundedNew
48If commercial third-party payors or government payors fail to provide coverage or adequate reimbursement, our revenue and prospects for profitability would be harmed
49Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug product candidates and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictions
50The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if approved53% rewritten
51significant coverage barriers, or refusing to cover these products outright, arguing that accelerated approval drugs have insufficient or limited evidence despite meeting the FDA’s standards for accelerated approvalNew
52Compliance with the HIPAA security, privacy and breach notification regulations may increase our costs
53the protection of computing systems maintaining electronic PHI40% rewritten
54Our employees, principal investigators, consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
55Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain drug product candidates outside of the United States and require us to develop and implement costly compliance programs
56If 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

Risks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock

57We anticipate future losses and negative cash flow, and it is uncertain if or when we will become profitable
58the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights32% rewritten
59We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
60Our stock price can be volatile and fluctuate significantly, and our stockholders may have difficulty selling their shares and/or suffer substantial losses
61general economic and market conditions, including recent adverse changes in the domestic and international financial markets, the impacts of inflation and the implementation of trade barriers and tariffs and government action in response thereto
62If we fail to regain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price and liquidity of our common stock and our ability to access the capital markets could be negatively impacted81% rewritten
63Thereafter, on November 11, 2025, we received a written notice from the Staff granting us an additional 180 calendar day compliance period (until May 11, 2026), or the Second Compliance Period, to regain compliance with the Minimum Bid RequirementNew
64We may be subject to securities litigation, which is expensive and could divert management attention
65If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, the price of our securities and trading volume could decline
66We have not paid dividends in the past and have no immediate plans to pay dividends
67Our ability to use net operating loss carryforwards and research and development tax credits to reduce future tax payments may be limited or restricted
68We incur significant costs as a result of being a public company and our management is required to devote substantial time to meet compliance obligations
69Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable
70provide that the Court of Chancery of the State of Delaware will be the exclusive forum for certain legal claims
71The choice of forum provisions will not apply to claims arising under the Securities Act of 1933, as amended, or the Securities Act, the Exchange Act, or any other claim for which federal courts have exclusive jurisdiction
72If we are unable to implement and maintain effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our securities may decrease
73If a significant number of our total outstanding shares are sold into the market, the market price of our common stock could drop significantly, even if our business is performing well40% rewritten
74In addition, we have filed registration statements registering all shares of common stock that we may issue under our equity compensation plans. These shares can be freely sold in the public market upon issuance, subject to black-out periods and volume limitations applicable to affiliates71% rewritten

Other Cue Biopharma 10-Ks

FY2024 10-K risk factors
68 risks
Cue Biopharma faces severe going concern doubts with $22.5 million in cash and an accumulated deficit of $340.9 million as of December 31, 2024. The company prioritizes preclinical autoimmune programs like CUE-401 and CUE-501 while seeking external partners for the CUE-100 and CUE-500 series.
Filed Mar 31, 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.