Decoy Therapeutics (DCOY) FY2025 10-K Risk Factors: 53 New, 33 Dropped

What the changes say

Nasdaq requires the company to regain its $1.00 bid-price compliance by March 20, 2026 or face delisting.
Auditors reported substantial doubt about continuity because cash will not fund the next 12 months, including planned DCOY-101 development.
The risk section now emphasizes preclinical drug development, continued losses, financing dependence, third-party execution and novel AI technology.
Merger-completion, ownership and transaction risks have been replaced by standalone operating and development risks.

What changed since the prior 10-K

New

NewRisks Related to our Business
Nasdaq may delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions
Nasdaq could delist the company unless its stock meets the $1.00 minimum bid-price requirement by March 20, 2026.
NewRisks Related to our Business
a decreased ability to issue additional securities or obtain additional financing in the future
A Nasdaq delisting could expose securities offerings to regulation in every state where the company offers securities.
NewRisks Related to our Business
Our financial condition raises substantial doubt regarding our ability to continue as a going concern
Cash is insufficient for the next 12 months, creating substantial doubt about continuity while the company pursues DCOY-101’s potential 2027 Phase 1 trial.
NewRisks Related to our Business
We have never generated revenue from product sales and all of our potential product candidates are currently in the pre-clinical stage, and we may continue to incur significant losses for the foreseeable future and never generate revenue from product sales
The preclinical pipeline has no product revenue, so substantial losses may continue for years while candidates undergo trials and FDA review.
NewRisks Related to our Business
Because we have yet to generate revenue from product sales on which to evaluate our potential for future success and to determine if we will be able to execute our business plan, it is difficult to evaluate our prospects and the likelihood of success or failure of our business
With no candidate in clinical trials or commercial revenue, investors have little evidence to evaluate the business plan or future success.
NewRisks Related to our Business
attracting, hiring and retaining qualified personnel
Unexpected studies, trials and commercialization costs could increase expenses, while revenue may still be insufficient to achieve profitability.
NewRisks Related to our Business
Because early-stage drug development requires major capital investment, as we continue to incur operating losses, we will need to raise additional capital or form strategic partnerships to support our research and development activities in the future
Advancing candidates into clinical trials will require substantial capital or partnerships, which may be unavailable, dilutive or constrained by supply and enrollment problems.
NewRisks Related to our Business
for new potential product candidates other than programs currently partnered. We will require additional capital to obtain regulatory approval for, and to commercialize, potential product candidates
Insufficient financing could force development delays, discontinued programs or earlier and less favorable strategic alliances.
NewRisks Related to our Business
relinquish or license on unfavorable terms, our rights to technologies or any potential product candidates we otherwise would seek to develop or commercialize ourselves
Funding shortfalls could force the company to license or relinquish technologies and candidates on unfavorable terms.
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
If any strategic alliances on which we depend are unsuccessful or are terminated, we may be unable to develop or commercialize certain potential product candidates and we may be unable to generate revenues from our development programs
Partners, vendors or data-service providers could shift priorities, fail performance requirements, terminate relationships or cease operations, disrupting development and revenue plans.
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
Since we expect to rely on third parties to conduct, supervise and monitor any future clinical trials, if those third parties fail to perform in a satisfactory manner and one that meets applicable regulatory, scientific and safety requirements, it may materially harm our business
CROs and clinical sites may mishandle future trials or violate FDA clinical-practice, data-integrity, safety and participant-protection requirements.
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
Because the approach we are taking to discover and develop drugs is novel, including the usage of AI, it may never lead to marketable products
The company’s unproven AI-enabled drug-discovery approach may fail to produce viable products as the underlying technology continues changing.
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
If we do not succeed in our efforts to identify or discover additional potential product candidates, your investment may be lost
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
we or our partners may change their development profiles for potential product candidates or abandon a therapeutic area
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
Because our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
years, and can vary substantially based on the type, complexity, and novelty of the potential product candidates involved. Our ability to generate revenue would be adversely affected if we are delayed or unable to successfully develop our products
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
If we are unable to successfully complete preclinical testing and clinical trials of our potential product candidates or experience significant delays in doing so, our business will be materially harmed
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
commercializing our products, if and when approved, whether alone or in collaboration with others
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
We may be unable to demonstrate safety and efficacy of our potential product candidates to the satisfaction of regulatory authorities, or we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our potential product candidates
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their potential product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for their products
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
delays by contract manufacturers in producing and delivering sufficient supply of clinical trial materials
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
Our potential product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
our reputation may suffer
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
Following regulatory approval for a product candidate, we will still face extensive regulatory requirements, and the approved product may face future development and regulatory difficulties
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
refuse to allow us to enter into supply contracts, including government contracts
NewRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
We have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain approvals for marketing our potential product candidates, including approval by the FDA
NewRisks Related to Our Operations and Industry
If we cannot obtain or protect intellectual property rights related to our future products and potential product candidates, we may not be able to compete effectively in our markets
NewRisks Related to Our Operations and Industry
If third-party intellectual property infringement claims are asserted against us, it may prevent or delay our development and commercialization efforts and have a material adverse effect on our business and future prospects
NewRisks Related to Our Operations and Industry
We may need to obtain additional licenses to intellectual property rights from third parties
NewRisks Related to Our Operations and Industry
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
NewRisks Related to Our Operations and Industry
Because we face significant competition from other biotechnology and pharmaceutical companies, our operating results will suffer if we fail to compete effectively
NewRisks Related to Our Operations and Industry
Our business could be negatively impacted by cybersecurity threats and other security threats and disruptions
NewRisks Related to Our Operations and Industry
damage our reputation with industry participants, existing or prospective strategic alliances, and the public generally
NewRisks Related to Our Operations and Industry
Failure of our information technology infrastructure to operate effectively could adversely affect our business
NewRisks Related to Our Operations and Industry
The commercial success of our potential product candidates will depend upon the acceptance of these potential product candidates by the medical community, including physicians, patients and healthcare payors
NewRisks Related to Our Operations and Industry
If we obtain regulatory approval for one product candidate, we expect sales to generate substantially all of our product revenues, and as such, the failure of such product to find market acceptance would adversely affect our results of operations
NewRisks Related to Our Operations and Industry
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our potential product candidates, we may be unable to generate any revenues from product sales
NewRisks Related to Our Operations and Industry
If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business
NewRisks Related to Our Operations and Industry
If we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience increases in our compensation costs, our business may materially suffer
NewRisks Related to Our Operations and Industry
Because we will face potential product liability as we further develop potential product candidates and more so if we can commercialize any product candidate, if claims are brought against us, we may incur substantial liability and costs
NewRisks Related to Our Operations and Industry
decreased demand for our potential product candidates, if approved for commercial sale
NewRisks Related to Our Operations and Industry
If we fail to comply with applicable laws and regulations, including 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 our business
NewRisks Related to Our Operations and Industry
Our ability to use our net operating losses and tax credits to offset future taxable income and income tax liabilities may be limited
NewRisks Related to Our Operations and Industry
Business interruptions resulting from natural disasters and adverse weather events could cause delays in research and development of our potential product candidates
NewRisks Related to Ownership of our Common Stock
The price of our common stock may fluctuate substantially
NewRisks Related to Ownership of our Common Stock
other events or factors, many of which may be out of our control
NewRisks Related to Ownership of our Common Stock
If we were deemed to be an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”), applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business, financial condition and results of operations
NewRisks Related to Ownership of our Common Stock
We are a “smaller reporting company” and are able to avail ourselves of reduced disclosure requirements applicable to smaller reporting companies, which could make our common stock less attractive to investors
NewRisks Related to Ownership of our Common Stock
Our certificate of incorporation, our bylaws, and Delaware law may have anti-takeover effects that could discourage, delay, or prevent a change in control, which may cause our stock price to decline
NewRisks Related to Ownership of our Common Stock
Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management is required to devote substantial time to compliance matters
NewRisks Related to Ownership of our Common Stock
If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline
NewRisks Related to Ownership of our Common Stock
Changes in tax laws or exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition and cash flows
NewRisks Related to Ownership of our Common Stock
Additional indirect taxes in various jurisdictions could materially adversely affect our business, financial condition, results of operations, and prospects

Dropped

DroppedRisks Related to the Merger
The Merger may be completed even though certain events occur prior to Merger Closing that materially and adversely affect Salarius
Merger closing despite adverse pre-closing events affecting Salarius.
DroppedRisks Related to the Merger
If adverse changes occur and Salarius and Decoy still complete the Merger, the market price of the combined company’s common stock may suffer. This in turn may reduce the value of the Merger to the stockholders of Salarius
Adverse changes and merger effects reducing the combined company’s stock price and merger value.
DroppedRisks Related to the Merger
$100,000 for every $100,000 below the threshold. To the extent the Company Cash Amount falls below $2.0 million, Decoy’s assumed value would be reduced by $100,000 for every $100,000 below the threshold
Cash below thresholds reducing Decoy’s assumed value and increasing dilution for Salarius stockholders.
DroppedRisks Related to the Merger
Stockholders of the combined company may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger and the Qualified Financing
Combined-company benefits failing to justify ownership dilution from the merger and financing.
DroppedRisks Related to the Merger
During the pendency of the Merger, Salarius may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect its business
Merger restrictions preventing Salarius from pursuing other favorable business combinations.
DroppedRisks Related to the Merger
Certain provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement
Merger provisions discouraging superior alternative takeover proposals.
DroppedRisks Related to the Merger
Because the lack of a public market for Decoy’s capital stock makes it difficult to evaluate the value of Decoy’s capital stock, the stockholders of Decoy may receive shares of Salarius common stock in the Merger that have a value that is greater than, the fair market value of Decoy’s capital stock
Decoy’s private valuation potentially causing Salarius to overpay with merger shares.
DroppedRisks Related to the Merger
The Merger Agreement between Salarius and Decoy may be terminated in accordance with its terms and the Merger may not be completed
DroppedRisks Related to the Merger
Salarius may not be able to effect the Merger pursuant to the Merger Agreement, and failure to complete the Merger would negatively impact Salarius’ stock price and materially adversely impact the future business and financial results of the Salarius
Merger agreement termination or failure to satisfy closing conditions.
DroppedRisks Related to the Merger
The market price of Salarius’ common stock following the Merger may decline as a result of the Merger
Merger failure, transaction costs and resulting harm to Salarius’ stock price and business.
DroppedRisks Related to the Merger
Salarius and Decoy securityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the Merger Closing as compared to their current ownership and voting interest in the respective companies
Combined-company stock-price decline following the merger.
DroppedRisks Related to the Merger
The combined company will need to raise additional capital by issuing securities or debt or through licensing or other strategic arrangements, which may cause dilution to the combined company’s stockholders or restrict the combined company's operations or impact its proprietary rights
Reduced ownership and voting influence after merger share issuance.
DroppedRisks Related to our Financial Position and Capital Needs
Salarius’ common stock may be subject to delisting from Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital or complete a strategic transaction
Combined company’s future capital raising causing dilution, operating restrictions or effects on proprietary rights.
DroppedRisks Related to our Financial Position and Capital Needs
listed securities is below $35 million. As a result, Salarius is not in compliance with the Stockholders’ Equity Requirement and expects to receive a delisting notice from Nasdaq
DroppedRisks Related to our Financial Position and Capital Needs
Salarius is substantially dependent on its remaining employees and consultants to facilitate the consummation of the Merger
DroppedRisks Related to our Financial Position and Capital Needs
The pendency of the Merger could have an adverse effect on the trading price of Salarius’ common stock and its business, financial condition and prospects
DroppedRisks Related to our Financial Position and Capital Needs
Salarius has never generated any revenue from product sales and may never generate revenue or be profitable
DroppedRisks Related to the Development of Salarius’ Product Candidates
The approach Salarius has taken to discover and develop novel oncology therapeutics using epigenetic enzymes to moderate transcription factors and thereby control abnormal protein expression is unproven and may never lead to marketable products
DroppedRisks Related to the Development of Salarius’ Product Candidates
Clinical trials are costly, time consuming and inherently risky, and may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities
DroppedRisks Related to the Development of Salarius’ Product Candidates
Salarius’ product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any
DroppedRisks Related to the Development of Salarius’ Product Candidates
Product development involves a lengthy and expensive process with an uncertain outcome, and results of earlier pre-clinical and clinical trials may not be predictive of future clinical trial results
DroppedRisks Related to the Development of Salarius’ Product Candidates
Difficulty in enrolling patients is a common hurdle faced by early stage biotechnology companies and could, and often does, delay or prevent clinical trials of product candidates
DroppedRisks Related to the Development of Salarius’ Product Candidates
Salarius may face potential product liability, and, if successful claims are brought against Salarius, Salarius may incur substantial liability and costs which could be greater than Salarius’ insurance coverage or overall resources
DroppedRisks Related to Regulatory Approval of Salarius’ Product Candidates and Other Legal Compliance Matters
regulatory agencies in the United States and foreign jurisdictions. Failure to obtain marketing approval for Salarius’ product candidates will prevent Salarius from commercializing them in those markets
DroppedRisks Related to Salarius’ Intellectual Property
Salarius intends to rely on patent rights for Salarius’ product candidates and any future product candidates. If Salarius is unable to obtain or maintain exclusivity from the combination of these approaches, Salarius may not be able to compete effectively in Salarius’ markets
DroppedRisks Related to Salarius’ Intellectual Property
intellectual property protection in the United States and in other countries with respect to Salarius’ proprietary technology and products
DroppedRisks Related to Salarius’ Intellectual Property
Salarius may not have sufficient patent term protections for Salarius’ product candidates to effectively protect Salarius’ business
DroppedRisks Related to Salarius’ Intellectual Property
exclusivity to protect Salarius’ product candidates, Salarius’ business and results of operations will be adversely affected
DroppedRisks Related to Salarius’ Intellectual Property
If Salarius is unable to maintain effective proprietary rights for Salarius’ product candidates or any future product candidates, Salarius may not be able to compete effectively in Salarius’ proposed markets
DroppedRisks Related to Salarius’ Intellectual Property
Salarius’ commercial success depends in part on Salarius’ ability to develop, manufacture, market and sell Salarius’ product candidates and use Salarius’ proprietary technology without infringing the patent rights of third parties
DroppedRisks Related to Salarius’ Intellectual Property
Salarius may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property rights from third parties that Salarius identifies as necessary for Salarius’ product candidates
DroppedRisks Related to Salarius’ Intellectual Property
Salarius may not be able to protect Salarius’ intellectual property rights throughout the world
DroppedRisks Related to Our Common Stock
Failure in our information technology and storage systems could significantly disrupt the operation of our business and/or lead to potential large liabilities

Reworded

100% rewrittenRisks Related to Our Operations and Industry
We may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful
The risk now covers Decoy’s and licensors’ patents, potential infringement defenses, adverse validity rulings and patent applications failing to issue.
Was: Salarius may be involved in lawsuits to protect or enforce Salarius’ patents or the patents of Salarius’ licensors, which could be expensive, time consuming, and unsuccessful
90% rewrittenRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
We may not succeed in obtaining or maintaining necessary rights to drug compounds and processes for our development pipeline through acquisitions and in-licenses
The risk removes Salarius’ specific epigenetic-target details and adds competition from larger companies and unfavorable licensing economics.
Was: Salarius may not be successful in obtaining or maintaining necessary rights to Salarius’ targets, product compounds and processes for Salarius’ development pipeline through acquisitions and in-licenses
80% rewrittenRisks Related to the Discovery , Development and Commercialization of Potential Product Candidates
Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our potential product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation
The risk now omits Salarius’ SP-2577 fast-track designation and focuses generally on FDA discretion and rescission of breakthrough status.
Was: Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if Salarius believes one of Salarius’ product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation
54% rewrittenRisks Related to Ownership of our Common Stock
Future sales of a significant number of our shares of common stock in the public markets, or the perception that such sales could occur, could depress the market price of our shares of our common stock or cause our stock price to decline
The risk shifts from public-market sales and warrant exercises to future equity or convertible offerings causing dilution and superior investor rights.
41% rewrittenRisks Related to our Business
We may become involved in securities class action litigation that could divert management’s attention and harm our business and insurance coverage may not be sufficient to cover all costs and damages
The risk changes from merger-related combined-company litigation to securities or shareholder litigation affecting the current business; insurance shortfall language is no longer stated.
Was: The combined company may become involved in securities class action litigation that could divert management’s attention and harm the combined company’s business and insurance coverage may not be sufficient to cover all costs and damages

All 59 risk factors

Headings as the filing states them, in filing order.

Risks Related to our Business

01Nasdaq may delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictionsNew
02a decreased ability to issue additional securities or obtain additional financing in the futureNew
03Our financial condition raises substantial doubt regarding our ability to continue as a going concernNew
04We have never generated revenue from product sales and all of our potential product candidates are currently in the pre-clinical stage, and we may continue to incur significant losses for the foreseeable future and never generate revenue from product salesNew
05Because we have yet to generate revenue from product sales on which to evaluate our potential for future success and to determine if we will be able to execute our business plan, it is difficult to evaluate our prospects and the likelihood of success or failure of our businessNew
06attracting, hiring and retaining qualified personnelNew
07Because early-stage drug development requires major capital investment, as we continue to incur operating losses, we will need to raise additional capital or form strategic partnerships to support our research and development activities in the futureNew
08for new potential product candidates other than programs currently partnered. We will require additional capital to obtain regulatory approval for, and to commercialize, potential product candidatesNew
09relinquish or license on unfavorable terms, our rights to technologies or any potential product candidates we otherwise would seek to develop or commercialize ourselvesNew
10We may become involved in securities class action litigation that could divert management’s attention and harm our business and insurance coverage may not be sufficient to cover all costs and damages41% rewritten

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

11If any strategic alliances on which we depend are unsuccessful or are terminated, we may be unable to develop or commercialize certain potential product candidates and we may be unable to generate revenues from our development programsNew
12Since we expect to rely on third parties to conduct, supervise and monitor any future clinical trials, if those third parties fail to perform in a satisfactory manner and one that meets applicable regulatory, scientific and safety requirements, it may materially harm our businessNew
13Because the approach we are taking to discover and develop drugs is novel, including the usage of AI, it may never lead to marketable productsNew
14If we do not succeed in our efforts to identify or discover additional potential product candidates, your investment may be lostNew
15we or our partners may change their development profiles for potential product candidates or abandon a therapeutic areaNew
16Because our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvalsNew
17years, and can vary substantially based on the type, complexity, and novelty of the potential product candidates involved. Our ability to generate revenue would be adversely affected if we are delayed or unable to successfully develop our productsNew
18If we are unable to successfully complete preclinical testing and clinical trials of our potential product candidates or experience significant delays in doing so, our business will be materially harmedNew
19commercializing our products, if and when approved, whether alone or in collaboration with othersNew
20We may be unable to demonstrate safety and efficacy of our potential product candidates to the satisfaction of regulatory authorities, or we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our potential product candidatesNew
21preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their potential product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for their productsNew
22delays by contract manufacturers in producing and delivering sufficient supply of clinical trial materialsNew
23Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our potential product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation80% rewritten
24Our potential product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptanceNew
25our reputation may sufferNew
26Following regulatory approval for a product candidate, we will still face extensive regulatory requirements, and the approved product may face future development and regulatory difficultiesNew
27refuse to allow us to enter into supply contracts, including government contractsNew
28We may not succeed in obtaining or maintaining necessary rights to drug compounds and processes for our development pipeline through acquisitions and in-licenses90% rewritten
29We have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain approvals for marketing our potential product candidates, including approval by the FDANew

Risks Related to Our Operations and Industry

30If we cannot obtain or protect intellectual property rights related to our future products and potential product candidates, we may not be able to compete effectively in our marketsNew
31If third-party intellectual property infringement claims are asserted against us, it may prevent or delay our development and commercialization efforts and have a material adverse effect on our business and future prospectsNew
32We may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful100% rewritten
33We may need to obtain additional licenses to intellectual property rights from third partiesNew
34We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third partiesNew
35Because we face significant competition from other biotechnology and pharmaceutical companies, our operating results will suffer if we fail to compete effectivelyNew
36Our business could be negatively impacted by cybersecurity threats and other security threats and disruptionsNew
37damage our reputation with industry participants, existing or prospective strategic alliances, and the public generallyNew
38Failure of our information technology infrastructure to operate effectively could adversely affect our businessNew
39The commercial success of our potential product candidates will depend upon the acceptance of these potential product candidates by the medical community, including physicians, patients and healthcare payorsNew
40If we obtain regulatory approval for one product candidate, we expect sales to generate substantially all of our product revenues, and as such, the failure of such product to find market acceptance would adversely affect our results of operationsNew
41If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our potential product candidates, we may be unable to generate any revenues from product salesNew
42If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our businessNew
43If we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience increases in our compensation costs, our business may materially sufferNew
44Because we will face potential product liability as we further develop potential product candidates and more so if we can commercialize any product candidate, if claims are brought against us, we may incur substantial liability and costsNew
45decreased demand for our potential product candidates, if approved for commercial saleNew
46If we fail to comply with applicable laws and regulations, including 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 our businessNew
47Our ability to use our net operating losses and tax credits to offset future taxable income and income tax liabilities may be limitedNew
48Business interruptions resulting from natural disasters and adverse weather events could cause delays in research and development of our potential product candidatesNew

Risks Related to Ownership of our Common Stock

49The price of our common stock may fluctuate substantiallyNew
50other events or factors, many of which may be out of our controlNew
51Future sales of a significant number of our shares of common stock in the public markets, or the perception that such sales could occur, could depress the market price of our shares of our common stock or cause our stock price to decline54% rewritten
52We do not currently intend to pay dividends on our common stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock
53If we were deemed to be an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”), applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business, financial condition and results of operationsNew
54We are a “smaller reporting company” and are able to avail ourselves of reduced disclosure requirements applicable to smaller reporting companies, which could make our common stock less attractive to investorsNew
55Our certificate of incorporation, our bylaws, and Delaware law may have anti-takeover effects that could discourage, delay, or prevent a change in control, which may cause our stock price to declineNew
56Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management is required to devote substantial time to compliance mattersNew
57If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may declineNew
58Changes in tax laws or exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition and cash flowsNew
59Additional indirect taxes in various jurisdictions could materially adversely affect our business, financial condition, results of operations, and prospectsNew

Other Decoy Therapeutics 10-Ks

FY2024 10-K risk factors
39 risks
Decoy Therapeutics faces primary risks centered on its pending merger with Salarius, including potential cash shortfalls and Nasdaq delisting. The company relies entirely on unproven oncology therapeutics without commercial revenue or funds for clinical trials.
Filed Mar 21, 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.