Avalo Therapeutics (AVTX) FY2025 10-K Risk Factors: 23 New, 15 Dropped

What the changes say

Avalo Therapeutics highlights heavy concentration on lead candidate abdakibart (AVTX-009).
Financial runway depends on cash reserves dropping to $98.3 million.
Regulatory risks emphasize reliance on third-party CROs and potential government agency slowdowns.

What changed since the prior 10-K

New

NewRisks Related to Our Financial Position and Capital Needs
We may never achieve or sustain profitability
We may never achieve profitability because developing biopharmaceutical products requires successful clinical trials, regulatory approvals, and commercialization.
NewRisks Related to Our Financial Position and Capital Needs
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
Raising additional capital without committed external funding sources may dilute stockholders, restrict operations, or force us to relinquish technology rights.
NewRisks Related to Our Financial Position and Capital Needs
In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income would decrease. Interest rate fluctuations can negatively impact the returns on our fixed-income investments, particularly during periods of rising interest rates
Declining interest rates, fixed-income losses, or bank failures exceeding insurance limits could reduce our interest income and liquidity.
NewRisks Related to Development of Our Product Candidates
abdakibart (AVTX-009). In October 2024 we announced the first patient enrolled in our global Phase 2 LOTUS clinical trial and in October 2025 we announced that we completed enrollment
Our lead candidate abdakibart (AVTX-009) completed enrollment in its Phase 2 LOTUS trial but requires extensive future development and regulatory approval.
NewRisks Related to Development of Our Product Candidates
and may not achieve or sustain profitability, which could materially and adversely affect our business, financial condition, results of operations, and prospects
Concentrating our limited resources on abdakibart (AVTX-009) increases our risk if we fail to prioritize more profitable product candidates.
NewRisks Related to Regulatory Approval of Our Product Candidates
government funding of the SEC, and other governmental agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable and may be affected by changes in congressional or executive priorities
Government actions under the Trump Administration to limit federal agency budgets have reduced FDA personnel and caused inspection backlogs.
NewRisks Related to Regulatory Approval of Our Product Candidates
We may fail to achieve our development and regulatory milestones on expected timelines, or at all, which could materially and adversely affect our business, financial condition, results of operations and prospects
Inaccurate assumptions regarding patient enrollment rates and clinical site initiation may cause us to miss expected development milestones.
NewRisks Related to Regulatory Approval of Our Product Candidates
Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely affect our business and profitability
Penetrating foreign markets exposes us to differing regulatory requirements and additional uncertainties regarding safety and efficacy compliance.
NewRisks Related to Regulatory Approval of Our Product Candidates
Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any
Strict price controls and limited government support programs outside the U.S. may adversely affect our revenues.
NewRisks Related to Regulatory Approval of Our Product Candidates
Current and future healthcare legislative reform measures may have a material adverse effect on our business and results of operations
Healthcare legislative and regulatory changes in the U.S. and abroad could restrict post-approval activities and lower drug prices.
NewRisks Related to Regulatory Approval of Our Product Candidates
If 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
Using hazardous, flammable, and radioactive materials in our operations exposes us to contamination liabilities exceeding our insurance coverage.
NewRisks Related to Regulatory Approval of Our Product Candidates
Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading laws
Employees, principal investigators, or consultants may engage in misconduct, healthcare fraud, or violations of securities and insider trading laws.
NewRisks Related to the Commercialization of Our Product Candidates
Even if we receive marketing approval for abdakibart (AVTX-009) or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales and could prevent us from achieving or sustaining profitability
NewRisks Related to Our Dependence on Third Parties
If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages
NewRisks Related to Employee Matters and Managing Our Growth
We or the third parties upon whom we depend may be adversely affected by unforeseen global events, natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
NewRisks Related to Employee Matters and Managing Our Growth
Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
NewRisks Related to our Stock, Charter and Bylaws
ability to issue additional common stock or other securities and our ability to obtain additional financing in the future on favorable terms
NewRisks Related to our Stock, Charter and Bylaws
Unstable global economic and geopolitical conditions may have serious adverse consequences on our business, financial condition, stock price and results of operations
NewRisks Related to our Stock, Charter and Bylaws
Our business is subject to risks arising from pandemics and epidemic diseases
NewRisks Related to our Stock, Charter and Bylaws
Changes in tax law may adversely affect us or our investors
NewRisks Related to our Stock, Charter and Bylaws
The rights associated with our outstanding Series D and Series E preferred stock may concentrate control of our Board of Directors and could adversely affect the interests of holders of our common stock
NewRisks Related to our Stock, Charter and Bylaws
We collect and process sensitive information, including confidential business information and information associated with clinical trials including in some limited cases, personal information and sensitive health-related data
NewRisks Related to our Stock, Charter and Bylaws
The U.S. Congress or the current administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business

Dropped

DroppedRisks Related to Our Financial Position and Capital Needs
Our role as a guarantor of certain obligations assigned to Aytu exposes us to risk of loss or illiquidity
DroppedRisks Related to Our Financial Position and Capital Needs
We have no approved commercial products
DroppedRisks Related to Development of Our Product Candidates
Our competitors will also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs
DroppedRisks Related to Development of Our Product Candidates
We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. Our focus and reliance on AVTX-009 increases the risk of such exposure
DroppedRisks Related to Development of Our Product Candidates
Our focus and reliance on AVTX-009 exposes us to risk if AVTX-009 does not perform in clinical trials or receive FDA approval and market acceptance
DroppedRisks Related to the Commercialization of Our Product Candidates
If we obtain approval to commercialize our product candidates, the markets in which we will be selling are highly competitive and we might be unable to compete successfully against new entrants or established companies
Guarantor obligations assigned to Aytu under a supply agreement with TRIS Pharma expose us to loss.
DroppedRisks Related to the Commercialization of Our Product Candidates
If we obtain approval to commercialize our product candidates outside of the United States, a variety of risks associated with international operations could materially adversely affect our business
Our supply and license agreement for our only commercial product, Millipred, expired on September 30, 2023.
DroppedRisks Related to the Commercialization of Our Product Candidates
Even if we commercialize any of our product candidates, these products may become subject to unfavorable third‑party coverage and reimbursement policies, healthcare reform initiatives, or pricing regulations, any of which could negatively impact our business
DroppedRisks Related to Our Dependence on Third Parties
We do not own or operate, and have no plans to establish, any manufacturing facilities for our product candidates. We have limited personnel with experience in drug manufacturing and we lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale
DroppedRisks Related to Intellectual Property
and other intellectual property rights, such rights may be reduced or eliminated. If our licensors, licensees or collaborators are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised
DroppedRisks Related to Legal Compliance
The Patient Protection and Affordable Care Act increased federal oversight of private health insurance plans and included a number of provisions designed to reduce Medicare expenditures and the cost of health care generally, to reduce fraud, waste, abuse and to provide access to increased health coverage
DroppedRisks Related to Legal Compliance
of 2003, and the FDA’s implementing regulations. It is unclear the extent to which any of these policies will continue under the new administration
DroppedRisks Related to Legal Compliance
State and federal healthcare program reform measures are ongoing, any of which could limit the amounts that we receive for our product candidates, result in reduced demand for our product candidates, if approved
DroppedRisks Related to our Stock
Low trading volume of our common stock on the Nasdaq Capital Market may increase price volatility
DroppedRisks Related to our Stock
We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage

Reworded

100% rewrittenRisks Related to Regulatory Approval of Our Product Candidates
Ongoing changes to healthcare laws and regulations may increase the difficulty of and costs associated with commercializing our products and may affect the prices we are paid for those products and the demand for such products
Updated to focus specifically on third-party coverage uncertainty, novel biologic therapies, and limited surrogate endpoint approvals rather than broad healthcare cost-containment.
Was: Ongoing changes to healthcare laws and regulations may increase the difficulty of and costs associated with commercializing our products and may affect the prices we are paid for those products
97% rewrittenRisks Related to Development of Our Product Candidates
We are substantially dependent on the success of abdakibart (AVTX-009), and our ongoing and anticipated clinical trials of abdakibart (AVTX-009) may not be successful
Added explicit mention of our March 2024 acquisition of abdakibart (AVTX-009) and the heightened single-product exposure.
Was: We are substantially dependent on the success of AVTX-009, and our ongoing and anticipated clinical trials of AVTX-009 may not be successful
85% rewrittenRisks Related to Our Financial Position and Capital Needs
We have incurred significant net losses in most periods since our inception and we expect to continue to incur net losses for the foreseeable future
Updated financial figures, noting a 2011 inception date, an accumulated deficit of $370.3 million, and a 2024 net loss of $35.1 million.
Was: We have incurred significant net losses in most periods since our inception and we expect to continue to incur net losses in the future
75% rewrittenRisks Related to Our Dependence on Third Parties
We rely on third parties to conduct and monitor our clinical trials. The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines could hinder our ability to commercialize or obtain marketing approval for our product candidates in a timely manner or at all
Expanded third-party oversight risks to include CDMOs and specified potential penalties ranging from warning letters to criminal prosecution.
72% rewrittenRisks Related to our Stock, Charter and Bylaws
Our business and operations could suffer in the event of information technology systems and infrastructure failures, cyber-attacks or deficiencies in our cyber-security
Expanded IT vendor scope to explicitly list CROs, CMOs, cloud providers, and HR platforms possessing sensitive data.
Was: Our business and operations could suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security
70% rewrittenRisks Related to Our Financial Position and Capital Needs
We may need to seek additional funds sooner than anticipated through public or private equity offerings, debt financings, collaborations, licensing agreements, or other sources. Such financing could dilute our stockholders, and failure to secure adequate funding may limit our operational activities
Replaced generic product references with abdakibart (AVTX-009) regarding collaboration milestone rights.
Was: We may need to seek additional funds sooner than anticipated through public or private equity offerings, debt financings, collaborations, licensing agreements, or other sources. Such financing could dilute our shareholders, and failure to secure adequate funding may limit our operational activities
68% rewrittenRisks Related to Our Financial Position and Capital Needs
Risks associated with short-term liquid investments
Updated cash and short-term investments balance to $98.3 million as of December 31, 2025, and added extreme market loss warnings.
Was: We face risks associated with short-term liquid investments
65% rewrittenRisks Related to Development of Our Product Candidates
We face substantial competition and rapid technological change and the possibility that others may discover, develop or commercialize products before or more successfully than us
Added specific mention of governmental agencies and research institutions as competitors, highlighting our limited commercial infrastructure.
63% rewrittenRisks Related to Development of Our Product Candidates
Our product candidate, abdakibart (AVTX-009), is a biologic. The process of manufacturing biologics and their components is complex, expensive, highly-regulated and subject to multiple risks
Was: Our product candidate, AVTX-009, is a biologic. The process of manufacturing biologics and their components is complex, expensive, highly-regulated and subject to multiple risks
59% rewrittenRisks Related to Development of Our Product Candidates
If we are unable to enroll appropriate subjects in clinical trials or retain patients in the clinical trials we perform, we may not be able to complete these trials on a timely basis, or at all
53% rewrittenRisks Related to Intellectual Property
We may be required to make significant payments in connection with our license and development agreements
45% rewrittenRisks Related to our Stock, Charter and Bylaws
Conversion of the outstanding shares of our preferred stock will dilute the percentage ownership of the holders of our common stock
44% rewrittenRisks Related to Regulatory Approval of Our Product Candidates
The marketing approval processes of the FDA and other regulatory authorities are lengthy, time‑consuming, costly and inherently unpredictable. Our inability to obtain regulatory approval for our product candidates would substantially harm our business and prospects
Was: The marketing approval processes of the FDA and other regulatory authorities are lengthy, time‑consuming, costly and inherently unpredictable. Our inability to obtain regulatory approval for our product candidates would substantially harm our business
42% rewrittenRisks Related to Development of Our Product Candidates
Changes in product candidate manufacturing or formulation may result in additional costs or delay
41% rewrittenRisks Related to Regulatory Approval of Our Product Candidates
The occurrence of any event or penalty described above may inhibit our ability to continue our development programs, commercialize our products and generate revenue and may require us to incur substantial remediation costs
Was: The occurrence of any event or penalty described above may inhibit our ability to continue our development programs, commercialize our products and generate revenue
41% rewrittenRisks Related to Development of Our Product Candidates
If we experience delays in clinical testing, we will be delayed in obtaining regulatory approvals and commercializing our product candidates, our costs may increase and our business may be harmed
38% rewrittenRisks Related to Our Financial Position and Capital Needs
Our operating results fluctuate from quarter to quarter and year to year, making future operating results difficult to predict
34% rewrittenRisks Related to Intellectual Property
We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time‑consuming and unsuccessful and have a material adverse effect on the success of our business
34% rewrittenRisks Related to our Stock, Charter and Bylaws
Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock
33% rewrittenRisks Related to Employee Matters and Managing Our Growth
If we fail to attract and keep management and other key personnel, as well as our board members, we may be unable to develop our product candidates or otherwise implement our business plan
31% rewrittenRisks Related to Employee Matters and Managing Our Growth
We may encounter difficulties in managing our growth, including the focus on abdakibart (AVTX-009) and the resources necessary for its development, and expanding our operations successfully
Was: We may encounter difficulties in managing our growth, including the focus on AVTX-009 and the resources necessary for its development, and expanding our operations successfully
28% rewrittenRisks Related to Intellectual Property
Our inability to protect our confidential information and trade secrets would harm our business and competitive position
28% rewrittenRisks Related to our Stock, Charter and Bylaws
We incur increased costs and obligations as a result of being a public company
28% rewrittenRisks Related to Our Financial Position and Capital Needs
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
28% rewrittenRisks Related to Intellectual Property
As appropriate, we intend to seek all available periods of regulatory exclusivity for our product candidates. However, there is no guarantee that we will be granted these periods of regulatory exclusivity or that we will be able to maintain these periods of exclusivity
28% rewrittenRisks Related to our Stock, Charter and Bylaws
We may be subject to future litigation against us, which could be costly and time‑consuming to defend
26% rewrittenRisks Related to Our Dependence on Third Parties
We might not succeed in establishing and maintaining development collaborations, which could adversely affect our ability to develop and commercialize product candidates
25% rewrittenRisks Related to the Commercialization of Our Product Candidates
If, in the future, we are unable to establish sales, marketing and distribution capabilities or enter into licensing or collaboration agreements for these purposes, we might not be successful in commercializing our product candidates
25% rewrittenRisks Related to Development of Our Product Candidates
Our current or future product candidates may cause undesirable side effects or have other properties that could delay or prevent their marketing approval, limit their commercial potential, or result in significant negative consequences following any marketing approval
Was: Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their marketing approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval
22% rewrittenRisks Related to Intellectual Property
Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
21% rewrittenRisks Related to our Stock, Charter and Bylaws
Future sales and issuances of shares of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
21% rewrittenRisks Related to Intellectual Property
If we breach the license and development agreements related to our product candidates, we could lose the ability to develop and commercialize our product candidates

All 71 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Position and Capital Needs

01We may never achieve or sustain profitabilityNew
02Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidatesNew
03We may need to seek additional funds sooner than anticipated through public or private equity offerings, debt financings, collaborations, licensing agreements, or other sources. Such financing could dilute our stockholders, and failure to secure adequate funding may limit our operational activities70% rewritten
04We have incurred significant net losses in most periods since our inception and we expect to continue to incur net losses for the foreseeable future85% rewritten
05Risks associated with short-term liquid investments68% rewritten
06In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income would decrease. Interest rate fluctuations can negatively impact the returns on our fixed-income investments, particularly during periods of rising interest ratesNew
07Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited28% rewritten
08Our operating results fluctuate from quarter to quarter and year to year, making future operating results difficult to predict38% rewritten
09With no commercial products, our operations are not expected to produce revenues for the foreseeable future, or at all, which might harm our ability to obtain additional financing and might require us to reduce or discontinue our operations

Risks Related to Development of Our Product Candidates

10We are substantially dependent on the success of abdakibart (AVTX-009), and our ongoing and anticipated clinical trials of abdakibart (AVTX-009) may not be successful97% rewritten
11abdakibart (AVTX-009). In October 2024 we announced the first patient enrolled in our global Phase 2 LOTUS clinical trial and in October 2025 we announced that we completed enrollmentNew
12If we experience delays in clinical testing, we will be delayed in obtaining regulatory approvals and commercializing our product candidates, our costs may increase and our business may be harmed41% rewritten
13If we are unable to enroll appropriate subjects in clinical trials or retain patients in the clinical trials we perform, we may not be able to complete these trials on a timely basis, or at all59% rewritten
14We may fail to successfully identify, in‑license, acquire, develop or commercialize potential product candidates
15Our current or future product candidates may cause undesirable side effects or have other properties that could delay or prevent their marketing approval, limit their commercial potential, or result in significant negative consequences following any marketing approval25% rewritten
16Changes in product candidate manufacturing or formulation may result in additional costs or delay42% rewritten
17Our product candidate, abdakibart (AVTX-009), is a biologic. The process of manufacturing biologics and their components is complex, expensive, highly-regulated and subject to multiple risks63% rewritten
18We face substantial competition and rapid technological change and the possibility that others may discover, develop or commercialize products before or more successfully than us65% rewritten
19Our products might not achieve adequate market acceptance among physicians, patients, third‑party payors and others in the medical community necessary for commercial success
20and may not achieve or sustain profitability, which could materially and adversely affect our business, financial condition, results of operations, and prospectsNew

Risks Related to Regulatory Approval of Our Product Candidates

21The marketing approval processes of the FDA and other regulatory authorities are lengthy, time‑consuming, costly and inherently unpredictable. Our inability to obtain regulatory approval for our product candidates would substantially harm our business and prospects44% rewritten
22Even if we complete the necessary clinical trials, we cannot predict when or if we will obtain marketing approval to commercialize a product candidate or the approval may be for a narrower indication than we expect or may be conditioned on costly post-approval obligations
23The occurrence of any event or penalty described above may inhibit our ability to continue our development programs, commercialize our products and generate revenue and may require us to incur substantial remediation costs41% rewritten
24government funding of the SEC, and other governmental agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable and may be affected by changes in congressional or executive prioritiesNew
25We are conducting clinical trials for abdakibart (AVTX-009) at sites in foreign jurisdictions, and the FDA might not accept data from trials conducted in such locations
26We may fail to achieve our development and regulatory milestones on expected timelines, or at all, which could materially and adversely affect our business, financial condition, results of operations and prospectsNew
27Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States, which would limit our market opportunities and adversely affect our business
28Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely affect our business and profitabilityNew
29Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if anyNew
30Current and future healthcare legislative reform measures may have a material adverse effect on our business and results of operationsNew
31If 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 businessNew
32Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading lawsNew
33Ongoing changes to healthcare laws and regulations may increase the difficulty of and costs associated with commercializing our products and may affect the prices we are paid for those products and the demand for such products100% rewritten

Risks Related to the Commercialization of Our Product Candidates

34We might not be successful in our efforts to develop and commercialize our product candidates
35If, in the future, we are unable to establish sales, marketing and distribution capabilities or enter into licensing or collaboration agreements for these purposes, we might not be successful in commercializing our product candidates25% rewritten
36Even if we receive marketing approval for abdakibart (AVTX-009) or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales and could prevent us from achieving or sustaining profitabilityNew
37Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any product candidates that we may develop

Risks Related to Our Dependence on Third Parties

38We rely on third parties to conduct and monitor our clinical trials. The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines could hinder our ability to commercialize or obtain marketing approval for our product candidates in a timely manner or at all75% rewritten
39If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damagesNew
40We might not succeed in establishing and maintaining development collaborations, which could adversely affect our ability to develop and commercialize product candidates26% rewritten

Risks Related to Intellectual Property

41As appropriate, we intend to seek all available periods of regulatory exclusivity for our product candidates. However, there is no guarantee that we will be granted these periods of regulatory exclusivity or that we will be able to maintain these periods of exclusivity28% rewritten
42If we breach the license and development agreements related to our product candidates, we could lose the ability to develop and commercialize our product candidates21% rewritten
43We may be required to make significant payments in connection with our license and development agreements53% rewritten
44Obtaining and maintaining our patent protection depends on our complying with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies worldwide, and our patent protection could be reduced or eliminated for non‑compliance with these requirements
45We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time‑consuming and unsuccessful and have a material adverse effect on the success of our business34% rewritten
46Our inability to protect our confidential information and trade secrets would harm our business and competitive position28% rewritten
47Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates22% rewritten
48We might not be able to protect our intellectual property rights throughout the world

Risks Related to Employee Matters and Managing Our Growth

49If we fail to attract and keep management and other key personnel, as well as our board members, we may be unable to develop our product candidates or otherwise implement our business plan33% rewritten
50We may encounter difficulties in managing our growth, including the focus on abdakibart (AVTX-009) and the resources necessary for its development, and expanding our operations successfully31% rewritten
51Our Chief Executive Officer has interests in the development of AVTX-006 pursuant to a royalty agreement that may conflict with interests of stockholders
52We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
53We or the third parties upon whom we depend may be adversely affected by unforeseen global events, natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disasterNew
54Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirementsNew

Risks Related to our Stock, Charter and Bylaws

55ability to issue additional common stock or other securities and our ability to obtain additional financing in the future on favorable termsNew
56Conversion of the outstanding shares of our preferred stock will dilute the percentage ownership of the holders of our common stock45% rewritten
57Future sales and issuances of shares of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall21% rewritten
58If we are not able to comply with the applicable continued listing requirements or standards of The Nasdaq Stock Market, Nasdaq could delist our common stock
59Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock34% rewritten
60Unstable global economic and geopolitical conditions may have serious adverse consequences on our business, financial condition, stock price and results of operationsNew
61Our business is subject to risks arising from pandemics and epidemic diseasesNew
62If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our securities prices and trading volume could decline
63Because we do not intend to declare cash dividends on our shares of common stock in the foreseeable future, stockholders must rely on appreciation of the value of our common stock for any return on their investment
64Changes in tax law may adversely affect us or our investorsNew
65We incur increased costs and obligations as a result of being a public company28% rewritten
66Some provisions of our charter documents and Delaware law may have anti‑takeover effects that could discourage an acquisition of us by others, even if an acquisition would benefit our stockholders and may prevent attempts by our stockholders to replace or remove our current management
67The rights associated with our outstanding Series D and Series E preferred stock may concentrate control of our Board of Directors and could adversely affect the interests of holders of our common stockNew
68Our business and operations could suffer in the event of information technology systems and infrastructure failures, cyber-attacks or deficiencies in our cyber-security72% rewritten
69We may be subject to future litigation against us, which could be costly and time‑consuming to defend28% rewritten
70We collect and process sensitive information, including confidential business information and information associated with clinical trials including in some limited cases, personal information and sensitive health-related dataNew
71The U.S. Congress or the current administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our businessNew

Other Avalo Therapeutics 10-Ks

FY2024 10-K risk factors
63 risks
Avalo Therapeutics focuses heavily on developing its lead biologic asset AVTX-009 for hidradenitis suppurativa.
Filed Mar 20, 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.