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AVTX on Nasdaq

Avalo Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead product candidate, abdakibart (AVTX-009), an anti-IL-1β monoclonal antibody is in a Phase 2 clinical trial for hidradenitis suppurativa. We are also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs.”3 It is headquartered in Wayne, Pennsylvania.1

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Last updated Oct 21, 2026.

Overview

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  • TickerAVTX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWayne, Pennsylvania1
  • Incorporated inDE2
  • Business address1500 Liberty Ridge Drive, Suite 321, Wayne, Pa 190872
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead product candidate, abdakibart (AVTX-009), an anti-IL-1β monoclonal antibody (“mAb”) is in a Phase 2 clinical trial for hidradenitis suppurativa (“HS”). We are also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs.3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-123601.7%Operating margin4
-132642.4%Net margin4
-86.6%Revenue growth, 20254
-94.2%Return on equity4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Income tax100¢$165.0K

Out of $59.0K in revenue.4 The company lost money this year.

Financial statements

Revenue567894$59.0K in 2025−99% since 2019
0$5.0M$10.0M$15.0M$20.0M2019: $6.8M$6.8M20192020: $6.7M$6.7M2020−1%2021: $5.4M$5.4M2021−19%2022: $18.1M$18.1M2022+234%2023: $1.9M$1.9M2023−89%2024: $441.0K$441.0K2024−77%2025: $59.0K$59.0K2025−87%
Operating income567894-$72.9M in 2025+352% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$16.1M-$16.1M20192020: -$72.8M-$72.8M2020+351%2021: -$82.1M-$82.1M2021+13%2022: -$37.4M-$37.4M2022−54%2023: -$27.4M-$27.4M2023−27%2024: -$68.5M-$68.5M2024+150%2025: -$72.9M-$72.9M2025+6%
Net income567894-$78.3M in 2025+387% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$16.1M-$16.1M20192020: -$63.5M-$63.5M2020+295%2021: -$84.4M-$84.4M2021+33%2022: -$41.7M-$41.7M2022−51%2023: -$31.5M-$31.5M2023−24%2024: -$35.1M-$35.1M2024+11%2025: -$78.3M-$78.3M2025+123%
Fiscal year2019202020212022202320242025
Revenue$6.8M5$6.7M6$5.4M7$18.1M8$1.9M9$441.0K4$59.0K4
Cost of revenue-$566.5K12$300.0K6$1.5M7$3.4M8$1.3M8
Research and development
Selling, general and admin$20.7M8$10.3M8
Operating expenses$87.5M7$55.5M8$29.3M9$69.0M4$73.0M4
Operating income-$16.1M5-$72.8M6-$82.1M7-$37.4M8-$27.4M9-$68.5M4-$72.9M4
Income before tax-$41.6M8-$31.5M9-$35.0M4-$78.1M4
Income tax$280.3K5-$2.8M6-$196.0K7$28.0K8$14.0K9$114.0K4$165.0K4
Net income-$16.1M5-$63.5M6-$84.4M7-$41.7M8-$31.5M9-$35.1M4-$78.3M4
Earnings per share-$1,063.008-$113.589-$7.944-$5.844
Earnings per share (diluted)-$1,063.008-$113.589-$20.914-$5.844
Shares (weighted, basic)39.2K shares8277.7K shares94.4M shares413.4M shares4
Shares (weighted, diluted)39.2K shares8277.7K shares97.5M shares413.4M shares4

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Corporate structure

Avalo Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Avalo Therapeutics, Inc.

  • Avalo Therapeutics, Inc. Wayne, Pennsylvania

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Avalo Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Operating-lease assets (leased space)$336.0K4 Dec 31, 2025$741.0K4 Dec 31, 2024−54.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$15.9M4 Dec 31, 2025$134.5M4 Dec 31, 2024−88.2%
Marketable securities, current$82.5M4 Dec 31, 2025$04 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$10.5M4 Dec 31, 2025$10.5M4 Dec 31, 20240%

Properties, in its own words

Our headquarters are located in Wayne (Chesterbrook), Pennsylvania, where we occupy approximately 11,000 square feet of administrative office space. The lease expires on February 28, 2027.

We believe that our existing facilities are adequate to meet our current needs, and that suitable spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 23, 2026.3

Leadership

Who has led Avalo Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Blake M. Paterson2015
  2. Uli Hacksell2016–2017
  3. Peter Greenleaf2018–2019
  4. Michael F. Cola2020–2021
  5. Garry Arthur Neil2022–now

Chair

  1. Simon Pedder2019–2020
  2. Garry Arthur Neil2022–2025

President

  1. Blake M. Paterson2015
  2. Uli Hacksell2016–2017
  3. Robert Moscato Jr.2017

Chief financial officer

  1. Joseph M. Miller2018–2020
  2. Schond L. Greenway2021

Chief operating officer

  1. Robert Moscato Jr.2017
20202025
Board members and other officers (39)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerChristopher Sullivan named Apr 9, 202459
  • DirectorGilla Kaplan, Ph.D. named Apr 9, 202459
  • DirectorJune Almenoff, M.D., Ph.D. named Apr 9, 202459
  • DirectorMagnus Persson, M.D., Ph.D. named Apr 9, 202459

Former names

  • Cerecor Inc.Apr 4, 2012 to Aug 18, 20212

Timeline

  1. Aug 6, 20268-K Results of operations60
  2. Jun 23, 20268-K Executive or director change61
  3. Jun 16, 20268-K Other events62
  4. Jun 12, 20268-K Unregistered sale of shares; Change to shareholders' rights; Executive or director change63
  5. Jun 8, 20268-K Executive or director change; Shareholder vote64
  6. May 13, 20268-K Results of operations65
  7. May 7, 20268-K Entered a material agreement; Results of operations; Regulation FD disclosure66
  8. May 5, 20268-K Other events67
  9. Apr 28, 20268-K Entered a material agreement; Regulation FD disclosure68
  10. Mar 27, 20268-K Executive or director change69
  11. Mar 23, 20268-K Results of operations70
  12. Jan 12, 20268-K Results of operations; Other events71
  13. Mar 10, 2022New chief executive Garry Arthur Neil becomes CEO13
  14. Feb 5, 2020New chief executive Michael F. Cola becomes CEO14
  15. Mar 29, 2018New chief executive Peter Greenleaf becomes CEO15
  16. Jan 12, 2016New chief executive Uli Hacksell becomes CEO16
  17. Oct 14, 2015New chief executive Blake M. Paterson becomes CEO17

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($2.19) a share, on Nov 6, 2025.72

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results60
  2. May 13, 2026Reported quarterly or annual results65
  3. May 7, 2026Reported quarterly or annual results66
  4. Mar 23, 2026Reported quarterly or annual results70
  5. Jan 12, 2026Reported quarterly or annual results71
  6. Nov 6, 2025Reported quarterly or annual results73
  7. Aug 7, 2025Reported quarterly or annual results74
  8. May 12, 2025Reported quarterly or annual results75

Drug trials and FDA: recently

  1. Feb 23, 2026Phase 2 trial completed Phase 2 trial of AVTX-009 Regimen 1 and AVTX-009 Regimen 2 in Hidradenitis Suppurativa: primary completion Feb 23, 2026, no results posted yet (ClinicalTrials.gov NCT06603077).76

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

485 filings to the SEC since October 2021: 5 annual reports, 16 quarterly reports, 98 major events, 195 insider forms, 94 large holders, 1 private raises, 76 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Sep 18, 20264 EDGAR
  5. Sep 11, 20264 EDGAR
  6. Sep 1, 20264 EDGAR
  7. Aug 19, 20264 EDGAR
  8. Aug 19, 20264 EDGAR
  9. Aug 18, 2026144 EDGAR
  10. Aug 17, 2026144 EDGAR
  11. Aug 17, 2026144 EDGAR
  12. Aug 17, 2026144 EDGAR
  13. Aug 14, 2026SCHEDULE 13G/A EDGAR
  14. Aug 14, 2026SCHEDULE 13G/A EDGAR
  15. Aug 14, 2026SCHEDULE 13G/A EDGAR
  16. Aug 14, 2026SCHEDULE 13G/A EDGAR
  17. Aug 14, 2026SCHEDULE 13G/A EDGAR
  18. Aug 14, 2026SCHEDULE 13G/A EDGAR
  19. Aug 14, 2026SCHEDULE 13G/A EDGAR
  20. Aug 13, 2026SCHEDULE 13G/A EDGAR

The 485 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

92 open-market trades by officers, directors and large owners since October 2021: 63 buys and 29 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Sullivan Christopher RyanChief Financial OfficerSale12,394$16.33$202.4KForm 4
Sep 10, 2026Sullivan Christopher RyanChief Financial OfficerSale10,185$17.62$179.5KForm 4
Aug 28, 2026Doyle MittieChief Medical OfficerSale679$20.00$13.6KForm 4
Aug 18, 2026Sullivan Christopher RyanChief Financial OfficerSale31,031$20.05$622.2KForm 4
Aug 17, 2026Doyle MittieChief Medical OfficerSale1,000$20.00$20.0KForm 4
Aug 17, 2026Sullivan Christopher RyanChief Financial OfficerSale41,694$19.86$828.0KForm 4
Aug 11, 2026Riley JenniferChief Strategy OfficerSale2,655$19.59$52.0KForm 4
Aug 10, 2026Doyle MittieChief Medical OfficerSale679$20.00$13.6KForm 4
Jul 27, 2026Doyle MittieChief Medical OfficerSale1,000$20.00$20.0KForm 4
Jun 30, 2026Doyle MittieChief Medical OfficerSale4,654$20.00$93.1KForm 4
Jun 23, 2026Doyle MittieChief Medical OfficerSale1,450$18.00$26.1KForm 4
May 28, 2026Doyle MittieChief Medical OfficerSale679$16.00$10.9KForm 4
May 15, 2026Doyle MittieChief Medical OfficerSale3,000$18.76$56.3KForm 4
May 7, 2026Sullivan Christopher RyanChief Financial OfficerSale18,606$24.12$448.8KForm 4
May 6, 2026Doyle MittieChief Medical OfficerSale106,555$20.68$2.2MForm 4
May 6, 2026Sullivan Christopher RyanChief Financial OfficerSale47,000$20.18$948.6KForm 4
May 6, 2026Chan MitchellDirectorSale3,167$22.88$72.5KForm 4
May 6, 2026VARKI PAULChief Legal OfficerSale75,063$20.17$1.5MForm 4
May 5, 2026Doyle MittieChief Medical OfficerSale1,679$16.00$26.9KForm 4
Apr 30, 2026Sullivan Christopher RyanChief Financial OfficerSale8,457$13.23$111.9KForm 4

All 92 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Garry Neil, M.D.Chief Executive Officer, President and principal executive officer72$590.0K$3.8M105
2025Taylor BoydChief Business Officer37$116.2K$3.2M105
2025Mittie Doyle, M.D., FACRChief Medical Officer61$512.5K$1.8M105
2024Garry Neil, M.D.Chief Executive Officer, President and principal executive officer72$532.5K$7.2M105
2024Mittie Doyle, M.D., FACRChief Medical Officer61$231.1K$3.0M105

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$130.6M 2024–2024
Money received by yearMoney received by year, 2024–2024: $130.6M in all. Private raises (Form D) $130.6M.$0$50M$100M$150M2024 · Private raises (Form D): $130.6M2024
Figures by year
YearPrivate raises (Form D)Total
2024$130.6M$130.6M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Mar 27, 2024Raised $130.6 million in a private offering of equity59 Form D: $200 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Fmr LLC5,100,216$94.3M0.0%+2,220,735
BlackRock, Inc.4,365,553$80.7M0.0%+4,038,471
Nantahala Capital Management, LLC3,724,500$68.8M2.1%+2,489,500
Deep Track Capital, LP3,610,000$66.7M1.0%New
Caligan Partners LP3,163,866$58.5M2.8%+1,528,843
TCG Crossover Management, LLC3,017,120$55.8M1.3%+2,278,737
Affinity Asset Advisors, LLC2,900,000$53.6M2.7%+1,559,160
State Street Corp2,889,287$53.4M0.0%+2,817,633
Farallon Capital Management, L.l.c.2,498,000$46.2M0.3%+1,582,000
Point72 Asset Management, L.P.2,387,026$44.1M0.1%+1,470,884
Avoro Capital Advisors LLC2,333,333$43.1M0.4%+923,333
Vanguard Capital Management LLC2,264,246$41.8M0.0%+1,544,552
Bvf Inc/il2,075,545$38.4M1.0%+442,700
Bank Of America Corp /de/1,913,829$35.4M0.0%+1,270,829
Adage Capital Partners Gp, L.l.c.1,729,000$32.0M0.0%+875,000
Soleus Capital Management, L.P.1,654,978$30.6M1.1%+1,213,000
Braidwell LP1,629,182$30.1M1.2%New
Alliancebernstein L.P.1,260,689$23.3M0.0%New
UBS Group AG1,209,059$22.3M0.0%+67,079
Logos Global Management LP1,150,000$21.3M0.9%+850,000
Geode Capital Management, LLC1,105,118$20.4M0.0%+935,229
Commodore Capital LP1,018,319$18.8M1.1%+535,319
Ra Capital Management, L.P.1,000,000$18.5M0.2%+337,032
Goldman Sachs Group Inc946,320$17.5M0.0%+886,214
Trails Edge Capital Partners, LP891,881$16.5M2.6%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Avalo Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARAvalo Therapeutics, Inc.1
  • CIK0001534120
  • Employer ID (EIN)45-07056483
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1500 Liberty Ridge Drive, Suite 321, Wayne, PA 190871
  • Phone410-522-87071
  • Shares outstanding53,629,989 as of Aug 3, 202611
  • Public float$53.7M as of Jun 30, 20253
  • AuditorErnst & Young LLP, Jericho, New York PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceApr 4, 20121
  • Filings1,213 in all: 4 (486), 8-K (201), 3 (63), 424B3 (59), SCHEDULE 13G/A (39), 10-Q (33), SC 13D/A (29), CORRESP (28)1
    All 47 form types

    UPLOAD (24), SCHEDULE 13G (22), SC 13G (19), 424B5 (18), SC 13G/A (18), 144 (16), S-8 (16), EFFECT (15), 8-K/A (13), DEFA14A (13), 10-K (11), DEF 14A (11), S-3 (11), D (6), PRE 14A (6), CT ORDER (5), S-3/A (5), ARS (4), S-1/A (4), 10-K/A (3), 10-Q/A (3), 25-NSE (3), 4/A (3), 425 (3), DRSLTR (3), FWP (3), SC 13D (3), DRS/A (2), S-1 (2), 424B4 (1), 8-A12B (1), CERTNAS (1), DEFR14A (1), DRS (1), POS AM (1), PRER14A (1), S-4 (1), S-4/A (1), S-8 POS (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 10, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 Par ValueAVTXNasdaq

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Avalo Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 23, 2026: 72 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Capital Needs
  • We expect to require additional capital in the future to continue to fund our operations and to finance the further advancement of our product candidates, which might not be available to us on acceptable terms, or at all. Failure to obtain any necessary capital could force us to delay, limit or terminate our product development efforts or significantly curtail or cease our operations altogether.
  • We may never achieve or sustain profitability.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • 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.
  • Risks associated with short-term liquid investments.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Our operating results fluctuate from quarter to quarter and year to year, making future operating results difficult to predict.
  • We have no approved commercial products.
  • Risks 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.
  • Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. Such data are inherently preliminary and should not be relied upon as definitive or predictive of final results.
The other 62 risks
  • If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of 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 product candidates.
  • Our product candidates that we intend to commercialize are in early to mid-stages of development. If we do not successfully complete nonclinical testing and clinical development of our product candidates or experience delays in doing so, our business may be materially harmed. Our focus and reliance on abdakibart (AVTX-009) increases the risk of such exposure.
  • 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.
  • 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.
  • We may fail to successfully identify, in‑license, acquire, develop or commercialize potential 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.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • Biological products are highly complex and expensive, and if the third-party manufacturers we contract with are unable to provide quality and timely offerings to our clinical trial sites, our clinical trials might be delayed.
  • 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.
  • Our products might not achieve adequate market acceptance among physicians, patients, third‑party payors and others in the medical community necessary for commercial success.
  • 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 concentration of resources and reliance on abdakibart (AVTX-009) materially increases our exposure to this risk.
  • Risks 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.
  • Even 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.
  • Even if our product candidates receive marketing approval, we will still be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and diversion of management attention. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and we may be subject to administrative sanctions or penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • Disruptions to the FDA, the SEC and other governmental agencies and regulatory authorities caused by funding shortages, changes in leadership and policy, or global health concerns could hinder the ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business and results of operations.
  • We 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.
  • 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.
  • Our 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.
  • 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.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Current and future healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • 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.
  • 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.
  • 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.
  • We may be subject to certain regulations, including federal and state healthcare fraud and abuse laws, physician payment transparency laws, anti-bribery and anti-corruption laws and health information privacy and security laws. Any actual or perceived failure to comply with these regulations could have a material adverse effect on our business and financial condition.
  • Risks Related to the Commercialization of Our Product Candidates
  • We might not be successful in our efforts to develop and commercialize 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.
  • 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.
  • Product 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
  • 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.
  • We use third parties to manufacture all of our product candidates. This may increase the risk that we will not have sufficient clinical or commercial quantities of our product candidates or such quantities at an acceptable cost, which could result in the delay, prevention, or impairment of clinical development and commercialization of our product candidates and could harm our business, financial condition and results of operations.
  • Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our preclinical and clinical programs and suspension or withdrawal of any regulatory approvals or could limit our ability to supply product for clinical trials or, if approved, for commercial sale.
  • 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.
  • We might not succeed in establishing and maintaining development collaborations, which could adversely affect our ability to develop and commercialize product candidates.
  • Risks Related to Intellectual Property
  • If we are unable to obtain or maintain intellectual property rights, or if the scope of our issued patents are not sufficiently broad, competitors could develop and commercialize products similar or identical to ours, and we might not be able to compete effectively in our market. Furthermore, our US composition-of-matter patent for abdakibart (AVTX-009) expired in February 2026.
  • 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.
  • 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.
  • We may be required to make significant payments in connection with our license and development agreements.
  • Obtaining 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.
  • 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.
  • Our inability to protect our confidential information and trade secrets would harm our business and competitive position.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We might not be able to protect our intellectual property rights throughout the world.
  • Risks 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.
  • 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.
  • Our Chief Executive Officer has interests in the development of AVTX-006 pursuant to a royalty agreement that may conflict with interests of stockholders.
  • We 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.
  • 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.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Risks Related to our Stock, Charter and Bylaws
  • The price of our common stock could be subject to rapid and substantial volatility. Such volatility, including any stock run-ups, may be unrelated to our actual or expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock. Volatility in our common stock price may subject us to securities litigation or regulatory scrutiny.
  • Conversion of the outstanding shares of our preferred stock will dilute the percentage ownership of the holders of our common stock.
  • 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.
  • If 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.
  • 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.
  • Unstable global economic and geopolitical conditions may have serious adverse consequences on our business, financial condition, stock price and results of operations.
  • If 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.
  • Because 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.
  • Changes in tax law may adversely affect us or our investors.
  • We incur increased costs and obligations as a result of being a public company.
  • Our amended and restated certificate of incorporation provides that unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Some 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.

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