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Avalo Therapeutics (NASDAQ: AVTX) advances AVTX-010 and posts strong HS Phase 2 data

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(High)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Avalo Therapeutics reported pipeline progress and updated investor materials. The company is advancing AVTX-010, a long-acting next‑generation anti‑IL‑1β antibody, with an Investigational New Drug application planned for the first half of 2027. AVTX-010 is intended for hidradenitis suppurativa (HS) and other inflammatory diseases.

Avalo highlighted abdakibart, its lead anti‑IL‑1β antibody, which produced a 42.5% HiSCR75 response at week 16 in the Phase 2 LOTUS HS trial, versus 25.6% on placebo, and a 61.7% HiSCR50 response versus 40.7%. Safety was described as favorable, with treatment‑emergent adverse event rates similar to placebo.

The investor presentation notes an HS therapeutics market projected above $10B by 2035 and describes Avalo as capitalized to fund operations into 2029, supported by approximately $479M in cash, cash equivalents and investments as of May 31, 2026.

Positive

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Insights

Strong Phase 2 HS data plus substantial cash runway support Avalo’s IL‑1β strategy.

Avalo Therapeutics is sharpening its focus on IL‑1β‑driven inflammatory diseases. Phase 2 LOTUS data in hidradenitis suppurativa show abdakibart achieved a 42.5% HiSCR75 response at week 16, versus 25.6% on placebo, with broadly favorable secondary endpoints and a placebo‑like safety profile.

The company is layering in AVTX‑010, a long‑acting next‑generation anti‑IL‑1β antibody, with an IND submission planned for 1H 2027. This follow‑on asset is designed for extended dosing intervals and potential IP enhancement, complementing abdakibart’s planned phase 3 HS program.

Financially, Avalo reports about $479M in cash, cash equivalents and investments as of May 31, 2026, and an expected runway into 2029, alongside an adjusted market capitalization of roughly $995.3M. This combination of clinical data, pipeline depth and capital supports continued execution of its IL‑1β strategy, though future value will depend on phase 3 results and regulatory outcomes.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
HiSCR75 response abdakibart 42.5% HiSCR75 at week 16 Combined abdakibart arms in Phase 2 LOTUS HS trial vs 25.6% placebo
HiSCR50 response abdakibart 61.7% HiSCR50 at week 16 Combined abdakibart arms in Phase 2 LOTUS HS trial vs 40.7% placebo
AVTX-010 IND timing IND planned 1H 2027 Planned Investigational New Drug submission for AVTX-010
Cash and investments $479M Cash, cash equivalents and investments as of May 31, 2026
Common shares outstanding 52.6M shares Common shares outstanding as of May 31, 2026
Adjusted common shares 62.4M shares Adjusted common shares outstanding including preferred and pre-funded as of May 31, 2026
Adjusted market capitalization $995.3M Based on $15.95 stock price as of May 29, 2026
HS market projection >$10B by 2035 Projected global hidradenitis suppurativa therapeutics market
Hidradenitis suppurativa (HS) medical
"with the potential for development in hidradenitis suppurativa (HS) as well as additional inflammatory disorders"
HiSCR75 medical
"42.5% (p=0.004) combined HiSCR75 and 61.7% (p=0.0009) combined HiSCR50 were observed"
HiSCR75 is a clinical-trial measure used in dermatology that indicates a 75% or greater reduction in the number of painful skin lesions and abscesses compared with baseline. For investors, it is an objective signal of a drug’s effectiveness in reducing disease burden—similar to saying a treatment cuts the symptom load by three-quarters—which can strongly influence regulatory decisions, market adoption and commercial value.
Investigational New Drug (IND) regulatory
"The Company expects to submit an Investigational New Drug (IND) application for AVTX-010 in the first half of 2027"
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.
IL-1β medical
"a long-acting next-generation anti-IL-1β monoclonal antibody (mAb) with the potential for development in hidradenitis suppurativa"
monoclonal antibody (mAb) medical
"AVTX-010 is an engineered anti-IL-1β mAb designed to extend dosing intervals"
A monoclonal antibody (mAb) is a lab-made protein engineered to recognize and stick to one specific molecule in the body, like a guided missile or a key fitting a single lock. For investors, mAbs matter because their clinical trial results, regulatory approvals, patent position and manufacturing complexity can drive a company’s future sales, costs and risk profile, making them major value drivers in healthcare stocks.
cash runway financial
"cash runway is expected to fund operations into 2029 including anticipated Phase 3 topline data"
Cash runway is the amount of time a company can continue operating using its available cash before needing additional funding or generating enough revenue. It’s like a countdown showing how long a business can keep running with its current funds. Knowing the cash runway helps investors assess the company's financial health and whether it has enough resources to reach its goals or needs to find more support soon.
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0001534120false00015341202026-06-162026-06-16


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549  

FORM 8-K
 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 16, 2026

AVALO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)  
Delaware
(State or other jurisdiction of incorporation)
001-3759045-0705648
(Commission File Number)(IRS Employer Identification No.)
1500 Liberty Ridge Drive, Suite 321, Wayne, Pennsylvania 19087
(Address of principal executive offices) (Zip Code)
Registrant’s Telephone Number, Including Area Code: (410) 522-8707

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐    Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 Par ValueAVTXNasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 8.01    Other Events.

On June 16, 2026, Avalo Therapeutics, Inc. (the “Company”) issued a press release announcing the advancement of AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody (mAb) with the potential for development in hidradenitis suppurativa (HS) as well as additional inflammatory disorders. A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The Company has posted on its website an updated investor presentation (the “Investor Presentation”). The Investor Presentation will be used from time to time in meetings with investors. A copy of the Investor Presentation is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1 and 99.2.

Item 9.01    Financial Statements and Exhibits.

(d)    Exhibits:

The following exhibits are being filed herewith:

Exhibit No. Description
99.1
Press release, dated June 16, 2026.
99.2
Investor Presentation, dated June 16, 2026.
104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AVALO THERAPEUTICS, INC.
Date: June 16, 2026By:/s/ Christopher Sullivan
Christopher Sullivan
Chief Financial Officer



1
Exhibit 99.1

avalo-logoxblk1.jpg
Avalo Therapeutics Expands Pipeline with AVTX-010, a Long-Acting Next-Generation Anti-IL-1β Antibody

•IND submission for AVTX-010 planned for the first half of 2027

WAYNE, PA, June 16, 2026 — Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced the advancement of AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody (mAb) with the potential for development in hidradenitis suppurativa (HS) as well as additional inflammatory disorders.

“Building on the strength of our abdakibart Phase 2 LOTUS topline data and our conviction in the IL-1β pathway, we believe developing a long-acting next-generation molecule is a natural and strategically important step in maximizing the full potential of our pipeline,” said Garry Neil, MD, Chief Executive Officer of Avalo Therapeutics. “Less frequent dosing is an important driver of physician and patient preference in chronic inflammatory diseases, and we believe AVTX-010 may further strengthen our potential in HS, while creating opportunities to expand into additional indications where extended dosing intervals may improve treatment convenience, adherence, and overall patient experience. We are also encouraged by the productive engagement with FDA, which enables a streamlined path to bring AVTX-010 to first-in-human studies. With the transformational financing completed in May, Avalo is excited to advance abdakibart into a pivotal phase 3 registrational program as well as expand our pipeline starting with AVTX-010.”

AVTX-010 is an engineered anti-IL-1β mAb designed to extend dosing intervals and build upon the differentiated profile established by abdakibart. AVTX-010 also has the potential to strengthen Avalo’s intellectual property position. The Company expects to submit an Investigational New Drug (IND) application for AVTX-010 in the first half of 2027.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, abdakibart, is an anti-IL-1β monoclonal antibody (mAb). Positive topline data was recently reported for abdakibart in a Phase 2 clinical trial in hidradenitis suppurativa (HS). In addition to HS, we’re exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. We are also advancing AVTX-010, an engineered anti-IL-1β mAb designed to extend dosing intervals and build upon the differentiated profile established by abdakibart. For more information about Avalo, please visit www.avalotx.com.


1

About Abdakibart

Abdakibart is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases.1 It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders. IL-1β inhibition has proven effective in multiple immune-mediated inflammatory diseases. 1-3

References:1Dinarello CA. Immunol Rev. 2018;281(1):8-27. 2Kany S et al. Int J Mol Sci. 2019;20(23):6008. 3Kimball AB et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA.

Forward-Looking Statements

This press release includes forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond our control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to our plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: therapeutic potential, clinical benefits and safety profiles of abdakibart (AVTX-009); plans to advance abdakibart into a registrational phase 3 program; plans to advance AVTX-010 into clinical trials; the timing of an IND submission for AVTX-010 in the first half of 2027; expectations regarding timing, success and data announcements of ongoing preclinical studies and clinical trials; drug development costs, reliance on investigators and enrollment of patients in clinical trials; and our plans to develop and commercialize our current and any future product candidates and the implementation of our business model and strategic plans for our business.

Any forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements including, without limitation, risks associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of our product candidates; the risk that the results of prior preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical studies and clinical trials, including those for abdakibart and AVTX-010; the timing and outcome of any interactions with regulatory authorities; obtaining, maintaining and protecting our intellectual property; the availability of funding sufficient for our operating expenses and capital expenditure requirements, reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in our filings with the Securities and Exchange Commission, available at www.sec.gov. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, any forward-looking statements represent our view only as of today and should not be relied upon as representing its views as of any subsequent date. You should not rely upon forward-looking statements as predictions of future events and actual results or events could differ materially from the plans, intentions and expectations disclosed herein. Except as required by applicable law, we expressly disclaim any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.


2

For media and investor inquiries

Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793

Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com
3
ne mission. Advancing an inspired pipeline of novel IL-1β therapies focused on treating unmet medical needs. CORPORATE OVERVIEW June 2026 | AVALO THERAPEUTICS, INC. (AVTX) Exhibit 99.2

 

Forward-Looking Statements This presentation includes forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond our control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to our plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: therapeutic potential, clinical benefits and safety profiles of abdakibart (AVTX-009) and AVTX- 010; expectations regarding timing, success and data announcements of ongoing preclinical studies and clinical trials; the preliminary cross-study assessments comparing non- head-to-head clinical data of abdakibart to published data for lutikizumab, sonelokimab, povorcitinib, bimekizumab, secukinumab and adalimumab; integration of abdakibart and AVTX-010 into our operations; drug development costs, reliance on investigators and enrollment of patients in clinical trials; our plans to develop and commercialize our current and any future product candidates and the implementation of our business model and strategic plans for our business, current; and any future product candidates. Any forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements including, without limitation, risks associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of our product candidates; the risk that the results of prior preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical studies and clinical trials, including those for abdakibart, the risk that cross-trial comparisons may not be reliable as no head-to-head trials have been conducted comparing abdakibart to lutikizumab, sonelokimab, povorcitinib, bimekizumab, secukinumab and adalimumab, and Phase 3 clinical data for abdakibart may not be directly comparable to clinical data of lutikizumab, sonelokimab, povorcitinib, bimekizumab, secukinumab and adalimumab due to differences in molecule composition, trial protocols, dosing regimens, and patient populations and characteristics; plans to advance AVTX-010 into clinical trials; the timing of an IND submission for AVTX-010 in the first half of 2027; the timing and outcome of any interactions with regulatory authorities; obtaining, maintaining and protecting our intellectual property; the availability of funding sufficient for our operating expenses and capital expenditure requirements, reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in our filings with the Securities and Exchange Commission, available at www.sec.gov. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, any forward-looking statements represent our view only as of today and should not be relied upon as representing its views as of any subsequent date. You should not rely upon forward-looking statements as predictions of future events and actual results or events could differ materially from the plans, intentions and expectations disclosed herein. Except as required by applicable law, we expressly disclaim any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Certain information contained in this presentation and statements made orally during this presentation relate to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. This presentation contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. 2

 

Avalo is targeting diseases of significance, like HS, that offer high growth and opportunity for meaningful patient impact • HS market expected to grow to > $10B by 20351 • Avalo continues to evaluate the potential of IL-1β inhibition across additional indications with high unmet need Two drug candidates with potential for best-in-class and best-in disease profile • Abdakibart: Positive Phase 2 topline data in moderate-to-severe Hidradenitis Suppurativa (HS); potentially leading efficacy, safety and dosing profile • AVTX-010: Long-acting next generation anti-IL-1β mAb expected to advance to IND in 1H 2027 Avalo Therapeutics: Advancing IL-1β Inhibition for Immune-Mediated Inflammatory Diseases 3 1. HS Market Research 2026. Avalo Data on File. Projected figures are based on management estimates and internal analyses, which rely on certain assumptions regarding growth in diagnosis and treated populations, biologic penetration rates and market dynamics IL-1β is a key immunoregulator with broad potential and established class safety Capitalized to deliver on upcoming milestones • Phase 3 initiation and AVTX-010 IND in 1H 2027 • $431.3M financing in May 2026; cash runway is expected to fund operations into 2029 including anticipated Phase 3 topline data

 

Avalo Management Team 4 A proven track record of successful leadership, product development, and commercialization in pharma and biotech Colleen Matkowski SVP, Global Regulatory Affairs, Quality Assurance Dino C. Miano, PhD SVP, CMC, Technical Operations Chris Sullivan Chief Financial Officer Mittie Doyle, MD Chief Medical Officer Paul Varki Chief Legal Officer Garry A. Neil, MD Chief Executive Officer Jennifer Riley Chief Strategy Officer 220+ Years of experience in biotech/pharmaAshley Ivanowicz SVP, Human Resources Taylor Boyd Chief Business Officer Kathleen Cohen SVP, Clinical Development Operations

 

Abdakibart: Building a New Standard in HS C O N F I D E N T I A L 5

 

Abdakibart: Building a New Standard in HS 6 HS, hidradenitis suppurativa; IL, interleukin; HiSCR, Hidradenitis Suppurativa Clinical Response. Note: The combined HiSCR50 abdakibart versus placebo analysis was performed post-hoc; Limitations exist in cross-trial comparisons across different phases of development. 1. Vossen ARJV, et al. J Invest Dermatol. 2020;140(7):1463-1466.e2; 2. Kelly G, et al. Br J Dermatol. 2015;173(6):1431-1439; 3. Kimball AB, et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA; 4. Sloan-Lancaster J, et al. Diabetes Care. 2013;36(8):2239-2246; 5. Data on file; 6. NCT04983732. Clinicaltrials.gov. Accessed September 5, 2024. https://clinicaltrials.gov/study/NCT04983732; 7. NCT00942188. Clinicaltrials.gov. Accessed September 5, 2024. https://clinicaltrials.gov/study/NCT00942188; 8. NCT00380744. Clinicaltrials.gov. Accessed September 5, 2024. https://clinicaltrials.gov/study/NCT00380744. Abdakibart (AVTX-009) highly potent, specific inhibitor of IL-1β • IL-1β (not IL-1α) is a key immunoregulator in HS, based on preclinical and clinical evidence1,2,3 Targeted Mechanism • 42.5% (p=0.004) combined HiSCR75 and 61.7% (p=0.0009) combined HiSCR50 were observed in the phase 2 LOTUS study in moderate-to-severe HS, the highest absolute response rates observed in a study of this size or larger • All secondary endpoints were statistically significant or numerically favorable • Response rates similar across doses and regardless of prior biologic exposure Compelling & Consistent Efficacy Response • ~500 patients studied in phase 1 and phase 2 trials4-8 • Abdakibart was well-tolerated. No adverse events related to neutropenia, serious or opportunistic infections Favorable Safety Profile • Potential for differentiated and patient friendly monthly dosing regimen starting at treatment initiation Simple Monthly Dosing

 

HS has Higher Growth and is Less Saturated than Other Dermatology I&I Markets 7 0% 5% 10% 15% 20% HS +18%1 Atopic dermatitis +9%2 Psoriasis +3%2 HS, hidradenitis suppurativa; U.S., United States. 1.HS Market Research 2026. Avalo Data on File. Projected figures are based on management estimates and internal analyses, which rely on certain assumptions regarding growth in diagnosis and treated populations, biologic penetration rates and market dynamics; Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61; 2. Evaluate Pharma; 3. FDA approval history as of June 2026 Comparison of Dermatology Projected Market Growth Rates (2025-2032 CAGR) • HS projected to be a $10B+ Global Therapeutics Market by 20351 • HS affects an estimated 1–4% of the population globally2 • ~100K biologic treated moderate-to- severe HS patients today in the U.S., increasing to ~40% share of segment1 • High unmet need and growth in diagnosis and treatment evidenced by the rapid adoption and quickly growing use of Cosentyx® and Bimzelx® Number of FDA advanced therapies for moderate-to- severe disease3 3 7 15

 

Chronic Inflammation in HS Progresses to Tissue Destruction 8 Photos from Mendes-Bastos P, et al. Front Med (Lausanne). 2024;11:1403455; Ovadja ZN, et al. Brit J Dermatol. 2019;181:243-244; Cotter C, Walsh S. Skin Health and Disease. 2021;1(1):e7. CC-BY-4.0 License.1. Diaz MJ, et al. Curr Issues Mol Biol. 2023;45:4400-4415; 2. Agnese ER, et al. Cureus. 2023;15(11):e49390; 3. de Oliveira ASLE, et al. Biomolecules. 2022;12(10):1371; 4. Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-1605. Long-term inflammatory dysregulation Formed from progressing abscesses Infection and malodorous discharge Scarring Follicular rupture Formed from follicular blockage DISEASE PROGRESSION TunnelsAbscessNodule Continued extracellular matrix breakdown and remodeling Nape of neck Breast/chest Buttocks and anus Inner thighs Groin and genitals Abdomen Armpit Areas commonly affected by HS include4: Back

 

Persistent Unmet Need in HS Despite Current Anti-TNF and Anti-IL-17 Biologic Therapies 9 HS, hidradenitis suppurativa. aCurrent HS biologics include Bimzelx®, Cosentyx®, Humira®. 1. Porter M, et al. presented at SHSA 2022, 2 Kimball AB et al., Presented at EADV 2023, 3. Kimball AB, et al. Lancet. 2024;403(10443):2504-2519; 4. Avalo Research, n=100 HS Treating physicians A Minority of Moderate to Severe HS Patients Obtain a Partial Response on Current HS Biologics Treatmentsa,1,2,3 % of Physicians Ranking Symptom Among Top 3 Most Burdensome to Patients Pain, Fistula and Malodorous Discharge Among the Most Burdensome HS Symptoms 4 23-36% Proportion of patients achieving HiSCR75 64-77% Proportion of patients not achieving HiSCR75 #1 Pain 73% #2 Draining Fistula 56% #3 Smell / Odor 43% #4 Inflammatory Nodules 40% #5 Abscesses 34% #6 Frequency of Flares 33%

 

IL-1β Plays a Central Role in the Pathophysiology of HS 10 DAMP, damage-associated molecular pattern molecule; DC, dendritic cell; HS, hidradenitis suppurativa; IL, interleukin; R, receptor; PAMP, pathogen-associated molecular pattern molecule. Figure adapted from Agnese ER et al. Cureus. 15(11):e49390. Creative Commons license, CC-BY 4.0. 1. Vossen ARJV, et al. J Invest Dermatol. 2020;140(7):1463-1466.e2; 2. Kelly G, et al. Br J Dermatol. 2015;173(6):1431-1439; 3. Agnese ER et al. Cureus. 15(11):e49390; 4. Kimball AB, et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA. • IL-1β is a key driver of the inflammatory cascade that leads to the destruction of the pilosebaceous unit • IL-1β gene expression is up to 100x increased in HS lesions compared to skin in healthy controls1,2 • IL-1β is upstream of IL-17 and TNFα, both major effectors of inflammation3 • Clinical benefit in HS has been observed with anti-IL-1 drugs4

 

0% 20% 40% 60% IL-1β is the Predominant IL-1 Isoform that Drives Chronic Inflammation in HS 11 HiSCR, hidradenitis suppurativa clinical response; HS, hidradenitis suppurativa; IL, interleukin; mAb, monoclonal antibody; QW, weekly, Q2W, every other week; wk, week. aFigure adapted from Kim JK et al. Creative commons license. CC-BY 4.0. 1. Kim JK, et al. JACI 2023;152:656-666; 2. ClinicalTrials.gov identifier: NCT04988308. Accessed September 5, 2024. https://clinicaltrials.gov/study/NCT04988308. IL-1 Expression in HS Skin1,a • IL-1β expression is elevated in HS skin vs no elevation of IL-1α1 • Suggests that anti-IL-1β agents may be more effective than anti-IL-1α in HS Phase 2 (interim analysis) NCT04988308 TRIAL 35/10535/105n/N 16 wk16 wkTime Lack of Clinical Data Supporting IL-1α Targeting in HS (HiSCR75) IL-1α Bermekimab2 1050 mg QW TNFα Adalimumab comparator 80 mg QW IL-1β IL-1α • Bermekimab, an IL-1α specific mAb, performed no better than placebo in a Phase 2 study with adalimumab comparator arm1,2 E xp re ss io n le ve l E xp re ss io n le ve l P ro p or tio n of p a tie nt s ac hi ev in g en dp oi n t Placebo Investigational drug (placebo adjusted)

 

Phase 2 LOTUS Study Designed to Evaluate the Efficacy and Safety of Abdakibart Treatment in Participants with Moderate-to-Severe HS 12 AN, abscess and inflammatory nodule; EOS, end of study; EOT, end of treatment; HiSCR, Hidradenitis Suppurativa Clinical Response; Q2W, every 2 weeks; Q4W, every 4 weeks; R, randomize; SC, subcutaneous. ClinicalTrials.gov/NCT06603077. • HS symptoms for ≥ 6 months prior to screening • Total AN count of ≥ 5 at baseline • HS lesions must be present in ≥ 2 distinct anatomic areas • At least one HS lesion that is Hurley stage II or III • Enrollment of patients who are both biologic naïve and biologic experienced Primary Endpoint: Proportion of participants achieving HiSCR75 at 16 weeks Abdakibart 600 mg SC loading dose then 300 mg SC Q4W Abdakibart 300 mg SC loading dose then 150 mg SC Q2W Placebo 6-week safety follow-up Screening day -28 to day -7 EOT WEEK Primary Study Endpoint Key Inclusion Criteria R 1:1:1 N=253 20181614121086420 EOSLast Dose

 

All Subjects N=253 Combined N=167 Abdakibart 300mg Q4W N=84 150mg Q2W N=83 Placebo N=86 38.438.739.038.437.7 Age (years, mean) 60.564.763.166.352.3Gender, female (%) 68.870.175.065.166.3Race, white (%) 35.135.734.936.433.9BMI (kg/m2, mean) 43.140.742.938.647.7Current smoker (%) 7.98.47.89.16.9Duration HS diagnosis (years, mean) 36.439.539.339.830.2Prior biologics use* (%) 5.96.04.87.25.8Concomitant Oral Antibiotic for HS (%) 42.343.144.042.240.7Hurley Stage III (%) 13.813.814.013.513.8AN count (mean) 2.93.03.22.72.8DT count (mean) 5.35.25.25.15.5Pain (NRS, mean) 14.813.513.313.617.5hs-CRP (mg/L, mean) Demographic and Baseline Characteristics 13 Q2W, every 2 weeks; Q4W, every 4 weeks; BMI, body mass index; AN, abscess and inflammatory nodule; DT, draining tunnel; hs-CRP, high sensitivity C-reactive protein *Prior treatment with adalimumab, secukinumab, and/or bimekizumab for the treatment of HS.

 

Primary Endpoint of HiSCR75 at Week 16 was Met for Each Active Dose Group and Both Groups Combined 14 Δ Difference between treatment arm and placebo; NRI: Non-response Imputation, Q2W, every 2 weeks; Q4W, every 4 weeks. Subjects who receive systemic rescue medication for HS or who discontinue due to an adverse event or lack of efficacy are treated as non-responders. Subjects with missing data are imputed as non-responders. Difference in responder rate and p-value are obtained using a Mantel-Haenszel (MH) test stratified by the randomization stratification factors. 25.6% 42.2% 42.9% 42.5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Placebo n=86 Abdakibart 150 mg Q2W n=83 Abdakibart 300 mg Q4W n=84 Combined Abdakibart Across Dose Arms n=167 H iS C R 75 R es po n de rs at W e ek 1 6 (N R I) ∆ 17.0%, p = 0.004 ∆ 17.2%, p = 0.015 ∆ 16.7%, p = 0.018

 

0% 10% 20% 30% 40% 50% STOP HS-2 Phase 3 STOP HS-1 Phase 3 Phase 2VELA-2 Phase 3 VELA-1 Phase 3 BE HEARD II Phase 3 BE HEARD I Phase 3 SUNSHINE Phase 3 SUNRISE Phase 3 PIONEER II Phase 3 PIONEER I Phase 3 LOTUS Phase 2TRIAL 208/619 202/608 39/15337/153276/417283/421291/509289/505181/361180/363163/326153/30784/25383/253 Sample Size Arm/Total Cross-Trial HiSCR75 Comparison Demonstrates Strong Efficacy 15 *NS, not statistically significant; HiSCR, hidradenitis suppurativa clinical response; IL, interleukin; JAK1, janus kinase 1; TNF, tumor necrosis factor; QD, daily; QW, weekly, Q2W, every other week; Q4W, every 4 weeks. Note: Data are derived from separate clinical trials with differences in design and patient populations. No head-to-head clinical trials have been conducted to date; cross-trial comparison limitations exist. All timepoints are at week 16 with the exception of povorcitnib (week 12). 1. LOTUS study. Avalo, unpublished data; 2. Porter M, et al. SHSA 2022, Poster 3814; 3. Kimball AB, et al. EADV Congress 2023, Abstract 4992; 4. Kimball AB, et al. Lancet. 2024;403(10443):2504-2519; 5. Moonlake VELA 1/2 Readout, September 29, 2025; 6. . Kimball AB, et al. JAMA Dermatol. Published online March 18, 2026; 7. Incyte STOP-HS1/2 Readout, March 17, 2025. P ro po rt io n of p at ie nt s ac hi ev in g H iS C R 75 Investigational drug Placebo response rate for study Sonelokimab5Bimekizumab4 Povorcitinib7Abdakibart1 Lutikizumab6Secukinumab3Adalimumab2 APPROVED HS THERAPIES 42.2% 42.9% 25% 35% 24% 27% 33% 36% 35% 34% *NS 46% Nominal p value 39% Nominal p value 25% *NS 28% SELECT PIPELINE THERAPIES 120 mg Q2W > Q4W320 mg Q2W 75 mg QD300 mg Q2W300 mg Q4W150 mg Q2W 300 mg Q2W 300 mg QW40 mg QW

 

HiSCR50 Response Rates were Statistically Significant Compared to Placebo in Both Abdakibart Arms 16 Δ Difference between treatment arm and placebo; NRI: Non-response Imputation, Q2W, every 2 weeks; Q4W, every 4 weeks. *The combined abdakibart versus placebo analysis was performed post-hoc. Subjects who receive systemic rescue medication for HS or who discontinue due to an adverse event or lack of efficacy are treated as non-responders. Subjects with missing data are imputed as non-responders. Difference in responder rate and p-value are obtained using a Mantel-Haenszel (MH) test stratified by the randomization stratification factors. 40.7% 59.0% 64.3% 61.7% 0% 10% 20% 30% 40% 50% 60% 70% Placebo n=86 Abdakibart 150 mg Q2W n=83 Abdakibart 300 mg Q4W n=84 Combined Abdakibart Across Dose Arms n=167 H iS C R 50 R es po n de rs at W e ek 1 6 (N R I) ∆ 21.1%, p = 0.0009* ∆ 23.6%, p = 0.001 ∆ 18.5%, p = 0.013

 

0% 10% 20% 30% 40% 50% 60% 70% STOP HS-2 Phase 3 STOP HS-1 Phase 3 Phase 2VELA-2 Phase 3 VELA-1 Phase 3 BE HEARD II Phase 3 BE HEARD I Phase 3 SUNSHINE Phase 3 SUNRISE Phase 3 PIONEER II Phase 3 PIONEER I Phase 3 LOTUS Phase 2TRIAL 208/619 202/608 39/15337/153276/417283/421291/509289/505181/361180/363163/326153/30784/25383/253 Sample Size Arm/Total Cross-Trial HiSCR50 Comparison Demonstrates Strong Efficacy 17 *NS, not statistically significant; HiSCR, hidradenitis suppurativa clinical response; IL, interleukin; JAK1, janus kinase 1; TNF, tumor necrosis factor; QD, daily; QW, weekly, Q2W, every other week; Q4W, every 4 weeks. Note: Data are derived from separate clinical trials with differences in design and patient populations. No head-to-head clinical trials have been conducted to date; cross-trial comparison limitations exist. All timepoints are at week 16 with the exception of povorcitnib (week 12) 1. LOTUS study. Avalo, unpublished data; 2. Kimball AB, et al. N Engl J Med. 2016;375:422-434; 3. Kimball AB, et al. Lancet. 2023;401(10378):747-761; 4. Kimball AB, et al. Lancet. 2024;403(10443):2504-2519; 5. Moonlake VELA 1/2 Readout, September 29, 2025; 6. Kimball AB, et al. JAMA Dermatol. Published online March 18, 2026; 7. Incyte STOP-HS1/2 Readout, March 17, 2025. P ro po rt io n of p at ie nt s ac hi ev in g H iS C R 50 Sonelokimab5 120 mg Q2W > Q4W Bimekizumab4 320 mg Q2W Povorcitinib7 75 mg QD300 mg Q2W Abdakibart1 300 mg Q4W150 mg Q2W Lutikizumab6 300 mg Q2W 300 mg QW Secukinumab3Adalimumab2 40 mg QW 42% 59% 42% 45% 48% 52% 51% 55% 60% *Nominal p value 49% *Nominal p value 41% *NS 43% 59.0% 64.3% Investigational drug Placebo response rate for study APPROVED HS THERAPIES SELECT PIPELINE THERAPIES

 

HiSCR75 Improvement Over Placebo Seen as Early as Week 4 for Both Abdakibart Treatment Groups 18 Weeks 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% 0 2 4 6 8 10 12 14 16 H iS C R 75 R es po n de rs by V is it (N R I) Placebo n=86 Abdakibart 150 mg Q2W n=83 Abdakibart 300 mg Q4W n=84 42.9%; p = 0.015 42.2%; p = 0.018 25.6% NRI: Non-response Imputation; Q2W, every 2 weeks; Q4W, every 4 weeks. Subjects who receive systemic rescue medication for HS or who discontinue due to an adverse event or lack of efficacy are treated as non-responders. Subjects with missing data are imputed as non-responders. Difference in responder rate and p-value are obtained using a Mantel-Haenszel (MH) test stratified by the randomization stratification factors.

 

25.6% 26.7% 23.1% 42.2% 48.0% 33.3% 42.9% 41.2% 45.5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% All Patients No Prior Biologic Use* Prior Biologic Use* H iS C R 75 R es po n de rs at W e ek 1 6 (N R I) Placebo Abdakibart 150 mg Q2W Abdakibart 300 mg Q4W n=86 n=83 n=84 n=60 n=50 n=51 n=26 n=33 n=33 HiSCR75 Responses were Similar in Patients with and without Prior Biologic Exposure 19 *Prior biologic use refers to treatment with adalimumab, secukinumab, and/or bimekizumab for the treatment of HS; NRI: Non-response Imputation; Q2W, every 2 weeks; Q4W, every 4 weeks. Subjects who receive systemic rescue medication for HS or who discontinue due to an adverse event or lack of efficacy are treated as non-responders. Subjects with missing data are imputed as non-responders. Difference in responder rate and p-value are obtained using a Mantel-Haenszel (MH) test stratified by the randomization stratification factors.

 

Key Secondary Endpoints were Statistically Significant or Numerically Improved Compared to Placebo 20 Δ Difference between treatment arm and placebo; AN, Abscess and Inflammatory Nodule; IHS4: International Hidradenitis Suppurativa Severity Score System; NRI, Non-Response Imputation; NRS, Numerical Rating Scale;.Q2W, every 2 weeks; Q4W, every 4 weeks 1. Least square means are based on a mixed effects model for repeated measures (MMRM). 2. Flare defined as at least a 25% increase in the total AN count, plus an increase of >=2 in AN count compared to baseline. Subjects who receive systemic rescue medication for HS or who discontinue due to an adverse event or lack of efficacy are treated as having a flare. Subjects with missing Week 16 data are imputed as having a flare 3. For the analysis at Week 16, placebo, N=67; abdakibart 150 mg Q2W, N=72; abdakibart 300 mg Q4W N=74. 4. Subjects who receive systemic rescue medication for HS or who discontinue due to an adverse event or lack of efficacy are treated as non-responders. Subjects with missing data are imputed as non-responders. 5. Among subjects with Baseline Pain NRS >=3; placebo, N=71; abdakibart 150 mg Q2W, N=63; abdakibart 300 mg Q4W, N=67. The score is derived from the weekly average of daily responses. Response criteria are met if there is at least a 30% reduction and at least a 1-unit reduction from Baseline. Difference in rate and p-value are obtained using a Mantel-Haenszel (MH) test stratified by the randomization stratification factors. LS mean, difference in LS mean, and p-value are based on a mixed effects model for repeated measures (MMRM). AbdakibartPlacebo 300 mg Q4W N=84 150 mg Q2W N=83N=86Secondary Endpoints -15.9 p = 0.002 -14.5 p = 0.012 -8.2 IHS4 change from Baseline (LS mean) 1 -1.8 p = 0.008 -1.8 p = 0.006 -0.6 Draining Tunnel Count change from baseline (LS mean) 1 21.4% ∆ -15.8 p = 0.021 24.1% ∆ -13.3 p = 0.058 37.2%Flare Rate (NRI) 2 -9.1 ∆ -3.2 p = 0.008 -7.8 ∆ -1.9 p = 0.111 -5.8AN change from Baseline (LS mean) 3 23.8% ∆ 9.7% p = 0.100 22.9% ∆ 9.2% p = 0.116 14.0%HiSCR90 Responder Rate (NRI) 4 37.3% ∆ 13.7% p = 0.076 27.0% ∆ 4.1% p = 0.586 23.9%PGA Skin Pain NRS30 Responder Rate (NRI) 4,5

 

AbdakibartPlacebo 300 mg Q4W N=83 150 mg Q2W N=83N=86# of Subjects (%) 46 (55.4)43 (51.8)46 (53.5)Any TEAE* 1 (1.2)2 (2.4)2 (2.3)Any TESAE 1 (1.2)00 Non-cardiac chest pain 01 (1.2)0 Major depressive disorder 01 (1.2)2 (2.3)Hidradenitis 1 (1.2)2 (2.4)2 (2.3) Any TEAE leading to study drug discontinuation 000Deaths Favorable Safety and Tolerability Profile Rates of TEAEs, Including SAEs were Similar to Placebo; Few adverse events of special interest 21 MACE: major adverse cardiovascular event; Q2W, every 2 weeks; Q4W, every 4 weeks; TEAE: Treatment Emergent Adverse Event; TESAE: Treatment Emergent Serious Adverse Event; SAE: Serious Adverse Event One subject randomized to abdakibart 300 mg Q4W did not receive study drug and therefore is not included in safety population. *The most common TEAEs reported in both abdakibart arms were headache and nausea. One subject randomized to abdakibart 300 mg Q4W did not receive study drug and therefore is not included in safety population. AbdakibartPlacebo 300 mg Q4W N=83 150 mg Q2W N=83N=86# of Subjects (%) 000 Hypersensitivity reaction 5 (6.0)3 (3.6)4 (4.7) Injection site reaction 000Leukopenia 000Neutropenia 000Serious infections 000MACE 000Malignancy 000 Opportunistic infections 000Tuberculosis

 

Sonelokimab2Lutikizumab1Abdakibart Day 1 & 15 QW for first four weeks Q2W for first 16 weeks Q2W for first 6 weeks QW for first 16 weeks Single loading dose Loading / induction dosing QW or Q2WQ2W or Q4WQ4WQ4WQW or Q2WQ4W Maintenance dosing 8-147-1086164 Total # of doses in first 16 weeks 26-5016-28171534-5213 Total # of doses in first year of therapy Differentiated Monthly Dosing Regimen Starting at Treatment Initiation 22 1. ClinicalTrials.gov NCT06468228; 2. ClincialTrials.gov NCT06411899; 3. BIMZELX® package insert, UCB Inc. 2024; 4. COSENTYX® package insert, Novartis Pharmaceuticals Corp. 2024; 5. HUMIRA® package insert, AbbVie Inc. 2024 SELECT INVESTIGATIONAL THERAPIES APPROVED HS THERAPIES 3 4 5

 

AVTX-010: Long Acting Next Generation IL-1β Program C O N F I D E N T I A L 23

 

AVTX-010: Long-Acting Next Generation IL-1β Program • Engineered anti-IL-1β mAb designed for extended dosing interval • Streamlined path to first-in-human study • Potential new Avalo intellectual property • Planned for development as follow-on to abdakibart in HS as well as in additional IL-1β driven immune-mediated inflammatory disorders • IND submission planned in H1 2027 24IND, investigational new drug application.

 

Upcoming Milestones C O N F I D E N T I A L 25

 

Anticipated Upcoming Milestones 26IND, investigational new drug application. 1H 2027 Strong Track Record of Legacy Milestone Execution • Initiate Phase 3 registrational HS program • IND for AVTX-010 2H 2026 • End of Phase 2 regulatory discussions • March 2024 Merger with AlmataBio • July 2024 Active IND for abdakibart • October 2024 First Patient Enrolled in Phase 2 LOTUS Study • October 2025 Enrollment Completed • May 2026 LOTUS Topline Data

 

Broad Potential for Indication Expansion: Clinical Rationale for IL-1 Targeting Therapies in Additional Disease States 27 CRP, C-reactive protein; CV, cardiovascular; DIRA, deficiency of interleukin receptor 1 antagonist; HS, hidradenitis suppurativa; IBD, inflammatory bowel disease; MI, myocardial infarction; OA, osteoarthritis; RA, rheumatoid arthritis. 1. Ilaris. Package insert. Novartis Pharmaceuticals Corporation; 2023; 2. Kineret. Package insert. Swedish Orphan Biovitrum AB; 3. Schieker, et al. Annals of Internal Medicine. 2020;173(7):509-515; 4. Arcalyst. Package insert. Kiniksa Pharmaceuticals (UK), Ltd.; 2021; 5. Ridker, et al. NEJM . 2017;377(12):1119-1131; 6. Mao L, et al. Front Immunol.2018;9:2566. • While not a current focus for Avalo, IL-1 targeting therapies approved in rare autoinflammatory diseases (e.g., periodic fevers, DIRA, Still’s disease and recurrent pericarditis)1,2,4 • CANTOS study (Novartis): canakinumab reduced major CV events in patients with prior MI and elevated CRP5 • Additional indications with supporting mechanistic and clinical rationale including inflammatory bowel disease6 • IL-1 targeting therapies approved in RA and acute gout flare1,2 • CANTOS study (Novartis): IL-1β blockage with canakinumab reduced total joint replacements in OA patients with high CRP3 • Mechanistic rationale extends to other crystal-induced arthropathies (e.g., CPPD) Arthritis Indications Additional Indications with Established Clinical Proof of Concept Avalo is currently assessing additional immunology indications for investment

 

Avalo is targeting diseases of significance, like HS, that offer high growth and opportunity for meaningful patient impact • HS market expected to grow to > $10B by 20351 • Avalo continues to evaluate the potential of IL-1β inhibition across additional indications with high unmet need Two drug candidates with potential for best-in-class and best-in disease profile • Abdakibart: Positive Phase 2 topline data in moderate-to-severe Hidradenitis Suppurativa (HS); potentially leading efficacy, safety and dosing profile • AVTX-010: Long-acting next generation anti-IL-1β mAb expected to advance to IND in 1H 2027 Avalo Summary (NASDAQ: AVTX) 28 1. HS Market Research 2026. Avalo Data on File. Projected figures are based on management estimates and internal analyses, which rely on certain assumptions regarding growth in diagnosis and treated populations, biologic penetration rates and market dynamics IL-1β is a key immunoregulator with broad potential and established class safety Capitalized to deliver on upcoming milestones • Phase 3 initiation and AVTX-010 IND in 1H 2027 • $431.3M financing in May 2026; cash runway is expected to fund operations into 2029 including anticipated Phase 3 topline data

 

NASDAQ: AVTX www.avalotx.com 29

 

Appendix 30

 

Key Financial Metrics 31 1. Cash, cash equivalents and investments, common shares outstanding, preferred shares outstanding, and pre-funded warrants as of May 31, 2026 are preliminary, unaudited and subject to change, 2. Does not include 5.9M of stock options, restricted stock units and performance stock units outstanding resulting in a fully dilutive share count of 68.3M as of May 31, 2026, 3. As of May 29, 2026 since the market was closed on May 31, 2026 Cash, cash equivalents and investments of approximately $479M as of May 31, 20262, provides expected runway into 2029 Number of SharesAs of May 31, 2026 52.6MCommon shares outstanding1Common stock 9.8MPreferred stock & pre-funded warrants1Assuming conversion of preferred stock and pre-funded warrants 62.4MAdjusted common shares outstanding1,2Adjusted share count $15.953Stock price Adjusted market capitalization $995.3MAdjusted market capitalization

 

Source: View Original Filing on SEC EDGAR

FAQ

What did Avalo Therapeutics (AVTX) announce about AVTX-010 in this 8-K?

Avalo announced advancement of AVTX-010, a long-acting next-generation anti-IL‑1β monoclonal antibody. It plans to submit an Investigational New Drug (IND) application in the first half of 2027, targeting hidradenitis suppurativa (HS) and additional immune-mediated inflammatory disorders.

How did abdakibart perform in the Phase 2 LOTUS hidradenitis suppurativa trial for AVTX?

In the Phase 2 LOTUS trial, abdakibart achieved a 42.5% HiSCR75 response at week 16 across active arms, compared with 25.6% on placebo. HiSCR50 responses were 61.7% for abdakibart versus 40.7% for placebo, with secondary endpoints generally favorable.

What safety profile did Avalo report for abdakibart in HS patients?

Avalo reported a favorable safety and tolerability profile for abdakibart. Rates of treatment-emergent and serious adverse events were similar to placebo, with limited events of special interest such as serious infections, malignancy, neutropenia, or opportunistic infections in the Phase 2 LOTUS study.

What is Avalo Therapeutics’ cash position and runway according to the investor presentation?

Avalo reported approximately $479 million in cash, cash equivalents and investments as of May 31, 2026. Management states this capital is expected to fund operations into 2029, including the planned phase 3 hidradenitis suppurativa program and AVTX‑010 development milestones.

How large is the hidradenitis suppurativa market Avalo is targeting with AVTX-009 and AVTX-010?

Avalo cites research projecting the global hidradenitis suppurativa therapeutics market to exceed $10 billion by 2035. The company views HS as a high-growth, under-served segment where IL‑1β inhibition with abdakibart and AVTX‑010 may offer meaningful clinical and commercial opportunities.

What are Avalo Therapeutics’ key upcoming milestones mentioned in the filing?

Key milestones include initiation of a phase 3 registrational HS program for abdakibart and submission of an IND for AVTX-010 in 1H 2027. The company also highlights prior execution milestones such as completing LOTUS enrollment and reporting topline Phase 2 data.

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