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Investor releaseQuarter not tagged2026-08-06Avalo Therapeutics Reports Second Quarter 2026 Financial Results and Recent Business Updates
GlobeNewswire
Avalo Therapeutics Reports Second Quarter 2026 Financial Results and Recent Business Updates
Plans to initiate a registrational Phase 3 program evaluating abdakibart in hidradenitis suppurativa (HS) in the first half of 2027 Expanded pipeline with AVTX-010, a long-acting next-generation anti-IL-1β antibody, with IND submission planned for the first half of 2027 Appointed Ron Philip to the Board of Directors Cash, cash equivalents and investments of $472.2 million as of June 30, 2026, expected to provide runway into 2029 WAYNE, Pa., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases, today announced business updates and financial results for the second quarter of 2026. “In the second quarter, we achieved the key objectives that positioned Avalo for its next phase of growth,” said Garry Neil, MD, Chief Executive Officer of Avalo. “We delivered positive topline Phase 2 LOTUS results for abdakibart in HS, secured the capital to take it into a registrational Phase 3 program in HS, and expanded our pipeline with AVTX-010, a long-acting next-generation anti-IL-1β antibody. Our focus now is execution – starting with advancing abdakibart, which we believe has the potential to offer best in disease efficacy, safety and dosing convenience, toward Phase 3 initiation in HS as well as building a broader IL-1β franchise.” Recent Corporate Highlights and Upcoming Anticipated Milestones Avalo plans to initiate a registrational Phase 3 program evaluating abdakibart in HS in the first half of 2027. Announced the advancement of AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody with the potential for development in HS as well as other inflammatory disorders. The Company expects to submit an Investigational New Drug (IND) application in the first half of 2027. Appointed Ron Philip to its Board of Directors. Ron contributes deep strategic and commercial expertise, with a proven track record of bringing novel therapies to market. Added to the Russell 2000® and Russell 3000® Indexes as part of the FTSE Russell annual reconstitution. Second Quarter 2026 Financial Update Cash, cash equivalents and investments were $472.2 million as of June 30, 2026. Net cash used in operating activities was $37.7 million for the six months ended June 30, 2026. Avalo’s current cash, cash equivalents, and i…Read full documentShow less
Plans to initiate a registrational Phase 3 program evaluating abdakibart in hidradenitis suppurativa (HS) in the first half of 2027 Expanded pipeline with AVTX-010, a long-acting next-generation anti-IL-1β antibody, with IND submission planned for the first half of 2027 Appointed Ron Philip to the Board of Directors Cash, cash equivalents and investments of $472.2 million as of June 30, 2026, expected to provide runway into 2029 WAYNE, Pa., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases, today announced business updates and financial results for the second quarter of 2026. “In the second quarter, we achieved the key objectives that positioned Avalo for its next phase of growth,” said Garry Neil, MD, Chief Executive Officer of Avalo. “We delivered positive topline Phase 2 LOTUS results for abdakibart in HS, secured the capital to take it into a registrational Phase 3 program in HS, and expanded our pipeline with AVTX-010, a long-acting next-generation anti-IL-1β antibody. Our focus now is execution – starting with advancing abdakibart, which we believe has the potential to offer best in disease efficacy, safety and dosing convenience, toward Phase 3 initiation in HS as well as building a broader IL-1β franchise.” Recent Corporate Highlights and Upcoming Anticipated Milestones Avalo plans to initiate a registrational Phase 3 program evaluating abdakibart in HS in the first half of 2027. Announced the advancement of AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody with the potential for development in HS as well as other inflammatory disorders. The Company expects to submit an Investigational New Drug (IND) application in the first half of 2027. Appointed Ron Philip to its Board of Directors. Ron contributes deep strategic and commercial expertise, with a proven track record of bringing novel therapies to market. Added to the Russell 2000® and Russell 3000® Indexes as part of the FTSE Russell annual reconstitution. Second Quarter 2026 Financial Update Cash, cash equivalents and investments were $472.2 million as of June 30, 2026. Net cash used in operating activities was $37.7 million for the six months ended June 30, 2026. Avalo’s current cash, cash equivalents, and investments are expected to fund operations into 2029. Research and development expenses were $23.4 million for the second quarter of 2026, an increase of $9.3 million from the second quarter of 2025, driven by the recognition of a $10.0 million development milestone for abdakibart, as well as costs related to and supporting the development of abdakibart in HS. General and administrative expenses were $8.1 million for the second quarter of 2026, an increase of $2.9 million from the second quarter of 2025, primarily driven by stock-based compensation expense. Net loss was $36.4 million for the second quarter of 2026, an increase of $15.6 million from the second quarter of 2025. The difference was mainly driven by a $12.2 million increase in operating expenses due to the $9.3 million increase in research and development expenses and $2.9 million increase in general and administrative expenses, as discussed above. Basic and diluted net loss per share was $0.83 and $1.92 for the second quarters of 2026 and 2025, based on 43,602,044 and 10,829,760 weighted average common shares outstanding, respectively. The consolidated balance sheets as of June 30, 2026 and December 31, 2025 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements. The unaudited consolidated statements of operations for the three and six months ended June 30, 2026 and 2025 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1-4% of the population globally. Avalo is pursuing additional development opportunities in IL-1β driven indications. Avalo is also developing AVTX-010, a long-acting next-generation anti-IL-1β mAb. For more information about Avalo, please visit www.avalotx.com. 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. 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. About AVTX-010 AVTX-010 is an Fc-engineered, long-acting anti-IL-1β monoclonal antibody designed to extend half-life while preserving the pharmacology and specificity of abdakibart. 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; our financial condition and expected cash runway into 2029; 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. For media and investor inquiriesChristopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] or Meru AdvisorsLauren [email protected]
Investor releaseQuarter not tagged2026-05-13Avalo Therapeutics Reports First Quarter 2026 Financial Results and Recent Business Updates
GlobeNewswire
Avalo Therapeutics Reports First Quarter 2026 Financial Results and Recent Business Updates
Achieved positive topline results in Phase 2 LOTUS trial of abdakibart in moderate to severe hidradenitis suppurativa (HS) and plan to advance into a registrational phase 3 program Completed public offering of equity securities for gross proceeds of $431.3 million Cash, cash equivalents, and short-term investments of $82 million as of March 31, 2026, not including the subsequent financing WAYNE, Pa., May 13, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) (“Avalo”), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and first quarter 2026 financial results. “The positive Phase 2 LOTUS trial results of abdakibart in HS, which demonstrated a deep and consistent clinical response across both HiSCR75 and HiSCR50 endpoints, mark the beginning of a transformative period for Avalo,” said Garry Neil, MD, Chief Executive Officer of Avalo. “With our recently secured financing, Avalo is well-positioned to advance abdakibart into a registrational phase 3 program. Our focus remains on delivering this innovative mechanism of action via a patient-friendly potential monthly dosing regimen to provide a much-needed new treatment option for those living with HS.” Recent Corporate Highlights: On May 5, 2026, Avalo reported positive topline Phase 2 LOTUS results for abdakibart in adults with moderate to severe HS. The trial successfully met its primary endpoint at both doses studied (p=0.018 150mg, p=0.015 300mg and p=0.004, combined), demonstrating a 42.2% and 42.9% absolute improvement in HiSCR75 response rates at Week 16, respectively (42.5% combined; placebo rate 25.6%). These results represented the highest absolute improvement in HiSCR75 and HiSCR50 reported in similarly sized (or larger) HS trials at each individual dose and on a combined dose basis. Abdakibart also demonstrated statistically significant benefit across the key secondary endpoints, including HiSCR50, change in IHS4, and change in draining tunnel count. On May 7, 2026, Avalo completed an underwritten public offering of its common stock and pre-funded warrants to purchase shares of common stock for gross proceeds of $431.3 million. On April 26, 2026, Avalo entered into a Milestone Buyout Option and Amendment Agreement related to its March 2024 acquisition of AlmataBio, Inc. Un…Read full documentShow less
Achieved positive topline results in Phase 2 LOTUS trial of abdakibart in moderate to severe hidradenitis suppurativa (HS) and plan to advance into a registrational phase 3 program Completed public offering of equity securities for gross proceeds of $431.3 million Cash, cash equivalents, and short-term investments of $82 million as of March 31, 2026, not including the subsequent financing WAYNE, Pa., May 13, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) (“Avalo”), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and first quarter 2026 financial results. “The positive Phase 2 LOTUS trial results of abdakibart in HS, which demonstrated a deep and consistent clinical response across both HiSCR75 and HiSCR50 endpoints, mark the beginning of a transformative period for Avalo,” said Garry Neil, MD, Chief Executive Officer of Avalo. “With our recently secured financing, Avalo is well-positioned to advance abdakibart into a registrational phase 3 program. Our focus remains on delivering this innovative mechanism of action via a patient-friendly potential monthly dosing regimen to provide a much-needed new treatment option for those living with HS.” Recent Corporate Highlights: On May 5, 2026, Avalo reported positive topline Phase 2 LOTUS results for abdakibart in adults with moderate to severe HS. The trial successfully met its primary endpoint at both doses studied (p=0.018 150mg, p=0.015 300mg and p=0.004, combined), demonstrating a 42.2% and 42.9% absolute improvement in HiSCR75 response rates at Week 16, respectively (42.5% combined; placebo rate 25.6%). These results represented the highest absolute improvement in HiSCR75 and HiSCR50 reported in similarly sized (or larger) HS trials at each individual dose and on a combined dose basis. Abdakibart also demonstrated statistically significant benefit across the key secondary endpoints, including HiSCR50, change in IHS4, and change in draining tunnel count. On May 7, 2026, Avalo completed an underwritten public offering of its common stock and pre-funded warrants to purchase shares of common stock for gross proceeds of $431.3 million. On April 26, 2026, Avalo entered into a Milestone Buyout Option and Amendment Agreement related to its March 2024 acquisition of AlmataBio, Inc. Under the agreement, Avalo paid the former AlmataBio securityholders $2.25 million for an option, exercisable within 90 days of the effective date, to pay $5.125 million in cash or shares of Avalo common stock (or a combination) in lieu of the previously disclosed $15 million contingent milestone payment due upon dosing the first patient in a Phase 3 trial of abdakibart. First Quarter 2026 Financial Update: Cash, cash equivalents and short-term investments were $82.0 million as of March 31, 2026. Net cash used in operating activities was $17.7 million for the three months ended March 31, 2026. Subsequent to March 31, 2026, the Company completed an underwritten public offering of its common stock and pre-funded warrants for net proceeds of approximately $405.0 million. Our current cash, cash equivalents, and short-term investments are expected to fund operations into 2029. Research and development expenses were $14.0 million for the three months ended March 31, 2026, an increase of $4.9 million from the prior year, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $6.9 million for the three months ended March 31, 2026, an increase of $1.3 million from the prior year, primarily driven by headcount additions and stock-based compensation expense. Net loss was $19.6 million for the three months ended March 31, 2026, as compared to net loss of $13.1 million for the three months ended March 31, 2025. The difference was driven by a $6.2 million increase in operating expenses due to the $4.9 million increase in research and development expenses, as discussed above, and $1.3 million increase in general and administrative expenses, as discussed above. Basic and diluted net loss per share was $0.98 and $1.25 for the three months ended March 31, 2026 and 2025, based on 20,106,925 and 10,514,901 weighted average common shares outstanding, respectively. Consolidated Balance Sheets (In thousands, except share and per share data) The consolidated balance sheets as of March 31, 2026 and December 31, 2025 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements. Consolidated Statements of Operations (In thousands, except per share data) The consolidated statements of operations for the three months ended March 31, 2026 and 2025 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. 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). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com. 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 About the LOTUS Trial The LOTUS trial was a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two dose regimens to evaluate the efficacy, safety and tolerability of abdakibart in approximately 250 adults with moderate to severe hidradenitis suppurativa. Subjects were randomized (1:1:1) to receive either one of two dosing regimens of abdakibart or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining tunnel count, abscess and inflammatory nodule (AN) count, and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). For additional information this trial (NCT06603077), please visit www.clinicaltrials.gov or www.lotustrial.com. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic, progressive, often debilitating inflammatory skin disease that causes painful nodules, abscesses, and tunnels to form under the skin.4-6,8 Areas commonly affected by HS include the nape of the neck, breasts, chest, armpits, abdomen, buttocks and anus, groin and genitals, and inner thighs.7 If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.4-6,9 HS typically first presents in late adolescence or early adulthood and is estimated to affect 0.7–1.2% of the U.S. population, though some sources suggest the prevalence may be as high as 2–4%.10,11,12 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. 4Diaz MJ, et al. Curr Iss Mol Bio. 2023;45:4400-4415. 5Agnese ER, et al. Cureus. 2023;15(11):e49390. 6de Oliveira ASLE, et al. Biomolecules. 2022;12(10):1371. 7Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-160. 8Sabat R, et al. The Lancet. 2025;405(10476):P420-438. 9Jemec GB. Clinicalpractice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–164. 10Garg A, Kirby JS, Lavian J, Lin G, Strunk A. Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States. JAMA Dermatol. 2017;153(8):760–764. doi:10.1001/jamadermatol.2017.0201. 11Ingram, John R.British Journal of Dermatology. doi:10.1111/bjd.19435. 12Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61. 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; 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; the risk that cross-trial comparisons may not be reliable as no head-to-head trials of abdakibart have been conducted; 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. For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] 410-803-6793 Meru Advisors Lauren Glaser [email protected]
Investor releaseQuarter not tagged2026-05-06Avalo Therapeutics Achieves Positive Topline Results in Phase 2 LOTUS Trial of Abdakibart (AVTX-009) in Moderate to Severe Hidradenitis Suppurativa
GlobeNewswire
Avalo Therapeutics Achieves Positive Topline Results in Phase 2 LOTUS Trial of Abdakibart (AVTX-009) in Moderate to Severe Hidradenitis Suppurativa
Successfully met primary endpoint of HiSCR75 for both doses studied, demonstrating response rates of 42.2% for 150 mg dose (p=0.018) and 42.9% for 300 mg dose (p=0.015) at Week 16, which are the highest rates observed in a trial of this size or larger Statistically significant benefit was demonstrated on key secondary endpoints of HiSCR50, change in IHS4 and change in draining tunnel count Abdakibart was well tolerated with a favorable safety profile Avalo plans to advance abdakibart into a registrational phase 3 program WAYNE, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- 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 positive topline results from its Phase 2 LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS). The LOTUS trial successfully met its primary endpoint at both doses studied. Based on these data, Avalo plans to advance abdakibart into a registrational phase 3 program. "We are proud to report that abdakibart has delivered a strong, consistent, and deep response across both the HiSCR75 and HiSCR50 endpoints in our Phase 2 trial. This achievement powerfully validates the clinical promise of IL-1β inhibition for hidradenitis suppurativa," said Garry Neil, MD, Chief Executive Officer of Avalo Therapeutics. “This de-risking data set gives us tremendous confidence to advance abdakibart into a pivotal phase 3 registrational program. With a differentiated and patient friendly potential monthly dosing regimen, we aim to offer a truly innovative mechanism of action to the HS community. Our heartfelt thank you goes to the patients, caregivers, investigators, and site teams whose dedication made this successful Phase 2 trial possible." The LOTUS trial (NCT06603077), which enrolled 253 adults, was a randomized, double-blind, placebo-controlled parallel-group Phase 2 trial to evaluate the efficacy, safety and tolerability of abdakibart across two dose regimens and placebo in a 1:1:1 ratio over a 16-week treatment period. Subjects received either a 600mg loading dose of abdakibart followed by 300mg every four weeks or a 300mg loading dose followed by 150mg every two weeks. The trial’s primary efficacy endpoint was the proportion of patients achieving HiSCR…Read full documentShow less
Successfully met primary endpoint of HiSCR75 for both doses studied, demonstrating response rates of 42.2% for 150 mg dose (p=0.018) and 42.9% for 300 mg dose (p=0.015) at Week 16, which are the highest rates observed in a trial of this size or larger Statistically significant benefit was demonstrated on key secondary endpoints of HiSCR50, change in IHS4 and change in draining tunnel count Abdakibart was well tolerated with a favorable safety profile Avalo plans to advance abdakibart into a registrational phase 3 program WAYNE, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- 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 positive topline results from its Phase 2 LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS). The LOTUS trial successfully met its primary endpoint at both doses studied. Based on these data, Avalo plans to advance abdakibart into a registrational phase 3 program. "We are proud to report that abdakibart has delivered a strong, consistent, and deep response across both the HiSCR75 and HiSCR50 endpoints in our Phase 2 trial. This achievement powerfully validates the clinical promise of IL-1β inhibition for hidradenitis suppurativa," said Garry Neil, MD, Chief Executive Officer of Avalo Therapeutics. “This de-risking data set gives us tremendous confidence to advance abdakibart into a pivotal phase 3 registrational program. With a differentiated and patient friendly potential monthly dosing regimen, we aim to offer a truly innovative mechanism of action to the HS community. Our heartfelt thank you goes to the patients, caregivers, investigators, and site teams whose dedication made this successful Phase 2 trial possible." The LOTUS trial (NCT06603077), which enrolled 253 adults, was a randomized, double-blind, placebo-controlled parallel-group Phase 2 trial to evaluate the efficacy, safety and tolerability of abdakibart across two dose regimens and placebo in a 1:1:1 ratio over a 16-week treatment period. Subjects received either a 600mg loading dose of abdakibart followed by 300mg every four weeks or a 300mg loading dose followed by 150mg every two weeks. The trial’s primary efficacy endpoint was the proportion of patients achieving HiSCR75 at Week 16. The Phase 2 LOTUS trial successfully met its primary endpoint at both doses studied (p=0.018 150mg, p=0.015 300mg and p=0.004 combined), demonstrating a 42.2% and 42.9% absolute improvement in HiSCR75 response rates at Week 16, respectively (42.5% combined, placebo rate 25.6%). This was the highest absolute improvement in HiSCR75 and HiSCR50 in clinical trials of this size or larger at each individual dose and on a combined dose basis. Abdakibart regimens also demonstrated statistically significant benefit across the key secondary endpoints in HiSCR50, change in IHS4 and change in draining tunnel count. Numerically favorable responder rates were observed across all other key secondary endpoints. The HiSCR75 response was similar in patients with and without prior biologic exposure. “These Phase 2 results are highly promising for the HS community,” said Dr. John Frew, Professor of Dermatology, University of New South Wales, Sydney, Australia. “Achieving this level of improvement suggests that IL-1β inhibition with abdakibart may offer a meaningful new therapeutic option for people with HS who continue to struggle with this disease. The physical and emotional burden of HS is profound, and I am encouraged to see an investigational therapy showing such robust and clinically relevant results.” Across the study, abdakibart was well tolerated. The percentage of subjects with treatment-emergent adverse events (TEAE) were similar across abdakibart treatment arms and placebo with the most common being headache and nausea. Most adverse events were mild to moderate, and no unexpected safety findings emerged during the 16-week treatment period. There were no adverse events related to neutropenia, serious infections, or opportunistic infections. Avalo expects to present full results from the LOTUS trial at an upcoming medical congress. About Avalo Therapeutics Avalo Therapeutics (Nasdaq: AVTX) 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). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com. 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 About the LOTUS Trial The LOTUS trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two dose regimens to evaluate the efficacy, safety and tolerability of abdakibart in approximately 250 adults with moderate to severe hidradenitis suppurativa. Subjects were randomized (1:1:1) to receive either one of two dosing regimens of abdakibart or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining tunnel count, abscess and inflammatory nodule (AN) count, and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). For additional information about this trial (NCT06603077), please visit www.clinicaltrials.gov or www.lotustrial.com. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic, progressive, often debilitating inflammatory skin disease that causes painful nodules, abscesses, and tunnels to form under the skin.4-6,8 Areas commonly affected by HS include the nape of the neck, breasts, chest, armpits, abdomen, buttocks and anus, groin and genitals, and inner thighs.7 If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.4-6,9 HS typically first presents in late adolescence or early adulthood and is estimated to affect 0.7–1.2% of the U.S. population, though some sources suggest the prevalence may be as high as 2–4%.10,11,12 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. 4Diaz MJ, et al. Curr Iss Mol Bio. 2023;45:4400-4415. 5Agnese ER, et al. Cureus. 2023;15(11):e49390. 6de Oliveira ASLE, et al. Biomolecules. 2022;12(10):1371. 7Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-160. 8Sabat R, et al. The Lancet. 2025;405(10476):P420-438. 9Jemec GB. Clinicalpractice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–164. 10Garg A, Kirby JS, Lavian J, Lin G, Strunk A. Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States. JAMA Dermatol. 2017;153(8):760–764. doi:10.1001/jamadermatol.2017.0201. 11Ingram, John R.British Journal of Dermatology. doi:10.1111/bjd.19435. 12Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61. 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; 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; the risk that cross-trial comparisons may not be reliable as no head-to-head trials of abdakibart have been conducted; 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. For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] 410-803-6793 or Meru Advisors Lauren Glaser [email protected]
Investor releaseQuarter not tagged2026-03-23Avalo Therapeutics Reports 2025 Financial Results and Recent Business Updates
GlobeNewswire
Avalo Therapeutics Reports 2025 Financial Results and Recent Business Updates
Topline data expected from Phase 2 LOTUS trial of abdakibart (AVTX-009) for the treatment of hidradenitis suppurativa in the second quarter of 2026 Cash, cash equivalents and short-term investments of approximately $98 million as of December 31, 2025 expected to provide runway into 2028 WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) (“Avalo”), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and year-end financial results for 2025. “2025 was a year of disciplined execution focused on the LOTUS trial, and we are thrilled to be approaching a transformational milestone with our topline data release expected in the second quarter of 2026,” said Dr. Garry Neil, Chief Executive Officer. “We look forward to sharing the results which have the potential to demonstrate abdakibart’s (AVTX-009) high affinity inhibition of IL-1β and positive impact on addressing the large unmet need of patients living with hidradenitis suppurativa.” Upcoming Anticipated Milestone: Abdakibart (AVTX-009) Phase 2 LOTUS trial: The global study which includes approximately 250 adults with hidradenitis suppurativa (HS) is designed to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in the second quarter of 2026. 2025 Financial Update: Cash, cash equivalents and short-term investments were $98.3 million as of December 31, 2025. Net cash used in operating activities was $51.5 million for the year ended December 31, 2025. Avalo’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $50.1 million for the year ended December 31, 2025, an increase of $25.6 million from the year ended December 31, 2024, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $22.9 million for the year ended December 31, 2025, an increase of $5.7 million from the year ended December 31, 2024, primarily driven by stock-based compensation expense and headcount additions. Net loss was $78.3 million for the year ended December 31, 2025, as compared to net loss of $35.1 million for the year ended December 31, 2024. The difference was driven by $38.7 m…Read full documentShow less
Topline data expected from Phase 2 LOTUS trial of abdakibart (AVTX-009) for the treatment of hidradenitis suppurativa in the second quarter of 2026 Cash, cash equivalents and short-term investments of approximately $98 million as of December 31, 2025 expected to provide runway into 2028 WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) (“Avalo”), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and year-end financial results for 2025. “2025 was a year of disciplined execution focused on the LOTUS trial, and we are thrilled to be approaching a transformational milestone with our topline data release expected in the second quarter of 2026,” said Dr. Garry Neil, Chief Executive Officer. “We look forward to sharing the results which have the potential to demonstrate abdakibart’s (AVTX-009) high affinity inhibition of IL-1β and positive impact on addressing the large unmet need of patients living with hidradenitis suppurativa.” Upcoming Anticipated Milestone: Abdakibart (AVTX-009) Phase 2 LOTUS trial: The global study which includes approximately 250 adults with hidradenitis suppurativa (HS) is designed to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in the second quarter of 2026. 2025 Financial Update: Cash, cash equivalents and short-term investments were $98.3 million as of December 31, 2025. Net cash used in operating activities was $51.5 million for the year ended December 31, 2025. Avalo’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $50.1 million for the year ended December 31, 2025, an increase of $25.6 million from the year ended December 31, 2024, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $22.9 million for the year ended December 31, 2025, an increase of $5.7 million from the year ended December 31, 2024, primarily driven by stock-based compensation expense and headcount additions. Net loss was $78.3 million for the year ended December 31, 2025, as compared to net loss of $35.1 million for the year ended December 31, 2024. The difference was driven by $38.7 million change in other (expenses) income from the prior period primarily related to the warrants issued in the March 2024 private placement, all of which were fully exercised in 2024. Operating expenses increased by $4.0 million mainly due to a $25.6 million increase in research and development expenses, as discussed above, and $5.7 million increase in general and administrative expenses, as discussed above, largely offset by $27.6 million of in-process research and development recognized in 2024 that did not repeat. Basic and diluted net loss per share was $5.84 for the year-ended December 31, 2025 compared to basic net loss per share of $7.94, based on 13,404,830 weighted average common shares outstanding and 4,426,149 weighted average basic common shares outstanding, respectively. Diluted net loss per share for the year ended December 31, 2024 was $20.91, based on 7,496,389 weighted average diluted common shares outstanding. Consolidated Balance Sheets (In thousands, except share and per share data) The consolidated balance sheets as of December 31, 2025 and 2024 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements. Consolidated Statements of Operations (In thousands, except per share data) The consolidated statements of operations for the year ended December 31, 2025 and 2024 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. 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 (AVTX-009), is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com. About Abdakibart (AVTX-009) Abdakibart (AVTX-009) 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 About the LOTUS Trial The LOTUS trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two abdakibart (AVTX-009) dose regimens to evaluate the efficacy, safety and tolerability of abdakibart (AVTX-009) in approximately 250 adults with moderate to severe hidradenitis suppurativa. Subjects were randomized (1:1:1) to receive either one of two dosing regimens of abdakibart (AVTX-009) or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count, and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). For additional information this trial (NCT06603077), please visit www.clinicaltrials.gov or www.lotustrial.com. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic, progressive, often debilitating inflammatory skin disease that causes painful nodules, abscesses, and tunnels to form under the skin.4-6,8 Areas commonly affected by HS include the nape of the neck, breasts, chest, armpits, abdomen, buttocks and anus, groin and genitals, and inner thighs.7 If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.4-6,9 HS typically first presents in late adolescence or early adulthood and is estimated to affect 0.7–1.2% of the U.S. population, though some sources suggest the prevalence may be as high as 2–4%.10,11,12 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. 4Diaz MJ, et al. Curr Iss Mol Bio. 2023;45:4400-4415. 5Agnese ER, et al. Cureus. 2023;15(11):e49390. 6de Oliveira ASLE, et al. Biomolecules. 2022;12(10):1371. 7Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-160. 8Sabat R, et al. The Lancet. 2025;405(10476):P420-438. 9Jemec GB. Clinicalpractice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–164. 10Garg A, Kirby JS, Lavian J, Lin G, Strunk A. Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States. JAMA Dermatol. 2017;153(8):760–764. doi:10.1001/jamadermatol.2017.0201. 11Ingram, John R.British Journal of Dermatology. doi:10.1111/bjd.19435. 12Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61. Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Forward-looking statements are statements that are not historical facts. These statements are based on various assumptions, whether or not identified in this press release, and are the current expectations of Avalo’s management and are not predictions of actual performance. 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 Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s 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) that predict or indicate future trends or events. These forward-looking statements include, without limitation, statements regarding Avalo’s expectations regarding its growth, strategy, progress and timing of its clinical trials for abdakibart (AVTX-009) and any other future product candidates, the design and conduct of the Phase 2 LOTUS trial, including expected timelines for clinical data readouts, and Avalo’s beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, including statements regarding anticipated operating expenses, Avalo’s cash runway and sufficiency of its cash and cash equivalents to fund its operations. These forward-looking statements are subject to a number of risks and uncertainties, such as: changes in domestic and foreign business, market, financial, political, and legal conditions;, or by discussions of future matters such as: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. In addition, forward-looking statements reflect Avalo’s expectations, plans, or forecasts of future events and views as of the date of this press release and are qualified in their entirety by reference to the cautionary statements herein. Avalo anticipates that subsequent events and developments will cause Avalo’s assessments to change. These forward-looking statements should not be relied upon as any guarantee, assurance, prediction or definitive statement of fact or probability or as representing Avalo’s assessments as of any date subsequent to the date of this press release. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] 410-803-6793 Meru Advisors Lauren Glaser [email protected]
Investor releaseQuarter not tagged2025-11-06Avalo Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business Updates
GlobeNewswire
Avalo Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business Updates
Completed enrollment in Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa; topline data expected mid-2026 Appointed Kevin Lind to Board of Directors Expanded leadership team with key appointments in business development and human resources Cash and short-term investments of approximately $112 million as of September 30, 2025 expected to provide runway into 2028 WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- 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 business updates and financial results for the third quarter of 2025. “Now that enrollment is complete, we’re fully focused on completing the LOTUS trial, preparing for the data readout in mid-2026, and progressing our Phase 3 planning,” said Dr. Garry Neil, Chief Executive Officer. “This marks an important transition for Avalo as we turn our focus from enrollment to completion of the trial, guided by strong conviction in AVTX-009’s high-affinity inhibition of IL-1β and its potential to deliver meaningful benefit for people living with hidradenitis suppurativa.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Announced completion of enrollment of the Phase 2 LOTUS trial. The global trial includes approximately 250 adults with moderate to severe hidradenitis suppurativa to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in mid-2026. Appointed Kevin Lind to the Board of Directors. Mr. Lind brings extensive leadership experience spanning financial and corporate strategy as well as business development execution at development-stage biotech companies. Expanded leadership team with the appointment of Taylor Boyd as Chief Business Officer and Ashley Ivanowicz as Senior Vice President, Human Resources. Third Quarter 2025 Financial Update: Cash, cash equivalents and short-term investments were $111.6 million as of September 30, 2025. Net cash used in operating activities was $37.2 million for the nine months ended September 30, 2025. The Company’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $13.6 million for the third quarter of 2025, an increase of $4.1 mi…Read full documentShow less
Completed enrollment in Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa; topline data expected mid-2026 Appointed Kevin Lind to Board of Directors Expanded leadership team with key appointments in business development and human resources Cash and short-term investments of approximately $112 million as of September 30, 2025 expected to provide runway into 2028 WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- 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 business updates and financial results for the third quarter of 2025. “Now that enrollment is complete, we’re fully focused on completing the LOTUS trial, preparing for the data readout in mid-2026, and progressing our Phase 3 planning,” said Dr. Garry Neil, Chief Executive Officer. “This marks an important transition for Avalo as we turn our focus from enrollment to completion of the trial, guided by strong conviction in AVTX-009’s high-affinity inhibition of IL-1β and its potential to deliver meaningful benefit for people living with hidradenitis suppurativa.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Announced completion of enrollment of the Phase 2 LOTUS trial. The global trial includes approximately 250 adults with moderate to severe hidradenitis suppurativa to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in mid-2026. Appointed Kevin Lind to the Board of Directors. Mr. Lind brings extensive leadership experience spanning financial and corporate strategy as well as business development execution at development-stage biotech companies. Expanded leadership team with the appointment of Taylor Boyd as Chief Business Officer and Ashley Ivanowicz as Senior Vice President, Human Resources. Third Quarter 2025 Financial Update: Cash, cash equivalents and short-term investments were $111.6 million as of September 30, 2025. Net cash used in operating activities was $37.2 million for the nine months ended September 30, 2025. The Company’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $13.6 million for the third quarter of 2025, an increase of $4.1 million from the third quarter of 2024, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $5.6 million for the third quarter of 2025, an increase of $1.3 million from the third quarter of 2024, primarily driven by stock-based compensation expense. Net loss was $30.6 million for the third quarter of 2025, as compared to net income of $23.0 million for the third quarter of 2024. The difference was driven by a $47.3 million change in other expenses from the prior period primarily related to the warrants issued in the March 2024 private placement, all of which were fully exercised in 2024. Additionally, research and development expenses increased $4.1 million, as discussed above. Basic and diluted net loss per share was $2.19 for the third quarter of 2025 compared to basic net income per share of $0.98 for the third quarter of 2024, based on 14,000,451 weighted average common shares outstanding and 5,546,257 weighted average basic common shares outstanding, respectively. Diluted net loss per share for the third quarter of 2024 was $2.83, based on 10,784,037 weighted average diluted common shares outstanding. Consolidated Balance Sheets (In thousands, except share and per share data) The consolidated balance sheets as of September 30, 2025 and December 31, 2024 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. Consolidated Statements of Operations (In thousands, except per share data) The unaudited consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. 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, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com. About AVTX-009 AVTX-009 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 About the LOTUS Trial The LOTUS trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy, safety and tolerability of AVTX-009 in approximately 250 adults with moderate to severe hidradenitis suppurativa. Subjects were randomized (1:1:1) to receive either one of two dosing regimens of AVTX-009 or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count, and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). For additional information this trial (NCT06603077), please visit www.clinicaltrials.gov or www.lotustrial.com. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic, progressive, often debilitating inflammatory skin disease that causes painful nodules, abscesses, and tunnels to form under the skin.4-6,8 Areas commonly affected by HS include the nape of the neck, breasts, chest, armpits, abdomen, buttocks and anus, groin and genitals, and inner thighs.7 If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.4-6,9 HS typically first presents in late adolescence or early adulthood and is estimated to affect 0.7–1.2% of the U.S. population, though some sources suggest the prevalence may be as high as 2–4%.10,11,12 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. 4Diaz MJ, et al. Curr Iss Mol Bio. 2023;45:4400-4415. 5Agnese ER, et al. Cureus. 2023;15(11):e49390. 6de Oliveira ASLE, et al. Biomolecules. 2022;12(10):1371. 7Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-160. 8Sabat R, et al. The Lancet. 2025;405(10476):P420-438. 9Jemec GB. Clinicalpractice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–164. 10Garg A, Kirby JS, Lavian J, Lin G, Strunk A. Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States. JAMA Dermatol. 2017;153(8):760–764. doi:10.1001/jamadermatol.2017.0201. 11Ingram, John R.British Journal of Dermatology. doi:10.1111/bjd.19435. 12Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61. Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. 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 Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s 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: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; 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 Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] 410-803-6793 Meru Advisors Lauren Glaser [email protected]
Investor releaseQuarter not tagged2025-08-07Avalo Reports Second Quarter 2025 Financial Results and Recent Business Updates
GlobeNewswire
Avalo Reports Second Quarter 2025 Financial Results and Recent Business Updates
Topline data from Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa expected mid-2026 Rita Jain, M.D. appointed to Board of Directors Cash and short-term investments of approximately $113 million as of June 30, 2025 expected to provide runway into 2028 WAYNE, Pa., Aug. 07, 2025 (GLOBE NEWSWIRE) -- 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 business updates and financial results for the second quarter of 2025. “The team has made tremendous progress on the execution of the Phase 2 LOTUS trial in hidradenitis suppurativa (HS). We have enrolled over three-quarters of the planned patients and are on track to complete enrollment by year end with top-line results expected mid-2026,” said Dr. Garry Neil, Chief Executive Officer. “We are focused on executing the LOTUS trial and advancing toward Phase 3 readiness.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Phase 2 LOTUS trial: The global study design includes approximately 222 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in mid-2026. Appointed Rita Jain, M.D. to the Board of Directors. Dr. Jain brings extensive experience spanning clinical development, regulatory strategy, and executive leadership at development-stage biopharma companies. Second Quarter 2025 Financial Update: Cash, cash equivalents and short-term investments were $113.3 million as of June 30, 2025. Net cash used in operating activities was $20.8 million for the six months ended June 30, 2025. The Company’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $14.1 million for the second quarter of 2025, an increase of $9.5 million from the second quarter of 2024, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $5.2 million for the second quarter of 2025, an increase of $0.7 million from the second quarter of 2024, primarily driven by stock-based compensation expense. Net loss was $20.8 million for the second quarter of 2025, as compared to net income of $98.5 million for the second quarter of 2024. The differe…Read full documentShow less
Topline data from Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa expected mid-2026 Rita Jain, M.D. appointed to Board of Directors Cash and short-term investments of approximately $113 million as of June 30, 2025 expected to provide runway into 2028 WAYNE, Pa., Aug. 07, 2025 (GLOBE NEWSWIRE) -- 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 business updates and financial results for the second quarter of 2025. “The team has made tremendous progress on the execution of the Phase 2 LOTUS trial in hidradenitis suppurativa (HS). We have enrolled over three-quarters of the planned patients and are on track to complete enrollment by year end with top-line results expected mid-2026,” said Dr. Garry Neil, Chief Executive Officer. “We are focused on executing the LOTUS trial and advancing toward Phase 3 readiness.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Phase 2 LOTUS trial: The global study design includes approximately 222 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in mid-2026. Appointed Rita Jain, M.D. to the Board of Directors. Dr. Jain brings extensive experience spanning clinical development, regulatory strategy, and executive leadership at development-stage biopharma companies. Second Quarter 2025 Financial Update: Cash, cash equivalents and short-term investments were $113.3 million as of June 30, 2025. Net cash used in operating activities was $20.8 million for the six months ended June 30, 2025. The Company’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $14.1 million for the second quarter of 2025, an increase of $9.5 million from the second quarter of 2024, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $5.2 million for the second quarter of 2025, an increase of $0.7 million from the second quarter of 2024, primarily driven by stock-based compensation expense. Net loss was $20.8 million for the second quarter of 2025, as compared to net income of $98.5 million for the second quarter of 2024. The difference was driven by a $109.5 million change in other expenses in the prior period primarily related to the warrants issued in the March 2024 private placement, all of which were fully exercised in 2024. Additionally, research and development expenses increased $9.5 million, as discussed above. Basic and diluted net loss per share was $1.92 for the second quarter of 2025 compared to basic net income per share of $4.21, based on 10,829,760 weighted average common shares outstanding and 1,034,130 weighted average basic common shares outstanding, respectively. Diluted net loss per share for the second quarter of 2024 was $14.07, based on 7,653,302 weighted average diluted common shares outstanding. Consolidated Balance Sheets (In thousands, except share and per share data) The consolidated balance sheets as of June 30, 2025 and December 31, 2024 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements. Consolidated Statements of Operations (In thousands, except per share data) The unaudited consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. 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, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com. About AVTX-009 AVTX-009 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 About the LOTUS Trial The LOTUS trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy, safety and tolerability of AVTX-009 in approximately 222 adults with moderate to severe hidradenitis suppurativa. Subjects will be randomized (1:1:1) to receive either one of two dosing regimens of AVTX-009 or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count, and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). For additional information this trial (NCT06603077), please visit www.clinicaltrials.gov or www.lotustrial.com. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic, progressive, often debilitating inflammatory skin disease that causes painful nodules, abscesses, and tunnels to form under the skin.4-6,8 Areas commonly affected by HS include the nape of the neck, breasts, chest, armpits, abdomen, buttocks and anus, groin and genitals, and inner thighs.7 If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.4-6,9 HS typically first presents in late adolescence or early adulthood and is estimated to affect 0.7–1.2% of the U.S. population, though some sources suggest the prevalence may be as high as 2–4%.10,11,12 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. 4Diaz MJ, et al. Curr Iss Mol Bio. 2023;45:4400-4415. 5Agnese ER, et al. Cureus. 2023;15(11):e49390. 6de Oliveira ASLE, et al. Biomolecules. 2022;12(10):1371. 7Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-160. 8Sabat R, et al. The Lancet. 2025;405(10476):P420-438. 9Jemec GB. Clinicalpractice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–164. 10Garg A, Kirby JS, Lavian J, Lin G, Strunk A. Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States. JAMA Dermatol. 2017;153(8):760–764. doi:10.1001/jamadermatol.2017.0201. 11Ingram, John R.British Journal of Dermatology. doi:10.1111/bjd.19435. 12Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61. Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. 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 Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s 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: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; 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 Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] 410-803-6793 Meru Advisors Lauren Glaser [email protected]
Investor releaseQuarter not tagged2025-03-20Avalo Reports 2024 Financial Results and Recent Business Updates
GlobeNewswire
Avalo Reports 2024 Financial Results and Recent Business Updates
Topline data from Phase 2 LOTUS Trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026 Appointed Jennifer Riley as Chief Strategy Officer Cash on hand of approximately $135 million as of December 31, 2024 expected to provide runway into at least 2027 WAYNE, Pa. and ROCKVILLE, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced business updates and year-end financial results for 2024. “2024 was a transformational year for Avalo, and I am proud of the accomplishments the team has made in a short amount of time,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “In March 2024, we acquired AVTX-009, a promising monoclonal antibody targeting interleukin-1β. We filed our IND application with the FDA, designed and launched the Phase 2 LOTUS trial in hidradenitis suppurativa (“HS”) and rapidly progressed its initiation, including IND activation in July and enrollment of the first patient in October. Our primary focus in 2025 is executing the LOTUS trial to release data in 2026, while exploring broader applications for AVTX-009 and announcing a second indication.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Initiation of Phase 2 LOTUS trial: The global study design includes approximately 180 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data is expected in 2026. Second Indication Exploration: Avalo continues to evaluate AVTX-009 for additional immune-mediated diseases with plans to announce a second indication. Appointment of Jennifer Riley as Chief Strategy Officer: Effective January 1, 2025, Ms. Riley is guiding strategy and pipeline planning for HS and other inflammatory market opportunities. 2024 Financial Update: Cash and cash equivalents were $134.5 million as of December 31, 2024, supported by $185 million in gross proceeds received from a private placement in 2024. Net cash used in operating activities was $49.1 million for the year ended December 31, 2024, which includes $12.5 million of milestone payments to former shareholders of AlmataBio, Inc. pursuant to the terms of the acquisition. The Company’s current cash on hand is expected to fund operations i…Read full documentShow less
Topline data from Phase 2 LOTUS Trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026 Appointed Jennifer Riley as Chief Strategy Officer Cash on hand of approximately $135 million as of December 31, 2024 expected to provide runway into at least 2027 WAYNE, Pa. and ROCKVILLE, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced business updates and year-end financial results for 2024. “2024 was a transformational year for Avalo, and I am proud of the accomplishments the team has made in a short amount of time,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “In March 2024, we acquired AVTX-009, a promising monoclonal antibody targeting interleukin-1β. We filed our IND application with the FDA, designed and launched the Phase 2 LOTUS trial in hidradenitis suppurativa (“HS”) and rapidly progressed its initiation, including IND activation in July and enrollment of the first patient in October. Our primary focus in 2025 is executing the LOTUS trial to release data in 2026, while exploring broader applications for AVTX-009 and announcing a second indication.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Initiation of Phase 2 LOTUS trial: The global study design includes approximately 180 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data is expected in 2026. Second Indication Exploration: Avalo continues to evaluate AVTX-009 for additional immune-mediated diseases with plans to announce a second indication. Appointment of Jennifer Riley as Chief Strategy Officer: Effective January 1, 2025, Ms. Riley is guiding strategy and pipeline planning for HS and other inflammatory market opportunities. 2024 Financial Update: Cash and cash equivalents were $134.5 million as of December 31, 2024, supported by $185 million in gross proceeds received from a private placement in 2024. Net cash used in operating activities was $49.1 million for the year ended December 31, 2024, which includes $12.5 million of milestone payments to former shareholders of AlmataBio, Inc. pursuant to the terms of the acquisition. The Company’s current cash on hand is expected to fund operations into at least 2027. Research and development expenses were $24.4 million in 2024, an increase of $10.7 million from 2023, driven by costs of the Phase 2 LOTUS trial, which were partially offset by discontinued legacy program expenses from the prior year. General and administrative expenses were $17.2 million in 2024, an increase of $6.9 million from 2023, primarily driven by employee compensation costs, including stock-based compensation expense, as well as increased consulting, legal and other professional expenses following and largely related to the acquisition and financing in the first quarter of 2024. Net loss was $35.1 million for 2024, an increase of $3.6 million from the net loss of $31.5 million in 2023, mainly driven by a $39.7 million increase in operating expenses; this was partially offset by a $37.7 million increase in other income primarily related to the warrants issued as part of the private placement in 2024. The increase in operating expenses was attributable to a $27.6 million acquired in-process research and development charge for the acquisition of AlmataBio, Inc, as well as increases to research and development expenses and the general and administrative expenses as discussed above. Basic net loss per share, based on 4,426,149 weighted average common shares, was $7.94 for 2024 compared to a basic net loss per share of $113.58, based on 227,727 weighted average common shares outstanding, for 2023. Diluted net loss per share, based on 7,496,389 weighted average diluted common shares and which excludes the change in fair value of the warrant liability from diluted net loss, was $20.91 for 2024 compared to $113.58, based on 227,727 weighted average diluted common shares outstanding, for 2023. Consolidated Balance Sheets(In thousands, except share and per share data) The consolidated balance sheets as of December 31, 2024 and 2023 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements. Consolidated Statements of Operations(In thousands, except per share data) The consolidated statements of operations for the year ended December 31, 2024 and 2023 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. For more information about Avalo, please visit www.avalotx.com. About AVTX-009 AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in many autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in hidradenitis suppurativa and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology. About the LOTUS Trial The LOTUS Trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe hidradenitis suppurativa. Subjects will be randomized (1:1:1) to receive either one of two dosing regimens of AVTX-009 or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). The number of patients with anti-drug antibodies, safety, and tolerability will be assessed. For additional information on this trial (NCT06603077), please visit www.clinicaltrials.gov. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, and tunnels that form in areas of the body such as the armpits, groin, and buttocks, severely impacting the quality of life of affected individuals.1 HS is often underdiagnosed or misdiagnosed and therefore estimates of HS vary between 0.2-1.7% of the population worldwide.2-5 The exact cause of HS is not fully understood but is believed to involve a combination of genetic, hormonal, and environmental factors. While advances in treatment have been made, limited treatment options are available. IL-1β plays a crucial role in the inflammatory cascade underlying HS, contributing to tissue damage, inflammation, and disease progression. Given the involvement of IL-1β in the inflammatory process of HS, we believe therapies that target IL-1β offer a potential treatment option for HS. Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. 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 Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s 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: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; integration of AVTX-009 into our operations; 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 Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. References1Patel ZS et al. Curr Pain Headache Rep. 2017;21(12):49.2Egeberg A, et al. JAMA Dermatol 2016;152:429–343Phan K, et al Biomed Dermatol 2020; 4: 2-64Jfri, A, et al. JAMA Dermatol. 2021;157(8):924-315Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61 For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] or Meru AdvisorsLauren [email protected]

