Avalo Reports First Quarter 2025 Financial Results and Recent Business Updates
Avalo Therapeutics (NASDAQ: AVTX) reported its Q1 2025 financial results and business updates. The company ended Q1 with $125 million in cash, providing runway into 2027 with potential extension into 2028. The Phase 2 LOTUS trial for AVTX-009 in hidradenitis suppurativa (HS) is progressing as planned, with topline data expected in 2026.
Q1 2025 financial highlights include: net loss of $13.1 million ($1.25 per share), R&D expenses of $9.1 million (up $7.0M YoY), and G&A expenses of $5.5 million (up $2.4M YoY). The company is carefully evaluating the timing of additional development activities beyond LOTUS trial due to current market conditions.
Avalo Therapeutics (NASDAQ: AVTX) ha comunicato i risultati finanziari e gli aggiornamenti aziendali del primo trimestre 2025. La società ha chiuso il trimestre con 125 milioni di dollari in cassa, garantendo risorse finanziarie fino al 2027, con possibile estensione fino al 2028. La sperimentazione di fase 2 LOTUS per AVTX-009 nell'idrosadenite suppurativa (HS) procede secondo i piani, con dati principali attesi nel 2026.
I principali dati finanziari del primo trimestre 2025 includono una perdita netta di 13,1 milioni di dollari (1,25 dollari per azione), spese di ricerca e sviluppo pari a 9,1 milioni di dollari (in aumento di 7,0 milioni rispetto all'anno precedente) e spese generali e amministrative di 5,5 milioni di dollari (in aumento di 2,4 milioni rispetto all'anno precedente). L'azienda sta valutando con attenzione i tempi per ulteriori attività di sviluppo oltre la sperimentazione LOTUS, in considerazione delle condizioni attuali del mercato.
Avalo Therapeutics (NASDAQ: AVTX) informó sus resultados financieros y actualizaciones comerciales del primer trimestre de 2025. La compañía cerró el trimestre con 125 millones de dólares en efectivo, asegurando recursos hasta 2027, con posible extensión hasta 2028. El ensayo de fase 2 LOTUS para AVTX-009 en hidradenitis supurativa (HS) avanza según lo planeado, con datos principales esperados para 2026.
Los aspectos financieros destacados del primer trimestre de 2025 incluyen una pérdida neta de 13,1 millones de dólares (1,25 dólares por acción), gastos en I+D de 9,1 millones (un aumento de 7,0 millones interanual) y gastos generales y administrativos de 5,5 millones (un aumento de 2,4 millones interanual). La empresa está evaluando cuidadosamente el momento para actividades adicionales de desarrollo más allá del ensayo LOTUS debido a las condiciones actuales del mercado.
Avalo Therapeutics (NASDAQ: AVTX)는 2025년 1분기 재무 결과 및 사업 업데이트를 발표했습니다. 회사는 1분기를 1억 2500만 달러의 현금으로 마감했으며, 2027년까지 운영 자금을 확보했으며 2028년까지 연장 가능성이 있습니다. 농포성한선염(HS) 치료제 AVTX-009의 2상 LOTUS 임상시험은 계획대로 진행 중이며, 주요 결과는 2026년에 발표될 예정입니다.
2025년 1분기 재무 주요 내용은 순손실 1310만 달러(주당 1.25달러), 연구개발비 910만 달러(전년 동기 대비 700만 달러 증가), 일반관리비 550만 달러(전년 동기 대비 240만 달러 증가)를 포함합니다. 회사는 현재 시장 상황을 고려하여 LOTUS 임상시험 외 추가 개발 활동 시기를 신중히 검토하고 있습니다.
Avalo Therapeutics (NASDAQ: AVTX) a publié ses résultats financiers et mises à jour commerciales du premier trimestre 2025. La société a terminé le trimestre avec 125 millions de dollars en trésorerie, assurant une visibilité financière jusqu'en 2027, avec une possible extension jusqu'en 2028. L'essai de phase 2 LOTUS pour AVTX-009 dans l'hidrosadénite suppurée (HS) progresse comme prévu, avec des données principales attendues en 2026.
Les points financiers clés du premier trimestre 2025 incluent une perte nette de 13,1 millions de dollars (1,25 dollar par action), des dépenses en R&D de 9,1 millions de dollars (en hausse de 7,0 millions par rapport à l'année précédente) et des frais généraux et administratifs de 5,5 millions de dollars (en hausse de 2,4 millions par rapport à l'année précédente). L'entreprise évalue avec prudence le calendrier des activités de développement supplémentaires au-delà de l'essai LOTUS en raison des conditions actuelles du marché.
Avalo Therapeutics (NASDAQ: AVTX) veröffentlichte seine Finanzzahlen und Geschäftsupdates für das erste Quartal 2025. Das Unternehmen schloss das erste Quartal mit 125 Millionen US-Dollar in bar ab, was eine Finanzierung bis 2027 sicherstellt, mit möglicher Verlängerung bis 2028. Die Phase-2-LOTUS-Studie für AVTX-009 bei Hidradenitis suppurativa (HS) verläuft planmäßig, mit den wichtigsten Daten, die für 2026 erwartet werden.
Zu den finanziellen Highlights im ersten Quartal 2025 zählen ein Nettoverlust von 13,1 Millionen US-Dollar (1,25 US-Dollar pro Aktie), F&E-Ausgaben von 9,1 Millionen US-Dollar (ein Anstieg von 7,0 Millionen gegenüber dem Vorjahr) und Verwaltungsaufwendungen von 5,5 Millionen US-Dollar (ein Anstieg von 2,4 Millionen gegenüber dem Vorjahr). Das Unternehmen prüft sorgfältig den Zeitpunkt weiterer Entwicklungsaktivitäten über die LOTUS-Studie hinaus aufgrund der aktuellen Marktbedingungen.
- None.
- Increased R&D expenses by $7.0M YoY to $9.1M in Q1 2025
- Higher G&A expenses, up $2.4M YoY to $5.5M in Q1 2025
- Delay in pursuing additional development activities due to market conditions
Insights
Avalo maintains strong $125M cash position with 2-year runway while advancing its Phase 2 hidradenitis suppurativa trial toward 2026 readout.
Avalo's Q1 2025 results demonstrate a solid financial foundation with
The Phase 2 LOTUS trial in hidradenitis suppurativa (HS) is progressing as planned, with site activations, screenings, and enrollment tracking to original projections. This 180-patient study is evaluating bi-weekly and monthly subcutaneous dosing regimens against placebo, with topline data expected in 2026. This timeline puts Avalo in position to potentially enter the growing HS market, currently dominated by biologics with varying efficacy profiles.
Looking at cash burn, Q1 operational cash use was
The appointment of Mike Heffernan as Chairman strengthens Avalo's leadership as they navigate clinical development. With their LOTUS trial advancing well and plans to announce a second indication for AVTX-009, Avalo appears well-positioned to execute their clinical strategy despite challenging market conditions.
- Mike Heffernan appointed as Chairman of the Board
- Topline data from Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026
- Cash on hand of approximately
$125 million as of March 31, 2025 expected to provide runway into 2027, with optionality to extend into 2028
WAYNE, Pa., May 12, 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 financial results for the first quarter of 2025.
“We have made considerable progress in our Phase 2 LOTUS trial in hidradenitis suppurativa (HS) with site activations, screenings and enrollment progress all in line with our original projections as we have begun to meaningfully climb the enrollment curve. As such, we believe we are on track to deliver topline data in 2026 and look forward to demonstrating AVTX-009’s potential as a leading treatment in HS,” said Dr. Garry Neil, Chief Executive Officer. “We are cognizant of current market conditions and are fortunate to have more than sufficient capital to reach our LOTUS trial data readout. Given the current environment, the Company is carefully evaluating the optimal timing for pursuing additional development activities beyond the LOTUS trial, such as the initiation of a second indication, to preserve capital until markets stabilize. Changes to the timing of implementing these secondary development activities could extend cash runway into 2028.”
Recent Corporate Highlights and Upcoming Anticipated Milestones:
- 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.
First Quarter 2025 Financial Update:
- Cash and cash equivalents were
$125.0 million as of March 31, 2025. Net cash used in operating activities was$9.5 million for the first quarter of 2025. The Company’s current cash on hand is expected to fund operations into at least 2027. - Research and development expenses were
$9.1 million for the first quarter of 2025, an increase of$7.0 million from the first quarter of 2024, driven by direct costs and indirect supporting costs of the Phase 2 LOTUS trial. - General and administrative expenses were
$5.5 million for the first quarter of 2025, an increase of$2.4 million from the first quarter of 2024, primarily driven by stock-based compensation expense during the period related to increased equity grants and headcount additions. - Net loss was
$13.1 million for the first quarter of 2025, a decrease of$108.2 million from$121.3 million in the first quarter of 2024. The difference was driven primarily by a$90.0 million decrease in other expenses from the prior period primarily related to the warrants issued as part of the private placement in 2024. Additionally, operating expenses decreased by$18.1 million , which was attributable to a$27.5 million acquired in-process research and development charge for the acquisition of AlmataBio, Inc. in the prior period, partially offset by increased research and development and general and administrative expenses in the first quarter of 2025. Basic and diluted net loss per share, based on 10,514,901 weighted average common shares outstanding, was$1.25 for the first quarter of 2025 compared to$141.14 , based on 859,381 weighted average common shares outstanding for the first quarter of 2024.
| Consolidated Balance Sheets (In thousands, except share and per share data) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 125,046 | $ | 134,546 | ||||
| Prepaid expenses and other current assets | 1,833 | 4,325 | ||||||
| Restricted cash, current portion | 62 | 19 | ||||||
| Total current assets | 126,941 | 138,890 | ||||||
| Property and equipment, net | 949 | 1,209 | ||||||
| Goodwill | 10,502 | 10,502 | ||||||
| Restricted cash, net of current portion | 131 | 131 | ||||||
| Total assets | $ | 138,523 | $ | 150,732 | ||||
| Liabilities, mezzanine equity and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 681 | $ | 283 | ||||
| Accrued expenses and other current liabilities | 4,574 | 6,317 | ||||||
| Derivative liability, current | 360 | 360 | ||||||
| Total current liabilities | 5,615 | 6,960 | ||||||
| Royalty obligation | 2,000 | 2,000 | ||||||
| Deferred tax liability, net | 278 | 270 | ||||||
| Derivative liability, non-current | 7,740 | 8,120 | ||||||
| Other long-term liabilities | 275 | 350 | ||||||
| Total liabilities | 15,908 | 17,700 | ||||||
| Mezzanine equity: | ||||||||
| Series D Preferred Stock— | — | — | ||||||
| Series E Preferred Stock— | — | — | ||||||
| Stockholders’ equity: | ||||||||
| Common stock— | 11 | 10 | ||||||
| Series C Preferred Stock— | — | — | ||||||
| Additional paid-in capital | 506,016 | 503,285 | ||||||
| Accumulated deficit | (383,412 | ) | (370,263 | ) | ||||
| Total stockholders’ equity | 122,615 | 133,032 | ||||||
| Total liabilities, mezzanine equity and stockholders’ equity | $ | 138,523 | $ | 150,732 | ||||
The consolidated balance sheets as of March 31, 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) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Cost of product sales | — | (80 | ) | |||||
| Research and development | 9,123 | 2,116 | ||||||
| General and administrative | 5,546 | 3,193 | ||||||
| Acquired in-process research and development | — | 27,538 | ||||||
| Total operating expenses | 14,669 | 32,767 | ||||||
| Loss from operations | (14,669 | ) | (32,767 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of derivative liability | 380 | (120 | ) | |||||
| Interest income, net | 1,148 | 100 | ||||||
| Excess of initial warrant fair value over private placement proceeds | — | (79,276 | ) | |||||
| Private placement transaction costs | — | (9,220 | ) | |||||
| Total other income (expense), net | 1,528 | (88,516 | ) | |||||
| Loss before taxes | (13,141 | ) | (121,283 | ) | ||||
| Income tax expense | 8 | 7 | ||||||
| Net loss and comprehensive loss | $ | (13,149 | ) | $ | (121,290 | ) | ||
| Weighted average common shares outstanding | 10,514,901 | 859,381 | ||||||
| Net loss per share of common stock, basic and diluted | $ | (1.25 | ) | $ | (141.14 | ) | ||
The unaudited consolidated statements of operations for the three months ended March 31, 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 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, safety and tolerability 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
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
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.
References
1Patel ZS et al. Curr Pain Headache Rep. 2017;21(12):49.
2Egeberg A, et al. JAMA Dermatol 2016;152:429–34
3Phan K, et al Biomed Dermatol 2020; 4: 2-6
4Jfri, A, et al. JAMA Dermatol. 2021;157(8):924-31
5Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61
For media and investor inquiries
Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793
or
Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com
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